▪ 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.
Children and adolescents
Baraclude should not be used for children below 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 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.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
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.
Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216)
and sodium
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).