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SPC: CHOLESTAGEL Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cholestagel 625 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 625 mg colesevelam (as hydrochloride). For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). Off-white, capsule-shaped film-coated tablets imprinted with C625 on one side.

Therapeutic indications

Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density ...

Posology and method of administration

Posology Combination therapy The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day. The maximum recommended dose is 6 tablets per day taken ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bowel or biliary obstruction.

Special warnings and precautions for use

Secondary causes of hypercholesterolaemia Prior to initiating therapy with Cholestagel, if secondary causes of hypercholesterolaemia (i.e. poorly controlled diabetes mellitus, hypothyroidism, nephrotic ...

Interaction with other medicinal products and other forms of interaction

In general Cholestagel may affect the bioavailability of other medicinal products. Therefore when a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in ...

Fertility, pregnancy and lactation

Pregnancy No clinical data are available on the use of Cholestagel in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, ...

Effects on ability to drive and use machines

Cholestagel has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class. Tabulated list of adverse ...

Overdose

Since Cholestagel is not absorbed, the risk of systemic toxicity is low. Gastrointestinal symptoms could occur. Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been ...

Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants ATC code: C10AC04 Mechanism of action The mechanism of action for the activity of colesevelam, the active substance in Cholestagel, ...

Pharmacokinetic properties

Cholestagel is not absorbed from the gastrointestinal tract.

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

List of excipients

Tablet core: Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified Film-coating: Hypromellose (E464) Diacetylated monoglycerides Printing ink: Iron oxide black ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Keep the bottle tightly closed in order to protect from moisture.

Nature and contents of container

High density polyethylene bottles with a polypropylene cap. Package sizes are: 24 tablets (1 X 24) 100 tablets (2 X 50) 180 tablets (1 X 180) High density polyethylene bottles with a polypropylene cap ...

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

Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands

Marketing authorization number(s)

EU/1/03/268/001-004

Date of first authorization / renewal of the authorization

Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009

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