Vasilip tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

simvastatin

Available from:

KRKA d.d.

ATC code:

C10AA01

INN (International Name):

simvastatin

Dosage:

10mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-09-05

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Vasilip 10 mg film-coated tablets
Vasilip 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg or 20 mg simvastatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg tablets: Round, slightly biconvex, bevel edged, white or almost
white film coated tablets.
20 mg tablets: Round, slightly biconvex, bevel edged, white or almost
white film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to diet, when
response to diet and other non-pharmacological treatments (e.g.
exercise, weight reduction) is
inadequate.
Treatment of homozygous familial hypercholesterolaemia (HoFH) as an
adjunct to diet and other
lipid-lowering treatments (e.g. LDL apheresis) or if such treatments
are not appropriate.
Cardiovascular prevention
Reduction of cardiovascular mortality and morbidity in patients with
manifest atherosclerotic
cardiovascular disease or diabetes mellitus, with either normal or
increased cholesterol levels, as an
adjunct to correction of other risk factors and other cardioprotective
therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage range is 5-80 mg/day given orally as a single dose in the
evening. Adjustments of dosage,
if required, should be made at intervals of not less than 4 weeks, to
a maximum of 80 mg/day given as
a single dose in the evening. The 80-mg dose is only recommended in
patients with severe
hypercholesterolaemia and high risk for cardiovascular complications
who have not achieved their
treatment goals on lower doses and when the benefits are expected to
outweigh the potential risks (see
sections 4.4 and 5.1).
Hypercholesterolemia
The patient should be placed on a standard cholesterol lowering diet
and should continue on this diet
during treatment with simvastatin. The usual starting dose is 10-20
mg/day given as a