Entecavir 0.5 mg film-coated tablets

• 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.

1. What Entecavir is and what it is used for
2. What you need to know before you take Entecavir
3. How to take Entecavir
4. Possible side effects
5. How to store Entecavir
6. Contents of the pack and other information

Talk to your doctor or pharmacist before taking Entecavir

• if you have ever had problems with your kidneys, tell your doctor. This is important because Entecavir is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
• do not stop taking Entecavir without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Entecavir is stopped, your doctor will continue to monitor you and take blood tests for several months.
• discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir treatment may be.
• if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Entecavir to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Entecavir will not control your HIV infection.
• taking Entecavir will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.
• Entecavir belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Entecavir.
• if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Entecavir should not be used for children below 2 years of age or weighing less than 10 kg.

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

In most cases you may take Entecavir with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following: If you were switched over to Entecavir because the treatment with lamivudine was not successful, you should take Entecavir on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir on an empty stomach. Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

Children and adolescents (from 2 to less than 18 years of age) can take Entecavir with or without food.

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Entecavir is safe to use during pregnancy. Entecavir must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Entecavir use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Entecavir. Tell your doctor if you are breastfeeding. It is not known whether entecavir, the active ingredient in Entecavir, is excreted in human breast milk.

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

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

• whether you have been treated for HBV infection before, and what medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
• the condition of your liver.

For children and adolescents (from 2 to less than 18 years of age) your child's doctor will decide the right dose based on your child's weight.

An entecavir oral solution is recommended for patients weighing from 10 kg to 32.5 kg. Children weighing at least 32.6 kg may take an entecavir oral solution or the 0.5 mg tablet or may be available. All dosing will be taken once daily orally (by mouth). There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg.

Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Entecavir for as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.

Some patients must take Entecavir on an empty stomach (see Entecavir with food and drink in Section 2). If your doctor instructs you to take Entecavir on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

Contact your doctor at once.

It is important that you do not miss any doses. If you miss a dose of Entecavir, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take 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 dose.

Some people get very serious hepatitis symptoms when they stop taking Entecavir. Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.

Common (at least 1 in 100 patients):

• headache
• insomnia (inability to sleep), somnolence (sleepiness)
• fatigue (extreme tiredness)
• dizziness
• vomiting, diarrhoea, nausea, dyspepsia (indigestion)
• increased blood levels of liver enzymes

Uncommon (at least 1 in 1,000 patients):

• rash
• hair loss

Rare (at least 1 in 10,000 patients):

• severe allergic reaction

The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).

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 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.

• The active substance is entecavir.
• Entecavir 0.5 mg: Each film-coated tablet contains 0.5 mg entecavir.
• Entecavir 1 mg: Each film-coated tablet contains 1 mg entecavir.
• The other ingredients are:
  Tablet core: Lactose Monohydrate, Povidone K30, Crospovidone, Microcrystalline cellulose PH 102 and Magnesium stearate.
  Film coating:
  0.5 mg: Opadry 13B58802 White (containing HPMC 2910/Hypromellose (E464), Titanium dioxide (E171), Macrogol 400 (E1521) and Polysorbate 80 (E433)).
  1 mg: Opadry 13B84610 Pink (containing HPMC 2910/Hypromellose (E464), Titanium dioxide (E171), Macrogol 400 (E1521), Polysorbate 80 (E433) and iron oxide (red) (E172)).

Entecavir 0.5 mg film-coated tablets are white to off white, triangular shaped film coated tablets, of dimensions 8.60 X 8.30 mm, debossed with ‘RL1’ on one side and plain on other side.

Entecavir 1 mg film-coated tablets are light pink to pink, triangular shaped film-coated tablets, of dimensions 10.90 X 10.60 mm, debossed with ‘RL2’ on one side and plain on other side.

The film-coated tablets are available in HDPE bottle, in blister packs containing 30 or 90 film-coated tablets and in unit dose blister packs containing 30 x 1 or 90 x 1 film-coated tablets.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: ENTECAVIR BASICS 0.5 mg, Filmtabletten

ENTECAVIR BASICS 1 mg, Filmtabletten

Italy: Entecavir SUN 0.5 mg compresse rivestite con film

Entecavir SUN 1 mg compresse rivestite con film

Poland: Entecavir Ranbaxy

Romania: Entecavir Terapia 0.5 mg comprimate filmate

Entecavir Terapia 1 mg comprimate filmate

Spain: Entecavir SUN 0.5 mg comprimidos recubiertos con película EFG

Entevavir SUN 1 mg comprimidos recubiertos con película EFG

United Kingdom: Entecavir 0.5 mg film coated tablets

Entecavir 1 mg film coated tablets