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Hepsera (Adefovir dipivoxil)

What Hepsera is and what it is used for

What Hepsera is

Hepsera belongs to a group of medicines called antiviral medicines.

What it is used for

Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults. Infection with the hepatitis B virus leads to damage to the liver. Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage.

Before you take Hepsera

Do not take Hepsera

  • If you are allergic (hypersensitive) to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.

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

Take special care with 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. 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.

Do not use Hepsera in children or adolescents under 18 years of age. 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. Taking other medicines

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

Taking Hepsera with food and drink

Hepsera can be taken with or without food. Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any 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.

How to take Hepsera

It is important to take Hepsera exactly as your doctor has told you to make sure that your medicine is fully effective and to reduce the development of resistance to the treatment. Check with your doctor or pharmacist if you are not sure how to take Hepsera.

The usual dose is one 10 mg tablet each day, taken with or without food.

A different dose may be given to patients with kidney problems. If you take more Hepsera than you should

  • If you accidentally take too many Hepsera tablets, contact your doctor or nearest hospital immediately. If you miss a dose or you vomit It is important not to miss a dose.
  • If you do miss a dose of Hepsera, take it as soon as you can, and then take your next scheduled dose at its regular time.
  • If it is nearly time for your next dose, skip the missed dose. Wait and take the next dose at the regular time. Do not take a double dose (two doses close together).
  • If you are sick (vomit) less than 1 hour after taking Hepsera take another tablet. You do not need to take another tablet if you are sick more than 1 hour after taking Hepsera.

Effects when Hepsera is stopped

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

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

If you have any questions on how to use Hepsera, ask your pharmacist or doctor.

Possible side effects

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

Very rare side effects

(These can affect less than 1 in 10,000 people taking Hepsera)

Lactic acidosis is a serious but very rare side effect of taking Hepsera. It can cause too much lactic acid in the blood and enlargement of the liver. Lactic acidosis occurs more often in women, particularly if they are very overweight. People with liver disease may also be at risk.

Some of the signs of lactic acidosis are:

  • Feeling sick (nausea) and sickness (vomiting)
  • Stomach pain

Contact your doctor at once if you get any of these symptoms. They are the same as some of the common side effects of Hepsera. If you do get any of them, it is unlikely to be serious, but you need to check. Your doctor will monitor you regularly while you take Hepsera.

Common side effects

(These can affect 1 to 10 in every 100 people taking Hepsera)

  • Headache
  • Feeling sick (nausea)
  • Diarrhoea
  • Digestive problems including wind or discomfort after eating meals
  • Stomach pain
  • Kidney problems, as shown by blood tests

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

Very common side effects

(These can affect more than 10 in every 100 people taking Hepsera)

  • Weakness

Tell a doctor or pharmacist if you are worried about this. 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.

Other possible side effects

Some patients may also experience:

  • Kidney failure
  • Damage to kidney tubule cells
  • Muscle pain or weakness and softening of the bones (both associated with kidney problems)
  • Inflammation of the pancreas (pancreatitis)

If you notice any other effects, even ones not listed in this leaflet tell your doctor or pharmacist.

How to store Hepsera

Keep out of the reach and sight of children.

Do not use after the expiry date 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. Medicines should not be disposed of via wastewater or household waste – this helps protect the environment.

Further information

What Hepsera contains

The active substance in Hepsera is adefovir dipivoxil. Each tablet contains 10 mg adefovir dipivoxil.

The other ingredients are: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate.

What Hepsera looks like and contents of the pack

Hepsera 10 mg tablets are round, white to off-white tablets. The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side. Hepsera 10 mg tablets are supplied in bottles of 30 tablets with silica gel desiccant. The silica gel desiccant is contained in either a separate sachet or a small canister and should not be swallowed.

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