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SPC, UK: CRESTOR Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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.

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 ...

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 ...

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 ...

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 ...

Contraindications

Crestor is contraindicated: in patients with hypersensitivity to rosuvastatin or to any of the excipients. In patients with active liver disease including unexplained, persistent elevations of serum transaminases ...

Special warnings and precautions for use

Renal Effects Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of Crestor, in particular 40 mg, where it was transient or ...

Interaction with other medicinal products and other forms of interaction

Effect of co-administered medicinal products on rosuvastatin Transporter protein inhibitors Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 ...

Fertility, pregnancy and lactation

Crestor is contraindicated in pregnancy and lactation. Women of child bearing potential should use appropriate contraceptive measures. Since cholesterol and other products of cholesterol biosynthesis are ...

Effects on ability to drive and use machines

Studies to determine the effect of Crestor on the ability to drive and use machines have not been conducted. However, based on its pharmacodynamic properties, Crestor is unlikely to affect this ability. ...

Undesirable effects

The adverse reactions seen with Crestor are generally mild and transient. In controlled clinical trials, less than 4% of Crestor-treated patients were withdrawn due to adverse reactions. Tabulated list ...

Overdose

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels ...

Pharmacodynamic properties

Pharmacotherapeutic group: HMG-CoA reductase inhibitors ATC code: C10AA07 Mechanism of action Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts ...

Pharmacokinetic properties

Absorption Maximum rosuvastatin plasma concentrations are achieved approximately 5 hours after oral administration. The absolute bioavailability is approximately 20%. Distribution Rosuvastatin is taken ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity potential. Specific tests for effects on hERG have not been evaluated. ...

List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose Calcium phosphate Crospovidone Magnesium stearate Tablet coat: Lactose monohydrate Hypromellose Triacetin Titanium dioxide (E171) Ferric oxide, ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Blisters: Store below 30°C. Store in the original package in order to protect from moisture. HDPE containers: Store below 30°C. Keep bottle tightly closed in order to protect from moisture.

Nature and contents of container

5 mg, 10 mg, 20 mg and 40 mg: Blisters of aluminium laminate/aluminium foil of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets. HDPE containers: 30 and 100 tablets. Not all pack sizes ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, United Kingdom

Marketing authorization number(s)

5 mg: PL 17901/0243 10 mg: PL 17901/0201 20 mg: PL 17901/0202 40 mg: PL 17901/0203

Date of first authorization / renewal of the authorization

21<sup>st</sup> March 2003/6<sup>th</sup> November 2012

Date of revision of the text

19<sup>th</sup> December 2018

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