ENTECAVIR MYLAN 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir Mylan 0.5 mg film-coated tablets EFG

Entecavir Mylan 1 mg film-coated tablets EFG

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.

Contents of the pack

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

1. What is Entecavir Mylan and what is it used for

Entecavir Mylan tablets are an antiviral medicine used to treat long-term (chronic) hepatitis B virus (HBV) infection in adults.Entecavir Mylan may be used in patients whose liver is damaged but still functions properly (compensated liver disease) and in patients whose liver is damaged and does not function properly (decompensated liver disease).

Entecavir Mylan tablets are also used to treat chronic (long-term) HBV infection in children and adolescents from 2 to less than 18 years of age.Entecavir Mylan may be used in children whose liver is damaged but still functions properly (compensated liver disease).

Hepatitis B virus infection can damage the liver. Entecavir Mylan reduces the amount of virus in your body and improves the condition of your liver.

2. What you need to know before you take Entecavir Mylan

Do not take Entecavir Mylan

Warnings and precautions

Talk to your doctor or pharmacist before taking Entecavir Mylan

• , tell your doctor. This is important because Entecavir Mylan is removed from the body by the kidneys and it may be necessary to adjust your dose or treatment schedule.

• do not stop taking Entecavir Mylan without talking to your doctor, as your hepatitis may get worse when treatment is stopped. When you stop treatment with Entecavir Mylan, your doctor will follow you up and do blood tests for several months.

• ask your doctor if your liver is working properlyand, if not, about the possible effects that your treatment with Entecavir Mylan could have.

• , tell your doctor. You should not take Entecavir Mylan to treat your hepatitis B infection unless you are also taking medicines to treat your HIV infection, as the effectiveness of future HIV treatments may be reduced. Entecavir Mylan will not control your HIV infection.

• taking Entecavir Mylan will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent others from becoming infected with HBV. There is a vaccine to protect people at risk of HBV infection.

• Entecavir Mylan belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and an enlarged liver. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this serious side effect has been fatal. Lactic acidosis occurs more frequently in women, especially in those who are overweight. Your doctor will monitor you regularly while you are taking Entecavir Mylan.

• , please inform your doctor.

Children and adolescents

Entecavir Mylan should not be used in children under 2 years of age or weighing less than 10 kg.

Other medicines and Entecavir Mylan

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

Taking Entecavir Mylan with food and drinks

In most cases, you can take Entecavir Mylan with or without food. However, if you have received previous treatment with another medicine containing lamivudine as the active ingredient, you should consider the following. If you have switched to Entecavir Mylan because treatment with lamivudine was not successful, you should take Entecavir Mylan on an empty stomach, once a day. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Mylan on an empty stomach. An empty stomach means at least 2 hours after and 2 hours before the next meal.

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

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been proven that the use of entecavir is safe during pregnancy. You should not use Entecavir Mylan during pregnancy unless it is clearly necessary, according to your doctor. It is important that women of childbearing age using Entecavir Mylan use an effective method of contraception to avoid becoming pregnant.

You should not breastfeed during treatment with Entecavir Mylan. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient of Entecavir Mylan, is excreted in breast milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that could affect your ability to drive and use machines. If you are unsure, talk to your doctor.

Entecavir Mylan contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Entecavir Mylan

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

Follow your doctor's instructions exactly for taking this medicine.

If you are unsure, talk to your doctor or pharmacist again.

For adults, the recommended dose is 0.5 mg or 1 mg once a day (by mouth).

Your dose will depend on:

• whether you have been treated before for a hepatitis B infection, as well as the medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or tell 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 pediatrician will decide on the right dose based on the child's body weight. For children weighing at least 32.6 kg, they can take the 0.5 mg entecavir tablets or an oral solution may be available. An oral solution of entecavir is recommended for patients with a weight between 10 kg and 32.5 kg. All doses should be taken once a day (by mouth). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

For children and adolescents(from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg tablets or an oral solution may be available. Your pediatrician will decide on the correct dose based on your child's weight.

Your doctor will advise you on the right dose for you.

Always take the dose recommended by your doctor to ensure the medicine is fully effective and to reduce the development of resistance to treatment. Take Entecavir Mylan for as long as your doctor tells you. Your doctor will tell you when to stop treatment.

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

If you take more Entecavir Mylan than you should

Contact your doctor immediately.

If you forget to take Entecavir Mylan

It is important that you do not miss any dose. If you miss a dose of Entecavir Mylan, you should take it as soon as possible and then take the next dose at the usual time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Entecavir Mylan without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking entecavir. Tell your doctor immediately if you notice any change in symptoms after stopping treatment.

If you have any other questions about 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:

common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, drowsiness, vomiting, diarrhea, nausea, indigestion, and increased levels of liver enzymes in the blood; uncommon (at least 1 in 1,000 patients): skin rash, hair loss; rare (at least 1 in 10,000 patients): severe allergic reaction.

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Mylan

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Mylan

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

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

The other ingredients are:

Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2 "Entecavir Mylan contains lactose"), magnesium stearate

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

Appearance of Entecavir Mylan and pack contents

0.5 mg: white, film-coated, biconvex, beveled-edge, round tablets, engraved with "M" on one side and "EA" on the other.

1 mg: white, film-coated, biconvex, beveled-edge, round tablets, engraved with "M" on one side and "EB" on the other.

Entecavir Mylan 0.5 mg and 1 mg film-coated tablets are available in blister packs containing 30 tablets, perforated unit dose blister packs containing 30 x 1 or 90 x 1 tablets, and bottles containing 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allée des Parcs

69800 Saint Priest

France

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories

Unit 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1,

Komárom - 2900

Hungary

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.