Amlodipine-Perindopril-Richter tablets

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

产品特点 产品特点 (SPC)
19-11-2015

有效成分:

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

可用日期:

Gedeon Richter PLC

ATC代码:

C09BB04

INN(国际名称):

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

剂量:

5mg+ 4mg

药物剂型:

tablets

每包单位数:

(30/3x10/), in blister

处方类型:

Prescription

授权状态:

Registered

授权日期:

2015-11-18

产品特点

                                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
                                
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