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SPC, UK: Lipitor 10mg, 20mg, 40mg, 80mg Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Pfizer Limited
Διεύθυνση :
Ramsgate Road, Sandwich, Kent, CT13 9NJ
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Δωρεάν εγγραφή

Name of the medicinal product

Lipitor™ 10 mg, 20mg, 40mg, 80 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablets contains 10 mg, 20mg, 40mg or 80mg atorvastatin as atorvastatin calcium trihydrate. For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White, round, film-coated tablets debossed 10 on one side and ATV on the other side. White, round, film-coated tablets debossed 20 on one side and ATV on the other side. White, round, ...

Therapeutic indications

Hypercholesterolaemia Lipitor 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 ...

Posology and method of administration

Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor. The dose should be individualised ...

Contraindications

Lipitor is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients of this medicinal product with active liver disease or unexplained persistent elevations ...

Special warnings and precautions for use

Liver effects Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have ...

Interaction with other medicinal products and other forms of interaction

Effect of co-administered medicinal products on atorvastatin Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate to transport proteins e.g. the hepatic uptake transporter OATP1B1. ...

Pregnancy and lactation

Women of childbearing potential Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3). Pregnancy Lipitor is contraindicated during pregnancy ...

Effects on ability to drive and use machines

Lipitor has negligible influence on the ability to drive and use machines.

Undesirable effects

In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due ...

Overdose

Specific treatment is not available for Lipitor overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should ...

Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors ATC code: C10AA05 Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible ...

Pharmacokinetic properties

Absorption Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (Cmax) occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. ...

Preclinical safety data

Atorvastatin was negative for mutagenic and clastogenic potential in a battery of 4 in vitro tests and 1 in vivo assay. Atorvastatin was not found to be carcinogenic in rats, but high doses in mice (resulting ...

List of excipients

The 10-, 20-, and 40-mg dosage forms each contain the following excipients: Core: Calcium carbonate, E170 Microcrystalline cellulose, E460 Lactose monohydrate Croscarmellose sodium Polysorbate 80, E433 ...

Incompatibilities

Not applicable.

Shelf life

Three years.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating. The bottle is made of HDPE, containing desiccant, ...

Special precautions for disposal and other handling

No special instructions needed.

Marketing authorization holder

Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy Co Cork Ireland

Marketing authorization number(s)

Lipitor 10mg: PL 39933/0001 Lipitor 20mg: PL 39933/0002 Lipitor 40mg: PL 39933/0003 Lipitor 80mg: PL 39933/0004

Date of first authorization / renewal of the authorization

Lipitor 10mg, 20mg, and 40mg Tablets: 8 September 1997 Lipitor 80mg Tablets: 15 August 2000

Date of revision of the text

06/2012
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