Renitec tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

enalapril (enalapril maleate)

Available from:

Merck Sharp & Dohme B.V.

ATC code:

C09AA02

INN (International Name):

enalapril (enalapril maleate)

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(14/1x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-12-30

Summary of Product characteristics

2
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
Renitec 5 mg Tablets Renitec 10 mg
Tablets Renitec 20 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Renitec 5 mg
Each tablet contains 5 mg of enalapril maleate.
Renitec 10 mg
Each tablet contains 10 mg of enalapril maleate.
Excipient: each tablet contains 164 mg of lactose monohydrate. Renitec
20
mg
Each tablet contains 20 mg of enalapril maleate.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Strength
Appearance
5 mg
White, rounded triangle shaped tablet,
one side scored, the
other side marked
MSD 712
10 mg
Rust Red, rounded triangle shaped
tablet, one side
scored, the other side
marked MSD 713
20 mg
Peach, rounded triangle shaped tablet,
one side scored, the
other side marked
MSD 714
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of Hypertension
•
Treatment of Symptomatic Heart Failure
•
Prevention of Symptomatic Heart Failure in patients with Asymptomatic
Left Ventricular
Dysfunction (ejection fraction ≤35%)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The absorption of Renitec Tablets is not affected by food.
4
The dose should be individualised according to patient profile (see
section 4.4) and blood pressure response.
_Paediatric Population_
There is limited clinical trial experience of the use of Renitec in
hypertensive paediatric patients (see sections
4.4, 5.1 and 5.2).
_Hypertension_
The initial dose is 5 to maximally 20 mg, depending on the degree of
hypertension and the condition of the
patient (see below). Renitec is given once daily. In mild
hypertension, the recommended initial dose is 5 to 10
mg. Patients with a strongly activated renin-angiotensin-aldosterone
system (e.g., renovascular hypertension, salt
and/or volume depletion, cardiac decompensation, or severe
hypertension) may experience an excessive blood
pressure fall following the initial dose. A starting dose of 5 mg or
lower is recommended in such patients and the