Co-Amlessa tablets

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

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

Dostopno od:

KRKA d.d.

Koda artikla:

C09BX01

INN (mednarodno ime):

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

Odmerek:

4mg+ 10mg+ 1,25mg

Farmacevtska oblika:

tablets

Enote v paketu:

(30/3x10/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2016-07-20

Lastnosti izdelka

Summary of product characteristics
CONFIDENTIAL
Co-Amlessa tablet 2 mg/5 mg/0.625 mg, 4 mg/5 mg/1.25
mg, 4 mg/10 mg/1.25 mg, 8 mg/5 mg/2.5 mg, 8 mg/10
VOL: 1; P: 68 / 1048
1.3.1
Perindopril+Indapamide+Amlodipine
SPC, Labeling and Package Leaflet
AM
SmPCPIL153367_1
20.07.2020 – Updated: 20.07.2020
Page 1 of 27
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 tablet can be divided 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 s