Label: information for the user

Baraclude 0.5 mg film-coated tablets

Entecavir

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Baraclude tablets are an antiviral medication used to treat chronic (long-term) infection by the hepatitis B virus (VHB) in adults.Baraclude can be used in patients whose liver is damaged but still functioning properly (compensated liver disease) and in patients whose liver is damaged and not functioning properly (decompensated liver disease).

Baraclude tablets are also used to treat chronic (long-term) infection by the VHB in children and adolescents from 2 years to less than 18 years.Baraclude can be used in children whose liver is damaged but still functioning properly (compensated liver disease).

The hepatitis B virus infection can damage the liver. Baraclude reduces the amount of virus in the body and improves the liver's condition.

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

Consult your doctor or pharmacist before starting to take Baraclude

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

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

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

• if you are also infected with HIV(human immunodeficiency virus), make sure to inform your doctor. Do not take Baraclude for the treatment of your hepatitis B infection unless you are also taking medicines 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 others with the hepatitis B virus (HBV) through sexual contact or bodily fluids (including blood contamination). Therefore, it is essential to take the necessary precautions to prevent others from becoming infected with HBV. There is a vaccine to protect individuals 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 may indicate the development of lactic acidosis. In some cases, 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 periodically while you are taking Baraclude.

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

Children and adolescents

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

Taking Baraclude with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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, consider the following. If you have switched to Baraclude because lamivudine treatment was unsuccessful, take Baraclude on an empty stomach, once a day. If your liver disease is advanced, your doctor will also instruct you on taking Baraclude on an empty stomach. Empty stomach means at least 2hours after and 2hours before the next meal.

Children and adolescents (from2years to less than 18years of age) can take Baraclude with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. Baraclude has not been shown to be safe during pregnancy. Do not use Baraclude during pregnancy except when clearly necessary, according to your doctor. It is essential that women of childbearing age who are being treated with Baraclude use an effective contraceptive method to avoid becoming pregnant.

Do not breastfeed during treatment with Baraclude. If you are doing so, inform your doctor. The active ingredient of Baraclude, entecavir, is unknown to be excreted in breast milk.

Driving and operating machinery

Dizziness, fatigue, and drowsiness are common side effects that may impair your ability to drive and operate machinery. If you have any doubts, consult your doctor.

Baraclude contains lactose

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

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For adultsthe recommended dose is 0.5mg or 1mg once a day (oral administration).

Your dose will depend on:

• whether you have been previously treated for a hepatitis B virus infection, as well as the medication you have received.
• if you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.
• your liver condition.

For children and adolescents(from2years of age to less than 18years of age), your pediatrician will decide on the appropriate dose based on the child's body weight. Baraclude oral solution is recommended for patients with a weight between 10kg and 32.5kg. Children weighing at least 32.6 kg can take the oral solution or 0.5mg tablets. There are no recommendations for Baraclude in children under 2years of age or weighing less than 10kg.

Your doctor will advise you on what dose is correct for you. Always take the dose recommended by your doctor to ensure the medication is fully effective and to reduce the development of treatment resistance. Take Baraclude for the entire time your doctor has indicated. Your doctor will tell you when to stop treatment.

Some patients must take Baraclude on an empty stomach (seeBaraclude with food and drinksin theSection2). If your doctor tells you to take Baraclude on an empty stomach, empty stomach means at least 2hours after a meal and 2hours before the next meal.

If you take more Baraclude than you should

Get in touch with your doctor immediately.

If you forget to take Baraclude

It is essential not to forget any dose. If you forget a dose of Baraclude, take it as soon as you remember and then take the next scheduled 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 compensate for the missed doses.

Do not stop treatment with Baraclude without consulting your doctor

Some people develop severe hepatitis symptoms when stopping Baraclude. Inform your doctor immediately of any changes in symptoms you observe after stopping treatment.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Patients treated with Baraclude have reported the following adverse effects:

Adults

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

Children and Adolescents

The adverse effects experienced by children and adolescents are similar to those experienced by adults as described earlier, with the following exception:

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Bottle: do not store at a temperature above 25°C. Keep the bottle perfectly closed.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Baraclude

• The active ingredient is entecavir. Each film-coated tablet contains 0.5mg 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 packaging

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

Only some package sizes may be marketed in your country.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

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

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Last review date 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/.