SIMVASTAD Tablets 40 Milligram

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

SIMVASTATIN

Tilgængelig fra:

Stada Arzneimittel AG

Dosering:

40 Milligram

Lægemiddelform:

Tablets

Autorisation dato:

2004-07-30

Produktets egenskaber

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains simvastatin 40 mg respectively.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, slightly biconvex, bevel-edged, one-side scored,
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 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 ADMINSTRATION
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.
Hypercholesterolaemia
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 single dose in the evening. Patients who require 
a large reduction in LDL-C (more than 45%) may be started
at 20–40 mg/day given