Amlessa tablets

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

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

Saadav alates:

KRKA d.d.

ATC kood:

C09BB04

INN (Rahvusvaheline Nimetus):

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

Annus:

8mg+ 5mg

Ravimvorm:

tablets

Ühikuid pakis:

(30/3x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2018-10-16

Infovoldik

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SPC,
Labeling
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1.3.1
Perindopril/Amlodipine
SPC, Labeling and Package Leaflet
AM-Armenia
PI_Text053497_1
- Updated:
Page 1 of 23
1.
NAME OF THE MEDICINAL PRODUCT
Amlessa 4 mg/5 mg tablets
Amlessa 4 mg/10 mg tablets
Amlessa 8 mg/5 mg tablets
Amlessa 8 mg/10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlessa 4 mg/5 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril) and 5 mg
amlodipine (as besilate).
Amlessa 4 mg/10 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril) and 10 mg
amlodipine (as besilate).
Amlessa 8 mg/5 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine (equivalent to
6.68 mg perindopril) and 5 mg
amlodipine (as besilate).
Amlessa 8 mg/10 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine (equivalent to
6.68 mg perindopril) and 10 mg
amlodipine (as besilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4 mg/5 mg: White to almost white, round, slightly biconvex tablets
with bevelled edges.
4 mg/10 mg: White to almost white, capsule shaped, 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.
8 mg/5 mg: White to almost white, round, biconvex tablets with
bevelled edges.
8 mg/10 mg:
White to almost white, round, biconvex, one-side scored tablets with
bevel edges.
The tablet can be divided into equal halves.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amlessa 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
concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1.3.1
Perindopril/Amlodipine
SPC, Labeling and Package Leaflet
AM-Armenia
PI_Text053497_1
- Updated:
Page 2 of 23
Oral route.
One tablet per day as a single dose, preferably to be taken in the
morning and before a meal.
The fix