Country: Bretland
Tungumál: enska
Heimild: myHealthbox
bosentan
Dr. Reddy’s Laboratories (UK) Ltd.
C02KX01
bosentan
62.5mg
Film-coated tablet
oral use
Pack sizes: 14, 56 or 112 tablets
POM prescription only medicine
Dr. Reddy’s Laboratories (UK) Ltd.
other antihypertensives
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: • Primary (idiopathic and heritable) pulmonary arterial hypertension • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease • Pulmonary arterial hypertension associated with congenital systemic-topulmonary shunts and Eisenmenger’s physiology
authorized
2015-03-02
PACKAGE LEAFLET: INFORMATION FOR THE USER BOSENTAN 62.5 MG, 125 MG FILM-COATED TABLETS _ _ Bosentan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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. WHAT IS IN THIS LEAFLET 1. WHAT BOSENTAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BOSENTAN 3. HOW TO TAKE BOSENTAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BOSENTAN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BOSENTAN IS AND WHAT IT IS USED FOR Bosentan tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Bosentan therefore causes blood vessels to expand and belongs to the class of medicines called ‘endothelin receptor antagonists’. Bosentan is used to treat: PULMONARY ARTERIAL HYPERTENSION (PAH): PAH is a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. Bosentan widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood p Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bosentan Dr. Reddy’s 62.5 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 62.5 mg bosentan (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light orange, film-coated, round biconvex tablets (diameter 6 mm), debossed with “62.5” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: • Primary (idiopathic and heritable) pulmonary arterial hypertension • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease • Pulmonary arterial hypertension associated with congenital systemic-to- pulmonary shunts and Eisenmenger’s physiology Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Tablets are to be taken orally morning and evening, with or without food. The film- coated tablets are to be swallowed with water. Posology Pulmonary arterial hypertension Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. _Adults _ In adult patients, Bosentan treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. The same recommendations apply to re-introduction of Bosentan after treatment interruption (see section 4.4). _Paediatric population _ In c Lestu allt skjalið