Co-Amlessa tablets

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

perindopril (perindopril tert-butylamine), amlodipine (amlodipine besilate), indapamide

Предлага се от:

KRKA d.d.

АТС код:

C09BX01

INN (Международно Name):

perindopril (perindopril tert-butylamine), amlodipine (amlodipine besilate), indapamide

дозиране:

2mg+ 5mg+ 0,625mg

Лекарствена форма:

tablets

Броя в опаковка:

(30/3x10/) in blister

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2022-12-08

Данни за продукта

PI_Text033829_2
– Updated:
Page 1 of 28
1.
NAME OF THE MEDICINAL PRODUCT
Co-Amlessa 2 mg/5 mg/0.625 mg tablets
Co-Amlessa 4 mg/5 mg/1.25 mg tablets
Co-Amlessa 4 mg/10 mg/1.25 mg tablets
Co-Amlessa 8 mg/5 mg/2.5 mg tablets
Co-Amlessa 8 mg/10 mg/2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Amlessa 2 mg/5 mg/0.625 mg tablets
Each tablet contains 2 mg perindopril tert-butylamine, 5 mg amlodipine
(as besilate) and 0.625 mg
indapamide.
Co-Amlessa 4 mg/5 mg/1.25 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine, 5 mg amlodipine
(as besilate) and 1.25 mg
indapamide.
Co-Amlessa 4 mg/10 mg/1.25 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine, 10 mg
amlodipine (as besilate) and 1.25 mg
indapamide.
Co-Amlessa 8 mg/5 mg/2.5 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine, 5 mg amlodipine
(as besilate) and 2.5 mg
indapamide.
Co-Amlessa 8 mg/10 mg/2.5 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine, 10 mg
amlodipine (as besilate) and 2.5 mg
indapamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Co-Amlessa 2 mg/5 mg/0.625 mg tablets: White to almost white, oval,
biconvex tablets scored on one
side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal
doses.
Co-Amlessa 4 mg/5 mg/1.25 mg tablets: White to almost white, round,
slightly biconvex tablets with
bevel edges.
Co-Amlessa 4 mg/10 mg/1.25 mg tablets: White to almost white, oval,
biconvex tablets scored on one
side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal
doses.
Co-Amlessa 8 mg/5 mg/2.5 mg tablets: White to almost white, round,
biconvex tablets with bevel
edges.
Co-Amlessa 8 mg/10 mg/2.5 mg tablets: White to almost white, round,
biconvex tablets scored on one
side with bevel edges. The score line is only to facilitate breaking
for ease of swallowing and not to
divide into equal doses.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PI_Text033829