Prenessa tablets

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

perindopril (perindopril erbumine)

متاح من:

KRKA d.d.

ATC رمز:

C09AA04

INN (الاسم الدولي):

perindopril (perindopril erbumine)

جرعة:

4mg

الشكل الصيدلاني:

tablets

الوحدات في الحزمة:

(30/3x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2015-12-30

خصائص المنتج

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,