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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains perindopril 3.395 mg corresponding to 5 mg perindopril arginine.
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK and Hungary:_
Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and scored on both edges.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Coversyl Arginine 5 mg film-coated tablet is taken once daily in the morning before a meal.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response.
Hypertension:
Coversyl Arginine 5 mg may be used in monotherapy or in combination with other classes of antihypertensive therapy.
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt
and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood
pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 10 mg once daily after one month of treatm
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