Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
UNIMED SDN BHD
TELMISARTAN
10 x 10's tablet Tablets; 3 x 10 Tablets
Hetero Labs Limited
TELSAR 20/40/80 _Consumer Medication Information Leaflet (RiMUP) _ Telmisartan (20mg,40mg,80mg) WHAT IS IN THIS LEAFLET 1. What TELSAR is used for 2. How TELSAR works 3. Before you use TELSAR 4. How to use TELSAR 5. While you are using it 6. Side effects 7. Storage and Disposal of TELSAR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TELSAR IS USED FOR _Telmisartan _ belongs to a group of medicines used: • To treat essential hypertension (high blood pressure). ‘Essential’ means that the high blood pressure is not caused by any other condition. • to reduce cardiovascular events (i.e.heart attack or stroke) in patients who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have a stroke or have high risk of diabetes. HOW TELSAR WORKS _TELMISARTAN _ belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. _TELMISARTAN _ blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. BEFORE YOU USE TELSAR _When you must _ _not use it _DO NOT TAKE _TELMISARTAN_: • if you are allergic (hypersensitive) to the active substance of this medicine (telmisartan) or to any of the other ingredients of this medicine • If you are more than 3 months pregnant. (It is better to avoid Telmisartan in early pregnancy- see pregnancy section.) • If you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other liver disease. PREGNANCY AND LACTATION PREGNANCY Ask your doctor or pharmacist for advice before taking any medicine. You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking _Telmisartan _ before you become pregnant or as soon as you know you are pregnant and will advise you to ta Прочетете целия документ
PACKAGE INSERT TELSAR 20/40/80 1. PRODUCT NAME TELSAR 20/40/80 (Telmisartan tablets 20mg/40mg/80mg) 2. NAME AND STRENGTH OF ACTIVE INGREDIENT (S) Telmisartan tablets 20mg/40mg/80mg 3. PRODUCT DESCRIPTION TELSAR 20 (TELMISARTAN TABLETS 20MG) White to off white, round, flat bevel edged tablets, debossed with ‘H’ on one side and ‘162’ on other side. The thickness of the tablet is 2.60 ±0.40 mm. TELSAR 40 (TELMISARTAN TABLETS 40MG) White to off white, oval shaped, biconvex tablets, debossed with ‘H’ on one side and ‘163’on other side. The thickness of the tablet is 3.80 ±0.40 mm. TELSAR 80 (TELMISARTAN TABLETS 80MG) White to off white, oval shaped, biconvex tablets debossed with ‘H’ on one side and ‘164’on other side. The thickness of the tablet is 5.00 ±0.40 mm. 4. PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Telmisartan is an orally effective and specific angiotensin-II receptor (type AT 1 ) antagonist. It displaces angiotensin II with very high affinity from its binding site at the AT 1 receptor subtype, which is responsible for the unknown actions of angiotensin II. Telmisartan does not exhibit any partial agonist activity at the AT 1 receptor. Telmisartan selectively binds the AT 1 receptor. The binding long lasting. Telmisartan does not show affinity for other receptors, including AT 2 and other less characterized AT receptors. The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin. Therefore, it is not expected to potentiate bradykinin-mediated adverse effects. In man, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase. The inhibitory effect is maintained over 24 hours and Прочетете целия документ