Package leaflet: Information for the user

Hepsera 10 mg tablets

adefovir dipivoxil

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.

What is in this leaflet

1. What Hepsera is and what it is used for

2. What you need to know before you take Hepsera

3. How to take Hepsera

4. Possible side effects

5. How to store Hepsera

6. Contents of the pack and other information

1. What Hepsera is and what it is used for What Hepsera is

   Hepsera contains the active substance adefovir dipivoxil and 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.

   
   

2. What you need to know before you take Hepsera 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.

     
     

     Children and adolescents

     
     

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

     
     

     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, drink and alcohol

       
       

       Hepsera can be taken with or without food (see section 3).

       
       

       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.

     Driving and using machines

     Hepsera should not affect your ability to drive or use any tools or machinery.

     
     

     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.

     
     

     Hepsera contains sodium

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

     
     

3. How to take Hepsera

   
   

   Always take this medicine exactly as your doctor has told you. This is 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.

   
   

   • The recommended dose is one 10 mg tablet each day, taken orally 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 forget to take Hepsera

     
     

     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 to make up for a forgotten tablet (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.

     
     

     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.

     
     

4. Possible side effects

   
   

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

   Very rare side effects (may affect up to 1 in 10,000 people)

   
   

   • 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.

     
     

     Uncommon side effects (may affect up to 1 in 100 people)

     
     

   • Damage to kidney tubule cells

     
     

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

     
     

   • 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 (may affect more than 1 in 10 people)

     
     

   • 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

     
     

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

   • Kidney failure

     
     

   • Kidney problems may lead to softening of the bones (which causes bone pain and sometimes leads to fractures) and muscle pain or weakness.

     
     

   • Inflammation of the pancreas (pancreatitis)

     
     

     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.

     
     

5. How to store Hepsera

   
   

   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 30ºC. Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

   
   

   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.

   
   

6. Contents of the pack and other information What Hepsera contains

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

The following pack sizes are available: outer cartons containing 1 bottle of 30 tablets and outer cartons containing 90 (3 bottles of 30) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Gilead Sciences Ireland UC Carrigtohill

County Cork, T45 DP77 Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill County Cork Ireland

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

België/Belgique/Belgien

Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 24 01 35 50

Lietuva

Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702

България

Gilead Sciences Ireland UC Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg

Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 24 01 35 50

Česká 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 22 262 8702

Norge

Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849

Ελλάδα

Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100

Österreich

Gilead Sciences GesmbH Tel: + 43 1 260 830

España

Gilead Sciences, S.L.

Tel: + 34 91 378 98 30

Polska

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

France

Gilead Sciences

Tél: + 33 (0) 1 46 09 41 00

Portugal

Gilead Sciences, Lda.

Tel: + 351 21 7928790

Hrvatska

Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888

România

Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888

Ireland

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

Κύπρος

Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100

Sverige

Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849

Latvija

Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702

United Kingdom (Northern Ireland)

Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 700

This leaflet was last revised in {MM/YYYY}.

u

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.