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SPC, UK: EZETIMIBE / SANDOZ Tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ezetimibe 10mg Tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg of ezetimibe. Excipient(s) with known effect: 68 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White to almost white, oval tablets (7.4 mm x 4.1 mm) with debossing 10 on one side and EZT on the other side.

Therapeutic indications

Primary hypercholesterolaemia Ezetimibe, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial ...

Posology and method of administration

Posology The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezetimibe. Route of administration is oral. The recommended dose is one Ezetimibe ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. When Ezetimibe is co-administered with a statin, please refer to the SmPC for that particular medicinal product. ...

Special warnings and precautions for use

When Ezetimibe is co-administered with a statin, please refer to the SmPC for that particular medicinal product. Liver enzymes In controlled co-administration trials in patients receiving ezetimibe with ...

Interaction with other medicinal products and other forms of interaction

In preclinical studies, it has been shown that ezetimibe does not induce cytochrome P450 drug metabolising enzymes. No clinically significant pharmacokinetic interactions have been observed between ezetimibe ...

Fertility, pregnancy and lactation

Ezetimibe co-administered with a statin is contraindicated during pregnancy and lactation (see section 4.3), please refer to the SPC for that particular statin. Pregnancy Ezetimibe should be given to pregnant ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported. ...

Undesirable effects

Tabulated list of adverse reactions (clinical studies and post-marketing experience) In clinical studies of up to 112 weeks duration, ezetimibe 10 mg daily was administered alone in 2396 patients, with ...

Overdose

In clinical studies, administration of ezetimibe, 50 mg/day, to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days, was generally well ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other lipid modifying agents ATC code: C10AX09 Mechanism of action Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption ...

Pharmacokinetic properties

Absorption After oral administration, ezetimibe is rapidly absorbed and extensively conjugated to a pharmacologically-active phenolic glucuronide (ezetimibe-glucuronide). Mean maximum plasma concentrations ...

Preclinical safety data

Animal studies on the chronic toxicity of ezetimibe identified no target organs for toxic effects. In dogs treated for four weeks with ezetimibe (≥0.03 mg/kg/day) the cholesterol concentration in the cystic ...

List of excipients

Lactose monohydrate Hypromellose Croscarmellose sodium Microcrystalline cellulose Sodium lauryl sulfate Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. Bottles: After first opening: nine months. Do not store above 25°C.

Special precautions for storage

Blisters: Store in the original package in order to protect from moisture. Bottles: Keep the container tightly closed in order to protect from moisture. For storage conditions after first opening of the ...

Nature and contents of container

Al/Al blister or PVC/PVDC/Al blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets. White HDPE container closed with white, tamper-evident polypropylene screw cap ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/1387

Date of first authorization / renewal of the authorization

21/01/2014

Date of revision of the text

22/11/2017

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