产品特点
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 Greece, Poland and Hungary:_
_Poland and Greece_
Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and plain on ther other.
_Hungary:_
Light-green, rod-shaped film-coated tablet engraved with the servier logo on one face and plain on the other, scored on
both edges.
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 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 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 medi
阅读完整的文件
产品特点 