BARACLUDE 0.05 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Baraclude 0.05 mg/mloral solution

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. Storage of Baraclude
6. Contents of the pack and other information

1. What BARACLUDE is and what it is used for

Baracludeoral solutionis 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 works adequately (compensated liver disease) and in patients whose liver is damaged and does not work adequately (decompensated liver disease).

Baracludeoral solutionis also used to treat long-term (chronic) HBV infection in children and adolescents from2to less than 18years of age.Baraclude may be used in children whose liver is damaged but still works adequately (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

• if you are allergic (hypersensitive)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 Baraclude

• if you have ever had problems with your kidneys, inform 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 if 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 properlyand, if not, about the possible effects that treatment with Baraclude may have.

• (human immunodeficiency virus), make sure to inform 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 treatments for HIV 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 abdominal 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 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. 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, breastfeeding, 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 prevent pregnancy.

Do not breastfeed during treatment with Baraclude. If you are breastfeeding, 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 and use machines. If you are affected, do not drive or operate machinery.

Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), and sodium

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

This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".

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, consult your doctor or pharmacist again.

For adults, the recommended dose is 0.5 mg (10 ml) or 1 mg (20 ml) once daily (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 frequently than once daily.
• the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), your pediatrician will decide the appropriate dose based on the child's body weight. The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and taken once daily (by mouth) as follows:

There are no dose 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 to. Your doctor will tell you when to stop treatment.

Baraclude oral solution is intended for direct use. Do not dilute or mix this solution with water or other liquids.

Baraclude oral solution comes with a measuring spoon with markings from 0.5 to 10 ml. The measuring spoon is used as follows:

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, 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 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 treatment with 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. Storage of 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 is the last day of the month shown.

Do not store above 30°C. Keep the bottle in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Baraclude

• The active substance is entecavir. Each ml of oral solution contains 0.05 mg of entecavir.
• The other ingredients are: anhydrous citric acid, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavor (acacia and natural flavorings), sodium citrate, sodium hydroxide, hydrochloric acid, and purified water.

Appearance and packaging

The oral solution is clear, colorless to slightly yellowish. Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml of oral solution. Each carton includes a measuring spoon (made of polypropylene) with markings from 0.5 to 10 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

CATALENT ANAGNI S.R.L.

Loc. Fontana del Ceraso snc

Strada Provinciale 12 Casilina, 41

03012 Anagni (FR)Italy

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

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.

The authorized representative for Comar Plastics in the EEA is: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany.

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/.