HEPSERA 10 MG ADEFOVIR DIPIVOXIL TABLETS - patient leaflet, side effects, dosage

What Hepsera is

Hepsera belongs to a group of medicines called antiviral medicines.

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Hepsera®

10 mg tablets

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Do not take Hepsera

• ■ If you are allergic to adefovir, adefovir dipivoxil or any of the other ingredients of this medicine (listed in section 6).

• ■ Tell your doctor at once if you could be allergic to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.

Warnings and precautions

Talk to your doctor before using Hepsera.

• ■ Tell your doctor if you have had kidney disease , or if tests have shown problems with your kidneys. Hepsera can affect the way your kidneys work. The risk of this occurring is increased with long-term use of Hepsera. Your doctor should run tests to check your kidneys and liver are working properly, before and during your treatment. Depending on the results, your doctor may change how often you take Hepsera.

• ■ If you are over 65 years of age your doctor may monitor your health more closely.

• ■ Don’t stop taking Hepsera without your doctor’s advice.

• ■ After stopping Hepsera tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. Some patients have had symptoms or blood tests indicating that their hepatitis has worsened after stopping treatment with Hepsera. It’s best for your doctor to monitor your health after stopping treatment with Hepsera. You may need blood tests for several months after treatment.

• ■ Once you start taking Hepsera:

• ■ look out for possible signs of lactic acidosis -see section 4, Possible side effects.

• ■ your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.

• ■ Take care not to infect other people. Hepsera does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. You must continue to take precautions to avoid this. A vaccine is available to protect those at risk from becoming infected with HBV.

• ■ If you are HIV positive this medicine will not control your HIV infection.

Other medicines and Hepsera

• ■ Do not take Hepsera if you are taking any medicines containing tenofovir.

• ■ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines and herbal products obtained without a prescription.

• ■ It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:

• ■ vancomycin and aminoglycosides, used for bacterial infections

• ■ amphotericin B, for fungal infections

• ■ foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections

• ■ pentamidine, for other types of infection.

Hepsera with food and drink

Hepsera can be taken with or without 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 are pregnant or planning to become pregnant. It is not known whether Hepsera is safe to use during human pregnancy.

• ■ Use an effective method of contraception to avoid becoming pregnant if you are a woman of child-bearing age taking Hepsera.

• ■ Do not breast-feed while taking Hepsera. It is not known whether the active substance in this medicine passes into breast milk.

Hepsera contains lactose

If you are lactose-intolerant, or if you have been told that you have an intolerance to some sugars, talk to your doctor before taking Hepsera.

If you stop taking Hepsera

• ■ Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. See section 2 for more details.

• ■ Don’t stop taking Hepsera without your doctor’s advice.

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

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Children and adolescents

■Do not use Hepsera in children or adolescents under 18 years of age.

Side effects before or after having a liver transplant

Some patients have experienced:

• ■ Rash and itching – common

• ■ Feeling sick (nausea) or being sick (vomiting) – common

• ■ Kidney failure – common

• ■ Kidney problems – very common

^Tell a doctor or pharmacist if you are worried about any of these.

• ■ Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.

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 bottle and carton after {EXP}. The expiry date refers to the last day of that month.

Do not store above 30°C (86°F). Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

Return any left over tablets to your pharmacist. Only keep them if your doctor tells you to. 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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Sp'Z0'0' Tel:+ 44 (0)8000 113 700

Tel:+ 48 22 262 8702