Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Perindopril arginine
Les Laboratoires Servier
C09AA; C09AA04
Perindopril arginine
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; perindopril
Marketed
2005-10-28
Health Products Regulatory Authority 29 June 2022 CRN00CZVZ Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 10 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine One film-coated tablet contains 6.790 mg perindopril corresponding to 10 mg Perindopril arginine Excipient with known effect: 145.16 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Green, round, biconvex, film-coated tablet engraved with on one face and on the other face. 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 Posology 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 (see sections 4.3, 4.4, 4.5 and 5.1). The recommended starting dose is 5 mg given once dailyin 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 medical supervision. The dose may be increased to 10 mg once daily after one month of treatment. Symptomatic hypotension may occur following initiation of therapy with Coversyl Arginine; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning Read the complete document