Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
4 Milligram
Tablets
2008-11-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine 4mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tert-butylamine. One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylamine. Excipient: lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet scored on both faces. 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 Perindopril tert-butylamine Tablets 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: Perindopril tert-butylamine 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 tert-butylamine Tablets; this is Read the complete document