Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Telmisartan
Teva B.V.
C09CA07
telmisartan
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension in adults
Revision: 11
Withdrawn
2010-01-25
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN TEVA 20 MG TABLETS 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 Telmisartan Teva is and what it is used for 2. What you need to know before you take Telmisartan Teva 3. How to take Telmisartan Teva 4. Possible side effects 5. How to store Telmisartan Teva 6. Contents of the pack and other information 1. WHAT TELMISARTAN TEVA IS AND WHAT IT IS USED FOR Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. Telmisartan Teva 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 attacks, heart or kidney failure, strokes 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. Telmisartan Teva is 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, Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 20 mg tablets Telmisartan Teva 40 mg tablets Telmisartan Teva 80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Telmisartan Teva 20 mg tablets Each tablet contains 20 mg telmisartan Telmisartan Teva 40 mg tablets Each tablet contains 40 mg telmisartan Telmisartan Teva 80 mg tablets Each tablet contains 80 mg telmisartan Excipients with known effect: Telmisartan Teva 20 mg tablets Each tablet contains 21.4 mg sorbitol (E420) Telmisartan Teva 40 mg tablets Each tablet contains 42.8 mg sorbitol (E420) Telmisartan Teva 80 mg tablets Each tablet contains 85.6 mg sorbitol (E420) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Telmisartan Teva 20 mg tablets White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7458". Telmisartan Teva 40 mg tablets White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7459". Telmisartan Teva 80 mg tablets White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7460". 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. 3 Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or • type 2 diabetes mellitus with documented target organ damage 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _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 Pročitajte cijeli dokument