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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Servier 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent to 6.676 mg of Perindopril.
Excipients: also contains lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, round, convex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension.
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 Perindopril Tablets are taken once daily in the morning before a meal.
The dose should be individualised according to the patient profile (see 4.4 “Special warnings and special precautions
for use”) and blood pressure response.
Hypertension
Perindopril Tablets may be used in monotherapy or in combination with other classes of antihypertensive therapy.
The recommended starting dose is 4 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 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision. The dose may be increased to 8 mg once daily after one month
of treatment.
Symptomatic hypotension may occur following initiation of therapy with Perindopril Tablets; this is more likely in
patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients ma
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