SIMATOR 10 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
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Active ingredient:
SIMVASTATIN
Available from:
Arrow Generics Limited
INN (International Name):
SIMVASTATIN
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simator 10 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg simvastatin.
Excipient: 73.43mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Shield-shaped, pink tablets with “SV 10” on one side and “ ” on the other.
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 aphaeresis) 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
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 Simator tablets. The usual starting dose is 10-20 mg/day given as a single dose in
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