(bosentan monohydrate) film coated tablet
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Bosentan GH.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What BOSENTAN GH is used for
Bosentan GH is used for the treatment of high blood pressure in the blood vessels between the heart and the lungs. This condition is called pulmonary arterial hypertension.
This medicine acts to reduce abnormally high blood pressure by widening these blood vessels. It belongs to the class of medicines known as endothelin receptor antagonists.
Your doctor however, may prescribe Bosentan GH for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor's prescription.
Before you take BOSENTAN GH
When you must not take it
Do not take this medicine if you are:
- Pregnant or intend to become pregnant. You must stop taking the medicine at least 3 months before trying to become pregnant. It is known that this medicine causes harm to the developing baby if you take it during pregnancy and in the 3 months before becoming pregnant.
- Breastfeeding: Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if this medicine is prescribed for you because it is not known if this drug passes into the milk in women who are taking this medicine.
- Being treated with cyclosporine A (a medicine used after a transplant or to treat psoriasis).
- Being treated with glibenclamide (a medicine used for diabetes).
Do not take Bosentan GH if you are allergic to it or any of the ingredients listed at the end of this leaflet.
Do not take Bosentan GH if you have moderate to severe liver disorder.
Do not take it after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.
Do not take it if the packaging is torn or shows signs of tampering.
Before you start to take it
Bosentan GH may harm sperm. All men should use effective birth control while taking this medicine and for 3 months after they stop taking it.
If sexually active, you must use a hormonal and barrier method of contraception. This medicine may reduce the effectiveness of hormone contraceptives such as the pill and hormone patches, implants or injection. It is important to use other contraceptives, like condoms or an intrauterine device.
Your doctor will advise you about using reliable contraceptives before taking this medicine.
You must have a negative pregnancy test at the time of starting treatment if you are sexually active. Your doctor will need evidence that you are not pregnant.
Tell your doctor if:
- you are a woman of childbearing potential and not using reliable contraceptive methods. You must have a negative pregnancy test before beginning treatment. The test should be performed on the second day of a normal menstrual period or 11 days after the last unprotected sexual intercourse, whichever is later. Your doctor will advise you about using reliable contraception before taking or whilst taking this medicine. Hormonal contraception on its own is not a reliable option because this medicine may make this method ineffective in preventing pregnancy. Hormonal contraceptives include ones you take orally (the pill), patches you put on your skin, ones that are injected and implants. You should ALWAYS use additional