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TEST PURPOSES ONLY - Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

If Biktarvy has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

If Biktarvy has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).

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What is in this leaflet

What Biktarvy is and what it is used for

What you need to know before you take Biktarvy

How to take Biktarvy

Possible side effects

How to store Biktarvy

Contents of the pack and other information

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1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for

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1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for

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Biktarvy contains three active substances:

bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)

emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)

tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)

Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, adolescents and children 2 years of age and older, who weigh at least 14 kg.

Biktarvy reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.

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2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Do not take Biktarvy

If you are allergic to bictegravir, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).

If you are currently taking any of the following medicines:

rifampicin used to treat some bacterial infections such as tuberculosis

St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.

If any of these apply to you, do not take Biktarvy and tell your doctor immediately.

Warnings and precautions

Talk to your doctor before taking Biktarvy:

If you have liver problems or a history of liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B infection. Liver problems may become worse after you stop taking Biktarvy

Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. For more details, see section 3, Do not stop taking Biktarvy.

If you have had kidney disease or if tests have shown problems with your kidneys. Your doctor may order blood tests to monitor how your kidneys work when starting and during treatment with Biktarvy.

While you are taking Biktarvy

Once you start taking Biktarvy, look out for:

Signs of inflammation or infection

Joint pain, stiffness or bone problems

If you notice any of these symptoms, tell your doctor immediately. For more information see section 4, Possible side effects.

There is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time (see Warnings and precautions).

This medicine is not a cure for HIV infection. While taking Biktarvy you may still develop infections or other illnesses associated with HIV infection.

Children and adolescents

Do not give this medicine to children under 2 years of age, or weighing less than 14 kg regardless of age. The use of Biktarvy in children under 2 years of age, or weighing less than 14 kg has not yet been studied. For children and adolescents who weigh 25 kg or more, Biktarvy 50 mg/200 mg/25 mg film-coated tablets are available.

Loss of bone mass has been reported in some children from 3 to less than 12 years of age who received one of the medicinal products (tenofovir alafenamide) contained in Biktarvy. The effects on long term bone health and future fracture risk in children is uncertain. Your doctor will monitor your child’s bone health as needed.

Other medicines and Biktarvy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Biktarvy may interact with other medicines. As a result, the amounts of Biktarvy or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.

Medicines that must never be taken with Biktarvy:

rifampicin used to treat some bacterial infections such as tuberculosis

St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.

If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.

Talk to your doctor if you are taking:

medicines used for treating HIV and/or hepatitis B, containing:

adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil

antibiotics used to treat bacterial infections, containing:

azithromycin, clarithromycin, rifabutin or rifapentine

anticonvulsants used to treat epilepsy, containing:

carbamazepine, oxcarbazepine, phenobarbital or phenytoin

immunosuppressants used to control your body’s immune response after a transplant, containing ciclosporin

ulcer-healing medicines containing sucralfate

Tell your doctor if you are taking any of these medicines. Do not stop your treatment without contacting your doctor.

Get advice from a doctor or pharmacist if you are taking:

antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide

mineral supplements or vitamins containing magnesium or iron

Get advice from your doctor or pharmacist before taking Biktarvy if you are taking any of these medicines.

Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before antacids or supplements containing aluminium and/or magnesium. Or you can take Biktarvy with food at least 2 hours after.

Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you can take them together with food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor immediately if you become pregnant and ask about the potential benefits and risks of your antiretroviral therapy to you and your child.

If you have taken Biktarvy during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Do not breast-feed during treatment with Biktarvy. This is because some of the active substances in this medicine pass into human breast milk. Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Biktarvy can cause dizziness. If you feel dizzy when taking Biktarvy, do not drive or ride a bicycle and do not use any tools or machines.

Biktarvy contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

There are two strengths of Biktarvy tablets. Your doctor will prescribe the appropriate tablet for your age and weight.

The recommended dose is:

Children 2 years of age and older, who weigh at least 14 kg but less than 25 kg: one tablet each day with or without food (one 30 mg/120 mg/15 mg tablet).

Due to the bitter taste, it is recommended not to chew or crush the tablet. If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet.

The score line on the tablet is only there to help you break the tablet if your child has difficulty swallowing it whole.

The 90-day multipack contains three 30-day packs together.

Get advice from a doctor or pharmacist if you are taking:

antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide

mineral supplements or vitamins containing magnesium or iron

See section 2 for more information on taking these medicines with Biktarvy.

If you are on dialysis, take your daily dose of Biktarvy following completion of dialysis.

If you take more Biktarvy than you should

If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet bottle or carton with you so that you can easily describe what you have taken.

If you forget to take Biktarvy

It is important not to miss a dose of Biktarvy.

If you miss a dose:

If you notice within 18 hours of the time you usually take Biktarvy, you must take the tablet as soon as possible. Then take the next dose as usual.

If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the missed dose. Wait and take the next dose at your usual time.

If you vomit less than 1 hour after taking Biktarvy, take another tablet. If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.

Do not stop taking Biktarvy

Do not stop taking Biktarvy without talking to your doctor. Stopping Biktarvy can seriously affect how future treatment works. If Biktarvy is stopped for any reason, speak to your doctor before you restart taking Biktarvy tablets.

When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The disease may then become harder to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop your Biktarvy treatment without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.

Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects: tell a doctor immediately

Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:

muscle weakness

weakness beginning in the hands and feet and moving up towards the trunk of the body

palpitations, tremor or hyperactivity

If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.

Common side effects (may affect up to 1 in 10 people)

depression

abnormal dreams

headache

dizziness

diarrhoea

feeling sick (nausea)

tiredness (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people)

anaemia

vomiting

stomach pain

problems with digestion resulting in discomfort after meals (dyspepsia)

wind (flatulence)

swelling of the face, lips, tongue or throat (angioedema)

itching (pruritus)

rash

hives (urticaria)

joint pain (arthralgia)

suicidal thoughts and suicide attempt (particularly in patients who have had depression or mental health problems before)

anxiety

sleep disorders Blood tests may also show:

higher levels of substances called bilirubin and/or serum creatinine in the blood

Rare side effects

(may affect up to 1 in 1000 people)

Stevens-Johnson syndrome (SJS) is a serious life-threatening condition which usually starts with flu- like symptoms. A few days later other symptoms appear including:

Painful red or purple skin that looks burned and peels off

Blisters on your skin, mouth, nose, and genitals

Red, painful, watery eyes

If you have any of these symptoms, stop your medicine immediately and tell your doctor straight away.

If any of the side effects get serious, tell your doctor.

Other effects that may be seen during HIV treatment

The frequency of the following side effects is not known (frequency cannot be estimated from the available data).

Bone problems. Some patients taking combination antiretroviral medicines such as Biktarvy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:

joint stiffness

joint aches and pains (especially of the hip, knee and shoulder)

difficulty with movement

If you notice any of these symptoms tell your doctor.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle or blister strips after {EXP}. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use if the seal over the bottle opening is broken or missing.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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What Biktarvy contains

The active substances are bictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet contains bictegravir sodium equivalent to 30 mg of bictegravir, 120 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 15 mg of tenofovir alafenamide.

The other ingredients are Tablet coreMicrocrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b).

Film-coatingPolyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172).

What Biktarvy looks like and contents of the pack

Biktarvy 30 mg/120 mg/15 mg film-coated tablets are pink, capsule-shaped, film-coated tablets, debossed with “BVY” on one side and a score line on the other side of the tablet.

The tablets are supplied in a bottle. Not all pack sizes may be marketed.

Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

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Carrigtohill, County Cork, T45 County Cork IR

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30

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Medicinal product subject to medical prescription

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

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TEST PURPOSES ONLY - Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Leia com atenção todo este folheto antes de começar a tomar este medicamento, pois contém informação importante para si.

Conserve este folheto. Pode ter necessidade de o ler novamente.

Caso ainda tenha dúvidas, fale com o seu médico ou farmacêutico.

Este medicamento foi receitado apenas para si. Não deve dá-lo a outros. O medicamento pode ser-lhes prejudicial mesmo que apresentem os mesmos sinais de doença.

Se tiver quaisquer efeitos indesejáveis, incluindo possíveis efeitos indesejáveis não indicados neste folheto, fale com o seu médico ou farmacêutico. Ver secção 4.

Se Biktarvy foi prescrito para a criança a seu cargo, tenha em atenção que todas as informações neste folheto são dirigidas à criança a seu cargo (neste caso, leia “a criança a seu cargo” em vez de “você”).

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O que contém este folheto:

O que é Biktarvy e para que é utilizado

O que precisa de saber antes de tomar Biktarvy

Como tomar Biktarvy

Efeitos indesejáveis possíveis

Como conservar Biktarvy

Conteúdo da embalagem e outras informações

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1. What Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película is and what it is used for

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1. What Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película is and what it is used for

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Biktarvy contém três substâncias ativas:

bictegravir, um tipo de medicamento antirretrovírico conhecido como inibidor da transferência de cadeia da integrase (ITI)

emtricitabina, um tipo de medicamento antirretrovírico conhecido como inibidor nucleósido da transcriptase reversa (INTR)

tenofovir alafenamida, um tipo de medicamento antirretrovírico conhecido como inibidor nucleotídeo da transcriptase reversa (INtTR)

Biktarvy é um comprimido único para o tratamento da infeção pelo vírus da imunodeficiência humana 1 (VIH-1) em adultos, adolescentes e crianças com idade igual ou superior a 2 anos, que pesem pelo menos 14 kg.

Biktarvy diminui a quantidade de VIH no seu corpo. Isto irá melhorar o seu sistema imunológico e diminuir o risco de desenvolvimento de doenças ligadas à infeção pelo VIH.

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2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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Não tome Biktarvy

Se tem alergia ao bictegravir, emtricitabina, tenofovir alafenamida ou a qualquer outro componente deste medicamento (indicados na secção 6).

Se estiver atualmente a tomar algum dos seguintes medicamentos:

rifampicina utilizada para tratar algumas infeções causadas por bactérias, como a tuberculose

hipericão (Hypericum perforatum), um produto à base de plantas para tratar a depressão e ansiedade ou produtos que o contenham.

Se qualquer uma destas situações se aplicar a si, não tome Biktarvy e informe imediatamente o seu médico.

Advertências e precauções

Fale com o seu médico antes de tomar Biktarvy:

Se tem problemas do fígado ou antecedentes de doença do fígado, incluindo hepatite. Os doentes com doença do fígado, incluindo hepatite B ou C crónica, que estejam a ser tratados com antirretrovíricos, apresentam um risco superior de complicações ao nível do fígado graves e potencialmente fatais. Se tem infeção pelo vírus da hepatite B, o seu médico irá considerar cuidadosamente o melhor regime de tratamento para si.

Se tem infeção pelo vírus da hepatite B. Os problemas do fígado podem piorar depois de parar de tomar Biktarvy.

Não pare de tomar Biktarvy se tiver hepatite B. Fale primeiro com o seu médico. Para obter mais informação, consulte a secção 3, Não pare de tomar Biktarvy.

Se teve doença renal ou se as análises revelaram problemas nos seus rins. O seu médico pode pedir-lhe para efetuar análises ao sangue para monitorizar o funcionamento dos seus rins no início e durante o tratamento com Biktarvy.

Enquanto estiver a tomar Biktarvy

Assim que começar a tomar Biktarvy, fique atento a:

Sinais de inflamação ou infeção

Dores nas articulações, rigidez ou problemas nos ossos

Se observar quaisquer destes sintomas, informe o seu médico imediatamente. Para obter mais informação, consulte a secção 4, Efeitos indesejáveis possíveis.

Existe a possibilidade de vir a ter problemas nos rins se tomar Biktarvy durante um longo período de tempo (ver Advertências e precauções).

Este medicamento não é uma cura para a infeção pelo VIH. Enquanto tomar Biktarvy pode desenvolver na mesma infeções ou outras doenças associadas com a infeção pelo VIH.

Crianças e adolescentes

Não dê este medicamento a crianças com menos de 2 anos de idade, ou que pesem menos de 14 kg independentemente da idade. A utilização de Biktarvy em crianças com menos de 2 anos de idade ou que pesem menos de 14 kg ainda não foi estudada. Para crianças e adolescentes que pesem 25 kg ou mais, estão disponíveis comprimidos revestidos por película de Biktarvy 50 mg/200 mg/25 mg.

Foi notificada perda de massa óssea em algumas crianças com idade entre 3 e menos de 12 anos que receberam um dos medicamentos (tenofovir alafenamida) contido em Biktarvy. Os efeitos na saúde óssea a longo prazo e o risco futuro de fratura em crianças é incerto. O seu médico monitorizará a saúde óssea do seu filho conforme necessário.

Outros medicamentos e Biktarvy

Informe o seu médico ou farmacêutico se estiver a tomar, tiver tomado recentemente, ou se vier a tomar outros medicamentos. Biktarvy pode interferir com outros medicamentos. Como resultado, as quantidades de Biktarvy ou dos outros medicamentos no seu sangue podem alterar-se. Isto pode fazer com que os seus medicamentos parem de funcionar corretamente ou piorar quaisquer efeitos indesejáveis. Em alguns casos, o seu médico pode precisar de ajustar a sua dose ou verificar os níveis dos medicamentos no seu sangue.

Medicamentos que nunca podem ser tomados com Biktarvy:

rifampicina utilizada para tratar algumas infeções causadas por bactérias, como a tuberculose

hipericão (Hypericum perforatum), um produto à base de plantas para tratar a depressão e ansiedade ou produtos que o contenham.

Se estiver a tomar qualquer um destes medicamentos, não tome Biktarvy e informe o seu médico imediatamente.

Fale com o seu médico se estiver a tomar:

medicamentos utilizados para tratar o VIH e/ou a hepatite B que contenham:

adefovir dipivoxil, atazanavir, bictegravir, emtricitabina, lamivudina, tenofovir alafenamida ou tenofovir disoproxil

antibióticos utilizados para tratar infeções causadas por bactérias contendo:

azitromicina, claritromicina, rifabutina ou rifapentina

anticonvulsivantes utilizados para tratar a epilepsia, contendo:

carbamazepina, oxcarbazepina, fenobarbital ou fenitoína

imunossupressores utilizados para controlar a resposta imunitária do seu corpo após um transplante, contendo ciclosporina

medicamentos para as úlceras do aparelho digestivo contendo sucralfato

Informe o seu médico se estiver a tomar qualquer um destes medicamentos. Não pare o seu tratamento sem contactar o seu médico.

Consulte um médico ou farmacêutico se estiver a tomar:

antiácidos para tratar úlceras do estômago, azia ou refluxo ácido, contendo alumínio e/ou hidróxido de magnésio

suplementos minerais ou vitaminas contendo magnésio ou ferro

Consulte o seu médico ou farmacêutico antes de tomar Biktarvy se estiver a tomar algum destes medicamentos.

Antiácidos e suplementos de magnésio: terá de tomar Biktarvy, pelo menos, 2 horas antes de tomar antiácidos ou suplementos contendo alumínio e/ou magnésio. Ou pode tomar Biktarvy com alimentos, pelo menos, 2 horas depois.

Suplementos de ferro: terá de tomar Biktarvy, pelo menos, 2 horas antes de tomar suplementos de ferro ou pode tomá-los juntamente com alimentos.

Gravidez e amamentação

Se está grávida ou a amamentar, se pensa estar grávida ou planeia engravidar, consulte o seu médico ou farmacêutico antes de tomar este medicamento.

Se engravidar, informe imediatamente o seu médico e pergunte quais são os potenciais benefícios e riscos da sua terapêutica antirretroviral para si e para o bebé.

Se tomou Biktarvy durante a gravidez, o seu médico pode pedir-lhe para efetuar análises ao sangue e outros testes de diagnóstico regulares para verificar o desenvolvimento da sua criança. Nas crianças cujas mães tomaram inibidores nucleósidos da transcriptase reversa (INTR) durante a gravidez, o benefício da menor possibilidade de infeção pelo VIH é superior ao risco de sofrerem efeitos indesejáveis.

Não amamente durante o tratamento com Biktarvy. Isto deve-se ao facto de algumas das substâncias ativas deste medicamento serem excretadas no leite humano. A amamentação não é recomendada em mulheres que vivem com VIH, uma vez que a infeção pelo VIH pode ser transmitida ao bebé através do leite materno. Se estiver a amamentar ou planeia vir a amamentar, deve falar com o seu médico o mais rapidamente possível.

Condução de veículos e utilização de máquinas

Biktarvy pode causar tonturas. Se sentir tonturas enquanto estiver a tomar Biktarvy, não conduza nem ande de bicicleta e não utilize quaisquer ferramentas ou máquinas.

Biktarvy contém sódio

Este medicamento contém menos do que 1 mmol (23 mg) de sódio por comprimido, ou seja, é praticamente “isento de sódio”.

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3. How to take Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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3. How to take Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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Tome este medicamento exatamente como indicado pelo seu médico. Fale com o seu médico ou farmacêutico se tiver dúvidas.

Existem duas dosagens de comprimidos de Biktarvy. O seu médico irá prescrever o comprimido apropriado para a sua idade e peso.

A dose recomendada é:

Crianças com idade igual ou superior a 2 anos, que pesem pelo menos 14 kg, mas menos de 25 kg: um comprimido por dia com ou sem alimentos (um comprimido de 30 mg/120 mg/15 mg).

Devido ao sabor amargo, recomenda-se que não mastigue ou esmague o comprimido. Se tiver dificuldade em engolir o comprimido inteiro pode dividi-lo ao meio. Tome ambas as metades do comprimido uma a seguir à outra para obter a dose total. Não guarde o comprimido dividido.

A ranhura no comprimido existe apenas para ajudá-lo a partir o comprimido se a criança a seu cargo tiver dificuldade em engoli-lo inteiro. A embalagem múltipla de 90 dias contém um conjunto de três embalagens de 30 dias.

Consulte um médico ou farmacêutico se estiver a tomar:

antiácidos para tratar úlceras do estômago, azia ou refluxo ácido, contendo alumínio e/ou hidróxido de magnésio

suplementos minerais ou vitaminas contendo magnésio ou ferro

Consulte a secção 2 para obter mais informação sobre como tomar estes medicamentos com Biktarvy.

Se estiver a fazer diálise, tome a sua dose diária de Biktarvy após terminar a diálise.

Se tomar mais Biktarvy do que deveria

Se tomar mais do que a dose recomendada de Biktarvy pode ter um maior risco de efeitos indesejáveis com este medicamento (ver secção 4, Efeitos indesejáveis possíveis).

Entre imediatamente em contacto com o seu médico ou aconselhe-se junto do serviço de urgência mais próximo. Mantenha ou leve o frasco ou embalagem de comprimidos consigo para que facilmente possa descrever o que tomou.

Caso se tenha esquecido de tomar Biktarvy

É importante que não falhe nenhuma dose de Biktarvy.

Caso se tenha esquecido de tomar uma dose:

Caso se aperceba no período de 18 horas após a hora em que habitualmente toma Biktarvy, deve necessariamente tomar o comprimido o mais rapidamente possível. Depois tome a sua dose seguinte como é habitual.

Caso se aperceba 18 horas ou mais após a hora em que habitualmente toma Biktarvy, não tome a dose que falhou. Espere e tome a dose seguinte à hora habitual.

Se vomitar em menos de 1 hora após a toma de Biktarvy, tome outro comprimido. Se vomitar mais de 1 hora após a toma de Biktarvy, não necessita de tomar outro comprimido até ao seu próximo comprimido de acordo com o esquema habitual.

Não pare de tomar Biktarvy

Não pare de tomar Biktarvy sem falar com o seu médico. A interrupção do tratamento com Biktarvy pode afetar gravemente a sua resposta a um tratamento futuro. Se o tratamento com Biktarvy for interrompido por qualquer razão, fale com o seu médico antes de voltar a tomar os comprimidos de Biktarvy.

Quando a quantidade de Biktarvy começar a escassear, obtenha mais junto do seu médico ou farmacêutico. É muito importante que o faça porque a quantidade de vírus pode começar a aumentar se o medicamento for interrompido, mesmo por um curto período de tempo. A doença pode então tornarse mais difícil de tratar.

Se tiver infeção por VIH e hepatite B, é particularmente importante não parar o tratamento com Biktarvy sem previamente consultar o seu médico. Pode necessitar de análises ao sangue durante vários meses após interrupção do tratamento. Em alguns doentes com doença hepática (do fígado) avançada ou cirrose, a interrupção do tratamento não é recomendada, uma vez que pode levar a um agravamento da sua hepatite, que pode ser potencialmente fatal.

Informe imediatamente o seu médico se surgirem quaisquer sintomas novos ou pouco habituais após parar o tratamento, particularmente sintomas que associaria à sua hepatite B.

Caso ainda tenha dúvidas sobre a utilização deste medicamento, fale com o seu médico ou farmacêutico.

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Como todos os medicamentos, este medicamento pode causar efeitos indesejáveis, embora estes não se manifestem em todas as pessoas.

Efeitos indesejáveis possíveis: informe o seu médico imediatamente

Quaisquer sinais de inflamação ou infeção. Em alguns doentes com infeção pelo VIH avançada (SIDA) e antecedentes de infeções oportunistas (infeções que ocorrem em pessoas com um sistema imunológico fraco), podem ocorrer sinais e sintomas de inflamação de infeções prévias logo após iniciar o tratamento contra o VIH. Pensa-se que estes sintomas são devidos a uma melhoria na resposta imunológica do corpo, permitindo que o corpo lute contra infeções que podem estar presentes sem sintomas óbvios.

Doenças autoimunes, quando o sistema imunitário ataca os tecidos saudáveis do corpo, após começar a tomar medicamentos para a sua infeção pelo VIH. As doenças autoimunes podem ocorrer muitos meses depois do início do tratamento. Esteja atento a quaisquer sintomas de infeção ou outros sintomas, como:

fraqueza muscular

fraqueza que começa nas mãos e nos pés e que progride para o tronco

palpitações, tremores ou hiperatividade

Se observar estes ou quaisquer outros sintomas de inflamação ou infeção, informe o seu médico imediatamente.

Efeitos indesejáveis frequentes (podem afetar até 1 em cada 10 pessoas)*

depressão

sonhos anormais

dores de cabeça

tonturas

diarreia

sentir-se enjoado (náuseas)

cansaço (fadiga)

Efeitos indesejáveis pouco frequentes (podem afetar até 1 em cada 100 pessoas)

anemia

vómitos

dor de estômago

problemas digestivos que podem resultar em desconforto após as refeições (dispepsia)

gases (flatulência)

inchaço da face, lábios, língua ou garganta (angioedema)

comichão (prurido)

erupção na pele

urticária

dor nas articulações (artralgia)

pensamentos suicidas e tentativa de suicídio (particularmente em doentes que tiveram depressão ou problemas de saúde mental anteriormente)

ansiedade

perturbações do sono

As análises ao sangue também poderão revelar:

níveis mais elevados de substâncias chamadas bilirrubina e/ou creatinina sérica no sangue

Efeitos indesejáveis raros (podem afetar até 1 em cada 1000 pessoas)

síndrome de Stevens-Johnson (SSJ), uma doença grave potencialmente fatal que normalmente começa com sintomas gripais. Alguns dias mais tarde, aparecem outros sintomas, incluindo:

Pele dolorosa vermelha ou roxa que parece queimada e descamada

Bolhas na pele, boca, nariz e genitais

Olhos vermelhos, dolorosos e lacrimejantes

Se tiver algum destes sintomas, pare de imediato o seu medicamento e informe logo o seu médico.

Se qualquer um dos efeitos indesejáveis se agravar informe o seu médico.

Outros efeitos que podem ser observados durante o tratamento do VIH

A frequência dos efeitos indesejáveis seguintes é desconhecida (a frequência não pode ser calculada a partir dos dados disponíveis).

Problemas nos ossos. Alguns doentes tratados com associações de medicamentos antirretrovíricos tais como Biktarvy podem desenvolver uma doença óssea chamada osteonecrose (morte do tecido ósseo causada pela perda da irrigação de sangue no osso). Tomar este tipo de medicamentos durante um período prolongado, tomar corticosteroides, consumir bebidas alcoólicas, ter um sistema imunológico muito fraco e ter excesso de peso, podem ser alguns dos muitos fatores de risco para o desenvolvimento desta doença. Sinais de osteonecrose são:

rigidez das articulações

dores nas articulações (especialmente na anca, joelho e ombro)

dificuldade em se movimentar

Se observar qualquer um destes sintomas, informe o seu médico.

Durante a terapêutica para o VIH pode haver um aumento do peso e dos níveis de lípidos e glucose no sangue. Isto está em parte associado a uma recuperação da saúde e do estilo de vida e, no caso dos lípidos no sangue, por vezes aos próprios medicamentos para o VIH. O seu médico irá realizar testes para determinar estas alterações.

Comunicação de efeitos indesejáveis

Se tiver quaisquer efeitos indesejáveis, incluindo possíveis efeitos indesejáveis não indicados neste folheto, fale com o seu médico ou farmacêutico. Também poderá comunicar efeitos indesejáveis diretamente através do sistema nacional de notificação mencionado no Apêndice V. Ao comunicar efeitos indesejáveis, estará a ajudar a fornecer mais informações sobre a segurança deste medicamento

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5. How to store Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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5. How to store Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película

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Manter este medicamento fora da vista e do alcance das crianças.

Não utilize este medicamento após o prazo de validade impresso na embalagem exterior e no frasco ou fita blister, após {VAL}. O prazo de validade corresponde ao último dia do mês indicado.

Conservar na embalagem de origem para proteger da humidade. Manter o frasco bem fechado. Não utilizar se o selo por cima da abertura do frasco estiver partido ou ausente.

Não deite fora quaisquer medicamentos na canalização ou no lixo doméstico. Pergunte ao seu farmacêutico como deitar fora os medicamentos que já não utiliza. Estas medidas ajudarão a proteger o ambiente.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Qual a composição de Biktarvy

As substâncias ativas são o bictegravir, a emtricitabina e o tenofovir alafenamida. Cada comprimido de Biktarvy contém bictegravir sódico equivalente a 30 mg de bictegravir, 120 mg de emtricitabina e tenofovir alafenamida fumarato equivalente a 15 mg de tenofovir alafenamida.

Os outros componentes são Núcleo do comprimido Celulose microcristalina (E460), croscarmelose sódica (E468), estearato de magnésio (E470b). Película de revestimento Álcool polivinílico (E203), dióxido de titânio (E171), macrogol (E1521), talco (E553b), óxido de ferro vermelho (E172), óxido de ferro preto (E172).

Qual o aspeto de Biktarvy e conteúdo da embalagem Biktarvy 30 mg/120 mg/15 mg comprimidos revestidos por película são comprimidos revestidos por película cor-de-rosa, em forma de cápsula, com “BVY” gravado num lado do comprimido e uma ranhura no outro lado do comprimido.

Os comprimidos são fornecidos num frasco. É possível que não sejam comercializadas todas as apresentações.

Biktarvy apresenta-se em embalagens contendo 1 frasco de 30 comprimidos e em embalagens com 3 frascos, cada um dos quais contendo 30 comprimidos. Cada frasco contém um exsicante de sílica gel que deve ser mantido dentro do frasco para ajudar a proteger os seus comprimidos. O exsicante de sílica gel está contido numa saqueta ou recipiente separado e não deve ser engolido.

Titular da Autorização de Introdução no Mercado

Gilead Sciences Ireland UC Carrigtohill County Cork, T45 DP77 Irlanda

Fabricante

Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill County Cork Irlanda

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Carrigtohill, County Cork, T45 County Cork IR

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30

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Medicinal product subject to medical prescription

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Karvea 300 mg comprimidos

irbesartan

Leia com atenção todo este folheto antes de começar a tomar este medicamento, pois contém informação importante para si.

Conserve este folheto. Pode ter necessidade de o ler novamente.

Caso ainda tenha dúvidas, fale com o seu médico ou farmacêutico.

Este medicamento foi receitado apenas para si. Não deve dá-lo a outros; o medicamento pode serlhes prejudicial mesmo que apresentem os mesmos sinais de doença.

Se tiver quaisquer efeitos secundários, incluindo efeitos secundários não indicados neste folheto, fale com o seu médico ou farmacêutico.

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O que contém este folheto:

O que é Karvea e para que é utilizado

O que precisa de saber antes de tomar Karvea

Como tomar Karvea

Efeitos secundários possíveis

Como conservar Karvea

Conteúdo da embalagem e outras informações

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1. What Karvea is and what it is used for

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1. What Karvea is and what it is used for

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Karvea pertence a um grupo de medicamentos conhecidos como antagonistas dos recetores da angiotensina-II. A angiotensina-II é uma substância produzida no organismo que se liga a recetores nos vasos sanguíneos, provocando o seu estreitamento, o que conduz ao aumento da pressão arterial. Karvea impede a ligação da angiotensina-II a estes recetores, fazendo com que os vasos sanguíneos se relaxem e a pressão arterial baixe. Karvea atrasa a diminuição da função renal nos doentes com pressão arterial elevada e diabetes do tipo 2.

Karvea é usado em doentes adultos

para tratar a pressão arterial elevada (hipertensão essencial)

para proteger os rins nos doentes com pressão arterial elevada, diabetes do tipo 2 e evidência laboratorial de insuficiência dos rins.

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2. What you need to know before you take Karvea

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2. What you need to know before you take Karvea

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Não tome Karvea

se tem alergia ao irbesartan ou a qualquer outro componente deste medicamento (indicados na secção 6).

se tiver mais do que três meses de gravidez. (Também é preferível não tomar Karvea no início da gravidez - ver secção Gravidez

se tem diabetes ou função renal diminuída e está a ser tratado com um medicamento que contém aliscireno para diminuir a pressão arterial

Advertências e precauções

Fale com o seu médico antes de tomar Karvea e se alguma das seguintes situações se aplicar a si:

se tiver vómitos ou diarreia prolongados

se sofrer de problemas nos rins

se sofre de problemas do coração

se receber Karvea para doença nos rins diabética. Neste caso, o seu médico pode efetuar-lhe análises ao sangue com regularidade, especialmente para medir os níveis sanguíneos de potássio em caso de insuficiência dos rins se desenvolver baixos níveis de açúcar no sangue (os sintomas podem incluir sudação, fraqueza, fome, tonturas, tremores, dor de cabeça, rubor ou palidez, dormência, batimento cardíaco acelerado e palpitante), especialmente se estiver a ser tratado para a diabetes.

se vai ser submetido a uma operação (cirurgia) ou se lhe vão ser administrados anestésicos

se está a tomar algum dos seguintes medicamentos para tratar a pressão arterial elevada:

um inibidor da ECA (por exemplo enalapril, lisinopril, ramipril), em particular se tiver problemas nos rins relacionados com diabetes.

aliscireno

O seu médico pode verificar a sua função renal, pressão arterial e a quantidade de eletrólitos (por exemplo, o potássio) no seu sangue em intervalos regulares.

Ver também a informação sob o título “Não tome Karvea”

Deve informar o seu médico se pensa que está (ou pode vir a estar) grávida. Karvea não está recomendado no início da gravidez e não pode ser tomado após o terceiro mês de gravidez, uma vez que pode ser gravemente prejudicial para o bebé se utilizado a partir desta altura (ver secção Gravidez).

Crianças e adolescentes

Este medicamento não deve ser utilizado em crianças e adolescentes uma vez que não foram ainda completamente estabelecidas a segurança e eficácia.

Outros medicamentos e Karvea

Informe o seu médico ou farmacêutico se estiver a tomar, tiver tomado ou se vier a tomar outros medicamentos. O seu médico pode precisar de alterar a dose e/ou tomar outras precauções se estiver a tomar aliscireno. Se está a tomar um inibidor da ECA ou aliscireno (ver também informações sob os títulos “Não tome Karvea” e “Advertências e precauções”).

Poderá necessitar de fazer algumas verificações ao sangue caso tome:

suplementos de potássio

substitutos de sal contendo potássio

medicamentos poupadores de potássio (como sejam alguns diuréticos)

medicamentos contendo lítio

repaglinida (medicamento utilizado para baixar os níveis de açúcar no sangue)

Se tomar alguns medicamentos para as dores, denominados anti-inflamatórios não-esteroides, o efeito do irbesartan poderá ser reduzido.

Karvea com alimentos e bebidas

Karvea pode ser tomado com ou sem alimentos.

Gravidez e amamentação

Gravidez

Deve informar o seu médico se pensa que está (ou pode vir a estar) grávida. O seu médico normalmente aconselha-la-á a interromper Karvea antes de engravidar ou assim que estiver grávida e a tomar outro medicamento em vez de Karvea. Karvea não está recomendado no início da gravidez e não pode ser tomado após o terceiro mês de gravidez, uma vez que pode ser gravemente prejudicial para o bebé se utilizado a partir desta altura.

Amamentação

Deverá informar o seu médico de que se encontra a amamentar ou que está prestes a iniciar o aleitamento. Karvea não está recomendado em mães a amamentar, especialmente se o bebé for recémnascido ou prematuro; nestes casos o seu médico poderá indicar outro tratamento.

Condução de veículos e utilização de máquinas

Não é provável que Karvea afete a sua capacidade de conduzir e usar máquinas. Contudo, ocasionalmente, podem ocorrer tonturas ou fadiga durante o tratamento da hipertensão. Se sentir estes efeitos, fale com o seu médico antes de tentar conduzir ou utilizar máquinas.

Karvea contém lactose. Se foi informado pelo seu médico de que é intolerante a alguns açúcares (por exemplo, a lactose), deverá contactá-lo antes de tomar este medicamento.

Karvea contém sódio. Este medicamento contém menos de 1 mmol de sódio (23 mg) por comprimido, ou seja, é praticamente 'isento de sódio'.

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Tomar este medicamento exatamente como indicado pelo seu médico. Fale com o seu médico ou farmacêutico se tiver dúvidas.

Modo de administração

Karvea destina-se à via oral. Engolir os comprimidos com uma quantidade suficiente de líquidos (por exemplo um copo com água). Pode tomar Karvea com ou sem alimentos. Tente tomar a dose diária sempre à mesma hora. É importante que continue a tomar Karvea até que o seu médico lhe dê outra indicação.

Doentes com pressão arterial elevada

A dose habitual é 150 mg uma vez ao dia. Em função da resposta da pressão arterial, a dose pode ser aumentada para 300 mg, uma vez ao dia.

Doentes com pressão arterial elevada e diabetes do tipo 2 com doença nos rins

Nos doentes com pressão arterial elevada e diabetes do tipo 2, a dose de manutenção preferível para o tratamento da doença renal associada é de 300 mg uma vez por dia.

O médico pode receitar uma dose mais baixa, sobretudo quando se inicia o tratamento em certos doentes, como sejam os que estão em hemodiálise ou os que têm mais de 75 anos.

O efeito hipotensor máximo deve obter-se às 4 a 6 semanas após o início do tratamento.

Utilização em crianças e adolescentes

Karvea não deve ser administrado a crianças com idade idade inferior a 18 anos. Se uma criança engolir alguns comprimidos, deve contactar o médico imediatamente.

Se tomar mais Karvea do que deveria

Se, acidentalmente, tomar demasiados comprimidos, contacte o médico imediatamente. Caso se tenha esquecido de tomar Karvea Se, acidentalmente, não tomar uma dose diária, tome a dose seguinte como planeado. Não tome uma dose a dobrar para compensar uma dose que se esqueceu de tomar.

Caso ainda tenha dúvidas sobre a utilização deste medicamento, fale com o seu médico ou farmacêutico.

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Como todos os medicamentos, este medicamento pode causar efeitos secundários, embora estes não se manifestem em todas as pessoas. Alguns destes efeitos podem ser graves e requerer cuidados médicos.

Tal como acontece com medicamentos semelhantes, em doentes a tomar irbesartan foram notificados casos raros de reações alérgicas na pele (erupção na pele, erupção na pele com comichão), assim como inchaço localizado da face, lábios e/ou língua. Se tiver algum destes sintomas, ou se tiver dificuldade em respirar, pare de tomar Karvea e contacte o médico imediatamente.

A frequência dos efeitos adversos listados abaixo é definida utilizando a seguinte convenção:

Muito frequentes: podem afetar mais de 1 em 10 pessoas

Frequentes: podem afetar até 1 em 10 pessoas

Pouco frequentes: podem afetar até 1 em 100 pessoas

Os efeitos secundários notificados em estudos clínicos para os doentes tratados com Karvea foram:

Muito frequentes (podem afetar mais de 1 em 10 pessoas): se tiver pressão arterial elevada e diabetes do tipo 2 com doença nos rins, as análises ao sangue podem mostrar níveis de potássio aumentados.

Frequentes (podem afetar até 1 em 10 pessoas): tonturas, mal estar/vómitos, fadiga e as análises ao sangue podem mostrar níveis de uma enzima que avalia a função muscular e cardíaca (enzima creatina cinase) aumentados. Em doentes com pressão arterial elevada e diabetes do tipo 2 com doença nos rins foram também notificados tonturas quando se passa da posição deitada ou sentada para a posição de pé, pressão arterial baixa quando se passa da posição deitada ou sentada para a posição de pé, dor nas articulações ou músculos e níveis de uma proteína nos glóbulos vermelhos (hemoglobina) diminuídos.

Pouco frequentes (podem afetar até 1 em 100 pessoas): ritmo cardíaco rápido, rubor (vermelhidão), tosse, diarreia, indigestão/pirose (azia), disfunção sexual (problemas com o desempenho sexual) e dor torácica.

Alguns efeitos indesejáveis foram notificados desde a comercialização de Karvea. Os efeitos indesejáveis em que a frequência não é conhecida são: sensação de girar, cefaleias (dores de cabeça), alteração do paladar, zumbidos, cãimbras musculares, dor nas articulações e músculos, redução do número de glóbulos vermelhos (anemia - os sintomas podem incluir cansaço, dores de cabeça, falta de ar durante a prática de exercício físico, tonturas e aparência pálida), redução do número de plaquetas, função hepática (do fígado) alterada, níveis sanguíneos de potássio aumentados, compromisso da função dos rins e inflamação dos vasos sanguíneos pequenos afetando principalmente a pele (uma situação conhecida como vasculite leucocitoclásica) , reacções alérgicas graves (choque anafiláctico) e baixos níveis de açúcar no sangue. Foram também notificados casos pouco frequentes de icterícia (amarelecimento da pele e/ou da zona branca dos olhos).

Comunicação de efeitos secundários

Se tiver quaisquer efeitos secundários, incluindo possíveis efeitos secundários não indicados neste folheto, fale com o seu médico ou farmacêutico. Também poderá comunicar efeitos secundários diretamente através do sistema nacional de notificação mencionado no Apêndice V. Ao comunicar efeitos secundários, estará a ajudar a fornecer mais informações sobre a segurança deste medicamento.

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Manter este medicamento fora da vista e do alcance das crianças.

Não utilize este medicamento após o prazo de validade impresso na embalagem exterior e no blister, após VAL. O prazo de validade corresponde ao último dia do mês indicado.

Não conservar acima de 30ºC.

Não deite fora quaisquer medicamentos na canalização ou no lixo doméstico. Pergunte ao seu farmacêutico como deitar fora os medicamentos que já não necessita. Estas medidas ajudarão a proteger o ambiente.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Qual a composição de Karvea

A substância ativa é o irbesartan. Cada comprimido de Karvea 300 mg contém 300 mg de irbesartan.

Os outros componentes são celulose microcristalina, croscarmelose sódica, lactose monohidratada, estearato de magnésio, sílica coloidal hidratada, amido de milho pré-gelificado e poloxamero 188. Por favor ver a secção 2 “Karvea contém lactose”.

Qual o aspeto de Karvea e conteúdo da embalagem

Os comprimidos de Karvea 300 mg são de cor branca a esbranquiçada, biconvexos, de forma oval, com um coração marcado numa das faces e o número 2773 gravado na outra face.

Os comprimidos de Karvea a 300 mg são fornecidos em embalagens de 14, 28, 56 ou 98 comprimidos acondicionados em blister. Estão também disponíveis, para uso hospitalar, embalagens de 56 x 1 comprimido em blister para dose unitária.

É possível que não sejam comercializadas todas as apresentações.

Titular da Autorização de Introdução no Mercado Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly França

Fabricante

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex - França

SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - França

Para quaisquer informações sobre este medicamento, queira contactar o representante local do Titular da Autorização de Introdução no Mercado.

België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00

България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40

Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111

Magyarország SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050

Danmark Sanofi A/S Tlf: +45 45 16 70 00

Malta Sanofi S.r.l.. Tel: +39 02 39394275

Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131

Nederland Sanofi B.V. Tel: +31 20 245 4000

Eesti Swixx Biopharma OÜ Tel: +372 640 10 30

Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00

Ελλάδα Sanofi-Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A. Tel: +34 93 485 94 00

Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23

Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500

Ireland sanofi-aventis Ireland Ltd. Tel: +353 (0) 1 403 56 00

România Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

Ísland Vistor hf. Sími: +354 535 7000

Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

Italia Sanofi S.r.l.Tel: 800536389

Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300

Κύπρος C.A. Papaellinas Ltd. Τηλ: +357 22 741741

Sverige Sanofi AB Tel: +46 (0)8 634 50 00

Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

Este folheto foi revisto pela última vez em

Informação pormenorizada sobre este medicamento está disponível na Internet no site da Agência Europeia de Medicamentos http://www.ema.europa.eu/

# entry[].resource.entry[].resource.description
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

# entry[].resource.entry[].resource.contact[].address.text
1, rue de la Vierge Ambarès & Lagrave FR

# entry[].resource.entry[].resource.legalStatusOfSupply.coding[].display
Medicinal product subject to medical prescription

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unavailable

# entry[].resource.entry[].resource.section[].section[].title
Package leaflet: Information for the user

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Package leaflet: Information for the user

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Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet

What Flucelvax Tetra is and what it is used for

What you need to know before you receive Flucelvax Tetra

How Flucelvax Tetra is given

Possible side effects

How to store Flucelvax Tetra

Contents of the pack and other information

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1. What Flucelvax is and what it is used for

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1. What Flucelvax is and what it is used for

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Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.

When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.

Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.

The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.

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2. What you need to know before you take Flucelvax

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2. What you need to know before you take Flucelvax

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You should not receive Flucelvax Tetra:

If you are allergic to:

the active ingredients or any of the other ingredients of this medicine (listed in section 6)

beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.

BEFORE receiving the vaccine.

Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.

You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.

You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).

You should tell your doctor if you have a bleeding problem or bruise easily.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.

As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.

Other medicines and Flucelvax Tetra

Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine. Flucelvax Tetra may be given at the same time as other vaccines.

Pregnancy and breast-feeding

Pregnancy and breast-feeding

Pregnancy:

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy.

Breast-feeding:

Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.

Driving and using machines

Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.

Flucelvax Tetra contains sodium chloride and potassium chloride

This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’

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Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).

Adults and children from 2 years of age:

One dose of 0.5 ml

If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical trials and during general use:

Very serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:

Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

Serious side effects

Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:

You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.

Extensive swelling of injected limb

Mild side effects

Very common (may affect more than 1 in 10 people):

Injection site pain, bruising, reddening and hardening or swelling at the site of the injection

Headache

Muscle pain

Tiredness

Loss of appetite

Irritability (only reported in children from 2 to < 6 years)

Sleepiness (only reported in children 2 to < 6 years) Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly. Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, eldery and children 9 to < 18 years.

Common (may affect up to 1 in 10 people):

Nausea, vomiting, diarrhoea

Joint pain

Shivering

Change in eating habits (only reported in children from 2 to < 6 years)

Fever (> 38°C) Vomiting was uncommon in the elderly. Fever was uncommon in adults and the elderly.

Not known (frequency cannot be estimated from the available data):

Numbness and tingling sensation (paraesthesia)

Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.

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Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2 °C to 8 °C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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What Flucelvax Tetra contains

The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) 15 micrograms HA**

A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15 micrograms HA**

B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA**

B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**

per 0.5 ml dose

..............................................

* propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown);

** haemagglutinin

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

What Flucelvax Tetra looks like and contents of the pack

Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe). Flucelvax Tetra is a clear to slightly opalescent suspension. A single syringe contains 0.5 ml of suspension for injection. Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre- filled syringes with or without needles. Not all pack sizes may be marketed.

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INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

# entry[].resource.entry[].resource.substance.code.concept.coding[].display
INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

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INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

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suspension for injection in pre-filled syringe

# entry[].resource.entry[].resource.contact[].address.text
Paasheuvelweg 28 1105BJ Amsterdam Netherlands

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Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1

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Medicinal product subject to medical prescription

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Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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suspension for injection in pre-filled syringe

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Karvea 75 mg tablets

irbesartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What Karvea is and what it is used for

What you need to know before you take Karvea

How to take Karvea

Possible side effects

How to store Karvea

Contents of the pack and other information

# entry[].resource.entry[].resource.section[].section[].title
1. What Karvea is and what it is used for

# entry[].resource.entry[].resource.section[].section[].code.text
1. What Karvea is and what it is used for

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Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

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2. What you need to know before you take Karvea

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2. What you need to know before you take Karvea

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Do not take Karvea

if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)

if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:

if you get excessive vomiting or diarrhoea

if you suffer from kidney problems

if you suffer from heart problems

if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.

if you are going to have an operation (surgery) or be given anaesthetics

an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).
You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium-sparing medicines (such as certain diuretics)

medicines containing lithium

repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Karvea with food and drink
Karvea can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you take more Karvea than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Karvea
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:

Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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What Karvea contains

The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.
Marketing Authorisation Holder:
sanofi-aventis groupe

54, rue La Boétie

F-75008 Paris - France

Manufacturer:

SANOFI WINTHROP INDUSTRIE

1, rue de la Vierge

Ambarès and Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

България

Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o. Tel: +420 233 086 111

Magyarország

SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Norge

sanofi-aventis Norge AS Tlf: +47 67 10 71 00

Eesti

Swixx Biopharma OÜ Tel: +372 640 10 30

Österreich

sanofi-aventis GmbH Tel: +43 1 80 185 – 0

Ελλάδα

sanofi-aventis AEBE Τηλ: +30 210 900 16 00

Polska

sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

España

sanofi-aventis, S.A. Tel: +34 93 485 94 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o. Tel: +385 1 2078 500

România

Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

Slovenija

Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

Italia

Sanofi S.r.l. Tel: 800 536389

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

C.A. Papaellinas Ltd. Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

Swixx Biopharma SIA Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

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White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

# entry[].resource.entry[].resource.contact[].address.text
1, rue de la Vierge Ambarès & Lagrave FR

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Prospecto: información para el usuario

Calcio/Vitamina D 3 ROVI 1000 mg / 880 UI comprimidos efervescentes

Carbonato c álcico/colecalciferol (Vitamina D3)

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

-Conserve este prospecto, ya que puede tener que volver a leerlo.

-Si tiene alguna duda, consulte a su médico o farmacéutico.

-Este medicamento se le ha recetado solamente a usted, y no debe d árselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.

-Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

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Contenido del prospecto

Qué es Calcio/Vitamina D3 ROVI y para qué se utiliza

Qué necesita saber antes de empezar a tomar Calcio/Vitamina D3 ROVI

Cómo tomar Calcio/Vitamina D3 ROVI

Posibles efectos adversos

Conservación de Calcio/Vitamina D3 ROVI

Contenido del envase e información adicional

# entry[].resource.entry[].resource.section[].section[].title
1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for

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1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for

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Calcio/Vitamina D3 ROVI son comprimidos efervescentes. Se presentan en envases con 30 comprimidos.

Este medicamento es una asociación de calcio y vitamina D que est á indicada para la corrección de la deficiencia combinada de vitamina D y calcio en pacientes de edad avanzada así como suplemento de vitamina D y calcio como coadyuvante a la terapia específica para el tratamiento de la osteoporosis en pacientes con deficiencia o con alto riesgo de deficiencia combinada de vitamina D y calcio.

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2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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No tome Calcio/Vitamina D 3 ROVI:

si es alérgico a los principios activos o a alguno de los dem ás componentes de este medicamento (incluidos en la sección 6),

si usted presenta hipercalcemia (nivel de calcio anormalmente elevado en sangre),

si usted presenta hipercalciuria (eliminación exagerada de calcio en orina),

si usted tiene litiasis c álcica (c álculos en riñones), calcificación tisular (depósito de sales de calcio en los tejidos),

si usted padece una enfermedad crónica del riñón,

si usted presenta inmovilización prolongada acompañada por hipercalciuria y/o hipercalcemia.

Este medicamento contiene aceite de soja. No debe utilizarse en caso de alergia al cacahuete o a la soja.

Advertencias y precauciones:

Consulte a su médico o farmacéutico antes de empezar a tomar Calcio/Vitamina D3 ROVI:

- si tiene insuficiencia renal (incapacidad del riñón para realizar correctamente su función),

- si tiene c álculos en el riñón,

- si padece una enfermedad del corazón, sarcoidosis (inflamación a nivel de los ganglios linf áticos, los pulmones, el hígado, los ojos, la piel y otros tejidos), o se encuentra en tratamiento con glucósidos cardíacos (medicamentos utilizados cuando existe una incapacidad del corazón para realizar correctamente su función),

- si recibe un tratamiento conjunto con otros productos con vitamina D, o est á sometido a un tratamiento prolongado o con dosis elevadas de suplementos de calcio. En este caso es posible que su médico deba efectuar controles clínicos de forma regular. Su médico le indicar á la frecuencia de estos controles.

Toma de Calcio/Vitamina D 3 ROVI con otros medicamentos:

Informe a su médico o farmacéutico si est á utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento. Ciertos medicamentos pueden interferir con Calcio/Vitamina D3 ROVI; en estos casos puede ser necesario cambiar la dosis, interrumpir el tratamiento con alguno de ellos o esperar al menos unas horas entre la administración de ambos.

Es importante que informe a su médico si est á tomando o ha tomado recientemente alguno de los siguientes medicamentos:

Glucósidos cardíacos (medicamentos para el corazón).

Tetraciclinas (ciertos antibióticos), esperar un intervalo de al menos 3 horas.

Diuréticos tiazídicos (medicamentos que aumentan la eliminación de orina).

Anticonvulsivantes.

Corticosteroides sistémicos.

Bifosfonatos y fluoruro sódico, esperar un intervalo de 3 horas.

Barbitúricos o fenitoína.

Toma de Calcio / Vitamina D 3 ROVI con alimentos y, bebidas:

Si toma este medicamento juntamente con alimentos y bebidas que contengan ácido ox álico (un compuesto presente en espinacas y ruibarbos) o ácido fítico (presente en el pan integral y cereales) y el fósforo que se encuentra en la leche pueden producirse interacciones, por lo que se aconseja no tomar este medicamento durante las 2 horas siguientes después de haber tomado este tipo de alimentos.

Embarazo y lactancia

Si est á embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Debido al contenido en vitamina D (880 UI) de Calcio/Vitamina D3 ROVI, no est á indicado su uso durante el embarazo y la lactancia, ya que la dosis diaria recomendada de vitamina D no debe superar las 600 UI/día.

Conducción y uso de máquinas:

No se han descrito efectos sobre la conducción o uso de m áquinas.

Calcio/Vitamina D 3 ROVI contiene sacarosa, sodio, lactosa y glucosa.

Este medicamento contiene sacarosa. Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento. Puede producir caries.

Este medicamento contiene 96,15 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada comprimido. Esto equivale al 4,8 % de la ingesta diaria m áxima de sodio recomendada para un adulto.

Este medicamento contiene lactosa. Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

Este medicamento contiene glucosa (en maltodextrina procedente de maíz). Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

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3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

# entry[].resource.entry[].resource.section[].section[].text.div
Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Dosis

Adultos

La dosis recomendada es de 1 comprimido efervescente (1000 mg de calcio y 880 UI de Vitamina D3) al día.

Forma y vía de administración

Este medicamento se administra por vía oral.

Disolver el comprimido en un vaso de agua y beber inmediatamente.

Duración del tratamiento

Su médico le indicar á la duración de su tratamiento con Calcio / Vitamina D3 ROVI. No suspenda antes el tratamiento.

Siga estas instrucciones a menos que su médico le haya dado otras indicaciones distintas. En estos casos es conveniente solicitar al médico las instrucciones por escrito y asegurarse de haberlas entendido bien.

Si estima que la acción de Calcio/Vitamina D3 ROVI es demasiado fuerte o débil, comuníqueselo a su médico o farmacéutico.

Recuerde tomar su medicamento.

Si toma m ás Calcio/Vitamina D 3 ROVI del que debe

Si toma m ás Calcio/Vitamina D3 ROVI del que debe, o en caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 91.562.04.20, indicando el medicamento y la cantidad ingerida.

La sobredosis puede provocar hipervitaminosis D (exceso de vitamina D) e hipercalcemia (nivel de calcio anormalmente elevado en sangre). Los síntomas en caso de sobredosis son: n áuseas, vómitos, anorexia (trastorno de la alimentación), dolor en el abdomen, sequedad de boca o poliuria (aumento del volumen de orina eliminado), o bien, irritabilidad, letargia (cansancio excesivo), estupor (disminución de la respuesta a los estímulos) y coma (pérdida de la conciencia) en casos severos.

Si olvidó tomar Calcio/Vitamina D 3 ROVI

No tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Calcio/Vitamina D 3 ROVI

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

- Poco frecuentes (pueden afectar a entre 1 y 10 de cada 1.000 pacientes ):

niveles altos de calcio en sangre hipercalcemia,

niveles altos de calcio en orina hipercalciuria.

- Raros (pueden afectar a entre 1 y 10 de cada 10.000 pacientes ):

estreñimiento,

flatulencia,

n áuseas,

dolor epig ástrico,

diarrea.

- Muy raros (pueden afectar a menos de 1 de cada 10.000 pacientes):):

picor (prurito),

erupción de la piel (exantema),

ronchas (urticaria).

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar m ás información sobre la seguridad de este medicamento.

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5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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Mantener este medicamento fuera de la vista y del alcance de los niños.

Conservar en el envase original para protegerlo de la humedad.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD. La fecha de caducidad es el último día del mes que se indica.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudar á a proteger el medio ambiente

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Composición de Calcio/Vitamina D 3 ROVI

-Los principios activos son: carbonato de calcio y concentrado de colecalciferol (en forma de polvo). Cada comprimido contiene 2500 mg de carbonato de calcio (equivalente a 1.000 mg de calcio) y 22 microgramos de concentrado de colecalciferol en forma de polvo (equivalente a 880 UI de colecalciferol = vitamina D3).

-Los dem ás componentes (excipientes) son: ácido cítrico anhidro, bicarbonato de sodio, lactosa monohidratada, povidona, sacarina sódica, ciclamato de sodio, macrogol 6000, aroma de naranja (contiene maltodextrina procedente de maíz), emulsión de simeticona, ?-tocoferol, aceite de soja hidrogenado, gelatina, sacarosa y almidón de maíz sin gluten.

Aspecto del producto y contenido del envase

Comprimidos efervescentes cilíndricos, de color blanco o blanquecino.

Se presentan en tubos de polipropileno, que contienen 15 comprimidos efervescentes cada uno. Cada envase contiene dos tubos (30 comprimidos efervescentes).

Titular de la autorización de comercialización

Laboratorios Farmacéuticos ROVI, S.A.

C/ Juli án Camarillo, 35

28037 - Madrid

España

Responsable de la fabricación:

Laboratorios Losan Pharma GMBH

Otto-Hahn-Strasse 13

79395 - Neuenburg

Alemania

Fecha de la última revisión de este prospecto: julio 2019

La información detallada de este medicamento est á disponible en la p ágina web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (https://www.aemps.gob.es/)

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Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30

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Medicinal product subject to medical prescription

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Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

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TEST PURPOSES ONLY - HIPÉRICO ARKOPHARMA cápsulas duras

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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PROSPECTO: INFORMACIÓN PARA EL USUARIO

HIPÉRICO ARKOPHARMA cápsulas duras

Hypericum perforatum L.

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico, médico o enfermero.

- Conserve este prospecto, ya que puede tener que volver a leerlo.

- Si necesita consejo o más información, consulte a su farmacéutico.

- Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto.

- Debe consultar a un médico si empeora o si no mejora después de 28 días de tratamiento.

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Contenido del prospecto

1. Qué es HIPÉRICO ARKOPHARMA y para qué se utiliza

2. Qué necesita saber antes de empezar a tomar HIPÉRICO ARKOPHARMA

3. Cómo tomar HIPÉRICO ARKOPHARMA

4. Posibles efectos adversos

5. Conservación de HIPÉRICO ARKOPHARMA 6. Contenido del envase e información adicional.

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1. What HIPÉRICO ARKOPHARMA cápsulas duras is and what it is used for

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1. What HIPÉRICO ARKOPHARMA cápsulas duras is and what it is used for

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Medicamento a base de plantas para el tratamiento sintomático de los estados de decaimiento que cursan con desánimo, pérdida de interés, cansancio y alteraciones del sueño.

Debe consultar a un médico si empeora o si no mejora después de 28 días.

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2. What you need to know before you take HIPÉRICO ARKOPHARMA cápsulas duras

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2. What you need to know before you take HIPÉRICO ARKOPHARMA cápsulas duras

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No tome HIPÉRICO ARKOPHARMA

Si es menor de 18 años.

Si usted está embarazada o en periodo de lactancia.

Si es alérgico a Hypericum perforatum L. o a cualquiera de los componentes del medicamento.

Si va a someterse a alguna intervención quirúrgica que requiera tratamiento con otros medicamentos.

Si usted está en tratamiento con alguno de los medicamentos indicados en este prospecto. Algunos componentes del hipérico (Hypericum perforatum L.) pueden producir interacciones farmacocinéticas con gran número de medicamentos, ocasionando un posible descenso de su efectividad; (ver la información sobre la toma de otros medicamentos).

Advertencias y precauciones

Consulte a su farmacéutico, médico o enfermero antes de empezar a tomar HIPÉRICO ARKOPHARMA.

Si usted está tomando HIPÉRICO ARKOPHARMA, evite exposiciones intensas a los rayos UV (largas exposiciones al sol o baños de rayos UVA).

Las mujeres que utilizan anticonceptivos orales no deben utilizar simultáneamente este medicamento porque puede producir sangrado entre los ciclos menstruales y falta de eficacia; de los medicamentos anticonceptivos.

Evite las exposiciones a radiación solar intensa o a radiación ultravioleta artificial durante la toma de; este medicamento. No se recomienda el uso de este medicamento durante tratamientos de fototerapia (tratamientos con rayos UVA) o si va a ser sometido a algún estudio de fotodiagnóstico, particularmente en personas de piel clara, ya que se podrían producir; reacciones similares a las quemaduras solares en la piel expuesta.

Si usted ha sido diagnosticado de depresión y está en tratamiento con medicamentos psicotrópicos o con antidepresivos inhibidores selectivos de la recaptación de serotonina o medicamentos del grupo de los triptanos, no debe utilizar este medicamento.

Se deberá dejar de tomar este medicamento 10 días antes de una operación quirúrgica u otra intervención clínica programada a fin de evitar interacciones potenciales con otros medicamentos, durante el uso de anestesia general o local.

Niños y adolescentes

No deben utilizar este medicamento los niños y adolescentes menores de 18 años.

Uso de HIPÉRICO ARKOPHARMA con otros medicamentos

Algunos componentes del hipérico (Hypericum perforatum L.) pueden producir una reducción de los efectos terapéuticos de otros medicamentos, cuando se toman simultáneamente con hipérico. En los tratamientos que pueden verse afectados por este medicamento se incluyen los medicamentos recomendados por su médico y también los que usted puede adquirir sin prescripción del médico.

No deben comenzar a utilizar preparados de hipérico sin consultar antes con su médico o farmacéutico, los pacientes que estén tomando los siguientes medicamentos:

para el SIDA (antirretrovirales)

para el rechazo de trasplantes (ciclosporina)

para la epilepsia

para el corazón (digoxina)

para el tratamiento del asma o bronquitis crónica (teofilina)

para la migraña

para la depresión

anticoagulantes orales

anticonceptivos orales

Para mayor información, consulte la siguiente lista:

No tome este medicamento si usted está en tratamiento con cualquier medicamento de los indicados en este listado:

•Agonistas 5HT (Triptanes): tales como almotriptan, eleptriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan; •Analgésicos: tales como tramadol; •Anestésicos/ medicamentos para la preparación de una intervención quirúrgica: tales como fentanilo, propofol, midazolam, sevoflurano; •Ansiolíticos: tales como buspirona; •Antagonistas hormonales:; tales como exemestano; •Antianginosos: tales como ivabradina; •Antiarrítmicos: tales como amiodarona; Antibacterianos: tales como eritromicina, claritromicina, telitromicina; •Anticoagulantes: tales como warfarina, acenocumarol; •Anticonceptivos Hormonales: anticonceptivos orales, anticonceptivos hormonales de emergencia (Píldora del día después), implantes e inyecciones hormonales, parches transdérmicos, dispositivos intrauterinos con hormonas; •Anticonvulsivantes (Antiepilépticos): tales como carbamazepina, fenobarbital, fenitoína, primidona, valproato sódico; •Antidepresivos Tricíclicos: tales como amitriptilina, clomipramina; IMAO: tales como moclobemida; ISRS (inhibidores selectivos de la recaptación de serotonina) tales como citalopram, fluoxetina, fluvoxamina, paroxetina, sertralina; Otros antidepresivos como duloxetina, venlafaxina; •Antifúngicos:; tales como itraconazol, voriconazol; •Antimaláricos: tales como lumefantrina; •Antiparkinsonianos: tales como rasagilina; •Antisicóticos:; tales como aripiprazol; •Todos los Antivirales:; tales como Inhibidores de Proteasa (amprenavir, atazanavir, darunavir, fosamprenavir indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); Inhibidores de transcriptasa inversa no nucleósidos (efavirenz, nevirapina, delavirdina); •Aprepitant (se utiliza para evitar vómitos, tras un tratamiento con quimioterapia); •Barbituratos tales como butobarbital, fenobarbital; •Bloqueadores de los canales del Calcio: tales como amlodipina, nifedipina, verapamilo, felodipina; •Citotóxicos: como irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposido, mitotano; •Diuréticos: tales como eplerenona; •Estimulantes de SNC:; tales como metilfenidato; •Glucósidos cardiacos: tales como digoxina; •Hipoglucemiantes orales (antidiabéticos orales): tales como gliclazida; •Hipolipemiantes: tales como; simvastatina, atorvastatina; •Hormonas tiroideas: todos los medicamentos de esta clase incluido Tiroxina; •Inhibidores de la bomba de protones: tales como lansoprazol, omeprazol; •Inmunosupresores: tales como ciclosporina, tacrolimus; •Litio; •Teofilina; •Terapia hormonal de remplazo: tales como los parches, geles, anillo vaginal)

En caso de tratamiento concomitante de HIPÉRICO ARKOPHARMA con medicamentos anticoagulantes (como fenprocumona, warfarina, clopidogrel, ácido acetilsalicílico y otros antireumáticos no esteroideos) no puede excluirse que el efecto de estas preparaciones se vea aumentado.

No puede excluirse que HIPÉRICO ARKOPHARMA actúe sobre la metabolización de otros medicamentos lo que puede afectar a la potencia y/o duración del efecto de los medicamentos a los que se refiere. Por esta razón, consulte con su médico o farmacéutico antes de tomar HIPÉRICO ARKOPHARMA con otros tratamientos.

Informe a su médico o farmacéutico si está tomando o ha tomado recientemente cualquier otro medicamento, incluso los adquiridos sin receta médica.

Informe también a su médico o farmacéutico sobre cualquier sospecha de cambio en los efectos de los medicamentos que está tomando a la vez que HIPÉRICO ARKOPHARMA.

Toma de HIPÉRICO ARKOPHARMA con los alimentos y bebidas

Los alimentos y las bebidas no tienen influencia sobre el efecto del medicamento.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que pudiera estar embarazada o tiene intención de quedarse embarazada, consulte a su farmacéutico o médico antes de utilizar este medicamento. No se recomienda su administración en estas circunstancias.

Conducción y uso de máquinas

No se han realizado estudios sobre la capacidad de conducir y el uso de máquinas.

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3. How to take HIPÉRICO ARKOPHARMA cápsulas duras

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3. How to take HIPÉRICO ARKOPHARMA cápsulas duras

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Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico, médico o enfermero. En caso de duda, pregunte a su farmacéutico, médico o enfermero.

La dosis recomendada es:

Adultos: tomar 2 cápsulas, 2 ó 3 veces al día con un vaso de agua.

Es aconsejable que las tomas se realicen siempre a las mismas horas.

Este medicamento se utiliza vía oral.

La duración de tratamiento es de 6 semanas.

El efecto del medicamento aparece generalmente a las 4 semanas. Si los síntomas persisten, debería consultar con un profesional sanitario.

Una vez abierto el envase, se retirará la bolsita absorbente que no es apta para consumo humano y no debe ser ingerida.

Uso en niños y adolescentes

No utilizar en niños y adolescentes menores de 18 años

Si toma más HIPÉRICO ARKOPHARMA del que debe

Si se ha tomado una dosis excesiva de HIPÉRICO ARKOPHARMA pueden aparecer convulsiones o estado de confusión.

En caso de la toma de una dosis excesiva de hipérico, se debe proteger de las radiaciones solares o de cualquier otra fuente de rayos UV durante 1-2 semanas.

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su farmacéutico o médico o llame al Servicio de Información Toxicológica, teléfono 91 562 04 20, indicando el producto y la cantidad ingerida.

Si olvidó tomar HIPÉRICO ARKOPHARMA

En caso de olvido de una dosis, tome el medicamento lo antes posible continuando el tratamiento de la forma prescrita. Sin embargo, si está próxima la siguiente dosis, es mejor que no tome la dosis olvidada y espere a la siguiente. En ningún caso tome una dosis doble para compensar la dosis olvidada.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

En casos raros, con una frecuencia que afecta a menos de un caso por cada 1000 pacientes, se han descrito problemas digestivos tales como náusea, dolor abdominal, diarrea, pérdida de apetito; o reacciones en la piel como picor, irritación, enrojecimiento (urticaria) y muy raramente podrían ocurrir reacciones similares a las quemaduras solares, en la piel expuesta a radiación solar o artificial intensa.

También se ha descrito dolor de cabeza, neuropatía, ansiedad, mareo, fatiga, manía o alergias, para los que se desconoce la frecuencia de aparición.

Comunicación de reacciones adversas:

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

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5. How to store HIPÉRICO ARKOPHARMA cápsulas duras

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5. How to store HIPÉRICO ARKOPHARMA cápsulas duras

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Mantener este medicamento fuera de la vista y del alcance de los niños.

No conservar a temperatura superior a 25ºC.

Una vez abierto, desechar después de 21 días.

No utilice HIPÉRICO ARKOPHARMA después de la fecha de caducidad que aparece en el envase, después de la abreviatura “CAD”. La fecha de caducidad es el último día del mes que se indica.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesite en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Composición de HIPÉRICO ARKOPHARMA

Cada cápsula contiene como principio activo:

175 mg de extracto seco hidroalcohólico de Hypericum perforatum L. herba (sumidades floridas de hipérico) (3.5-6:1) que corresponden a: 0,27 mg a 0,46mg de hipericinas totales, ≥ 10,5 mg de flavonoides y 2,71 mg a 4,63 mg de hiperforina.

Disolvente de extracción: etanol 60% m/m

Los demás componentes son los excipientes: celulosa microcristalina, estearato de magnesio, sílice coloidalhidrófoba y maltodextrina.

Composición de la cápsula: hipromelosa, dióxido de titanio y óxido de hierro amarillo.

Aspecto del producto y contenido del envase

Existe 1 presentación en frascos que contienen 42 cápsulas, con una bolsita absorbente en su interior.

Una vez abierto el envase, se retirará la bolsita absorbente que no es apta para consumo humano y no debe ser ingerida.

Titular de la autorización de comercialización y responsable de la fabricación:

Titular

Arkopharma LABORATORIOS, S.A.U,

C/ Amaltea, 9

28045 MADRID

Responsable de la fabricación

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

Fecha de la última revisión de este prospecto: septiembre 2016

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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unavailable

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Package leaflet: Information for the user

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Prospecto: información para el usuario

Biktarvy 50 mg/200 mg/25 mg comprimidos recubiertos con película

bictegravir/emtricitabina/tenofovir alafenamida

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

Conserve este prospecto, ya que puede tener que volver a leerlo.

Si tiene alguna duda, consulte a su médico o farmacéutico.

Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.

Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

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Contenido del prospecto

Qué es Biktarvy y para qué se utiliza

Qué necesita saber antes de empezar a tomar Biktarvy

Cómo tomar Biktarvy

Posibles efectos adversos

Conservación de Biktarvy

Contenido del envase e información adicional

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1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for

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1. Qué es Biktarvy y para qué se utiliza

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Biktarvy contiene tres principios activos:

bictegravir, un medicamento antirretroviral conocido como inhibidor de la transferencia de las hebras de la integrasa (INI)

emtricitabina, un medicamento antirretroviral de un tipo conocido como nucleósido inhibidor de la transcriptasa inversa (ITIAN)

tenofovir alafenamida, un medicamento antirretroviral de un tipo conocido como nucleótido inhibidor de la transcriptasa inversa (ITIANt)

Biktarvy es un comprimido único para el tratamiento de la infección por el virus de la inmunodeficiencia humana 1 (VIH-1) en adultos.

Biktarvy reduce la cantidad de VIH presente en el organismo. Esto mejora el sistema inmunitario y disminuye el riesgo de desarrollar enfermedades asociadas con la infección por el VIH.

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2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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2. Qué necesita saber antes de empezar a tomar Biktarvy

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No tome Biktarvy

Si es alérgico a bictegravir, emtricitabina, tenofovir alafenamida o a alguno de los demás componentes de este medicamento (incluidos en la sección 6 de este prospecto).

Si actualmente está tomando alguno de los siguientes medicamentos:

rifampicina utilizada para tratar algunas infecciones bacterianas como la tuberculosis

hierba de San Juan (Hypericum perforatum, hipérico), un medicamento a base de plantas utilizado para la depresión y la ansiedad, o productos que la contengan.

Si está tomando alguno de estos medicamentos, no tome Biktarvy y consulte a su médico inmediatamente.
Advertencias y precauciones

Consulte a su médico antes de empezar a tomar Biktarvy:

Si tiene problemas hepáticos o antecedentes de enfermedad hepática, incluida la hepatitis. Los pacientes que padecen de enfermedades hepáticas, como la hepatitis B o C crónica, y están en tratamiento con antirretrovirales tienen más riesgo de presentar complicaciones hepáticas graves y potencialmente mortales. Si tiene infección por el virus de la hepatitis B, su médico evaluará detenidamente la mejor pauta terapéutica para usted.

Si tiene hepatitis B. Los problemas hepáticos pueden empeorar después de dejar de tomar Biktarvy.

No deje de tomar Biktarvy si tiene hepatitis B. Hable antes con su médico. Puede consultar más detalles en la sección 3, No interrumpa el tratamiento con Biktarvy.

Mientras esté tomando Biktarvy

Una vez que empiece a tomar Biktarvy, esté atento a:

Signos de inflamación o infección

Dolor articular, rigidez o problemas óseos

Si nota cualquiera de estos síntomas, informe a su médico inmediatamente. Puede consultar más información en la sección 4, Posibles efectos adversos.
Aunque no se han observado problemas renales con Biktarvy, existe la posibilidad de que pueda experimentar problemas renales si toma Biktarvy durante un periodo de tiempo prolongado.

Mientras esté tomando este medicamento aún puede transmitir el VIH a los demás, aunque un tratamiento antirretroviral eficaz reduzca el riesgo. Consulte a su médico sobre qué precauciones son necesarias para no infectar a otras personas. Este medicamento no es una cura para la infección por el VIH. Mientras usted esté tomando Biktarvy podrá seguir padeciendo infecciones u otras enfermedades asociadas con la infección por el VIH.

Niños y adolescentes

No administre este medicamento a niños y adolescentes menores de 18 años de edad. No se ha estudiado todavía el uso de Biktarvy en niños y adolescentes menores de 18 años de edad.

Otros medicamentos y Biktarvy

Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento. Biktarvy puede interaccionar con otros medicamentos. Como consecuencia, los niveles sanguíneos de Biktarvy o de otros medicamentos se pueden ver afectados. Esto puede impedir que sus medicamentos funcionen correctamente o empeorar sus posibles efectos adversos. En algunos casos, su médico puede tener que ajustar la dosis o comprobar sus concentraciones sanguíneas.

Medicamentos que nunca se deben tomar con Biktarvy:

rifampicina utilizada para tratar algunas infecciones bacterianas como la tuberculosis

hierba de San Juan (Hypericum perforatum, hipérico), un medicamento a base de plantas utilizado para la depresión y la ansiedad, o productos que lo contengan.

Si está tomando alguno de estos medicamentos, no tome Biktarvy e informe a su médico inmediatamente.
Consulte con su médico si está tomando:

medicamentos utilizados para tratar el VIH y/o la hepatitis B que contengan:

adefovir dipivoxil, atazanavir, bictegravir, emtricitabina, lamivudina, tenofovir alafenamida o tenofovir disoproxilo

antibióticos, utilizados para tratar las infecciones bacterianas, que contengan:

azitromicina, claritromicina, rifabutina o rifapentina

antiepilépticos, utilizados para tratar la epilepsia, que contengan:

carbamazepina, oxcarbazepina, fenobarbital o fenitoína

inmunosupresores, utilizados para controlar la respuesta inmunitaria del organismo tras un trasplante, que contengan ciclosporina

medicamentos para la curación de úlceras que contengan sucralfato

Informe a su médico si está tomando alguno de estos medicamentos. No interrumpa su tratamiento sin consultar con su médico.
Consulte a su médico o farmacéutico si está tomando:

antiácidos para tratar úlceras estomacales, acidez estomacal o reflujo ácido, que contengan hidróxido de aluminio y/o de magnesio

suplementos de minerales o de vitaminas, que contengan magnesio o hierro

Consulte a su médico o farmacéutico antes de tomar Biktarvy si está tomando alguno de estos medicamentos.
Antiácidos y suplementos de magnesio: tendrá que tomar Biktarvy al menos 2 horas antes de tomar los antiácidos o suplementos que contengan aluminio y/o magnesio. O puede tomar Biktarvy junto con alimentos al menos 2 horas después de la toma del antiácido o suplemento que contenga aluminio y/o magnesio.

Suplementos de hierro: tendrá que tomar Biktarvy al menos 2 horas antes de tomar los suplementos de hierro o puede tomarlos todos juntos con alimentos.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Informe a su médico inmediatamente si se queda embarazada y pregunte sobre los posibles beneficios y riesgos de su tratamiento antirretroviral para usted y para su hijo.

Si ha tomado Biktarvy durante su embarazo su médico puede solicitar que se haga análisis de sangre periódicos y otras pruebas diagnósticas para controlar el desarrollo de su niño. En niños cuyas madres tomaron nucleósidos inhibidores de la transcriptasa inversa (ITIAN) durante el embarazo, el beneficio de la protección frente al VIH fue mayor que el riesgo de que se produjeran efectos adversos.

No dé el pecho a su hijo durante el tratamiento con Biktarvy. Esto se debe a que algunos de los principios activos de este medicamento pasan a la leche materna. Se recomienda que no dé el pecho para evitar que transmita el virus al niño a través de la leche materna. Si realmente desea amamantar, hable primero con su médico.

Conducción y uso de máquinas

Biktarvy puede causar mareo. Si nota mareo durante el tratamiento con Biktarvy, no conduzca ni maneje herramientas o máquinas.

Biktarvy contiene sodio

Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.

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3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico.

En caso de duda, consulte de nuevo a su médico o farmacéutico.

La dosis recomendada es:

Adultos: un comprimido al día, con o sin alimentos

No mastique, triture ni divida el comprimido.

Consulte a su médico o farmacéutico si está tomando:

antiácidos para tratar úlceras estomacales, acidez estomacal o reflujo ácido, que contengan hidróxido de aluminio y/o de magnesio

suplementos de minerales o vitaminas que contengan magnesio o hierro

Vea la sección 2 para más información sobre cómo tomar estos medicamentos con Biktarvy.

Si toma más Biktarvy del que debe

Si toma más cantidad de la dosis recomendada de Biktarvy puede correr mayor riesgo de experimentar posibles efectos adversos con este medicamento (ver sección 4, Posibles efectos adversos).

Consulte inmediatamente a su médico o acuda al servicio de urgencias más cercano. Lleve consigo el frasco de comprimidos para que pueda describir fácilmente qué ha tomado.

Si olvidó tomar Biktarvy

Es importante que no olvide una dosis de Biktarvy.

Si olvida una dosis:

Si se da cuenta en las 18 horas posteriores a la hora a la que normalmente toma Biktarvy, debe tomar el comprimido tan pronto como sea posible. Luego tome la dosis siguiente de la forma habitual.

Si se da cuenta después de 18 horas o más de la hora a la que normalmente toma Biktarvy, no tome la dosis olvidada. Espere y tome la siguiente dosis a la hora habitual.

Si vomita antes de que transcurra 1 hora tras haber tomado Biktarvy, tome otro comprimido. Si vomita transcurrida 1 hora de haber tomado Biktarvy, no necesita tomar otro comprimido hasta el momento de la hora habitual.

No interrumpa el tratamiento con Biktarvy

No interrumpa el tratamiento con Biktarvy sin hablar antes con su médico. Interrumpir Biktarvy puede afectar gravemente el funcionamiento de tratamientos futuros. Si se interrumpe Biktarvy por algún motivo, consulte con su médico antes de reiniciar la toma de comprimidos de Biktarvy.

Cuando vea que le queda poca cantidad de Biktarvy, acuda a su médico o farmacéutico para que le proporcione más. Esto es muy importante, ya que la cantidad de virus puede empezar a aumentar si el medicamento se interrumpe incluso durante un corto periodo de tiempo. Es posible que entonces la enfermedad se vuelva más difícil de tratar.

Si tiene infección por VIH y hepatitis B es especialmente importante no suspender su tratamiento con Biktarvy sin antes hablar con su médico. Puede necesitar hacerse análisis de sangre durante varios meses tras suspender el tratamiento. En algunos pacientes con enfermedad hepática avanzada o cirrosis no se recomienda suspender el tratamiento ya que esto puede producir un empeoramiento de su hepatitis, situación que puede ser potencialmente mortal.
Hable con su médico inmediatamente acerca de síntomas nuevos o inusuales tras suspender su tratamiento, particularmente síntomas que asocie con la infección por el virus de la hepatitis B.
Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Posibles efectos adversos: informe a un médico inmediatamente

Cualquier signo de inflamación o de infección. En algunos pacientes con infección avanzada por el VIH (sida) y antecedentes de infecciones oportunistas (infecciones que ocurren en personas con un sistema inmunitario débil), se pueden producir signos y síntomas de inflamación por infecciones previas poco después de iniciar el tratamiento contra el VIH. Se cree que estos síntomas se deben a una mejoría de la respuesta inmunitaria del organismo, que le permite combatir infecciones que podrían haber estado presentes sin síntomas obvios.

Se pueden producir también trastornos autoinmunitarios, en los que el sistema inmunitario ataca a los tejidos sanos del organismo, después de que empiece a tomar medicamentos para la infección por el VIH. Los trastornos autoinmunitarios se pueden producir muchos meses después del inicio del tratamiento. Esté atento a cualquier síntoma de infección u otros síntomas, como:

debilidad muscular

debilidad que se inicia en las manos y los pies y se desplaza hacia el tronco

palpitaciones, temblor o hiperactividad

Si nota cualquiera de estos síntomas o cualquier síntoma de inflamación o infección, informe a su médico inmediatamente.
Efectos adversos frecuentes

(pueden afectar hasta 1 de cada 10 personas)

depresión

sueños anormales

dolor de cabeza

mareo

diarrea

ganas de vomitar (náuseas)

cansancio (fatiga)

Efectos adversos poco frecuentes

(pueden afectar hasta 1 de cada 100 personas)

anemia

vómitos

dolor de estómago

problemas digestivos que generan molestias después de las comidas (dispepsia)

gases (flatulencia)

hinchazón de la cara, labios, lengua o garganta (angioedema)

picazón (prurito)

erupción

habones (urticaria)

dolor en las articulaciones (artralgia)

comportamiento suicida

ansiedad

trastornos del sueño

Los análisis de sangre también pueden mostrar:

Concentraciones más altas de sustancias llamadas bilirrubina y/o creatinina sérica en la sangre

Si considera que alguno de los efectos adversos que sufre es grave, informe a su médico.
Otros efectos que se pueden observar durante el tratamiento contra el VIH

La frecuencia de los siguientes efectos adversos se considera no conocida (la frecuencia no se puede estimar a partir de los datos disponibles).

Problemas óseos. Algunos pacientes tratados con medicamentos antirretrovirales combinados como Biktarvy pueden desarrollar una enfermedad de los huesos llamada osteonecrosis (muerte del tejido óseo debida a una pérdida del suministro de sangre al hueso). Tomar este tipo de medicamentos durante un tiempo prolongado, tomar corticosteroides, beber alcohol, tener un sistema inmunitario muy débil y tener sobrepeso, pueden ser algunos de los muchos factores de riesgo para desarrollar esta enfermedad. Los signos de osteonecrosis son:

rigidez articular

molestias y dolores articulares (especialmente de la cadera, la rodilla y el hombro)

dificultad para moverse

Si nota cualquiera de estos síntomas, informe a su médico.
Durante el tratamiento del VIH puede haber un aumento en el peso y en los niveles de glucosa y lípidos en la sangre. Esto puede estar en parte relacionado con la recuperación de la salud y con el estilo de vida y, en el caso de los lípidos en la sangre, algunas veces con los medicamentos contra el VIH por sí mismos. Su médico le controlará estos cambios.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

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5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en la caja y en el frasco después de {CAD}. La fecha de caducidad es el último día del mes que se indica.

Conservar en el embalaje original para protegerlo de la humedad. Mantener el frasco perfectamente cerrado. No utilizar si falta el sello del frasco o está roto.

Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

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6. Contents of the pack and other information

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6. Contenido del envase e información adicional

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Composición de Biktarvy

Los principios activos son bictegravir, emtricitabina y tenofovir alafenamida. Cada comprimido de Biktarvy contiene bictegravir sódico equivalente a 50 mg de bictegravir, 200 mg de emtricitabina y tenofovir alafenamida fumarato equivalente a 25 mg de tenofovir alafenamida.

Los demás componentes son

Núcleo del comprimido

Celulosa microcristalina, croscarmelosa sódica, estearato de magnesio.

Recubrimiento con película

Alcohol polivinílico, dióxido de titanio (E171), macrogol, talco, óxido de hierro rojo (E172), óxido de hierro negro (E172).

Aspecto del producto y contenido del envase

Los comprimidos recubiertos con película de Biktarvy son comprimidos recubiertos con película de color marrón purpúreo, con forma de cápsula, marcados en una de las caras del comprimido con «GSI» y en la otra cara del comprimido con «9883». Biktarvy se presenta en frascos de 30 comprimidos y en envases de 3 frascos, conteniendo cada uno de ellos 30 comprimidos. Cada frasco contiene un desecante de gel de sílice que debe conservarse en el frasco para ayudar a proteger los comprimidos. El desecante de gel de sílice está contenido en un sobre o recipiente separado, y no se debe tragar.

Puede que solamente estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Irlanda

Responsable de la fabricación

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Irlanda

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

België/Belgique/Belgien

Gilead Sciences Belgium SPRL-BVBA

Tél/Tel: + 32 (0) 24 01 35 50

Lietuva

Gilead Sciences Poland Sp. z o.o.

Tel.: + 48 (0) 22 262 8702

????????

Gilead Sciences Ireland UC

???.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg

Gilead Sciences Belgium SPRL-BVBA

Tél/Tel: + 32 (0) 24 01 35 50

Ceská republika

Gilead Sciences s.r.o.

Tel: + 420 (0) 910 871 986

Magyarország

Gilead Sciences Ireland UC

Tel.: + 353 (0) 1 686 1888

Danmark

Gilead Sciences Sweden AB

Tlf: + 46 (0) 8 5057 1849

Malta

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Deutschland

Gilead Sciences GmbH

Tel: + 49 (0) 89 899890-0

Nederland

Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98

Eesti

Gilead Sciences Poland Sp. z o.o.

Tel.: +48 (0) 22 262 8702

Norge

Gilead Sciences Sweden AB

Tlf: + 46 (0) 8 5057 1849

Ελλ?δα

Gilead Sciences Ελλ?ς Μ.ΕΠΕ.

Τηλ: + 30 (0) 210 8930 100

Österreich

Gilead Sciences GesmbH

Tel: + 43 (0) 1 260 830

España

Gilead Sciences, S.L.

Tel: + 34 (0) 91 378 98 30

Polska

Gilead Sciences Poland Sp. z o.o.

Tel.: + 48 (0) 22 262 870 2

France

Gilead Sciences

Tél: + 33 (0) 1 46 09 41 00

Portugal

Gilead Sciences, Lda.

Tel: + 351 (0) 21 7928790

Hrvatska

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

România

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Irlanda

Gilead Sciences Ireland UC

Tel: + 353 (0) 214 825 999

Slovenija

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Ísland

Gilead Sciences Sweden AB

Sími: + 46 (0) 8 5057 1849

Slovenská republika

Gilead Sciences Slovakia s.r.o.

Tel: + 421 (0) 232 121 210

Italia

Gilead Sciences S.r.l.

Tel: + 39 02 439201

Suomi/Finland

Gilead Sciences Sweden AB

Puh/Tel: + 46 (0) 8 5057 1849

Κ?προς

Gilead Sciences Ελλ?ς Μ.ΕΠΕ.

Τηλ: + 30 (0) 210 8930 100

Sverige

Gilead Sciences Sweden A B

Tel: + 46 (0) 8 5057 1849

Latvija

Gilead Sciences Poland Sp. z o.o.

Tel.: + 48 (0) 22 262 8702

Reino Unido

Gilead Sciences Ltd.

Tel: + 44 (0) 8000 113 700

Fecha de la última revisión de este prospecto:

La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos: http://www.ema.europa.eu.

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Carrigtohill, County Cork, T45 County Cork IR

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90

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Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30

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Medicinal product subject to medical prescription

# entry[].resource.entry[].resource.name[].productName
Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

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TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

Conserve este prospecto, ya que puede tener que volver a leerlo.

Si tiene alguna duda, consulte a su médico o farmacéutico.

Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.

Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

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Qué es Dovato y para qué se utiliza

Qué necesita saber antes de empezar a tomar Dovato

Cómo tomar Dovato

Posibles efectos adversos

Conservación de Dovato

Contenido del envase e información adicional

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1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for

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1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for

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Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).

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2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película

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2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película

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No tome Dovato

si es alérgico (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6)

si está tomando un medicamento llamado fampridina (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).

Si cree que algo de esto le aplica, consulte a su médico.

Advertencias y precauciones Algunas personas que toman Dovato u otros tratamientos combinados frente al VIH tienen un mayor riesgo de desarrollar efectos adversos graves que otras. Usted necesita saber que hay un mayor riesgo:

si tiene una enfermedad hepática moderada o grave

si alguna vez ha tenido una enfermedad hepática, incluyendo hepatitis B o C (si tiene hepatitis B no deje de tomar Dovato sin el consejo de su médico, ya que podría empeorar)

si tiene un problema de riñón.

Consulte a su médico antes de empezar a tomar Dovato si le aplica alguna de estas condiciones. Puede necesitar pruebas adicionales, incluyendo análisis de sangre, mientras toma este medicamento. Para más información, ver sección 4.

Reacciones alérgicas

Dovato contiene dolutegravir. Dolutegravir puede producir una reacción alérgica grave conocida como reacción de hipersensibilidad. Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.

Lea la información “Reacciones alérgicas” en la sección 4 de este prospecto.

Esté atento a los síntomas importantes

Algunas personas que toman medicamentos para la infección por el VIH desarrollan otros trastornos, que pueden ser graves. Estos incluyen:

síntomas de infecciones e inflamación

dolor en las articulaciones, rigidez y problemas de huesos.

Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.

Lea la información sobre “Otros posibles efectos adversos” en la sección 4 de este prospecto.

Niños

Este medicamento no está indicado en niños menores de 12 años, porque no ha sido estudiado en estos pacientes.

Otros medicamentos y Dovato Informe a su médico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

No tome Dovato con el siguiente medicamento:

fampridina (también conocido como dalfampridina), utilizado para tratar la esclerosis múltiple.

Algunos medicamentos pueden afectar al funcionamiento de Dovato o aumentar la probabilidad de sufrir efectos adversos. Dovato también puede afectar al funcionamiento de algunos otros medicamentos.

Informe a su médico si está tomando alguno de los siguientes medicamentos:

metformina, para tratar la diabetes

medicamentos llamados antiácidos, para tratar la indigestión y el ardor de estómago. No tome un antiácido durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).

suplementos o multivitamínicos que contienen calcio, hierro o magnesio. Si toma Dovato con comida, puede tomar los suplementos o multivitamínicos que contengan calcio, hierro o magnesio a la vez que Dovato. Si no toma Dovato con comida, no puede tomar un suplemento o multivitamínico que contenga calcio, hierro o magnesio durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).

emtricitabina, etravirina, efavirenz, nevirapina o tipranavir/ritonavir, para tratar la infección por el VIH medicamentos (generalmente líquidos) que contengan sorbitol y otros polialcoholes (como xilitol, manitol, lactitol o maltitol), si se toman con regularidad

cladribina, utilizada para tratar la leucemia o la esclerosis múltiple

rifampicina, para tratar la tuberculosis (TB) y otras infecciones bacterianas

fenitoína y fenobarbital, para tratar la epilepsia

oxcarbazepina y carbamazepina, para tratar la epilepsia o el trastorno bipolar

hierba de San Juan (Hypericum perforatum), un medicamento a base de plantas para tratar la depresión.

Informe a su médico o farmacéutico si está tomando alguno de estos medicamentos. Su médico puede decidir ajustar su dosis o que usted necesite chequeos adicionales.

Embarazo

Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada:

Consulte a su médico sobre los riegos y beneficios de tomar Dovato.

Tomar Dovato en el momento de quedarse embarazada o durante las primeras seis semanas de embarazo puede aumentar el riesgo de un defecto de nacimiento, denominado defecto del tubo neural, como la espina bífida (malformación de la médula espinal).

Si existe la posibilidad de quedarse embarazada mientras está tomando Dovato:

Consulte a su médico y valore si existe la necesidad de utilizar un método anticonceptivo, como preservativos o anticonceptivos orales.

Informe a su médico de inmediato si se queda embarazada o tiene intención de quedarse embarazada. Su médico revisará su tratamiento. No interrumpa el tratamiento con Dovato sin consultar a su médico, ya que esto podría dañarles a usted y a su hijo.

Lactancia

No se recomienda que las mujeres que conviven con el VIH den el pecho porque la infección por VIH puede transmitirse al bebé a través de la leche materna.

Una pequeña cantidad de los componentes de Dovato también pueden pasar a la leche materna.

Si está dando el pecho o piensa en dar el pecho, debe consultar con su médico lo antes posible.

Conducción y uso de máquinas Dovato puede hacer que se sienta mareado y puede tener otros efectos adversos que reduzcan su atención.

No conduzca ni maneje maquinaria, a menos que esté seguro que no está afectado.

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3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película

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3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película

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Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

La dosis recomendada de Dovato es un comprimido una vez al día.

Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.

Uso en adolescentes

Los adolescentes de entre 12 y 17 años y que pesen por lo menos 40 kg pueden tomar la dosis de adultos de un comprimido una vez al día.

Medicamentos antiácidos

Los antiácidos para tratar la indigestión y el ardor de estómago pueden hacer que Dovato no sea absorbido por su cuerpo y hacerlo menos efectivo.

No tome un antiácido durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo.

Otros medicamentos que disminuyen la acidez, como ranitidina y omeprazol, pueden tomarse al mismo tiempo que Dovato.

Consulte con su médico para que le aconseje sobre qué medicamentos contra la acidez puede tomar con Dovato.

Suplementos o multivitamínicos que contienen calcio, hierro o magnesio

Los suplementos o multivitamínicos que contengan calcio, hierro o magnesio pueden hacer que Dovato no sea absorbido en su cuerpo y hacerlo menos efectivo.

Si toma Dovato con comida, puede tomar los suplementos o multivitamínicos que contengan calcio, hierro o magnesio a la vez que Dovato. Si no toma Dovato con comida, no puede tomar un suplemento o multivitamínico que contenga calcio, hierro o magnesio durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo.

Consulte con su médico para que le aconseje sobre cómo tomar suplementos o multivitamínicos que contengan calcio, hierro o magnesio con Dovato.

Si toma más Dovato del que debe

Si excede el número de comprimidos de Dovato, contacte con su médico o farmacéutico para que le aconseje. Si es posible, muéstreles la caja de Dovato.

Si olvidó tomar Dovato

Si olvida una dosis, tómela tan pronto como lo recuerde. Pero si quedan menos de 4 horas para su próxima dosis, sáltese esa dosis que olvidó y tome la siguiente a la hora habitual. Luego continúe su tratamiento como antes.

No tome una dosis doble para compensar las dosis olvidadas.

No interrumpa el tratamiento con Dovato sin la recomendación de su médico

Tome Dovato hasta que su médico se lo indique. No deje de tomarlo a menos que su médico se lo aconseje. La interrupción del tratamiento con Dovato puede afectar a su salud y al funcionamiento futuro del tratamiento.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.

Reacciones alérgicas

Dovato contiene dolutegravir. Dolutegravir puede producir una reacción alérgica grave conocida como reacción de hipersensibilidad. Esta es una reacción poco frecuente (puede afectar hasta 1 de cada 100 personas) en personas que toman dolutegravir. Si tiene alguno de los siguientes síntomas:

erupción cutánea

una temperatura alta (fiebre)

falta de energía (cansancio)

hinchazón, a veces de la cara o la boca (angioedema), que causa dificultad para respirar

dolores musculares o articulares.

Acuda a un médico inmediatamente. Su médico puede decidir realizar pruebas hepáticas, de riñón o sanguíneas y puede que le indique que deje de tomar Dovato.

Efectos adversos muy frecuentes

Estos pueden afectar a más de 1 de cada 10 personas:

dolor de cabeza

diarrea

náuseas.

Efectos adversos frecuentes

Estos pueden afectar hasta 1 de cada 10 personas:

depresión (sensación de tristeza profunda y falta de autoestima)

erupción cutánea

picor (prurito)

vómitos

dolor o molestias en el estómago (abdominal)

aumento de peso

gases (flatulencia)

mareo

somnolencia

dificultad para conciliar el sueño (insomnio)

sueños anormales

falta de energía (cansancio)

pérdida de cabello

ansiedad

dolor articular

dolor muscular.

Los efectos adversos frecuentes que pueden aparecer en los análisis de sangre son:

aumento en el nivel de las enzimas del hígado (aminotransferasas)

aumento en el nivel de las enzimas producidas en los músculos (creatinfosfoquinasa).

Efectos adversos poco frecuentes

Estos pueden afectar hasta 1 de cada 100 personas:

inflamación del hígado (hepatitis)

intento de suicidio (especialmente en pacientes que anteriormente han tenido depresión o problemas de salud mental)

pensamientos suicidas (especialmente en pacientes que anteriormente han tenido depresión o problemas de salud mental)

crisis de angustia.

Los efectos adversos poco frecuentes que pueden aparecer en los análisis de sangre son:

una disminución de las células involucradas en la coagulación sanguínea (trombocitopenia)

un recuento bajo de glóbulos rojos (anemia) o recuento bajo de glóbulos blancos (neutropenia).

Efectos adversos raros

Estos pueden afectar hasta 1 de cada 1.000 personas:

insuficiencia hepática (los signos pueden incluir coloración amarillenta de la piel y del blanco de los ojos u orina inusualmente oscura)

hinchazón, a veces de la cara o la boca (angioedema), causando dificultad para respirar

inflamación del páncreas (pancreatitis)

rotura del tejido muscular

suicidio (especialmente en pacientes que anteriormente han tenido depresión o problemas de salud mental).

Informe a su médico de inmediato si experimenta algún problema de salud mental (consulte también otros problemas de salud mental que aparecen más arriba).

Los efectos adversos raros que pueden aparecer en los análisis de sangre son:

aumento de bilirrubina (prueba de función del hígado)

aumento de una enzima llamada amilasa.

Efectos adversos muy raros

Estos pueden afectar hasta 1 de cada 10.000 personas:

acidosis láctica (exceso de ácido láctico en la sangre)

entumecimiento, sensación de hormigueo en la piel (pinchazos)

sensación de debilidad en las extremidades.

Los efectos adversos muy raros que pueden aparecer en los análisis de sangre son:

un fallo de la médula ósea en producir nuevos glóbulos rojos (aplasia pura de glóbulos rojos).

Otros posibles efectos adversos

Las personas que toman un tratamiento de combinación para el VIH pueden tener otros efectos adversos.

Síntomas de infección e inflamación

Las personas con infección por el VIH avanzada (SIDA) tienen un sistema inmunitario debilitado y es más probable que desarrollen infecciones graves (infecciones oportunistas). Tales infecciones pueden haberse desarrollado de manera "silenciosa", no siendo detectadas por el sistema inmunitario debilitado antes de que el tratamiento se iniciara. Después de iniciar el tratamiento, el sistema inmunitario se vuelve más fuerte y puede luchar contra estas infecciones, lo que puede causar síntomas de infección o inflamación. Los síntomas generalmente incluyen fiebre, además de algunos de los siguientes:

dolor de cabeza

dolor de estómago

dificultad para respirar.

En casos raros, como el sistema inmunitario se vuelve más fuerte, también puede atacar tejidos sanos (trastornos autoinmunes). Los síntomas de los trastornos autoinmunes pueden aparecer muchos meses después de comenzar a tomar medicamentos para tratar la infección por el VIH. Los síntomas pueden incluir:

palpitaciones (latido cardíaco rápido o irregular) o temblor

hiperactividad (excesiva inquietud y movimiento)

debilidad que empieza en las manos y pies y que asciende hacia el tronco del cuerpo.

Si tiene cualquier síntoma de infección o si nota cualquiera de los síntomas anteriores:

Consulte a su médico inmediatamente. No tome otros medicamentos para la infección sin consultar antes con su médico.

Dolor en las articulaciones, rigidez y problemas de huesos

Algunas personas en tratamiento combinado para el VIH desarrollan osteonecrosis. En esta afección, partes del tejido óseo se dañan permanentemente debido al menor aporte de sangre a los huesos. Las personas pueden ser más propensas a padecer esta afección:

si han tomado un tratamiento combinado durante un largo tiempo

si también están tomando medicamentos antiinflamatorios llamados corticosteroides

si beben alcohol

si su sistema inmunitario está muy debilitado

si tienen sobrepeso.

Los signos de la osteonecrosis incluyen:

rigidez en las articulaciones

molestias y dolores en las articulaciones (especialmente en la cadera, rodilla u hombro)

dificultad de movimiento.

Si nota alguno de estos síntomas:

Informe a su médico.

Efectos en el peso, los lípidos y la glucosa en sangre:

Durante el tratamiento frente al VIH puede haber un aumento en el peso y en los niveles de lípidos y glucosa en la sangre. Esto está parcialmente relacionado con la recuperación de la salud y el estilo de vida y, a veces, con los propios medicamentos para tratar el VIH. Su médico evaluará estos cambios.

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5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película

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5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película

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Mantener este medicamento fuera de la vista y del alcance de los niños

No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica.

Este medicamento no requiere ninguna condición especial de conservación.

Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Composición de Dovato

Los principios activos son dolutegravir y lamivudina. Cada comprimido contiene dolutegravir sódico equivalente a 50 mg de dolutegravir y 300 mg de lamivudina.

Los demás componentes son celulosa microcristalina, carboximetilalmidón sódico, estearato de magnesio, manitol (E421), povidona (K29/32), fumarato estearilo de sodio, hipromelosa (E464), macrogol, dióxido de titanio (E171).

Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.

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Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES

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Avda. Extremadura 3, 09400 Aranda De Duero

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Van Asch van Wijckstraat 55H Amersfoort NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est

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Dovato 50 mg/300 mg film-coated tablets 30

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets

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Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Dovato 50 mg/300 mg film-coated tablets

dolutegravir/lamivudine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What in this leaflet

What Dovato is and what it is used for

What you need to know before you take Dovato

How to take Dovato

Possible side effects

How to store Dovato

Contents of the pack and other information

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1. What Dovato 50 mg/300 mg film-coated tablets is and what it is used for

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1. What Dovato 50 mg/300 mg film-coated tablets is and what it is used for

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Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Dovato is used to treat HIV in adults and adolescents over 12 years old who weigh at least 40 kg.

Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

Not everyone responds to treatment with Dovato in the same way. Your doctor will monitor the effectiveness of your treatment.

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2. What you need to know before you take Dovato 50 mg/300 mg film-coated tablets

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2. What you need to know before you take Dovato 50 mg/300 mg film-coated tablets

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Do not take Dovato

if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).

If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).

If you think any of these apply to you, tell your doctor. Warnings and precautions Some people taking Dovato or other combination treatments for HIV are more at risk of serious side effects than others. You need to be aware of the extra risks:

if you have moderate or severe liver disease if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don’t stop Dovato without your doctor’s advice, as your hepatitis may come back) • if you have a kidney problem. → Talk to your doctor before using Dovato if any of these apply to you. You may need extra checkups, including blood tests, while you’re taking your medicine. See section 4 for more information. Allergic reactions Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about important signs and symptoms to look out for while you’re taking Dovato. → Read the information ‘Allergic reactions’ in section 4 of this leaflet. Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious. These include: • symptoms of infections and inflammation • joint pain, stiffness and bone problems. You need to know about important signs and symptoms to look out for while you’re taking Dovato. → Read the information ‘Other possible side effects’ in section 4 of this leaflet.

Children

This medicine is not for use in children under 12 years of age, because it has not been studied in these patients.

Other medicines and Dovato

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Don't take Dovato with the following medicine:

fampridine (also known as dalfampridine), used in multiple sclerosis.

Some medicines can affect how Dovato works or make it more likely that you will have side effects. Dovato can also affect how some other medicines work.

Tell your doctor if you are taking any of the medicines in the following list:

metformin, to treat diabetes

medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato’)

supplements or multivitamins containing calcium, iron or magnesium. If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato. If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato’)

emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection

medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly

cladribine, to treat leukaemia or multiple sclerosis

rifampicin, to treat tuberculosis (TB) and other bacterial infections

phenytoin and phenobarbital, to treat epilepsy

oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder

St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression.

Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra check ups.

Pregnancy

If you are pregnant, think you may be pregnant, or if you are planning to have a baby:

Talk to your doctor about the risks and benefits of taking Dovato.

Taking Dovato at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).

If you could get pregnant while taking Dovato:

Talk to your doctor and discuss whether there is a need for contraception, such as condom or pills.

Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking Dovato without consulting your doctor, as this may harm you and your unborn child.

Breast-feeding

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. A small amount of the ingredients in Dovato can also pass into your breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Dovato can make you dizzy, and have other side effects that make you less alert.

Don’t drive or operate machinery unless you are sure you’re not affected.

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3. How to take Dovato 50 mg/300 mg film-coated tablets

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3. How to take Dovato 50 mg/300 mg film-coated tablets

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Dovato is one tablet once a day.

Swallow the tablet with some liquid. Dovato can be taken with or without food.

Use in adolescents

Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.

Antacid medicines

Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.

Talk to your doctor for further advice on taking acid-lowering medicines with Dovato.

Supplements or multivitamins containing calcium, iron or magnesium

Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into your body and make it less effective. If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato. If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it.

Talk to your doctor for further advice on taking supplements or multivitamins containing calcium, iron or magnesium with Dovato.

If you take more Dovato than you should

If you take too many tablets of Dovato contact your doctor or pharmacist for advice. If possible, show them the Dovato pack.

If you forget to take Dovato

If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

Do not take a double dose to make up for a forgotten dose.

Don’t stop taking Dovato without advice from your doctor

Take Dovato for as long as your doctor recommends. Don’t stop unless your doctor tells you to. Stopping Dovato can affect your health and how future treatment works.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.

Allergic reactions

Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir. If you get any of the following symptoms:

skin rash

a high temperature (fever)

lack of energy (fatigue)

swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing

muscle or joint aches.

See a doctor straight away. Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Dovato.

Very common side effects

These may affect more than 1 in 10 people:

headache

diarrhoea

feeling sick (nausea).

Common side effects

These may affect up to 1 in 10 people:

depression (feelings of deep sadness and unworthiness)

rash

itching (pruritus)

being sick (vomiting)

stomach (abdominal) pain or discomfort

weight gain

wind (flatulence)

dizziness

feeling drowsy

difficulty sleeping (insomnia)

abnormal dreams

lack of energy (fatigue)

hair loss

anxiety

joint pain

muscle pain.

Common side effects that may show up in blood tests are:

increase in the level of liver enzymes (aminotransferases)

increase in the level of enzymes produced in the muscles (creatine phosphokinase).

Uncommon side effects

These may affect up to 1 in 100 people:

inflammation of the liver (hepatitis)

suicidal attempt (particularly in patients who have had depression or mental health problems before)

suicidal thoughts (particularly in patients who have had depression or mental health problems before).

panic attack

Uncommon side effects that may show up in blood tests are:

a decreased number of cells involved in blood clotting (thrombocytopenia)

a low red blood cell count (anaemia) or low white blood cell count (neutropenia).

Rare side effects

These may affect up to 1 in 1000 people:

liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)

swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing

inflammation of the pancreas (pancreatitis)

breakdown of muscle tissue.

suicide (particularly in patients who have had depression or mental health problems before)

Tell your doctor immediately if you experience any mental health problems (see also other mental health problems above).

Rare side effects that may show up in blood tests are:

increase in bilirubin (a test of liver function)

increase in an enzyme called amylase.

Very rare side effects These may affect up to 1 in 10,000 people:

lactic acidosis (excess lactic acid in the blood)

numbness, tingly feelings in the skin (pins and needles)

sensation of weakness in the limbs.

Very rare side effects that may show up in blood tests are:

a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

Other possible side effects

People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:

headache

stomach ache

difficulty breathing. In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

palpitations (rapid or irregular heartbeat) or tremor

hyperactivity (excessive restlessness and movement)

weakness beginning in the hands and feet and moving up towards the trunk of the body. If you get any symptoms of infection or if you notice any of the symptoms above:

Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue are permanently damaged because of reduced blood supply to the bone. People may be more likely to get this condition:

if they have been taking combination therapy for a long time

if they are also taking anti-inflammatory medicines called corticosteroids

if they drink alcohol

if their immune systems are very weak

if they are overweight.

Signs of osteonecrosis include:

stiffness in the joints

aches and pains in the joints (especially in the hip, knee or shoulder)

difficulty moving. If you notice any of these symptoms:

Tell your doctor.

Weight, blood lipid and blood glucose effects:

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Dovato 50 mg/300 mg film-coated tablets

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5. How to store Dovato 50 mg/300 mg film-coated tablets

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Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Contents of the pack and other information What Dovato contains

The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.

The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.

What Dovato looks like and contents of the pack

Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face.

The film-coated tablets are provided in bottles closed with child-resistant closures.

Each bottle contains 30 film-coated tablets.

Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available. Not all pack sizes may be available in your c ountry

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Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES

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Avda. Extremadura 3, 09400 Aranda De Duero

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Van Asch van Wijckstraat 55H Amersfoort NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL

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Carretera De Martorell 41 61, Poligono Industrial Nord-Est

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Dovato 50 mg/300 mg film-coated tablets 30

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - HIPÉRICO ARKOPHARMA cápsulas duras

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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PROSPECTO: INFORMACIÓN PARA EL USUARIO

HIPÉRICO ARKOPHARMA cápsulas duras

Hypericum perforatum L.

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico, médico o enfermero.

- Conserve este prospecto, ya que puede tener que volver a leerlo.

- Si necesita consejo o más información, consulte a su farmacéutico.

- Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto.

- Debe consultar a un médico si empeora o si no mejora después de 28 días de tratamiento.

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Contenido del prospecto

1. Qué es HIPÉRICO ARKOPHARMA y para qué se utiliza

2. Qué necesita saber antes de empezar a tomar HIPÉRICO ARKOPHARMA

3. Cómo tomar HIPÉRICO ARKOPHARMA

4. Posibles efectos adversos

5. Conservación de HIPÉRICO ARKOPHARMA 6. Contenido del envase e información adicional.

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1. What HIPÉRICO ARKOPHARMA cápsulas duras is and what it is used for

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1. What HIPÉRICO ARKOPHARMA cápsulas duras is and what it is used for

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Medicamento a base de plantas para el tratamiento sintomático de los estados de decaimiento que cursan con desánimo, pérdida de interés, cansancio y alteraciones del sueño.

Debe consultar a un médico si empeora o si no mejora después de 28 días.

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2. What you need to know before you take HIPÉRICO ARKOPHARMA cápsulas duras

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2. What you need to know before you take HIPÉRICO ARKOPHARMA cápsulas duras

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No tome HIPÉRICO ARKOPHARMA

Si es menor de 18 años.

Si usted está embarazada o en periodo de lactancia.

Si es alérgico a Hypericum perforatum L. o a cualquiera de los componentes del medicamento.

Si va a someterse a alguna intervención quirúrgica que requiera tratamiento con otros medicamentos.

Si usted está en tratamiento con alguno de los medicamentos indicados en este prospecto. Algunos componentes del hipérico (Hypericum perforatum L.) pueden producir interacciones farmacocinéticas con gran número de medicamentos, ocasionando un posible descenso de su efectividad; (ver la información sobre la toma de otros medicamentos).

Advertencias y precauciones

Consulte a su farmacéutico, médico o enfermero antes de empezar a tomar HIPÉRICO ARKOPHARMA.

Si usted está tomando HIPÉRICO ARKOPHARMA, evite exposiciones intensas a los rayos UV (largas exposiciones al sol o baños de rayos UVA).

Las mujeres que utilizan anticonceptivos orales no deben utilizar simultáneamente este medicamento porque puede producir sangrado entre los ciclos menstruales y falta de eficacia; de los medicamentos anticonceptivos.

Evite las exposiciones a radiación solar intensa o a radiación ultravioleta artificial durante la toma de; este medicamento. No se recomienda el uso de este medicamento durante tratamientos de fototerapia (tratamientos con rayos UVA) o si va a ser sometido a algún estudio de fotodiagnóstico, particularmente en personas de piel clara, ya que se podrían producir; reacciones similares a las quemaduras solares en la piel expuesta.

Si usted ha sido diagnosticado de depresión y está en tratamiento con medicamentos psicotrópicos o con antidepresivos inhibidores selectivos de la recaptación de serotonina o medicamentos del grupo de los triptanos, no debe utilizar este medicamento.

Se deberá dejar de tomar este medicamento 10 días antes de una operación quirúrgica u otra intervención clínica programada a fin de evitar interacciones potenciales con otros medicamentos, durante el uso de anestesia general o local.

Niños y adolescentes

No deben utilizar este medicamento los niños y adolescentes menores de 18 años.

Uso de HIPÉRICO ARKOPHARMA; con otros medicamentos

Algunos componentes del hipérico (Hypericum perforatum L.) pueden producir una reducción de los efectos terapéuticos de otros medicamentos, cuando se toman simultáneamente con hipérico. En los tratamientos que pueden verse afectados por este medicamento se incluyen los medicamentos recomendados por su médico y también los que usted puede adquirir sin prescripción del médico.

No deben comenzar a utilizar preparados de hipérico sin consultar antes con su médico o farmacéutico, los pacientes que estén tomando los siguientes medicamentos:

para el SIDA (antirretrovirales)

para el rechazo de trasplantes (ciclosporina)

para la epilepsia

para el corazón (digoxina)

para el tratamiento del asma o bronquitis crónica (teofilina)

para la migraña

para la depresión

anticoagulantes orales

anticonceptivos orales

Para mayor información, consulte la siguiente lista:

No tome este medicamento si usted está en tratamiento con cualquier medicamento de los indicados en este listado:

•Agonistas 5HT (Triptanes): tales como almotriptan, eleptriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan; •Analgésicos: tales como tramadol; •Anestésicos/ medicamentos para la preparación de una intervención quirúrgica: tales como fentanilo, propofol, midazolam, sevoflurano; •Ansiolíticos: tales como buspirona; •Antagonistas hormonales:; tales como exemestano; •Antianginosos: tales como ivabradina; •Antiarrítmicos: tales como amiodarona; Antibacterianos: tales como eritromicina, claritromicina, telitromicina; •Anticoagulantes: tales como warfarina, acenocumarol; •Anticonceptivos Hormonales: anticonceptivos orales, anticonceptivos hormonales de emergencia (Píldora del día después), implantes e inyecciones hormonales, parches transdérmicos, dispositivos intrauterinos con hormonas; •Anticonvulsivantes (Antiepilépticos): tales como carbamazepina, fenobarbital, fenitoína, primidona, valproato sódico; •Antidepresivos Tricíclicos: tales como amitriptilina, clomipramina; IMAO: tales como moclobemida; ISRS (inhibidores selectivos de la recaptación de serotonina) tales como citalopram, fluoxetina, fluvoxamina, paroxetina, sertralina; Otros antidepresivos como duloxetina, venlafaxina; •Antifúngicos:; tales como itraconazol, voriconazol; •Antimaláricos: tales como lumefantrina; •Antiparkinsonianos: tales como rasagilina; •Antisicóticos:; tales como aripiprazol; •Todos los Antivirales:; tales como Inhibidores de Proteasa (amprenavir, atazanavir, darunavir, fosamprenavir indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); Inhibidores de transcriptasa inversa no nucleósidos (efavirenz, nevirapina, delavirdina); •Aprepitant (se utiliza para evitar vómitos, tras un tratamiento con quimioterapia); •Barbituratos tales como butobarbital, fenobarbital; •Bloqueadores de los canales del Calcio: tales como amlodipina, nifedipina, verapamilo, felodipina; •Citotóxicos: como irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposido, mitotano; •Diuréticos: tales como eplerenona; •Estimulantes de SNC:; tales como metilfenidato; •Glucósidos cardiacos: tales como digoxina; •Hipoglucemiantes orales (antidiabéticos orales): tales como gliclazida; •Hipolipemiantes: tales como; simvastatina, atorvastatina; •Hormonas tiroideas: todos los medicamentos de esta clase incluido Tiroxina; •Inhibidores de la bomba de protones: tales como lansoprazol, omeprazol; •Inmunosupresores: tales como ciclosporina, tacrolimus; •Litio; •Teofilina; •Terapia hormonal de remplazo: tales como los parches, geles, anillo vaginal)

En caso de tratamiento concomitante de HIPÉRICO ARKOPHARMA con medicamentos anticoagulantes (como fenprocumona, warfarina, clopidogrel, ácido acetilsalicílico y otros antireumáticos no esteroideos) no puede excluirse que el efecto de estas preparaciones se vea aumentado.

No puede excluirse que HIPÉRICO ARKOPHARMA actúe sobre la metabolización de otros medicamentos lo que puede afectar a la potencia y/o duración del efecto de los medicamentos a los que se refiere. Por esta razón, consulte con su médico o farmacéutico antes de tomar HIPÉRICO ARKOPHARMA con otros tratamientos.

Informe a su médico o farmacéutico si está tomando o ha tomado recientemente cualquier otro medicamento, incluso los adquiridos sin receta médica.

Informe también a su médico o farmacéutico sobre cualquier sospecha de cambio en los efectos de los medicamentos que está tomando a la vez que HIPÉRICO ARKOPHARMA.

Toma de HIPÉRICO ARKOPHARMA con los alimentos y bebidas

Los alimentos y las bebidas no tienen influencia sobre el efecto del medicamento.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que pudiera estar embarazada o tiene intención de quedarse embarazada, consulte a su farmacéutico o médico antes de utilizar este medicamento. No se recomienda su administración en estas circunstancias.

Conducción y uso de máquinas

No se han realizado estudios sobre la capacidad de conducir y el uso de máquinas.

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3. How to take HIPÉRICO ARKOPHARMA cápsulas duras

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3. How to take HIPÉRICO ARKOPHARMA cápsulas duras

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Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico, médico o enfermero. En caso de duda, pregunte a su farmacéutico, médico o enfermero.

La dosis recomendada es:

Adultos: tomar 2 cápsulas, 2 ó 3 veces al día con un vaso de agua.

Es aconsejable que las tomas se realicen siempre a las mismas horas.

Este medicamento se utiliza vía oral.

La duración de tratamiento es de 6 semanas.

El efecto del medicamento aparece generalmente a las 4 semanas. Si los síntomas persisten, debería consultar con un profesional sanitario.

Una vez abierto el envase, se retirará la bolsita absorbente que no es apta para consumo humano y no debe ser ingerida.

Uso en niños y adolescentes

No utilizar en niños y adolescentes menores de 18 años

Si toma más HIPÉRICO ARKOPHARMA del que debe

Si se ha tomado una dosis excesiva de HIPÉRICO ARKOPHARMA pueden aparecer convulsiones o estado de confusión.

En caso de la toma de una dosis excesiva de hipérico, se debe proteger de las radiaciones solares o de cualquier otra fuente de rayos UV durante 1-2 semanas.

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su farmacéutico o médico o llame al Servicio de Información Toxicológica, teléfono 91 562 04 20, indicando el producto y la cantidad ingerida.

Si olvidó tomar HIPÉRICO ARKOPHARMA

En caso de olvido de una dosis, tome el medicamento lo antes posible continuando el tratamiento de la forma prescrita. Sin embargo, si está próxima la siguiente dosis, es mejor que no tome la dosis olvidada y espere a la siguiente. En ningún caso tome una dosis doble para compensar la dosis olvidada.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

En casos raros, con una frecuencia que afecta a menos de un caso por cada 1000 pacientes, se han descrito problemas digestivos tales como náusea, dolor abdominal, diarrea, pérdida de apetito; o reacciones en la piel como picor, irritación, enrojecimiento (urticaria) y muy raramente podrían ocurrir reacciones similares a las quemaduras solares, en la piel expuesta a radiación solar o artificial intensa.

También se ha descrito dolor de cabeza, neuropatía, ansiedad, mareo, fatiga, manía o alergias, para los que se desconoce la frecuencia de aparición.

Comunicación de reacciones adversas:

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

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5. How to store HIPÉRICO ARKOPHARMA cápsulas duras

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5. How to store HIPÉRICO ARKOPHARMA cápsulas duras

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Mantener este medicamento fuera de la vista y del alcance de los niños.

No conservar a temperatura superior a 25ºC.

Una vez abierto, desechar después de 21 días.

No utilice HIPÉRICO ARKOPHARMA después de la fecha de caducidad que aparece en el envase, después de la abreviatura “CAD”. La fecha de caducidad es el último día del mes que se indica.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesite en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Composición de HIPÉRICO ARKOPHARMA

Cada cápsula contiene como principio activo:

175 mg de extracto seco hidroalcohólico de Hypericum perforatum L. herba (sumidades floridas de hipérico) (3.5-6:1) que corresponden a: 0,27 mg a 0,46mg de hipericinas totales, ≥ 10,5 mg de flavonoides y 2,71 mg a 4,63 mg de hiperforina.

Disolvente de extracción: etanol 60% m/m

Los demás componentes son los excipientes: celulosa microcristalina, estearato de magnesio, sílice coloidalhidrófoba y maltodextrina.

Composición de la cápsula: hipromelosa, dióxido de titanio y óxido de hierro amarillo.

Aspecto del producto y contenido del envase

Existe 1 presentación en frascos que contienen 42 cápsulas, con una bolsita absorbente en su interior.

Una vez abierto el envase, se retirará la bolsita absorbente que no es apta para consumo humano y no debe ser ingerida.

Titular de la autorización de comercialización y responsable de la fabricación:

Titular

Arkopharma LABORATORIOS, S.A.U,

C/ Amaltea, 9

28045 MADRID

Responsable de la fabricación

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

Fecha de la última revisión de este prospecto: septiembre 2016

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/

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Medicinal product subject to medical prescription

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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PATIENT INFORMATION LEAFLET

CALCICHEW*-D3 FORTE 500 mg/400 IU CHEWABLE TABLETS calcium/colecalciferol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
- Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must talk to a doctor if you do not feel better or if you feel worse after two weeks. - If you get any side effects talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet:
1. What Calcichew-D3 Forte is and what it is used for 2. What you need to know before you take Calcichew-D3 Forte
3. How to take Calcichew-D3 Forte
4. Possible side effects 5. How to store Calcichew-D3 Forte
6. Contents of the pack and other information

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1. What Calcichew-D3 Forte is and what it is used for

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1. What Calcichew-D3 Forte is and what it is used for

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WHAT CALCICHEW- D3 FORTE IS AND WHAT IT IS USED FOR

Calcichew-D3 Forte Chewable Tablets are lemon flavoured chewable tablets containing calcium and vitamin D3 which are both important substances in bone formation. Both are found in the diet and vitamin D is also produced in the skin after exposure to the sun.

Calcichew-D3 Forte is used to treat and prevent vitamin D/calcium deficiency, which may occur when your diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or during pregnancy.

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2. What you need to know before you take Calcichew-D3 Forte

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2. What you need to know before you take Calcichew-D3 Forte

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WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW- D3 FORTE

Do not take Calcichew- D3 Forte if you: • are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)
• have severe kidney problems
• have a condition that causes excessive amounts of calcium in your blood or urine
(hypercalcaemia or hypercalciuria) e.g. o renal (kidney) failure o cancer that has affected your bones • have excessive amounts of vitamin D in your blood • have kidney stones.

Warnings and precautions Talk to your doctor or pharmacist before taking Calcichew- D3 Forte: • if you have osteoporosis (brittle bones) and are also unable to move around • if you are on long term treatment, especially if you are taking medicines for a heart disorder (cardiac glycosides), or diuretics (used in the treatment of high blood pressure or oedema) • if you have signs of impaired kidney function or a high tendency to kidney stone (calculus) formation • if you have cancer or any other conditions that may have affected your bones • if you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body).

If you have any of the following conditions your serum calcium or phosphate levels, or urinary calcium excretion must be monitored. Calcichew should be taken under close medical supervision. • sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes) • kidney problems
• you are on long-term treatment with Calcichew • you are already taking additional doses of calcium or vitamin D.

If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Calcichew-D3 Forte should be reduced or the treatment discontinued.

Other medicines and Calcichew- D3 Forte Tell your pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, the following medicines may interact with Calcichew-D3 Forte chewable tablets: * thiazide diuretics (water tablets); your serum calcium levels should be monitored regularly. * cardiac glycosides (heart medicines); you should be monitored by electrocardiogram (ECG) and your serum calcium levels measured. * tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.
levothyroxine (hormone used to treat thyroid deficiency); these should be taken at least four hours before or after taking Calcichew- D3 Forte
quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin): the effect of these medicines may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcichew- D3 Forte. * bisphosphonates; should be taken at least one hour before Calcichew-D3 Forte * Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew-D3 Forte
* Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D3.

If you are taking any of the above-mentioned medicines, your pharmacist will give you further instructions.

Taking Calcichew-D3 Forte with food and drink Calcichew-D3 Forte can be taken with or without food and drink.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your pharmacist for advice before taking Calcichew-D3 Forte.

If you are pregnant, you may use Calcichew-D3 Forte in case of a calcium and vitamin D deficiency. During pregnancy you should not take more than 2500 mg calcium and 4000 IU vitamin D per day, as overdoses may harm the unborn child.

Calcichew-D3 Forte can be used during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.

Driving and using machines Calcichew- D3 Forte has no known influence on the ability to drive or use machines.

Calcichew- D3 Forte contains isomalt and sucrose.
Calcichew-D3 Forte contains isomalt (E953) and sucrose (E420): if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. May be harmful to teeth.

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HOW TO TAKE CALCICHEW- D3 FORTE

Always take Calcichew- D3 Forte Tablets exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

Dosage The recommended dose is two tablets a day, preferably one tablet in the morning and one tablet in the evening. The tablet may be chewed or sucked.

Children Calcichew-D3 Forte chewable tablets are not recommended for use in children

If you take more than you should If you have taken more Calcichew- D3 Forte than you should, talk to your pharmacist immediately.

If you forget to take Calcichew- D3 Forte Chewable Tablets Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this medicine, ask your pharmacist.

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POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking your medicine and see a doctor immediately if you experience: •
Frequent urge to urinate * Headache •
Loss of appetite, nausea or vomiting •
Unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment

Side effects may include:

Uncommon side effects (may affect up to 1 in 100 people): * excessive amounts of calcium in your blood (hypercalcaemia) or in your urine (hypercalcuria) may occur with large doses

Rare side effects (may affect up to 1 in 1,000 people): * nausea * stomach ache * constipation * heartburn (dyspepsia) * diarrhoea * wind (flatulence) * rash * hives * itching

Very rare side effects (may affect up to 1 in 10,000 people): * Milk alkali syndrome (also called Burnett’s Syndrome and usually only seen when excessive amounts of calcium have been ingested), symptoms are frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment.

Not known (frequency cannot be estimated from the available data):
* Hypersensitivity reactions such as swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema). * If you have impaired renal function, you may be at risk of increased amounts of phosphate in the blood, renal stone formation and increased amounts of calcium in the kidneys.

Reporting of side effects If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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HOW TO STORE CALCICHEW-D3 FORTE

Keep out of the sight and reach of children.

Store in the original package. Keep the container tightly closed to protect from moisture. Do not store above 30°C

Do not use Calcichew- D3 Forte Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. If the tablets have changed shape or colour do not use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcichew-D3 Forte Chewable Tablets contain The active ingredients in each tablet are: • 1250mg calcium carbonate (equivalent to 500mg calcium) • 400IU colecalciferol (equivalent to 10 micrograms vitamin D3)

The other ingredients are: xylitol (E967), povidone, isomalt (E953), fatty acid mono- and di- glycerides, magnesium stearate, lemon flavour, sucralose (E955), sucrose, tocopherol, modified maize starch, medium-chain triglycerides, sodium ascorbate and anhydrous colloidal silica (see also end of Section 2 “Calcichew-D3 Forte contains isomalt and sucrose”).

What Calcichew-D3 Forte look like and contents of the pack The tablets are round, white, uncoated, convex and lemon flavoured; they may have small specks. The tablets are packed in white, plastic bottles of 60 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, UK

Manufacturer Asker Contract Manufacturing AS, Drammensveien 852, N-1385 Asker, Norway.

This leaflet was last revised in March 2023.
Additional Information
Calcichew-D3 Forte are a combination of calcium and vitamin D designed to keep bones healthy. Calcium is an essential component of bones while vitamin D plays an important role in the absorption of calcium from food.

Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew-D3 Forte have been designed to give people whose intakes of calcium and vitamin D are low a boost to the recommended amounts.

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.

The Royal Osteoporosis Society is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The Royal Osteoporosis Society offers support to people with osteoporosis and raises awareness of the importance of healthy bones.

If you are concerned about osteoporosis, please contact the Royal Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel: 01761 471 771 or email: info@theros.org.uk.
*Registered Trademark

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8 The Chase, John Tate Road, Foxholes Business Park, Hertford Hertfordshire UK

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8 The Chase, John Tate Road, Foxholes Business Park, Hertford

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet

What Flucelvax Tetra is and what it is used for

What you need to know before you receive Flucelvax Tetra

How Flucelvax Tetra is given

Possible side effects

How to store Flucelvax Tetra

Contents of the pack and other information

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1. What Flucelvax is and what it is used for

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1. What Flucelvax is and what it is used for

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Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.

When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.

Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.

The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.

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2. What you need to know before you take Flucelvax

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2. What you need to know before you take Flucelvax

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You should not receive Flucelvax Tetra:

If you are allergic to:

the active ingredients or any of the other ingredients of this medicine (listed in section 6)

beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.

BEFORE receiving the vaccine.

Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.

You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.

You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).

You should tell your doctor if you have a bleeding problem or bruise easily.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.

As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.

Other medicines and Flucelvax Tetra

Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine. Flucelvax Tetra may be given at the same time as other vaccines.

Pregnancy and breast-feeding

Pregnancy:

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy.

Breast-feeding:

Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.

Driving and using machines

Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.

Flucelvax Tetra contains sodium chloride and potassium chloride

This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’

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Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).

Adults and children from 2 years of age:

One dose of 0.5 ml

If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical trials and during general use:

Very serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:

Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

Serious side effects

Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:

You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.

Extensive swelling of injected limb

Mild side effects

Very common (may affect more than 1 in 10 people):

Injection site pain, bruising, reddening and hardening or swelling at the site of the injection

Headache

Muscle pain

Tiredness

Loss of appetite

Irritability (only reported in children from 2 to < 6 years)

Sleepiness (only reported in children 2 to < 6 years) Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly. Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, eldery and children 9 to < 18 years.

Common (may affect up to 1 in 10 people):

Nausea, vomiting, diarrhoea

Joint pain

Shivering

Change in eating habits (only reported in children from 2 to < 6 years)

Fever (> 38°C) Vomiting was uncommon in the elderly. Fever was uncommon in adults and the elderly.

Not known (frequency cannot be estimated from the available data):

Numbness and tingling sensation (paraesthesia)

Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.

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Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2 °C to 8 °C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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What Flucelvax Tetra contains

The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) 15 micrograms HA**

A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15 micrograms HA**

B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA**

B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**

per 0.5 ml dose

..............................................

* propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown);

** haemagglutinin

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

What Flucelvax Tetra looks like and contents of the pack

Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).

Flucelvax Tetra is a clear to slightly opalescent suspension.A single syringe contains 0.5 ml of suspension for injection.Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre- filled syringes with or without needles.

Not all pack sizes may be marketed.

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INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

# entry[].resource.entry[].resource.substance.code.concept.coding[].display
INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

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INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

# entry[].resource.entry[].resource.administrableDoseForm.coding[].display
suspension for injection in pre-filled syringe

# entry[].resource.entry[].resource.contact[].address.text
Paasheuvelweg 28 1105BJ Amsterdam Netherlands

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Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1

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Medicinal product subject to medical prescription

# entry[].resource.entry[].resource.name[].productName
Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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suspension for injection in pre-filled syringe

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TEST PURPOSES ONLY - amoxicillin 250 mg tablets

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet

What Amoxicillin capsules is and what it is used for

What you need to know before you take Amoxicillin capsules

How to take Amoxicillin capsules

Possible side effects

How to store Amoxicillin capsules

Contents of the pack and other information

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1. What amoxicillin is and what it is used for

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1. What amoxicillin is and what it is used for

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What Amoxicillin capsules is and what it is used for

What Amoxicillin Capsule is Amoxicillin 250 mg and 500 mg Capsules is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’.

What Amoxicillin Capsule is used for Amoxicillin Capsule is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Capsule may also be used in combination with other medicines to treat stomach ulcers.

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2. What you need to know before you take amoxicillin

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2. What you need to know before you take amoxicillin

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Do not take Amoxicillin capsule:

if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6)

if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. Do not take Amoxicillin Capsules if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin Capsules.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amoxicillin Capsule if you:

have glandular fever (fever, sore throat, swollen glands and extreme tiredness)

have kidney problems

are not urinating regularly. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin Capsules.

Blood and urine tests

If you are having:

Urine tests (glucose) or blood tests for liver function

Oestriol tests (used during pregnancy to check the baby is developing normally) Tell your doctor or pharmacist that you are taking Amoxicillin Capsule. This is because Amoxicillin Capsule can affect the results of these tests.

Other medicines and Amoxicillin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking allopurinol (used for gout) with Amoxicillin Capsules, it may be more likely that you will have an allergic skin reaction.

If you are taking probenecid, (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. Your doctor may decide to adjust your dose of Amoxicillin Capsules.

If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.

If you are taking other antibiotics (such as tetracycline) Amoxicillin Capsules may be less effective.

If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin Capsules can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow with water without opening capsule.

Space the doses evenly during the day, at least 4 hours apart.

The recommended dose is:

Children weighing less than 40 kg

All doses are worked out depending on the child’s body weight in kilograms.

Your doctor will advise you how much Amoxicillin Capsules you should give to your baby or child.

The usual dose is 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses.

The maximum recommended dose is 100 mg for each kilogram of body weight a day.

Adults, elderly patients and children weighing 40 kg or more

The usual dose of Amoxicillin Capsules is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times a day.

Urinary tract infection: 3 g twice daily for one day.

Lyme disease (an infection spread by parasites called ticks): Isolated erythema migrans (early stage – red or pink circular rash): 4 g a day, Systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body): up to 6 g a day.

Stomach ulcers: one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers.

To prevent heart infection during surgery: the dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details.

The maximum recommended dose is 6 g per day.

Kidney problems

If you have kidney problems the dose might be lower than the usual dose.

If you take more Amoxicillin Capsules than you should

If you have taken too much Amoxicillin Capsules, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Amoxicillin Capsules

If you forget to take a dose, take it as soon as you remember.

Do not take the next dose too soon, wait about 4 hours before taking the next dose.

Do not take a double dose to make up for a forgotten dose. How long should you take Amoxicillin Capsules for?

Keep taking Amoxicillin Capsules for as long as your doctor has told you to, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.

Once you finish treatment, if you still feel unwell you should go back to see the doctor. Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxicillin Capsules is used for a long time. If this occurs tell your doctor. If you take Amoxicillin Capsules for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Amoxicillin Capsules and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

The following are very rare (may affect up to 1 in 10,000 people)

allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred

rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems

a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin Capsules, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms

a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired

other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches

flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells

the Jarisch-Herxheimer reaction which occur during treatment with Amoxicillin Capsules for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.

inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever

serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell doctor urgently if you get:

severe diarrhoea with bleeding

blisters, redness or bruising of the skin

darker urine or paler stools

yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.

These can happen when having the medicines or for up to several weeks after.

If any of the above happens stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as:

a middle itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people). If you have any of these talk to your doctor as Amoxicillin Capsules will need to be stopped. The other possible side effects are:

Common (may affect up to 1 in 10 people)

skin rash

feeling sick (nausea)

diarrhoea.

Uncommon (may affect up to 1 in 100 people)

being sick (vomiting).

Very rare (may affect up to 1 in 10,000 people)

thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist

kidney problems

fits (convulsions), seen in patients on high doses or with kidney problems

dizziness

hyperactivity

crystals in urine, leading to acute renal injury which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chances of these symptoms

the tongue may change to yellow, brown or black and it may have a hairy appearance

an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes

low number of white blood cells

low number of cells involved in blood clotting

the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.

Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)

Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug administration). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.

Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)

Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original pack below 30°C.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Medicinal product subject to medical prescription

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Karvea 75 mg tablets

irbesartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What Karvea is and what it is used for

What you need to know before you take Karvea

How to take Karvea

Possible side effects

How to store Karvea

Contents of the pack and other information

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1. What Karvea is and what it is used for

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1. What Karvea is and what it is used for

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Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

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2. What you need to know before you take Karvea

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2. What you need to know before you take Karvea

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Do not take Karvea

if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)

if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:

if you get excessive vomiting or diarrhoea

if you suffer from kidney problems

if you suffer from heart problems

if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.

if you are going to have an operation (surgery) or be given anaesthetics

an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).
You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium-sparing medicines (such as certain diuretics)

medicines containing lithium

repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Karvea with food and drink
Karvea can be taken with or without food.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Karvea contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Karvea contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you take more Karvea than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Karvea
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:

Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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What Karvea contains

The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.
Marketing Authorisation Holder:
sanofi-aventis groupe

54, rue La Boétie

F-75008 Paris - France

Manufacturer:

SANOFI WINTHROP INDUSTRIE

1, rue de la Vierge

Ambarès and Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

България

Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o. Tel: +420 233 086 111

Magyarország

SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Norge

sanofi-aventis Norge AS Tlf: +47 67 10 71 00

Eesti

Swixx Biopharma OÜ Tel: +372 640 10 30

Österreich

sanofi-aventis GmbH Tel: +43 1 80 185 – 0

Ελλάδα

sanofi-aventis AEBE Τηλ: +30 210 900 16 00

Polska

sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

España

sanofi-aventis, S.A. Tel: +34 93 485 94 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o. Tel: +385 1 2078 500

România

Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

Slovenija

Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

Italia

Sanofi S.r.l. Tel: 800 536389

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

C.A. Papaellinas Ltd. Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

Swixx Biopharma SIA Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

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White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

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1, rue de la Vierge Ambarès & Lagrave FR

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Medicinal product subject to medical prescription

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TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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unavailable

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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Prospecto: información para el usuario

Calcio/Vitamina D 3 ROVI 1000 mg / 880 UI comprimidos efervescentes

Carbonato c álcico/colecalciferol (Vitamina D3)

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

-Conserve este prospecto, ya que puede tener que volver a leerlo.

-Si tiene alguna duda, consulte a su médico o farmacéutico.

-Este medicamento se le ha recetado solamente a usted, y no debe d árselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.

-Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

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Contenido del prospecto

Qué es Calcio/Vitamina D3 ROVI y para qué se utiliza

Qué necesita saber antes de empezar a tomar Calcio/Vitamina D3 ROVI

Cómo tomar Calcio/Vitamina D3 ROVI

Posibles efectos adversos

Conservación de Calcio/Vitamina D3 ROVI

Contenido del envase e información adicional

# entry[].resource.entry[].resource.section[].section[].title
1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for

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1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for

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Calcio/Vitamina D3 ROVI son comprimidos efervescentes. Se presentan en envases con 30 comprimidos.

Este medicamento es una asociación de calcio y vitamina D que est á indicada para la corrección de la deficiencia combinada de vitamina D y calcio en pacientes de edad avanzada así como suplemento de vitamina D y calcio como coadyuvante a la terapia específica para el tratamiento de la osteoporosis en pacientes con deficiencia o con alto riesgo de deficiencia combinada de vitamina D y calcio.

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2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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No tome Calcio/Vitamina D 3 ROVI:

si es alérgico a los principios activos o a alguno de los dem ás componentes de este medicamento (incluidos en la sección 6),

si usted presenta hipercalcemia (nivel de calcio anormalmente elevado en sangre),

si usted presenta hipercalciuria (eliminación exagerada de calcio en orina),

si usted tiene litiasis c álcica (c álculos en riñones), calcificación tisular (depósito de sales de calcio en los tejidos),

si usted padece una enfermedad crónica del riñón,

si usted presenta inmovilización prolongada acompañada por hipercalciuria y/o hipercalcemia.

Este medicamento contiene aceite de soja. No debe utilizarse en caso de alergia al cacahuete o a la soja.

Advertencias y precauciones:

Consulte a su médico o farmacéutico antes de empezar a tomar Calcio/Vitamina D3 ROVI:

- si tiene insuficiencia renal (incapacidad del riñón para realizar correctamente su función),

- si tiene c álculos en el riñón,

- si padece una enfermedad del corazón, sarcoidosis (inflamación a nivel de los ganglios linf áticos, los pulmones, el hígado, los ojos, la piel y otros tejidos), o se encuentra en tratamiento con glucósidos cardíacos (medicamentos utilizados cuando existe una incapacidad del corazón para realizar correctamente su función),

- si recibe un tratamiento conjunto con otros productos con vitamina D, o est á sometido a un tratamiento prolongado o con dosis elevadas de suplementos de calcio. En este caso es posible que su médico deba efectuar controles clínicos de forma regular. Su médico le indicar á la frecuencia de estos controles.

Toma de Calcio/Vitamina D 3 ROVI con otros medicamentos:

Informe a su médico o farmacéutico si est á utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento. Ciertos medicamentos pueden interferir con Calcio/Vitamina D3 ROVI; en estos casos puede ser necesario cambiar la dosis, interrumpir el tratamiento con alguno de ellos o esperar al menos unas horas entre la administración de ambos.

Es importante que informe a su médico si est á tomando o ha tomado recientemente alguno de los siguientes medicamentos:

Glucósidos cardíacos (medicamentos para el corazón).

Tetraciclinas (ciertos antibióticos), esperar un intervalo de al menos 3 horas.

Diuréticos tiazídicos (medicamentos que aumentan la eliminación de orina).

Anticonvulsivantes.

Corticosteroides sistémicos.

Bifosfonatos y fluoruro sódico, esperar un intervalo de 3 horas.

Barbitúricos o fenitoína.

Toma de Calcio / Vitamina D 3 ROVI con alimentos y, bebidas:

Si toma este medicamento juntamente con alimentos y bebidas que contengan ácido ox álico (un compuesto presente en espinacas y ruibarbos) o ácido fítico (presente en el pan integral y cereales) y el fósforo que se encuentra en la leche pueden producirse interacciones, por lo que se aconseja no tomar este medicamento durante las 2 horas siguientes después de haber tomado este tipo de alimentos.

Embarazo y lactancia

Si est á embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Debido al contenido en vitamina D (880 UI) de Calcio/Vitamina D3 ROVI, no est á indicado su uso durante el embarazo y la lactancia, ya que la dosis diaria recomendada de vitamina D no debe superar las 600 UI/día.

Conducción y uso de máquinas:

No se han descrito efectos sobre la conducción o uso de m áquinas.

Calcio/Vitamina D 3 ROVI contiene sacarosa, sodio, lactosa y glucosa.

Este medicamento contiene sacarosa. Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento. Puede producir caries.

Este medicamento contiene 96,15 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada comprimido. Esto equivale al 4,8 % de la ingesta diaria m áxima de sodio recomendada para un adulto.

Este medicamento contiene lactosa. Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

Este medicamento contiene glucosa (en maltodextrina procedente de maíz). Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

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3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Dosis

Adultos

La dosis recomendada es de 1 comprimido efervescente (1000 mg de calcio y 880 UI de Vitamina D3) al día.

Forma y vía de administración

Este medicamento se administra por vía oral.

Disolver el comprimido en un vaso de agua y beber inmediatamente.

Duración del tratamiento

Su médico le indicar á la duración de su tratamiento con Calcio / Vitamina D3 ROVI. No suspenda antes el tratamiento.

Siga estas instrucciones a menos que su médico le haya dado otras indicaciones distintas. En estos casos es conveniente solicitar al médico las instrucciones por escrito y asegurarse de haberlas entendido bien.

Si estima que la acción de Calcio/Vitamina D3 ROVI es demasiado fuerte o débil, comuníqueselo a su médico o farmacéutico.

Recuerde tomar su medicamento.

Si toma m ás Calcio/Vitamina D 3 ROVI del que debe

Si toma m ás Calcio/Vitamina D3 ROVI del que debe, o en caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 91.562.04.20, indicando el medicamento y la cantidad ingerida.

La sobredosis puede provocar hipervitaminosis D (exceso de vitamina D) e hipercalcemia (nivel de calcio anormalmente elevado en sangre). Los síntomas en caso de sobredosis son: n áuseas, vómitos, anorexia (trastorno de la alimentación), dolor en el abdomen, sequedad de boca o poliuria (aumento del volumen de orina eliminado), o bien, irritabilidad, letargia (cansancio excesivo), estupor (disminución de la respuesta a los estímulos) y coma (pérdida de la conciencia) en casos severos.

Si olvidó tomar Calcio/Vitamina D 3 ROVI

No tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Calcio/Vitamina D 3 ROVI

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

-Poco frecuentes (pueden afectar a entre 1 y 10 de cada 1.000 pacientes ):

niveles altos de calcio en sangre hipercalcemia,

niveles altos de calcio en orina hipercalciuria.

-Raros (pueden afectar a entre 1 y 10 de cada 10.000 pacientes ):

estreñimiento,

flatulencia,

n áuseas,

dolor epig ástrico,

diarrea.

-Muy raros (pueden afectar a menos de 1 de cada 10.000 pacientes):):

picor (prurito),

erupción de la piel (exantema),

ronchas (urticaria).

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar m ás información sobre la seguridad de este medicamento.

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5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES

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Mantener este medicamento fuera de la vista y del alcance de los niños.

Conservar en el envase original para protegerlo de la humedad.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD. La fecha de caducidad es el último día del mes que se indica.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudar á a proteger el medio ambiente

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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Composición de Calcio/Vitamina D 3 ROVI

-Los principios activos son: carbonato de calcio y concentrado de colecalciferol (en forma de polvo). Cada comprimido contiene 2500 mg de carbonato de calcio (equivalente a 1.000 mg de calcio) y 22 microgramos de concentrado de colecalciferol en forma de polvo (equivalente a 880 UI de colecalciferol = vitamina D3).

-Los dem ás componentes (excipientes) son: ácido cítrico anhidro, bicarbonato de sodio, lactosa monohidratada, povidona, sacarina sódica, ciclamato de sodio, macrogol 6000, aroma de naranja (contiene maltodextrina procedente de maíz), emulsión de simeticona, ?-tocoferol, aceite de soja hidrogenado, gelatina, sacarosa y almidón de maíz sin gluten.

Aspecto del producto y contenido del envase

Comprimidos efervescentes cilíndricos, de color blanco o blanquecino.

Se presentan en tubos de polipropileno, que contienen 15 comprimidos efervescentes cada uno. Cada envase contiene dos tubos (30 comprimidos efervescentes).

Titular de la autorización de comercialización

Laboratorios Farmacéuticos ROVI, S.A.

C/ Juli án Camarillo, 35

28037 - Madrid

España

Responsable de la fabricación:

Laboratorios Losan Pharma GMBH

Otto-Hahn-Strasse 13

79395 - Neuenburg

Alemania

Fecha de la última revisión de este prospecto: julio 2019

La información detallada de este medicamento est á disponible en la p ágina web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (https://www.aemps.gob.es/)

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Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30

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Medicinal product subject to medical prescription

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Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

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Patient Medicination Information Xyntha® Lyophilized Powder for Reconstitution in a Vial

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Xyntha®

Lyophilized Powder for Reconstitution in a Vial

250, 500, 1000, or 2000 IU in single-use vials and one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride for reconstitution*

Antihemophilic Factor (Recombinant) [BDDrFVIII]

For Intravenous Injection

Antihemorrhagic Blood Coagulation Factor VIII

Reference Market: Canada

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Xyntha®

Moroctocog alfa, Antihemophilic Factor (Recombinant)

Xyntha 250, 500, 1000, & 2000 IU Powder and Solvent for Solution for Injection

This leaflet is a summary and will not tell you everything about Xyntha. Contact your doctor or hemophilia treatment center if you have any questions about the drug.

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What the medication is used for:

Coagulation Factor VIII is a protein that is necessary for blood to clot. People who have the hereditary bleeding disease factor VIII deficiency (hemophilia A) lack this clotting factor, causing their blood to take longer to form a clot. Xyntha is a form of coagulation factor VIII.

Xyntha is used for the control and treatment of bleeding and the routine and surgical prevention of bleeding in people with hemophilia A.

What is does:

Administering Xyntha increases blood levels of factor VIII and helps prevent and control bleeding episodes in patients with hemophilia A. Xyntha has the same clot-promoting effects as factor VIII protein made from human plasma.

When it should not be used:

You should not take Xyntha unless your doctor confirms you have hemophilia A. Xyntha should not be used for the treatment of other clotting factor deficiencies such as von Willebrand’s disease or hemophilia B.

Xyntha is produced in hamster cells and may contain trace amounts of hamster proteins. Patients who have a known history of allergic reactions to hamster proteins should not take Xyntha. Your doctor will advise you if you have had allergic reactions to hamster proteins.

Do not use Xyntha after the expiry date printed on the pack.

Do not use Xyntha if the packaging is torn or shows signs of tampering.

What the medicinal ingredient is:

Xyntha is a coagulation factor VIII product that is produced by recombinant technology.

Xyntha does not contain any human blood or plasma, albumin, preservatives, or added animal or human components in the final product, making it naturally free from the risk of transmission of blood-borne pathogens such as human immunodeficiency virus (HIV), hepatitis viruses, and parvovirus.

What the important nonmedicinal ingredients are:

Polysorbate 80 (0.4 mg/vial), Sucrose (12 mg/vial), L-Histidine (6 mg/vial), Calcium Chloride Dihydrate (1 mg/vial), Sodium Chloride (72 mg/vial) [after reconstitution with diluent].

What dosage forms it comes in:

Xyntha is supplied in kits that include single-use vials that contain nominally 250, 500, 1000, or 2000 IU per vial with pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride for reconstitution.

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Serious Warnings and Precautions

Xyntha may cause allergic reactions. Signs of allergy include hives (rash with itching), swelling, chest tightness, difficulty breathing, wheezing, faintness, and rapid heart rate. If any of these symptoms occur, stop using Xyntha immediately and contact your hemophilia doctor or seek emergency medical care. The initial infusions of Xyntha should be administered under proper medical supervision, where proper medical care for allergic reactions could be provided.

Notify your hemophilia doctor if you are unable to prevent or control episodes of bleeding with your normal dose of Xyntha.  Your body may produce inhibitors against Xyntha. Inhibitors are antibodies produced by your immune system that can prevent Xyntha from working properly. Check with your hemophilia doctor to make sure you are closely monitored with blood tests for the presence of inhibitors.

BEFORE you use Xyntha talk to your hemophilia doctor if:

You are pregnant or planning to become pregnant. It is not known whether Xyntha can affect your ability to have children or harm your developing baby.

You are breastfeeding or planning to breast feed. It is not known whether Xyntha passes into breast milk.

You are taking other medicines. Tell your hemophilia doctor if you are taking any other medicines or naturopathic products, including any that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Your hemophilia doctor will advise you whether or not to take Xyntha or if you need to adjust the dose, or adapt your treatment.

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No interactions of Xyntha with other medicinal products are known.

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You should always follow the specific instructions given by your hemophilia doctor.

The steps listed below are general guidelines for using Xyntha. If you are unsure of the procedures, please call your hemophilia doctor or nurse before using.

Your hemophilia doctor will decide the dose of Xyntha you will receive. The dose and duration of Xyntha treatment will depend on your individual need for replacement factor VIII therapy.

Your hemophilia doctor may decide to change your dose of Xyntha. In the presence of an inhibitor, you may need higher doses or specific treatment. Contact your hemophilia doctor or nurse immediately if bleeding is not controlled after using Xyntha.

Do not stop taking Xyntha or lower your dose, without checking with your hemophilia doctor, unless you think you are having an allergic reaction.

Your doctor may occasionally need to take blood tests to make sure that the level of factor VIII in your blood is high enough to allow normal blood clotting.

Each Xyntha vial kit contains:

1 vial of Xyntha powder

1 syringe pre-filled with 4 mL of sodium chloride diluent

1 plunger rod for the syringe

1 vial adapter

1 sterile infusion set

2 alcohol swabs

1 bandage

1 gauze

1 package insert

Xyntha Hospital pack contains:

3 vial of Xyntha powder

3 syringe pre-filled with 4 mL of sodium chloride diluent

3 plunger rods for the syringe

3 vial adapters

1 package insert

Xyntha Hospital pack does not contain:

sterile infusion set (tubing and butterfly needle)

alcohol swabs

bandage

gauze

Not all strengths/pack sizes may be marketed.

Xyntha is supplied in a sterile, freeze-dried powder form, and it is intended for injection directly into your vein, usually either by yourself, your doctor, your hemophilia nurse, or other trained person.

Before it can be injected, the powder must be dissolved with the liquid diluent supplied (0.9% sodium chloride) to make it an injectable liquid.

An infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and bandages are required.

These devices are not included in the Xyntha Hospital package.

Always use an aseptic technique.

RECONSTITUTION

Always wash your hands before performing the following procedures. Use germ-free methods during the preparation procedures.

Use only the materials provided in the Xyntha kit for dissolving the Xyntha powder with the sodium chloride diluent.

All components used in the mixing and injection of Xyntha should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to room air.

Xyntha is administered by intravenous injection after dissolving with the supplied diluent (0.9% sodium chloride) in the pre-filled syringe.

Additional instructions for using Xyntha are provided after INFUSION (Intravenous Injection) that detail the use of a Xyntha Powder and Solvent for Solution for Injection.

Note: If you use more than one vial of Xyntha per injection, each vial should be dissolved according to the following instructions. The empty syringe should be removed leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the dissolved contents of each vial. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.

Allow the vial of freeze-dried Xyntha powder and the pre-filled diluent syringe to reach room temperature.

Remove the plastic flip-top cap from the Xyntha vial to expose the central portions of the rubber stopper.

Wipe the top of the vial with alcohol swab, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.If you need to use more than 1 vial to inject your prescribed dose, you must use a new alcohol swab for each vial.

Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.

Place the vial on a flat surface. While holding the adapter in the package, place the vial adapter over the vial. Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.

Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe by pushing and turning firmly.

Break off the tamper-resistant, plastic-tip cap from the diluent syringe by snapping the perforation of the cap. This is done by bending the cap up and down until the perforation is broken. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if the dissolved Xyntha is not used immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become contaminated.

Lift the package away from the adapter and discard the package.

Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.

Slowly depress the plunger rod to inject all the diluent into the Xyntha vial.

With the syringe still connected to the adapter, gentlyswirl the contents of the vial until the powder is dissolved.

Note: The final solution should be inspected visually for particulate matter before administration. The solution should be clear to slightly pearly and colorless. If it is not, the solution should be discarded and a new kit should be used.

Ensuring that the syringe plunger rod is still fully depressed, invert the vial. Slowly draw the solution into the syringe.

Note: If you prepared more than one vial of Xyntha, remove the diluent syringe from the vial adapter, leaving the vial adapter attached to the vial. Quickly attach a separate large luer lock syringe and draw back the dissolved contents as instructed above. Repeat this procedure with each vial in turn. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.

Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Discard the vial with the adapter attached. Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.

Xyntha should be infused within 3 hours after dissolving. The dissolved solution may be stored at room temperature prior to infusion.

INFUSION (Intravenous Injection)

You should inject Xyntha as instructed by your hemophilia doctor or nurse. Once you learn how to self-infuse, you can follow the instructions in this insert.

Always wash your hands before doing the following procedures. Germ-free methods should be used during injection. If you need to use more than 1 vial to inject your prescribed dose, you must use a new alcohol swab for each vial. Do not use the injection needle to withdraw the medicine from vial.

Xyntha should be administered using the pre-filled diluent syringe provided or a single sterile disposable plastic luer-lock syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.

Attach the syringe to the luer end of the infusion set tubing and perform venipuncture as instructed by your hemophilia doctor or nurse.

Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab.

Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. Infuse the reconstituted Xyntha product over several minutes. Your comfort level should determine the rate of infusion.

After injecting Xyntha, remove the infusion set and discard. The amount of drug product left in the infusion set will not affect your treatment. Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate sharps container used for throwing away waste that might hurt others if not handled properly.

You should record the lot number of the product every time you use Xyntha. The lot number can be found on the vial label. The peel-off label on the vial may be used to record the lot number.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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Xyntha may cause allergic reactions.

Some side effects of Xyntha include cold sensation, chest pain, rapid heart beat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or inflammation and weakness.

Contact your hemophilia doctor immediately if your bleeding does not stop as expected.

Your body can also produce inhibitors, or antibodies, against Xyntha, which may prevent Xyntha from working properly. If your bleeding is not controlled with the usual dose of Xyntha, call your hemophilia doctor or nurse. You should be monitored in order to find out whether a factor VIII inhibitor is present.

These are not all the possible side effects of Xyntha. Call your hemophilia doctor or nurse right away if any side effect becomes serious, if you notice any side effects not listed in this leaflet, or if there is any other side effect that concerns you.

Tell all your doctors, dentists, and pharmacists who are treating you that you are taking Xyntha.

If you are about to start taking any new medication, tell your doctor and pharmacist that you are taking Xyntha.

If you become pregnant while taking Xyntha, tell your hemophilia doctor and your doctor who will look after you during your pregnancy.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your doctor

Stop the infusion and call your doctor

Only if severe

In all cases

Uncommon

Headache

x

Rare

Fever

x

Nausea

x

Vomiting

x

Very Rare

Bleeding does not stop as expected after infusing Xyntha

x

Using an increasing amount of Xyntha to control your bleed

x

Chills

x

Flushing

x

Allergic reactions (such as skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face)

x

This is not a complete list of side effects. For any unexpected effects while taking Xyntha, contact your doctor or hemophilia treatment center.

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Keep the freeze-dried Xyntha vial and the diluent syringe in the refrigerator at a temperature of 2° to 8°C.

Xyntha may be stored at room temperature not above 25°C for up to 3 months and not to exceed the expiration date. You should write the date in the space provided on the outer carton when you first store Xyntha at room temperature.

After room temperature storage, the product can be returned to refrigerated storage until the expiration date. Do not store Xyntha at room temperature and return it to refrigerated storage more than once.

DO NOT freeze.

DO NOT use after the expiration date (month and year) on the label, even if it has been stored properly.

Avoid exposure of the Xyntha vials to light.

Xyntha does not contain a preservative. Use the dissolved solution as soon as possible after mixing. If the solution is not used right away, it can be stored at room temperature and must be used within 3 hours.

DO NOT use Xyntha if the dissolved solution is not clear to slightly pearly and colorless.

Keep Xyntha (and needles) where young children cannot reach it.

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Last revised: April 2016

Marketing Authorisation Holder:

Pfizer Canada ULC.

17300 Trans-Canada Highway

Kirkland, Quebec

Canada, H9J 2M5

Manufactured, Packaged and Released By:

Wyeth Farma S.A,

Autovia Del Norte A-1, KM 23

Desvio Algete, KM 1,

28700 San Sebastian De Los Reyes

Madrid, Spain

THIS IS A MEDICAMENT

Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you.

Follow strictly the doctor's prescription, the method of use and the instructions of the Pharmacist who sold the medicament.

The doctor and the Pharmacist are experts in medicines, their benefits and risks.

Do not by yourself interrupt the period of treatment prescribed.

Do not repeat the same prescription without consulting your doctor.

Keep all medicaments out of reach and sight of children

Council of Arab Health Ministers

Union of Arabic Pharmacists

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Manufactured, Packaged and Released By Wyeth Farma S.A

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Wyeth Farma S.A, Autovia Del Norte A-1, KM 23, Desvio Algete, KM 1, 28700 San Sebastian De Los Reyes, Madrid, Spain 

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Pfizer Canada ULC., 17300 Trans-Canada Highway, Kirkland, Quebec, Canada, H9J 2M5

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Package leaflet: Information for the user

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Package leaflet: Information for the user

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2. What you need to know before you take acme

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2. What you need to know before you take acme

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6. Contents of the pack and other information

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6. Contents of the pack and other information

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White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

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Medicinal product subject to medical prescription