Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE
KRKA Pharma Dublin Limited
8 Milligram
Tablets
2010-12-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Krka 8 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg perindopril tert-butylamine, equivalent to 6.676 mg perindopril. Excipient: Each tablet contains 120.8 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Tablets are white to almost white, round, slightly biconvex, one side scored tablets with bevelled edges. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 _Oral use_ It is recommended that perindopril 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 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. After one month of treatment, the daily dose may be increased to 8 mg once daily. Symptomatic hypotension may occur following initiation Read the complete document