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The product code(s) for this leaflet is: PLGB 15105/0128.
Baraclude 0.05mg/ml oral solution
Baraclude 0.05 mg/ml oral solution
Entecavir
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
Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Baraclude can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Baraclude oral solution is also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease).
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.
Talk to your doctor or pharmacist before taking Baraclude
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’.
Not all patients need to take the same dose of Baraclude.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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
Children and adolescents
The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:
Very common (at least 1 in 10 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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.
Yellow Card Scheme
Website: at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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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This leaflet was last revised in June 2022
Approved v1.0