Vasilip tablets film-coated

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

simvastatin

Commercializzato da:

KRKA d.d.

Codice ATC:

C10AA01

INN (Nome Internazionale):

simvastatin

Dosaggio:

40mg

Forma farmaceutica:

tablets film-coated

Confezione:

(28/4x7/) in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2016-04-19

Scheda tecnica

1.3.1
Simvastatin
SPC, Labeling and Package Leaflet
DK
SmPCPIL156164_1
25.09.2020 – Updated: 25.09.2020
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Vasilip 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 40 mg simvastatin.
Excipient(s) with known effect
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, slightly biconvex, film-coated tablets, white or almost white,
with beveled edge, one-side scored.
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