Baraclude 0.5 mg film-coated tablets

Package leaflet: Information for the user

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, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Baraclude is and what it is used for
2. What you need to know before taking Baraclude
3. How to take Baraclude
4. Possible side effects
5. How to store 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 chronic (long-term) hepatitis B virus (HBV) infection in adults. Baraclude can be used in patients whose liver is damaged but still functions adequately (compensated liver disease) and in patients whose liver is damaged and does not function adequately (decompensated liver disease).

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

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

2. What you need to know before starting to take BARACLUDE

Do not take Baraclude

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Baraclude

• if you have ever had kidney problems, inform your doctor. This is important because Baraclude is eliminated from the body through the kidneys, and your dose or treatment schedule may need to be adjusted.

• do not stop taking Baraclude without consulting your doctor, as your hepatitis may worsen if treatment is interrupted. When your treatment with Baraclude is stopped, your doctor will continue to monitor you and perform blood tests for several months.

• ask your doctor whether your liver is functioning properly and, if not, about the possible effects your treatment with Baraclude might have.

• if you are also infected with HIV (human immunodeficiency virus), make sure to inform your doctor. You should not take Baraclude for the treatment of hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as otherwise the effectiveness of future HIV treatments could be reduced. Baraclude will not control your HIV infection.

• taking Baraclude will not prevent you from infecting other people with the hepatitis B virus (HBV) through sexual contact or bodily fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect individuals at risk of HBV infection.

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

• if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

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

Taking Baraclude with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 previously been treated with another medicine containing lamivudine as the active ingredient, consider the following. If you have switched to Baraclude because lamivudine treatment was not successful, you should take Baraclude on an empty stomach, once daily. If your liver disease is very advanced, your doctor will also instruct you to take 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) may take Baraclude with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. The use of Baraclude during pregnancy has not been shown to be safe. Baraclude should not be used during pregnancy except when clearly necessary, as determined by your doctor. It is important that women of childbearing potential who are being treated with Baraclude use an effective method of contraception to avoid becoming pregnant.

You must not breastfeed during treatment with Baraclude. If you are currently breastfeeding, inform your doctor. It is unknown whether entecavir, the active substance in Baraclude, is excreted in human milk.

Driving and using machines

Dizziness, tiredness (fatigue), and numbness (somnolence) are common side effects that could affect your ability to drive and use machines. If you have any doubts, consult your doctor.

Baraclude contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take BARACLUDE

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

Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

For adults, the recommended dose is 0.5 mg or 1 mg once daily (orally).

Your dose will depend on:

• whether you have previously been treated for hepatitis B virus (HBV) infection, and which medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise you to take it less frequently than once daily.
• the condition of your liver.

For children and adolescents (aged 2 to less than 18 years), your paediatrician will determine 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 either the oral solution or the 0.5 mg tablets. All doses should be taken once daily (orally). Baraclude is not recommended for children under 2 years of age or those 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 the medicine is fully effective and to reduce the risk of developing treatment resistance. Take Baraclude for the entire duration prescribed by your doctor. Your doctor will tell you when to stop treatment.

Some patients should take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2). If your doctor instructs you to take Baraclude on an empty stomach, this 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 not to miss any doses. If you forget a dose of Baraclude, take it as soon as you remember, then take your 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 missed dose.

Do not stop treatment with Baraclude without consulting your doctor

Some people develop very severe hepatitis symptoms when they stop taking Baraclude. Inform your doctor immediately of any changes in symptoms you notice after stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported in patients treated with Baraclude:

Adults

• Common (affects at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased levels of liver enzymes in the blood.
• Uncommon (affects at least 1 in 1,000 patients): skin rash, hair loss.
• Rare (affects at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents

Adverse effects experienced in children and adolescents are similar to those observed in adults as described above, with the following difference:

Very common (affects at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell important in fighting infection).

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 packaging after EXP. The expiry date is the last day of the month indicated.

Blister: do not store above 30°C. Store in the original packaging.

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 any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Baraclude

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

Tablet core: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.

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

Appearance of the product and contents of the pack

The film-coated tablets (tablets) are white to off-white and triangular in shape. They are marked with "BMS" on one side and "1611" on the other side. 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.

Only certain pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

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

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.