SIMVASTATIN 40MG FILM-COATED TABLET 40 Milligram Film Coated Tablet
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
11-06-2024
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Ingredient activ:
SIMVASTATIN
Disponibil de la:
Norton Waterford
INN (nume internaţional):
SIMVASTATIN
Dozare:
40 Milligram
Forma farmaceutică:
Film Coated Tablet
Tip de prescriptie medicala:
Product subject to prescription which may be renewed (B)
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2013-01-25
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin 40mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg simvastatin.
Excipients:
Each film-coated tablet contains 278 mg lactose monohydrate.
Product also contains soya lecithin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Dark-pink film-coated tablets, lenticular in shape, provided with a break line on one side.
The tablets may be divided into equal halves only following a doctor’s instructions. The tablets are not to be broken by
hand (see section 4.2).
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 manifested 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 of cardiovascular
complications.
Hyper
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