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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
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