Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 64.541 mg
Arrotex Pharmaceuticals Pty Ltd
bosentan monohydrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; glycerol dibehenate; povidone; maize starch; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose
Oral
60
(S4) Prescription Only Medicine
Bosentan is indicated for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO functional Class II, III or IV symptoms
Visual Identification: The 62.5mg film-coated tablets are light peach to peach colored, round shaped, biconvex & debossed with '62.5' on one side & plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-07-11
BOSENTAN APO _Bosentan monohydrate_ CONSUMER MEDICINE INFORMATIO _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about bosentan. 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 TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Bosentan is used to treat high blood pressure in the blood vessels between the heart and the lungs. This condition is called pulmonary arterial hypertension. Bosentan belongs to a group of medicines called endothelin antagonists. _HOW IT WORKS_ Bosentan acts to reduce abnormally high blood pressure by widening the blood vessels between the heart and lungs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is limited experience with the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • bosentan • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. YOU MUST STOP TAKING THIS MEDICINE AT LEAST 3 MONTHS BEFORE TRYING TO BECOME PREGNANT. Bosentan is known to cause harm to a developing baby if you take it in the three months before becoming pregnant and duri Lees het volledige document
1 AUSTRALIAN PRODUCT INFORMATION – BOSENTAN APO (BOSENTAN AS MONOHYDRATE) Bosentan may cause birth defects and is contraindicated in pregnancy. See section 4.3 CONTRAINDICATIONS and section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. Rare cases of hepatic cirrhosis and hepatic failure have been reported in patients using bosentan. See section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. 1 NAME OF THE MEDICINE Bosentan monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 62.5 mg or 125 mg bosentan (as monohydrate), For the full list of excipients, see section 6.1LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 62.5 mg film coated tablets are light peach to peach coloured, round shaped, biconvex and debossed with ‘62.5’ on one side and plain on the other side (AUST R 257754). 125 mg film coated tablets are light peach to peach coloured, oval shaped, biconvex and debossed with ‘125’ on one side and plain on the other side (AUST R 257734). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bosentan is indicated for the treatment of ▪ idiopathic pulmonary arterial hypertension ▪ familial pulmonary arterial hypertension ▪ pulmonary arterial hypertension associated with scleroderma or ▪ pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger’s physiology in patients with WHO functional Class II, III or IV symptoms 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Bosentan should be administered under the supervision of a physician experienced in the management of pulmonary arterial hypertension . Bosentan treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks. Efficacy was demonstrated in clinical trial subjects who increased to a maintenance dose of 125 mg twice daily. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of liver injury. Tablets should be administered morning and evening with or without food. 2 Serum liver aminotransferase (AST & ALT) Lees het volledige document