Amlodipine-Perindopril-Richter tablets

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

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

Saatavilla:

Gedeon Richter PLC

ATC-koodi:

C09BB04

INN (Kansainvälinen yleisnimi):

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

Annos:

10mg+ 4mg

Lääkemuoto:

tablets

Kpl paketissa:

(30/3x10/), in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2015-11-18

Valmisteyhteenveto

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