Patient leaflet - ENTECAVIR 1 MG FILM-COATED TABLETS
1. what entecavir is and what it is used for
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. 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.
2. what you need to know before you take entecavir
Do not take Entecavir
- if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
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 this medicine 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 this medicine 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 taking Entecavir.
- If you have previously received treatment for chronic hepatitis B, please inform your doctor.
Children and adolescents
Entecavir should not be used for children below 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Entecavir with food and drink
In most cases you may take this medicine 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 0.5 mg tablets with or without food.
Pregnancy, breast-feeding and fertility
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.
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 this medicine use an effective method of contraception to avoid becoming pregnant.
You should not breast-feed during treatment with this medicine.
It is not known whether entecavir, the active substance in Entecavir, is excreted in human breast milk.
Driving and using machines
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.
Entecavir contains lactose
This medicine 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.
3. how to take entecavir
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).
Your dose will depend on:
- 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.
For 0.5 mg tablet: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available. For patients weighing from 10 kg to 32.5 kg an entecavir oral solution is recommended. 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.
For 1 mg tablet: Entecavir 0.5 mg tablets are available or an entecavir oral solution may be available.
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 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 this medicine on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
If you take more Entecavir than you should Contact your doctor at once.
If you forget to take Entecavir
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.
If you stop taking Entecavir
Do not stop Entecavir without your doctor’s advice. 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.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients treated with entecavir have reported the following side effects:
Adults
Common (may affect up to 1 in 10 people):
- headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness),
- vomiting, diarrhoea, nausea, dyspepsia (indigestion)
- increased blood levels of liver enzymes.
Uncommon (may affect up to 1 in 100 people):
- rash,
- hair loss.
Rare (may affect up to 1 in 1,000 people):
- severe allergic reaction.
Children and adolescents
The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:
Very common (may affect more than 1 in 10 people):
- low levels of neutrophils (one type of white blood cells, which are important in fighting infection).
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 Yellow Card scheme at:. By reporting side affects you can help provide more information on the safety of this medicine.
What Entecavir looks like and contents of the pack
Entecavir 0.5 mg film-coated tablets are presented as white to off white triangular-shaped tablets debossed with “0.5” on one side, with the following dimensions: median 8.4 mm ± 0.2 mm and thickness 3.7 mm ± 0.3 mm.
Entecavir 1.0 mg film-coated tablets are presented as pink triangular-shaped tablets debossed with “1” on one side, with the following dimensions: median 10.6mm ± 0.2 mm and thickness 4.5 mm ± 0.3 mm.
Entecavir is supplied in a cardboard box containing OPA/ALU/PVC – Aluminium foil blisters or a white HDPE bottle with PP child resistant cap and induction sealing.
Pack sizes
30 tablets (blister)
30 × 1 tablets (blister)
90 tablets (blister)
90 × 1 tablets (blister)
30 tablets (bottle)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court,
Eastgate Way
Manor Park, Runcorn, Cheshire, WA7 1NT, UK
Manufacturer:
Pharmathen SA
6 Dervenakion Str
Pallini, 15351
Greece
Or
Pharmathen Internaational S.A
Industrial Park Sapes, Rodopi Prefecture,
Block No 5
Rodopi, 69300,
Greece
Or
Heumann Pharma GmbH & Co. Generica KG
Sudwestpark 50
Nurnberg, 90449
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
5. how to store entecavir
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, blister or box after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening of the bottle, the tablets should be used within 30 days.
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.
Denmark Entecavir Pharmathen
United Kingdom Entecavir
Germany Entecavir Heumann 0,5 mg &
1 mg Filmtabletten
Italy Entecavir Kabi
Spain Entecavir Kabi 0,5 mg comprimidos
recubiertos con pelicula EFG Entecavir Kabi 1,0 mg comprimidos recubiertos con pelicula EFG
Poland Entecavir Synoptis
France ENTECAVIR PHARMATHEN 0,5 mg,
comprime pellicule
ENTECAVIR PHARMATHEN 1 mg, comprime pellicule
This leaflet was last revised in April 2020
6. contents of the pack and other information
VI
What Entecavir contains
- The active substance is entecavir.
Each film-coated tablet of Entecavir 0.5 mg contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Each film-coated tablet of Entecavir 1.0 mg contains entecavir monohydrate equivalent to 1 mg entecavir.
- The other ingredients are: