Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
8mg Milligram
Tablets
2004-12-17
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 Read the complete document