Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BOSENTAN MONOHYDRATE
RANBAXY (MALAYSIA) SDN. BHD.
BOSENTAN MONOHYDRATE
1x15tablet Tablets; 15tablet Tablets
Sun Pharmaceutical Industries Limited
PROART TABLETS 62.5/125 MG Page 1 PROART TABLETS 62.5 MG AND PROART TABLETS 125 MG (Bosentan Monohydrate Tablets 62.5 mg and 125 mg) _ _ _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What PROART TABLETS are used for 2. How PROART TABLETS work 3. Before you use PROART TABLETS 4. How to use PROART TABLETS 5. While you are using it 6. Side effects 7. Storage and Disposal of PROART TABLETS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision This leaflet answers some common questions about PROART TABLETS. It does not contain all of 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 taking PROART TABLETS against the benefits it is expected to 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 PROART TABLETS ARE USED FOR PROART TABLETS contain the active ingredient bosentan. It 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. HOW PROART TABLETS WORK PROART TABLETS contain bosentan which belongs to the class of medicines called “endothelin receptor antagonists”. Bosentan blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Thus, it acts to reduce abnormally high blood pressure by widening these blood vessels. Your doctor however, may have prescribed this medicine for another purpose. Ask your doctor if you have any questions why it has been prescribed for you. This medicine is only available with a doctor’s prescription. BEFORE YOU USE PROART TABLETS _ _ _WHEN YOU MUST NOT USE IT _ DO NOT TAKE PROART TABLETS: If you are allergic to bosentan or any of the other ingredients of this medicine (see product description at the end of this leaflet). Aqra d-dokument sħiħ
_For the use of a Registered Medical Practitioner only _ PRESCRIBING INFORMATION PROART TABLETS 62.5 MG AND PROART TABLETS 125 MG (Bosentan Monohydrate Tablets) COMPOSITION PROART 62.5 MG Each film coated tablet contains: Bosentan Monohydrate equivalent to Bosentan …………. 62.5 mg PROART 125 MG Each film coated tablet contains: Bosentan Monohydrate equivalent to Bosentan …………. 125 mg Excipients: Maize starch, Pregelatinized starc., Sodium starch glycolate, Povidone, Purified water, Glyceryl behenate, Magnesium stearate, Isopropyl alcohol and Opadry 21K520019 (Yellow) containing Hypromellose, Titanium Dioxide, Triacetin, Talc, Ethylcellulose, Iron Oxide Yellow, Hpmc /Hypromellose and Iron Oxide Red. DESCRIPTION For 62.5 mg Light peach to peach colored film coated round shaped biconvex tablet debossed with '62.5' on one side and plain the other side. For 125 mg Light peach to peach colored film coated Oval shaped biconvex tablet debossed with ‘125' on one side and plain the other side. PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01 1 _Mechanism of action _ Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ET A and ET B ) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate. The neurohormone endothelin-1 (ET-1) is one of the most potent vasoconstrictors known and can also promote fibrosis, cell proliferation, cardiac hypertrophy and remodelling, and is pro- inflammatory. These effects are mediated by endothelin binding to ET A and ET B receptors located in the endothelium and vascular smooth muscle cells. ET-1 concentrations in tissues and plasma are increased in several cardiovascular disorders and connective tissue diseases, including PAH, scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension and atherosclerosis, suggesting a pathogen Aqra d-dokument sħiħ