CHOLESTAGEL Film-coated tablets Ref.[7188] Active ingredients: Colesevelam

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands

Product name and form

Cholestagel 625 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.

Qualitative and quantitative composition

Each tablet contains 625 mg colesevelam (as hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Colesevelam

Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.

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 (E172)
Hypromellose (E464)
Propylene glycol

Pack sizes and marketing

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 without outer carton.

Package sizes are: 180 tablets (1 X 180)

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/03/268/001-004

Date of first authorisation: 10 March 2004

Date of latest renewal: 12 March 2009

Drugs

Drug Countries
CHOLESTAGEL Austria, Cyprus, Estonia, Spain, Finland, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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