Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
Ascend Laboratories Sdn Bhd
TELMISARTAN
6 x 10 Tablets; 3 x 10 Tablets
ALKEM LABORATORIES LTD
_Consumer Medication Information Leaflet (RiMUP) _ TSART 40/80 TELMISARTAN TABLETS USP 40MG/80MG Page 1 of 2 WHAT IS IN THIS LEAFLET? 1. What Telmisartan Tablets is used for 2. How Telmisartan Tablets works 3. Before you use Telmisartan Tablets 4. How to use Telmisartan Tablets 5. While you are using it 6. Side effects 7. Storage and Disposal of Telmisartan Tablets 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial number 1. WHAT TELMISARTAN TABLETS IS USED FOR Telmisartan is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition. Also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events. 2. HOW TELMISARTAN TABLETS 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. 3. BEFORE YOU USE TELMISARTAN TABLETS _-When you must not use it_ Do not take Telmisartan • if you are allergic to telmisartan or any other ingredients of this medicine • if you are more than 3 months pregnant. • 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 severe liver disease. • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan. _-Before you start to use it_ Talk to your doctor before taking Telmi Прочитајте комплетан документ
COMPOSITION: Each uncoated tablet of TSART 40 contains Telmisartan Ph. Eur ….. 40mg Each uncoated tablet of TSART 80 contains Telmisartan Ph. Eur ….. 80mg PRODUCT DESCRIPTION : TSART 40 : White to off white oblong shaped biconvex, uncoated tablets debossed with TELon one side and 40 on other side TSART 80 : White to off white oblong shaped biconvex, uncoated tablets debossed with TEL on one side and 80 on other side. PHARMACODYNAMICS Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07. Mechanism of action Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial agonist activity at the AT1receptor. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less characterised 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 human, 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 still measurable up to 48 hours. PHARMACOKINETICS: Absorption Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute bioavailability for telmisartan is about 50%. When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC ) Прочитајте комплетан документ