Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
perindopril (perindopril erbumine)
KRKA d.d.
C09AA04
perindopril (perindopril erbumine)
4mg
tablets
(30/3x10/) in blister
Prescription
Registered
2015-12-30
Summary of Product Characteristics CONFIDENTIAL Prenessa tablet 4 mg, 8 mg VOL: 1; P: 6 / 33 1.3.1 Perindopril erbumine SPC, Labeling and Package Leaflet BY SmPCPIL134639_1 02.04.2019 – Updated: 14.05.2019 Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Prenessa ® 2 mg tablets Prenessa ® 4 mg tablets Prenessa ® 8 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prenessa 2 mg tablets Each tablet contains 2 mg perindopril erbumine. Prenessa 4 mg tablets Each tablet contains 4 mg perindopril erbumine. Prenessa 8 mg tablets Each tablet contains 8 mg perindopril erbumine. Excipient with known effect: Lactose monohydrate. 2 mg tablets 4 mg tablets 8 mg tablets Quantity of lactose in each tablet 30.2 mg 60.4 mg 120.8 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 2 mg tablets: white to almost white, round, slightly biconvex tablets with bevelled edges. 4 mg tablets: white to almost white, oval, slightly biconvex, one side scored tablets with bevelled edges. The tablet can be divided into equal doses. 8 mg tablets are white to almost white, round, slightly biconvex, one side scored tablets with bevelled edges. The tablet can be divided into equal doses. 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 cardiovascular events in patients with a history of myocardial infarction and/or revascularisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CONFIDENTIAL Prenessa tablet 4 mg, 8 mg VOL: 1; P: 7 / 33 1.3.1 Perindopril erbumine SPC, Labeling and Package Leaflet BY SmPCPIL134639_1 02.04.2019 – Updated: 14.05.2019 Page 2 of 18 Posology _Hypertension_ Perindopril may be used in monotherapy or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). The recommended starting dose is 4 mg given once daily in the morning. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, Lesen Sie das vollständige Dokument