BARACLUDE 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Baraclude 0.5 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 experience 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 Baraclude is and what it is used for
2. What you need to know before you take Baraclude
3. How to take Baraclude
4. Possible side effects
5. Storing Baraclude
6. Contents of the pack and other information

1. What BARACLUDE is and what it is used for

Baraclude tablets are an antiviral medicine used to treat long-term (chronic) hepatitis B virus (HBV) infection in adults.Baraclude 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).

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

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

2. What you need to know before you take BARACLUDE

Do not take Baraclude

Warnings and precautions

Talk to your doctor or pharmacist before taking Baraclude

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

• do not stop taking Baraclude without talking to your doctor, as your hepatitis may get worse when you stop treatment. When you stop treatment with Baraclude, your doctor will monitor you and perform blood tests for several months.

• ask your doctorif your liver is working properly and, if not, about the possible effects that treatment with Baraclude could have.

• , make sure to tell your doctor. You should not take Baraclude 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. Baraclude will not control your HIV infection.

• taking Baraclude 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.

• Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and liver enlargement.Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this rare but 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 Baraclude.

• , please inform your doctor.

Children and adolescents

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

Taking Baraclude with other medicines

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

Taking Baraclude with food and drinks

In most cases, you can take Baraclude 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 Baraclude because treatment with lamivudine was not successful, you should take Baraclude on an empty stomach, once a day. If your liver disease is very advanced, your doctor will also instruct you on taking Baraclude 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 Baraclude 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 shown that the use of Baraclude is safe during pregnancy. Baraclude should not be used during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing age using Baraclude use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Baraclude. If you are breast-feeding, tell your doctor. It is not known whether entecavir, the active ingredient of Baraclude, is excreted in breast milk.

Driving and using machines

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

Baraclude 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 BARACLUDE

Not all patients need to take the same dose of Baraclude.

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, talk to your doctor or pharmacist.

For adultsthe recommended dose is 0.5 mg or 1 mg once daily (by mouth).

Your dose will depend on:

• if you have been treated for HBV infection before, as well as the medicine you received.
• if you have kidney problems. Your doctor may prescribe a lower dose or tell you to take it less frequently 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. Baraclude oral solution is recommended for patients weighing between 10 kg and 32.5 kg. Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablets. All doses should be taken once daily (by mouth). There are no recommendations for Baraclude in children under 2 years of age or weighing less than 10 kg.

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

Some patients must take Baraclude on an empty stomach (see Baraclude with food and drinksin Section 2). If your doctor tells you to take Baraclude 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 Baraclude than you should

Contact your doctor immediately.

If you forget to take Baraclude

It is important that you do not miss any dose. If you miss a dose of Baraclude, take it as soon as you remember 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 Baraclude without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking Baraclude. Tell your doctor immediately if you notice any changes in your 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 Baraclude have reported the following side effects:

Adults

• common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, somnolence, vomiting, diarrhea, nausea, dyspepsia, 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.

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 (a type of white blood cell important in fighting infection).

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you experience 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. Storing BARACLUDE

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.

Blister: Do not store above 30°C. Store in the original package.

Bottle: Do not store above 25°C. Keep the bottle tightly closed.

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 Baraclude contains

• The active substance is entecavir. Each film-coated tablet contains 0.5 mg of entecavir.
• The other ingredients are:

Core of the tablet: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

Coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).

Appearance and packaging

The film-coated tablets (tablets) are white to off-white and triangular in shape. They are marked with “BMS” on one side and with “1611” on the other side. The Baraclude 0.5 mg tablets are supplied in packs containing 30 x 1 or 90 x 1 film-coated tablets (in unit dose blisters) and in bottles containing 30 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Bristol-Myers Squibb Pharma EEIGPlaza 254Blanchardstown Corporate Park 2Dublin 15, D15 T867Ireland

Manufacturer:

Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

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/.