Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Bosentan monohydrate
Zentiva k.s.
C02KX01
Bosentan monohydrate
Film-coated tablet
bosentan
Not marketed
2024-02-23
PACKAGE LEAFLET: INFORMATION FOR THE USER BOSENTAN ZENTIVA 62.5 MG FILM-COATED TABLETS BOSENTAN ZENTIVA 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 The name of your medicine is Bosentan Zentiva 62.5 mg film-coated tablets or Bosentan Zentiva 125 mg film-coated tablets (called bosentan throughout this leaflet). 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 pressure and relieves the symptoms. Bosentan is used to treat patients with class III PAH to improve exercise capacity Citiți documentul complet
Health Products Regulatory Authority 23 February 2024 CRN00DJK3 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bosentan Zentiva 62.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 62.5 mg bosentan (as 64.54 mg bosentan monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Description: round, biconvex-shaped, light orange coloured film coated tablets with the diameter approx. 6.1 mm. 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). Bosentan is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Pulmonary arterial hypertension Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with bosentan is included in the pack. _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_ Paediatric pharmacokinetic data have shown that bosentan Citiți documentul complet