Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
HEALOL PHARMACEUTICALS SDN. BHD.
TELMISARTAN
3 x 10 Tablets
Jubilant Generics Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ JUBITEL (TELMISARTAN TABLETS 40MG & 80MG) Telmisartan (40mg & 80mg) 1 WHAT IS IN THIS LEAFLET 1. What JUBITEL is used for 2. How JUBITEL works 3. Before you use JUBITEL 4. How to use JUBITEL 5. While you are using it 6. Side effects 7. Storage and Disposal of JUBITEL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS JUBITEL USED FOR JUBITEL is used to treat high blood pressure. It is also used to reduce your risk of cardiovascular events such as a heart attack, stroke or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take a group of medicines called ACE inhibitors. JUBITEL can be used in additional to other needed treatment such as for blood pressure, anti-blood clotting or cholesterol lowering therapy. HOW JUBITEL WORKS JUBITEL works by blocking a receptor called angiotensin II receptor. 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 JUBITEL _-When you must not use it _ Do not use JUBITEL if you are allergic to Telmisartan or any other ingredients in this medication. If you are more than 3 months pregnant. It is best to avoid this medication in early pregnancy. 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 are diabetic or have renal (kidney) disease and are on a high blood pressure medication called Aliskiren. If you are breastfeeding. _-Before you start to use it _ Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses: Kidney disease or kidney transplant Renal artery stenosis (narrowing of the blood ves Perskaitykite visą dokumentą
Last modified: 1. November 2018, 11:48 AM For the use of a registered medical practitioner or a hospital or a laboratory only JUBITEL TELMISARTAN TABLETS 40 MG & 80 MG PRODUCT NAME Telmisartan Tablets 40 mg Telmisartan Tablets 80 mg NAME AND STRENGTH OF ACTIVE INGREDIENT EACH TABLET CONTAINS: FOR 40 MG: Telmisartan Ph.Eur. 40 mg FOR 80 MG: Telmisartan Ph.Eur. 80 mg PRODUCT DESCRIPTION FOR 40 MG: White to off white, capsule shaped tablets debossed with “H” on one side and plain on the other side. FOR 80 MG: White to off white, oval shaped tablets debossed with “D” on one side and plain on the other side. PHARMACODYNAMICS / PHARMACOKINETICS PHARMACOLOGICAL/CLINICAL PARTICULARS Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07. Mechanism of action Telmisartan is an orally active and specific angiotensin II receptor (type AT 1 ) antagonist. Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT 1 receptor subtype, which is responsible for the known 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 is 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 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. Clinical efficacy a Perskaitykite visą dokumentą