What is it and how is it used?

Baraclude oral solution is an anti-viral medicine, used to treat chronic hepatitis B virus (HBV) infection in adults.

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

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Baraclude

-- if you are allergic (hypersensitive) to entecavir or any of the other ingredients of Baraclude.

Take special care with Baraclude

-- if you have ever had problems with your kidneys, tell your doctor. This is important because Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.

do not stop taking Baraclude without your doctors advice since your hepatitis may worsen after stopping treatment. When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.

discuss with your doctor whether you have liver cirrhosis and what the possible effects on your Baraclude treatment may be.

if you are also infected with HIV human immunodeficiency virus be sure to tell your doctor. You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Baraclude will not control your HIV infection.

taking Baraclude will not stop you from infecting other people with hepatitis B virus HBV through sexual contact or body fluids including blood contamination. So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.

Baraclude belongs to a class of medicines that can cause lactic acidosis excess of lactic acid in your blood and enlargement of the liver. Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Baraclude.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Baraclude with food and drink

In most cases you may take Baraclude with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. If you were switched over to Baraclude because the treatment with lamivudine 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.Empty stomach means at least 2 hours after a meal or at least 2 hours before your next meal.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Baraclude is safe to use during human pregnancy. Baraclude must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Baraclude. Tell your doctor if you are breastfeeding. It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.

Driving and using machines

Baraclude is unlikely to affect your ability to drive or operate machines. Dizziness, fatigue and somnolence are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

Important information about some of the ingredients of Baraclude oral solution This medicinal product contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

How is it used?

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

Always take Baraclude exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).

Your dose will depend on:

--whether you have been treated for HBV infection before, and what medicine you received. --whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
- the condition of your liver.
Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Baraclude as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.

Entecavir oral solution is designed as a ready-to-use product. Do not dilute or mix this solution with water or anything else.

Baraclude oral solution comes with a measuring spoon with milliliter marks from 1 up to 10 milliliters. Use the spoon as follows:

1. Hold the spoon in a vertical upright position and fill it gradually to the mark corresponding to the prescribed dose. Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark. 2. Swallow the medicine directly from the measuring spoon. 3. After each use, rinse the spoon with water and allow it to air dry.

If you take more Baraclude than you should

Contact your doctor at once.

If you forget to take Baraclude

It is important that you do not miss any doses. If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

Do not stop Baraclude without your doctor?s advice

Some people get very serious hepatitis symptoms when they stop taking Baraclude. Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.

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

What are possible side effects?

Like all medicines, Baraclude can cause side effects, although not everybody gets them.

Patients treated with Baraclude have reported the following side effects:
common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
uncommon (at least 1 in 1,000 patients): rash, hair loss.
rare (at least 1 in 10,000 patients): severe allergic reaction.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Baraclude after the expiry date which is stated on bottle or carton after EXP. That expiry date refers to the last day of that month.

Do not store above 30°C. Keep the bottle in the outer carton in order to protect from light.

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.

Further information

What Baraclude contains

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

What Baraclude looks like and contents of the pack

The oral solution is a clear, colorless to pale yellow solution. Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
BRISTOL-MYERS SQUIBB PHARMA EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Manufacturer:
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11 LuxembourgLuxemburg BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11

BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Te. 359 800 12 400 Magyarország BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel. 36 1 301 9700

eská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 420 221 016 111 Malta BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61

Danmark BRISTOL-MYERS SQUIBB Tlf 45 45 93 05 06 Nederland BRISTOL-MYERS SQUIBB BV Tel 31 34 857 42 22

Deutschland BRISTOL-MYERS SQUIBB GMBH CO. KGAA Tel 49 89 121 42-0 Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf 47 67 55 53 50

Österreich BRISTOL-MYERS SQUIBB GESMBH Tel 43 1 60 14 30 Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 372 682 7400

BRISTOL-MYERS SQUIBB A.E. 30 210 6074300 Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel. 48 22 5796666

España BRISTOL-MYERS SQUIBB, S.A. Tel 34 91 456 53 00 Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S.A. Tel 351 21 440 70 00

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IrelandSlovenija
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDBRISTOL-MYERS SQUIBB SPOL. S R.O. Tel: + 353 (1 800) 749 749 Tel: + 386 1 236 47 00

Ísland VISTOR HF Sími 354 535 7000 Slovenská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 421 2 59298411

Italia BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61 SuomiFinland OY BRISTOL-MYERS SQUIBB FINLAND AB PuhTel 358 9 251 21 230

BRISTOL-MYERS SQUIBB A.E 357 800 92666 Sverige BRISTOL-MYERS SQUIBB AB Tel 46 8 704 71 00

United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDTel 44 0800 731 1736 Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 371 67 50 21 85

Lietuva
BRISTOL-MYERS SQUIBB
GYÓGYSZERKERESKEDELMI KFT.
Tel: + 370 5 2790 762

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

Authorised Representative in the EEA for Comar Plastics: MDSS, Burckhardstrasse 1, 30163 Hannover, Germany

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