What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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: PL 25258/0234 .


Entecavir 0.5-1 mg film-coated tablets

Package leaflet: Information for the user

Entecavir 0.5 mg film-coated tablets

Entecavir 1 mg film-coated tablets

Entecavir

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

1. What Entecavir tablets 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 tablets 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 tablets 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 tablets 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 tablets

Do not take Entecavir tablets

if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warning and precautions

Talk to your doctor or pharmacist before taking Entecavir tablets

  • 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 tablets without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Entecavir tablets 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 tablets treatment may be.
    • if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Entecavir tablets 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 tablets will not control your HIV infection.
  • taking Entecavir tablets 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 tablets 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 tablets
  • if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

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

Other medicines and Entecavir tablets

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

Entecavir tablets with food and drink

In most cases you may take Entecavir tablets 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 tablets because the treatment with lamivudine was not successful, you should take Entecavir tablets on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir tablets 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 tablets with or without food.

Pregnancy, breast-feeding and fertility

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

You should not breast-feed during treatment with Entecavir tablets Tell your doctor if you are breast- feeding. It is not known whether entecavir, the active ingredient in Entecavir tablets, 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 tablets contains lactose

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.

3. How to take Entecavir tablets

Not all patients need to take the same dose of Entecavir tablets.

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. 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.

Your child's doctor will decide the right dose based on your child's weight.

For children and adolescents (from 2 to less than 18 years of age), weighing at least 32.6 kg and requiring a dose of 0.5 mg (=halve a tablet of 1 mg), Entecavir tablets 0.5 mg tablets are also available.

All dosing will be taken once daily orally (by mouth).

For children and adolescents weighing less than 32.6 kg and for dosages below 0.5 mg an entecavir oral solution may be available.

Your child's doctor will decide the right dose based on your child's weight.

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

The tablet can be divided into equal doses.

If you take more Entecavir tablets than you should

Contact your doctor at once.

If you forget to take Entecavir tablets

It is important that you do not miss any doses. If you miss a dose of Entecavir tablets, 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.

Do not stop Entecavir tablets without your doctor’s advice

Some people get very serious hepatitis symptoms when they stop taking Entecavir tablets. 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 tablets have reported the following side effects:

Adults

  • common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and 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.

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 (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.

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 Yellow Card Scheme, Website: 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

5. How to store Entecavir tablets

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 blister or carton after EXP. That expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from moisture.

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 Entecavir film-coated tablets contains

Entecavir film-coated tablets 0.5 mg:

The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate corresponding to 0.5 mg entecavir.

The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch pregelatinised, crospovidone (Type A) (E1202) and magnesium stearate.

Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521) and polysorbate 80 (E433).

Entecavir film-coated tablets 1 mg:

The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate corresponding to 1 mg entecavir.

The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch pregelatinised,crospovidone (Type A) (E1202) and magnesium stearate.

Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521), polysorbate 80 (E433) and red iron oxide (E172)

What Entecavir film coated tablets looks like and contents of the pack

Entecavir film coated tablets 0.5 mg:

Entecavir film-coated tablets are white and oval-shaped with a break line on both sides.

Entecavir film coated tablets 1 mg:

Entecavir film-coated tablets are pink and oval-shaped with a break line on both sides.

Entecavir film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited
Laxmi House
2 B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom

Manufacturer

Medis International a.s., výrobní závod Bolatice
Průmyslová 961/16
Bolatice
74723
Czech Republic

This leaflet was last revised in December 2020