Zocor Forte

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

simvastatin

Prieinama:

Merck Sharp & Dohme B.V.

INN (Tarptautinis Pavadinimas):

simvastatin

Dozė:

40mg

Vaisto forma:

tablets film-coated

Recepto tipas:

Prescription

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zocor 10 mg, film-coated tablets.
Zocor 20 mg, film-coated tablets.
Zocor Forte 40 mg, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of simvastatin.
Each tablet contains 20 mg of simvastatin.
Each tablet contains 40 mg of simvastatin.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
Each 10 mg tablet contains 70.7 mg of lactose monohydrate.
Each 20 mg tablet contains 141.5 mg of lactose monohydrate.
Each 40 mg tablet contains 283.0 mg of lactose monohydrate.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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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).
3
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 at high risk for cardiovascular
complications who have not achieved t