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LIVAZO Film-coated tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Livazo 1mg film-coated tablets. Livazo 2mg film-coated tablets. Livazo 4mg film-coated tablets.

Qualitative and quantitative composition

1mg: Each film-coated tablet contains pitavastatin calcium equivalent to 1mg pitavastatin. Excipient(s) include 63.085mg Lactose monohydrate. For a full list of excipients see section 6.1. 2mg: Each film-coated ...

Pharmaceutical form

Film-coated tablet. Round white film-coated tablets embossed KC on one face and 1 on the reverse. Round white film-coated tablets embossed KC on one face and 2 on the reverse. Round white film-coated tablets ...

Therapeutic indications

Livazo is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia, including heterozygous ...

Posology and method of administration

Posology Patients should be on a cholesterol lowering diet before treatment. It is important that all patients continue dietary control during treatment. The usual starting dose is 1mg once daily. Adjustment ...

Contraindications

Livazo is contraindicated: in patients with known hypersensitivity to pitavastatin or to any of the excipients or other statins in patients with severe hepatic impairment, active liver disease or unexplained ...

Special warnings and precautions for use

Muscle Effects In common with other HMG-CoA reductase inhibitors (statins), there is the potential for myalgia, myopathy and, rarely, rhabdomyolysis to develop. Patients should be asked to report any muscle ...

Interaction with other medicinal products and other forms of interaction

Pitavastatin is actively transported into human hepatocytes by multiple hepatic transporters (including organic anion transporting polypeptide, OATP), which may be involved in some of the following interactions. ...

Pregnancy and lactation

Pregnancy Livazo is contraindicated during pregnancy (see section 4.3). Women of childbearing potential must take appropriate contraceptive precautions during treatment with Livazo. Since cholesterol and ...

Effects on ability to drive and use machines

There is no pattern of adverse events that suggests that patients taking Livazo will have any impairment of ability to drive and use hazardous machinery, but it should be taken into account that there ...

Undesirable effects

Summary of the safety profile In controlled clinical trials, at the recommended doses, less than 4% of Livazo treated patients were withdrawn due to adverse events. The most commonly reported pitavastatin ...

Overdose

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

Pharmacodynamic properties

Pharmacotherapeutic group: HMG-CoA reductase inhibitors ATC Code: C10AA08 Mechanism of Action Pitavastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in the biosynthesis of cholesterol, ...

Pharmacokinetic properties

Absorption Pitavastatin is rapidly absorbed from the upper gastrointestinal tract and peak plasma concentrations are achieved within one hour after oral administration. Absorption is not affected by food. ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on results from conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity carcinogenic potential, toxicity to reproduction. ...

List of excipients

Tablet core: Lactose monohydrate Low substituted hydroxypropylcellulose Hypromellose (E464) Magnesium Aluminometasilicate Magnesium stearate Film coating: Hypromellose (E464) Titanium dioxide (E171) Triethyl ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Do not store above 25ºC. To protect from light keep blister in the outer carton.

Nature and contents of container

1mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. Not all pack sizes may be marketed. 2mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. ...

Special precautions for disposal and other handling

To protect the environment, do not dispose of via waste water or household waste.

Marketing authorization holder

Kowa Pharmaceutical Europe Co. Ltd., Winnersh Triangle, Wokingham RG41 5RB, UK

Marketing authorization number(s)

1mg: PL32363/0011 2mg: PL32363/0001 4mg: PL32363/0002

Date of first authorization / renewal of the authorization

12/08/2010

Date of revision of the text

28/11/2017

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