Amprilan tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ramipril

Available from:

KRKA d.d.

ATC code:

C09AA05

INN (International Name):

ramipril

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-11-07

Summary of Product characteristics

PI_Text054135_2
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Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Amprilan tablets 1.25 mg
Amprilan tablets 2.5 mg
Amprilan tablets 5 mg
Amprilan tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 1.25 mg ramipril.
1 tablet contains 2.5 mg ramipril.
1 tablet contains 5 mg ramipril.
1 tablet contains 10 mg ramipril.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Amprilan tablets 1.25 mg: white to off-white, oval, flat, uncoated
tablets with bevelled edges.
Amprilan tablets 2.5 mg: light yellow, oval, flat, uncoated tablets
with bevelled edges.
Amprilan tablets 5 mg: pink, oval, flat, uncoated tablets with
bevelled edges and visible inclusions.
Amprilan tablets 10 mg: white to off-white, oval, flat, uncoated
tablets with bevelled edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
-
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease or
stroke, or peripheral vascular disease) or
-
diabetes with at least one cardiovascular risk factor (see section
5.1).
Treatment of renal disease:
-
incipient glomerular diabetic nephropathy as defined by the presence
of microalbuminuria,
-
manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with
at least one cardiovascular risk factor (see section 5.1),
-
manifest glomerular non-diabetic nephropathy as defined by
macroproteinuria ≥ 3 g/day
(see section 5.1).
Treatment of symptomatic heart failure.
Secondary prevention after acute myocardial infarction: reduction of
mortality from the acute
phase of myocardial infarction in patients with clinical signs of
heart failure when started > 48
hours following acute myocardial infarction.
CONFIDENTIAL
Amprilan tablet 1.25 mg, 2.5 mg, 5 mg, 10 mg
VOL: 1; P: 11 / 50
PI_Text054135_2
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Page 2 of 19
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Diuretic-treate