Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TELMISARTAN
Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)
C09CA07
TELMISARTAN
Tablet
MANNITOL (D-) (E 421) ; MEGLUMINE ; NATRIUMHYDROXIDE (E 524) ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201),
Oraal gebruik
Telmisartan
Hulpstoffen: MANNITOL (D-) (E 421); MEGLUMINE; NATRIUMHYDROXIDE (E 524); NATRIUMSTEARYLFUMARAAT; POVIDON K 30 (E 1201);
2012-07-17
Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC Page 1 NL pl NL/p/004/13/8 PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN TORRENT 20 MG TABLETTEN TELMISARTAN TORRENT 40 MG TABLETTEN TELMISARTAN TORRENT 80 MG TABLETTEN Telmisartan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [product name] is and what it is used for 2. What you need to know before you take [product name] 3. How to take [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [product name] 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. [product name] blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. [PRODUCT NAME] 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. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus, it is important to regularly measure blood pressure to verify if it is within the normal range. [PRODUCT NAME] IS ALSO USED TO reduce cardiovascular events (i.e. Olvassa el a teljes dokumentumot
Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC Page 1 NL SmPC NL/s/001/13/7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Telmisartan Torrent 20 mg tabletten Telmisartan Torrent 40 mg tabletten Telmisartan Torrent 80 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [product name] 20 mg tablets Each tablet contains 20 mg telmisartan. [product name] 40 mg tablets Each tablet contains 40 mg telmisartan. [product name] 80 mg tablets Each tablet contains 80 mg telmisartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet [product name] 20 mg tablets White or off white to yellowish, round, uncoated tablets with a diameter of approx. 7.2 mm, plain on both sides. [product name] 40 mg tablets White or off-white to yellowish, oblong, biconvex uncoated tablets, approx. 12.0 x 5.9 mm, with breakline on one side and plain on the other side. The tablet can be divided into equal doses. [product name] 80 mg tablets White or off-white to yellowish, oval, biconvex uncoated tablets, approx. 16.3 x 6.9 mm, with breakline on one side and plain on other sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or ii) type 2 diabetes mellitus with documented target organ damage 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC Page 2 NL SmPC NL/s/001/13/7 Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination wi Olvassa el a teljes dokumentumot