Label: information for the user

Baraclude 1 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 caused by the hepatitis B virus (HBV) in adults.Baraclude may 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 caused by HBV in children and adolescents from 2 years to less than 18 years.Baraclude may be used in children whose liver is damaged but still functioning properly (compensated liver disease).

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

Do not take Baraclude

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

Warnings and precautions

Consult 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 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 you stop taking Baraclude, your doctor will continue to monitor you and perform blood tests for several months.

• ask your doctorif your liver is functioning properlyand if not, about the possible effects that your treatment with Baraclude may 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 medications for the treatment of HIV, 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 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 available to protect individuals at risk of HBV infection.

• Baraclude belongs to a class of medications that can cause lactic acidosis(excess 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 severe 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 2 years of age or weighing less than 10 kg.

Taking Baraclude with other medications

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

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 medication 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 2 hours after and 2 hours before the next meal.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or plan to become pregnant. Baraclude use has not been proven to be safe during pregnancy. Do not use Baraclude during pregnancy unless it is clearly necessary, according to your doctor. It is essential for women of childbearing age who are taking Baraclude to use an effective contraceptive method to avoid becoming pregnant.

Do not breastfeed during treatment with Baraclude. If you are breastfeeding, inform your doctor. The active ingredient in 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 medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

For adultsthe recommended dose is 0.5 mg or 1 mg 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(from 2 to less than 18 years of age), Baraclude oral solution or

Baraclude 0.5 mg tablets are available.

Your doctor will advise you on what dose is right 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 as long as your doctor has told you to. Your doctor will tell you when to stop treatment.

Some patients must take Baraclude on an empty stomach (seeBaraclude with food and drinksin theSection 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 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 make up for the missed doses.

Do not stop taking 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

• Common (occurring 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.
• Uncommon (occurring in at least 1 in 1,000 patients): skin rash, hair loss.
• Rare (occurring in at least 1 in 10,000 patients): severe allergic reaction.

Children and Adolescents

Adverse effects experienced by children and adolescents are similar to those experienced by adults as described above, with the following exception:

Very common (occurring in at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell 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 the Appendix 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 1

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)iron oxide red.

Appearance of the product and contents of the packaging

The film-coated tablets (tablets) are pink and have a triangular shape. They are marked with “BMS” on one side and with “1612” on the other side. Baraclude 1 mg 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 Company T/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

The detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.