Enap tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

enalapril (enalapril maleate)

Доступна с:

KRKA d.d.

код АТС:

C09AA02

ИНН (Международная Имя):

enalapril (enalapril maleate)

дозировка:

20mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(20/2x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2022-02-11

Характеристики продукта

1.3.1
Enalapril maleate
SPC, Labeling and Package Leaflet
AM
SmPCPIL164228_1
01.04.2021 – Updated: 01.04.2021
Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Enap
®
2.5 mg tablets
Enap
®
5 mg tablets
Enap
®
10 mg tablets
Enap
®
20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg enalapril maleate,
which is equivalent to 1.9 mg,
3.8 mg, 7.6 mg or 15.3 mg enalapril.
Excipient with known effect:
2.5 mg tablets
5 mg tablets
10 mg tablets
20 mg tablets
lactose
61.7 mg
123.3 mg
118.4 mg
111.9 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
2.5 mg: white, round, biconvex, bevel-edged tablets.
5 mg: white to almost white, round, flat, bevel-edged tablets scored
on one side. The tablet can be
divided into equal doses.
10 mg: round, flat, red-brown, one side scored tablets with bevel edge
and individual white spots on
the surface and within the mass of tablets. The scoreline is not
intended to facilitate breaking of the
tablet for ease of swallowing or to divide it into equal halves.
20 mg: round, flat, light-orange, one-side scored tablets with bevel
edge, and individual white spots on
the surface and within the mass of tablets. The scoreline is not
intended to facilitate breaking of the
tablet for ease of swallowing or to divide it into equal halves.
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
_Hypertension_
The initial dose is 5 mg to 20 mg, depending on the degree of
hypertension and the condition of the
patient. The drug should be taken once daily. In mild hypertension,
the recommended initial dose is 5
mg to 10 mg daily. Patients with a strongly activated
renin-angiotensin-aldosterone system, (e.g.
renovascular hypertension, salt and/or volume depletion, cardiac
decompensation or