CRESTOR Film Coated Tablet 10 Milligram
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
06-05-2024
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Virkt innihaldsefni:
ROSUVASTATIN CALCIUM
Fáanlegur frá:
B & S Healthcare
Skammtar:
10 Milligram
Lyfjaform:
Film Coated Tablet
Leyfisdagur:
2009-11-27
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crestor 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains rosuvastatin 10mg (as rosuvastatin calcium)
Excipients: contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from Italy:_
Round, pink biconvex, with ‘ZD4522’ and ‘10’ on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa including
heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to
diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL
apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are 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
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue
during treatment. The dose should be individualised according to the goal of therapy and patient response, using current
consensus guidelines. Crestor may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another
HMG CoA reductase inhibitor. The
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