EZETIMIBE SANDOZ Tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Ezetimibe 10mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10 mg of ezetimibe. <u>Excipient with known effect:</u> Each tablet contains 64.1 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to almost white, oval tablets (7.4 mm x 4.0 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
<b>Pharmacotherapeutic group:</b> Other lipid modifying agents <b>ATC code:</b> C10AX09 Mechanism of action Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal ...
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
3 years. <u>Bottles:</u> After first opening: 9 months. Do not store above 25°C.
Special precautions for storage
<u>Blisters:</u> Store in the original package in order to protect from moisture. <u>Bottles:</u> Keep the container tightly closed in order to protect from moisture. For storage conditions after first ...
Nature and contents of container
Alu/Alu 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 with mounted LDPE capsule ...
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
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Marketing authorization number(s)
PL 04416/1387
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 Jan 2014
Date of revision of the text
30/03/2022
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