Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
TELMISARTAN
4 x 7'stablet Tablets
TORRENT PHARMACEUTICAL LIMITED
TELDAY TABLETS Telmisartan (40mg , 80mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is TELDAY used for 2. How TELDAY works 3. Before you use TELDAY 4. How to use TELDAY 5. While you are using it 6. Side effects 7. Storage and Disposal of TELDAY 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TELDAY IS USED FOR TELDAY contains Telmisartan. It is used to treat essential hypertension (high blood pressure). ‘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. HOW TELDAY 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 TELDAY - _When you must not use it _ If you are allergic (hypersensitive) to Telmisartan or any other ingredients included in TELDAY tablets. 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. _Pregnancy and lactation_ _ _ Do not take TELDAY if you are pregnant, trying to get pregnant or think you may be pregnant. TELDAY is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage. Do not take TELDAY if you are breast- feeding. TELDAY is not recommended for mothers who are breast-feeding, and your doctor may choose Baca dokumen lengkap
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory TELDAY TABLETS 40/80 MG TELMISARTAN TABLETS 40/80 MG BRAND OR PRODUCT NAME TELDAY TABLETS 40/80 MG NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) TELDAY TABLETS 40 MG Each uncoated tablet contains: Telmisartan Ph. Eur……… 40 mg TELDAY TABLETS 80 MG Each uncoated tablet contains: Telmisartan Ph. Eur……… 80 mg PRODUCT DESCRIPTION TELDAY TABLETS 40 MG White or off-white to yellowish oblong biconvex uncoated tablets with break line on one side and plain on the other side. TELDAY TABLETS 80 MG White or off-white to yellowish oval biconvex uncoated tablets with break line on one side and plain on other side. DOSAGE FORM Uncoated tablet PHARMACODYNAMICS / PHARMACOKINETICS 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 AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is long- lasting. Telmisartan does not show affinity for other receptors, including AT2 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 human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure incr Baca dokumen lengkap