Baraclude 0.05 mg/ml oral solution

• Keep 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Baraclude is and what it is used for
2. What you need to know before you take Baraclude
3. How to take Baraclude
4. Possible side effects
5. How to store Baraclude
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking 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 doctor’s 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 your liver functions properly and, if not, 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.
• if you have previously received treatment for chronic hepatits B, please inform your doctor.

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

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

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 and at least 2 hours before your next meal.

Children and adolescents (from 2 to less than 18 years of age) can take Baraclude with or without food.

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Baraclude is safe to use during 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 breast-feeding. It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

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).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

• 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.

For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight. The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below:

Body Weight - Recommended Once Daily Dose of Oral Solution

10.0 - 14.1 kg - 4.0 ml

14.2 - 15.8 kg - 4.5 ml

15.9 - 17.4 kg - 5.0 ml

17.5 - 19.1 kg - 5.5 ml

19.2 - 20.8 kg - 6.0 ml

20.9 - 22.5 kg - 6.5 ml

22.6 - 24.1 kg - 7.0 ml

24.2 - 25.8 kg - 7.5 ml

25.9 - 27.5 kg - 8.0 ml

27.6 - 29.1 kg - 8.5 ml

29.2 - 30.8 kg - 9.0 ml

30.9 - 32.5 kg - 9.5 ml

At least 32.6 kg - 10.0 ml

There are no dosing recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.

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.

Baraclude 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 markings from 0.5 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.

Some patients must 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, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

Contact your doctor at once.

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.

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 get any side effects, talk to your doctor or pharmacist or. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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• 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.

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. Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml

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