0.5 mg film-coated tablets 
Entecavir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Baraclude is and what it is used for 
2. What you need to know before you use Baraclude 
3. How to use Baraclude 
4. Possible side effects 
5. How to store Baraclude 
6. Contents of the packaging and other information 

1. What Baraclude is and what it is used for

Baraclude tablet is anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults. Baraclude can be used by people whose liver is damaged but still works properly (compensated liver disease) and by people whose liver is damaged and does not work properly (decompensated liver disease).

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

Infection with the hepatitis B virus can lead to liver damage. Baraclude reduces the amount of virus in your body and improves the condition of the liver.

2. What you need to know before using 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 cautions

Talk to your doctor or pharmacist before taking Baraclude

  • If you have ever had kidney problems, tell your doctor. This is important because Baraclude is excreted from the body through the kidneys and your dose dosing schedule may need to be adjusted.
  • Do not stop taking Baraclude without your doctor’s advice, as your hepatitis B infection may worsen after stopping treatment. When your treatment with Baraclude ends, your doctor will follow up with the treatment and take blood samples for several months.
  • Discuss with your doctor if your liver is working properly, and if not, what effect this may have on your Baraclude treatment.
  • if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Baraclude to treat your hepatitis B infection unless you are taking HIV at the same time, as the effect of future HIV treatment may be reduced. Baraclude will not control your HIV – infection under control.
  • Using Baraclude does not prevent you from infecting other people with the hepatitis B virus through sexual intercourse or body fluids (including blood transfusions). Thus, it is important to take precautions to prevent others from becoming infected with the hepatitis B virus. There are vaccines that protect people who are at risk of contracting the hepatitis B virus.
  • Baraclude belongs to a group of medicines that can cause lactic acidosis (too much lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This rare but serious side effect has in some cases be fatal. Lactic acidosis is more common in women, especially if they are very overweight. Your doctor will perform regular check-ups when you take Baraclude.
  • Inform your doctor if you have previously been treated for chronic hepatitis B.

Children and young people

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

Other medicines and Baraclude

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

Baraclude with food and drink

In most cases, you can take Baraclude with or without food. However, if you have previously been treated with a medicine containing the active substance lamivudine, you should consider the following. If you have switched to Baraclude treatment because lamivudine treatment has not had sufficient effect, Baraclude should be taken once daily on an empty stomach. If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach. Fasting means at least 2 hours after one meal and at least 2 hours before your next meal.

Children and adolescents (from 2 to younger than 18 years) 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 it is safe to use Baraclude during pregnancy. Baraclude should not be used during pregnancy unless clearly instructed to do so by your doctor. It is important that women of childbearing potential receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.

Breast-feeding mothers should not breast-feed during treatment with Baraclude. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Baraclude, is excreted in human milk.

Driving and using machines

Dizziness, tiredness, and drowsiness are common side effects that can impair your ability to drive and use machines. If you have any further questions on the use of this product, ask your doctor.

Baraclude contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Baraclude

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

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

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

Your dosage depends on:

  • if you have been treated for hepatitis B infection before and what medicine you were given.
  • if you have kidney problems. Your doctor may prescribe a lower dose or instruct you to take dose one less often than once a day.
  • the condition of your liver.

For children and young people

(from 2 to younger than 18 years) the child’s doctor determines the correct dosages based on the child’s weight. Baraclude oral solution is recommended for patients weighing from 10 kg to 32.5 kg. Children weighing at least 32.6 kg can take the oral solution or 0.5 mg tablet. All doses are taken orally (orally) once daily. There are no recommendations for Baraclude for children under 2 years or weighing less than 10 kg.

Your doctor will prescribe a dose that is right for you. In order for the medicine to have full effect and to reduce the risk of developing resistance to the treatment, you should always take the dose recommended by your doctor. Your doctor will tell you if and when to stop treatment.

Some patients have to 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, fasting means at least 2 hours after a meal and at least two hours before the next meal.

If you take more Baraclude than you should

Contact your doctor immediately.

If you forget to use Baraclude

It is important that you do not forget to take your medicine. If you forget to take a dose of Baraclude, take it as soon as you can, and then take the next dose as usual at the time you should take it. Do not take the missed dose if you have only a short time to take your next dose. Then wait and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Baraclude without your doctor’s instructions

Some people get very severe hepatitis symptoms when they stop taking Baraclude. Talk to your doctor immediately if you notice any changes in symptoms when you stop treatment.

If you have any further questions on the use of this product, 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, drowsiness, vomiting, diarrhea, nausea, dyspepsia (problems with digestion that cause discomfort in the stomach and intestines after meals), and elevated levels of liver enzymes in the blood.
  • uncommon (at least 1 in 1,000 patients): rash, hair loss.
  • rare (at least 1 in 10,000 patients): severe allergic reactions.

Children and young people

The side effects experienced by children and adolescents are similar to those described above for adults with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell that is important in defending against infections ).

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store 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 can, pressure pack, or carton after EXP. The expiration date is the last day of the specified month.

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

Jar: Do not store above 25 ° C. Close the jar tightly.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is entecavir. Each film-coated tablet contains 0.5 mg entecavir.
  • The other ingredients are: 
    Tablet core: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. 
    Film coatings: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).

What the medicine looks like and the contents of the pack

The film-coated tablets (tablets) are white to off-white and triangular. They are marked with “BMS” on one side and “1611” on the other. Baraclude 0.5 mg film-coated tablets are sold in packs of 30 x 1 or 90 x 1 film-coated tablet (in single-dose blisters) and in cans of 30 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

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

Manufacturer:

CATALENT ANAGNI SRL 
Loc. Fontana del Ceraso snc 
Strada Provinciale 12 Casilina, 41

03012 Anagni (FR) 
Italy

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

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Belgique / België / BelgienNV Bristol-Myers Squibb Belgium SATel: + 32 2 352 76 11 LithuaniaBristol-Myers Squibb Kft.Tel: +370 52 369140
BulgariaBristol-Myers Squibb Kft.Tel: +359 2 4942 480 Luxembourg / LuxemburgNV Bristol-Myers Squibb Belgium SATel: + 32 2 352 76 11
Czech RepublicBristol-Myers Squibb spol. s roTel: + 420 221 016 111 HungaryBristol-Myers Squibb Kft.Tel .: + 36 1 9206 550
DenmarkBristol-Myers SquibbTel: + 45 45 93 05 06 MaltaBristol-Myers Squibb SrlTel: + 356 23976333
GermanyBristol-Myers Squibb GmbH & Co. KGaATel: 0800 0752002 (+49 (0) 89 121 42‑350) The NetherlandsBristol-Myers Squibb BVTel: + 31 (0) 30 300 2222
EestiBristol-Myers Squibb Kft.Tel: +372 640 1030 NorwayBristol-Myers Squibb Norway LtdTel: + 47 67 55 53 50
GreeceBristol-Myers Squibb AE:Ηλ: + 30 210 6074300 Ö sterreichBristol-Myers Squibb GesmbHTel: + 43 1 60 14 30
SpainBristol-Myers Squibb, SATel: + 34 91 456 53 00 PolandBristol-Myers Squibb Polska Sp. z ooTel .: + 48 22 2606400
FranceBristol-Myers Squibb SARLTel: +33 (0) 1 58 83 84 96 PortugalBristol-Myers Squibb Pharmacêutica Portuguesa, SATel: + 351 21 440 70 00
CroatiaBristol-Myers Squibb spol. s roTel: +385 1 2078 508 RomaniaBristol-Myers Squibb Kft.Tel: + 40 (0) 21 272 16 00
IrelandBristol-Myers Squibb Pharmaceuticals ucTel: + 353 (0) 1 483 3625 SloveniaBristol-Myers Squibb spol. s roTel: +386 1 2355 100
IcelandBristol-Myers Squibb AB at Vistor hf.Phone: + 354 535 7000 Slovak RepublicBristol-Myers Squibb spol. s Rotel: +421 2 20833 600
ItalyBristol-Myers Squibb SrlTel: + 39 06 50 39 61 Finland / FinlandOy Bristol-Myers Squibb (Finland) AbPuh / Tel: + 358 9 251 21 230
ΚύπροςBristol-Myers Squibb AE:Ηλ: + 357 800 92666
LatviaBristol-Myers Squibb Kft.Tel: +371 66164750 United KingdomBristol-Myers Squibb Pharmaceuticals LtdTel: + 44 (0800) 731 1736

Muhammad Nadeem

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