ENTECAVIR MYLAN 1 mg FILM-COATED TABLETS

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

• , inform 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 you stop treatment. When you stop treatment with Entecavir Mylan, your doctor will monitor you and perform blood tests for several months.

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

• , inform 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 otherwise the effectiveness of future HIV treatments may be reduced. Entecavir Mylan will not control your HIV infection.

• taking Entecavir Mylan will not prevent 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 other people 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 increase in liver size. 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 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 may affect your ability to drive and use machines. If you are unsure, consult your doctor.

Entecavir Mylan contains lactose

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

If you are unsure, consult 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 for HBV infection before, 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 appropriate dose based on the child's body weight. For children weighing at least 32.6 kg, they may 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 correct 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 missed doses.

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 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:

common (at least 1 in 100 patients): headache, insomnia (difficulty sleeping), fatigue (extreme tiredness), dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (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

What Entecavir Mylan contains

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-edged, round tablets, engraved with "M" on one side and "EA" on the other.

1 mg: white, film-coated, biconvex, beveled-edged, 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 website: http://www.ema.europa.eu.