The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL31750/0107.
Entecavir 0.5 mg & 1mg film-coated tablets
Entecavir 0.5 mg film-coated tablets
Entecavir 1 mg film-coated tablets
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
Entecavir tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Entecavir can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Entecavir tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entecavir can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Infection by the hepatitis B virus can lead to damage to the liver. Entecavir reduces the amount of virus in your body, and improves the condition of the liver.
Do not take Entecavir if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Entecavir
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.
Not all patients need to take the same dose of Entecavir.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients treated with entecavir have reported the following side effects:
Entecavir can cause a rare but serious side effect called lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Please see Section 2 under Warnings and Precautions for more information.
Common (at least 1 in 100 patients):
Uncommon (at least 1 in 1,000 patients):
Rare (at least 1 in 10,000 patients):
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.
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 label and carton after EXP.
That expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Bottle: Use within 30 days after the first opening of the bottle.
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.
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
This leaflet was last revised in February 2023.