Co-Amlessa tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

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

Available from:

KRKA d.d.

ATC code:

C09BX01

INN (International Name):

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

Dosage:

8mg+ 10mg+ 2,5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-12-08

Summary of Product characteristics

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