Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Telmisartan
Actavis Group PTC ehf
C09CA07
telmisartan
Agents acting on the renin-angiotensin system
Hypertension
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients 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.
Revision: 13
Authorised
2010-09-29
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN ACTAVIS 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 Actavis is and what it is used for 2. What you need to know before you take Telmisartan Actavis 3. How to take Telmisartan Actavis 4. Possible side effects 5. How to store Telmisartan Actavis 6. Contents of the pack and other information 1. WHAT TELMISARTAN ACTAVIS IS AND WHAT IT IS USED FOR Telmisartan Actavis contains the active substance telmisartan which 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 Actavis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. Telmisartan Actavis tablets are 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 Actavis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who a Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets Telmisartan Actavis 40 mg tablets Telmisartan Actavis 80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Telmisartan Actavis 20 mg tablets Each tablet contains 20 mg telmisartan Telmisartan Actavis 40 mg tablets Each tablet contains 40 mg telmisartan Telmisartan Actavis 80 mg tablets Each tablet contains 80 mg telmisartan For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Telmisartan Actavis 20 mg tablets White, round, flat tablets with logo T on one side. Telmisartan Actavis 40 mg tablets White, oval, biconvex tablets with a break line and logo T on one side. The tablet can be divided into equal halves. Telmisartan Actavis 80 mg tablets White, oval, biconvex tablets with logo T1 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. 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 3 increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazidetype diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1). _Cardiovascular prevention _ The recommended dose is 80 mg once daily. It is not known Διαβάστε το πλήρες έγγραφο