ATORVASTATIN 40 Milligram Film Coated Tablet
Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Charakteristika produktu
(SPC)
19-04-2024
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Aktivní složka:
ATORVASTATIN CALCIUM TRIHYDRATE
Dostupné s:
Rowex Ltd
INN (Mezinárodní Name):
ATORVASTATIN CALCIUM TRIHYDRATE
Dávkování:
40 Milligram
Léková forma:
Film Coated Tablet
Druh předpisu:
Product subject to prescription which may be renewed (B)
Stav Autorizace:
Authorised
Datum autorizace:
0000-00-00
Charakteristika produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 40 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium ).
Excipient: 7.2 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet
White, round film-coated tablet, with breaking notch for tablet quarters and embossment “40”.
The tablet can be divided into equal quarters.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolaemia:_
Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol
(LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary
hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed)
hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other
nonpharmacological measures is inadequate.
Atorvastatin is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia
as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
_Prevention of cardiovascular disease_
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section
5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue
on this diet during treatment with Atorvastatin.
The dose should be individualised according to baseline LDL-C levels, the goal
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