Amlodipine-Perindopril-Richter tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

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

Available from:

Gedeon Richter PLC

ATC code:

C09BB04

INN (International Name):

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

Dosage:

5mg+ 8mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-11-18

Summary of Product characteristics

PhD002023
1
H.
NAME OF THE MEDICINAL PRODUCT
Amlodipine-Perindopril-Richter 4
mg/5
mg
tablets
Amlodipine-Perindopril-Richter 8
mg/5
mg
tablets
/.mlodipine-Perindopril-Richter 4
mg/1
0
mg
tablets
Amlodipine-Perindopril-Richter 8
mg/1
0
mg
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine-Perindopril-Richter 4 mg
/5
mg
tablet:
Each tablet contains 4
mg
perindopril tert-butylamine and 5
mg
amlodipine (as amlodipine
besilate).
Amlodipine-Perindopril-Richter 8 mg
_I _
5 mg tablet:
Each tablet contains 8 mg perindopril tert-butylamine and 5 mg
an1lodipine (as amlodipine
besilate).
A1nlodipine-Perindopril-Richter 4 mg
/10
mg tablet:
Each tablet contains 4
mg
perindopril tert-butylamine and
10
mg amlodipine (as an1lodipine
besilate).
Amlodipine-Perindopril-Richter
s·
mg
_I _
10
mg tablet:
Each tablet contains 8
mg
perindopril tert-butylamine and
10
mg amlodipine (as amlodipine
besilate).
For a full list
of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
142/250
Amlodipine-Perindopril-Richter 4 mg
_I _
5 mg tablet: White or almost white, round, flat tablets
of8
mm. Engraving on one side:
"CH3",
other side is without engraving. Amlodipine-Perindopril-
Richter 8 mg
_I _
5 mg tablet: White or almost white, round, flat tablets
of
8
mm
..
Engraving on one
side: "CH4", other side is without engraving.
Amlodipine-Perindopril-Richter 4 mg
/10
mg
tablet: Whlte or almost white, round, flat tablets
of
11
mm
..
Engraving
on
one side:
"CH5",
other
side is without engraving. Amlodipine-Perindopril-Richter 8 mg
/10
mg tablet: White or almost
white, round, flat tablets
of
11
mm
..
Engraving
on
one side:
"CH6",
other side is without
engraving.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amlodipine-Perindopril-Richter is indicated as substitution therapy
for treatment
of
essential
hypertension and/or stable coronary artery disease, in patients
already controlled with perindopril
and amlodipine given concmrently at the same dose level.
4.2
POSOLOGY AND METHOD
OF
ADMINISTRATION
Oral route.
One tablet per day