10 mg tablets
adefovir dipivoxil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. WHAT HEPSERA IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE HEPSERA
3. HOW TO TAKE HEPSERA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE HEPSERA
6. FURTHER 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 in adults, an infection caused by the hepatitis B virus (HBV).

Infection with the hepatitis B virus leads to liver damage. Hepsera reduces the amount of virus in the body and has been shown to reduce liver damage.

2. 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 immediately if you may be allergic to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.

Warnings and cautions

Talk to your doctor before using Hepsera.

  • Tell your doctor if you have had kidney disease, or if tests have shown that you have kidney problems. Hepsera can affect kidney function. The risk of this happening increases with long-term use of Hepsera. Your doctor should take samples to check that your kidneys and liver are working properly, before and during treatment. Depending on the results, your doctor may change how often you should take Hepsera.
  • If you are over 65 years old , your doctor can check your health condition more closely.
  • Do not stop taking Hepsera without consulting your doctor.
  • When you stop taking Hepsera, tell your doctor immediately if you get any new, unusual or worsening symptoms that you notice after stopping treatment. Some patients have had symptoms or blood test results that have shown that their hepatitis has worsened after stopping treatment with Hepsera. It is therefore best that your doctor checks your state of health even after stopping treatment with Hepsera. You may need to submit blood samples for several months after treatment.
  • After starting treatment with Hepsera:
    • you should be aware of any 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 infection with hepatitis B under control.
  • Be careful not to infect other people . Hepsera does not reduce the risk of you infecting others with HBV through sexual contact or blood transfusions. You must continue to take precautions to avoid this. There is a vaccine that protects those who are at risk of becoming infected with HBV.
  • If you are HIV -positive, this drug is not to keep your HIV – infection under control.

Children and young people

  • Hepsera should not be used in children or adolescents under 18 years of age.

Taking other medicines

  • Do not take Hepsera if you are taking any other medicine containing tenofovir.
  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal remedies.
  • It is especially important that you tell your doctor if you are taking or have recently taken any of the following medicines that may damage your kidneys or interact with Hepsera:
    • vancomycin and aminoglycosides you against bacterial infection s
    • amphotericin B, against fungal infections
    • foscarnet, cidofovir or tenofovir disoproxil fumarate, against viral infections
    • pentamidine, against other types of infection er.

Taking Hepsera with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 if Hepsera is safe to use during pregnancy in humans.
  • Use an effective method of contraception to avoid becoming pregnant if you are a pregnant woman taking Hepsera.
  • Do not breast-feed while taking Hepsera . It is not known if the active substance in this medicine is excreted in human milk.

Driving and using machines

Hepsera should not affect your ability to drive or use tools and machines.

Hepsera contains lactose

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

Hepsera contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is 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 gives full effect and to reduce the development of resistance to the treatment. Ask your doctor or pharmacist if you are unsure.

  • The recommended dose is one 10 mg tablet every day, which is swallowed with or without food.
  • Another 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 or if you vomit

It is important that you do not miss a dose.

  • If you miss a dose of Hepsera, take it as soon as you can and then take the next dose at the usual time.
  • If it is soon time to take your next dose , skip the missed dose . Wait and take the next dose at the usual time. Do not take a double doseto compensate for a forgotten tablet (two doses close to each other).
  • If you vomit less than 1 hour after taking Hepsera, take a new tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Hepsera.

If you stop using Hepsera

If you stop taking Hepsera

  • Tell your doctor immediately if you get any new , unusual or worsening symptoms that you notice after stopping treatment. See section 2 for more information.
  • Do not stop taking Hepsera without consulting your doctor.

If you have any further questions on the use of this product, 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 effect s

may affect up to 1 in 10,000 people )

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

Some of the signs of lactic acidosis are:

  • Nausea and vomiting
  • Magont

-> Contact your doctor immediately if you get any of these symptoms. They are the same as some of Hepsera’s common side effects. If you get any of them, it’s probably not serious, but you need to check it out. Your doctor will check you regularly while you are taking Hepsera.

Uncommon side effects are

(May affect up to 1 in 100 people)

  • Damage to the kidney (cells in the renal tubules).

Common side effects are

(may affect up to 1 in 10 people)

  • Headache
  • Nausea
  • Diarrhea
  • Indigestion, including flatulence or discomfort after meals
  • Magont
  • Kidney problems, which show up in blood tests

– If you have any of these symptoms, talk to your doctor or pharmacist.

Very common side effects are

(may affect more than 1 in 10 people)

  • Weakness

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

Side effects are before or after liver transplantation

Some patients have experienced:

  • Skin rash and itching – common
  • Nausea or vomiting – common
  • Kidney failure – common
  • Kidney problems – very common

-> If you have any of these concerns, ask your doctor or pharmacist.

  • Blood tests may also show decreased phosphate levels (common) or elevated creatinine levels (very common) in the blood.

Other possible side effects are

The following side effects have been reported (affects an unknown number of people):

  • Kidney failure
  • Kidney problems can lead to decreased bone hardness (which causes skeletal pain and sometimes fractures ) and muscle pain or muscle weakness
  • Inflammation of the pancreas ( pancreatitis )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 jar and carton after {EXP}. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Moisture sensitive. Close the jar tightly.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Content declaration

  • The active substance in Hepsera is adefovir dipivoxil. Each tablet contains 10 mg adefovir dipivoxil.
  • The other ingredients are pregelatinized starch , croscarmellose sodium, lactose monohydrate , talc and magnesium stearate.

What the medicine looks like and contents of the pack

Hepsera 10 mg tablets are round, white to off-white tablets. The tablets are imprinted with “GILEAD” and “10” on one side and a stylized contour of a liver on the other side. Hepsera 10 mg tablets are supplied in jars containing 30 tablets and with silica gel as desiccant. The desiccant is available either in a separate bag or in a small box and must not be swallowed.

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

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

Contact the representative of the marketing authorization holder to find out more about this medicine.

Sweden

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Muhammad Nadeem

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