Crestor 5mg, 10mg, 20mg and 40mg film-coated tablets
1. Name of the medicinal product
Crestor 5 mg film-coated tablets.
Crestor 10 mg film-coated tablets.
Crestor 20 mg film-coated tablets.
Crestor 40 mg film-coated tablets.
2. Qualitative and quantitative composition
5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 94.88 mg lactose monohydrate.
10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 91.3 mg lactose monohydrate.
20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 182.6 mg lactose monohydrate.
40 mg: Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 168.32 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
5 mg: Film-coated tablet.
Round, yellow coloured tablets, intagliated with 'ZD4522' and '5' on one side and plain on the reverse.
10 mg: Film-coated tablet.
Round, pink coloured tablets, intagliated with 'ZD4522' and '10' on one side and plain on the reverse.
20 mg: Film-coated tablet.
Round, pink coloured tablets, intagliated with 'ZD4522' and '20' on one side and plain on the reverse.
40 mg: Film-coated tablet.
Oval, pink coloured tablets, intagliated with 'ZD4522' on one side and '40' on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of hypercholesterolaemia
Adults, adolescents and children aged 6 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.
Adults, adolescents and children aged 6 years or older with 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 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below). A dose adjustment to the next dose level can be made after 4 weeks, if necessary (see section 5.1). In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see section 4.8), a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterola |
