Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
TELMISARTAN
Actavis Group PTC ehf
80 Milligram
Tablets
2011-06-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actelsar 80 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 80 mg tablet contains 80 mg of telmisartan For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 80 mg tablets are white, oval, biconvex 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 patients 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 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 with thiazide-type 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 whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity. When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pres Lees het volledige document