Baraclude 0.5 mg film-coated tablets

Baraclude tablets are anti-viral medicines, 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.

Do not take Baraclude

-- ifyou 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 tablets

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

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 or 1 mg 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.

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.

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.

Keep out of the reach and sight of children.

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

Blister packs: do not store above 30°C. Store in the original carton.
Bottle packs: 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 medicines no longer required. These measures will help to protect the environment.

What Baraclude contains

--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, cellulose microcrystalline and povidone.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).

What Baraclude looks like and contents of the pack

The film-coated tablets (tablets) are white to off-white and triangular-shaped. They are marked with ?BMS? on one side and ?1611? on the other. Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets (in unit-dose blisters) and in bottles containing 30 film-coated tablets.

Not all pack sizes may be marketed.

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.

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