BINDREN Film-coated tablet Ref.[50321] Active ingredients: Colestilan

Source: European Medicines Agency (EU)  Revision Year: 2015  Publisher: Mitsubishi Tanabe Pharma Europe Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Tel: +44 (0)207 065 5000 Fax: +44 (0)207 065 5050 Email: info@mt-pharma-eu.com

Product name and form

BindRen 1 g film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, oval shaped, film-coated tablet approximately 20.2 mm in length and 10.7 mm wide printed with “BINDREN” (in blue ink) on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 1 g colestilan.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Colestilan

Colestilan is a non-absorbed, non-calcium, non-metallic phosphate-binding polymer. The binding sites become partially protonated in the stomach and interact through ionic and hydrogen bonding with both dietary phosphate anions and bile acids in the duodenum. By binding phosphate from food in the digestive tract, colestilan lowers the serum phosphorus concentration. Colestilan also binds bile acids, thereby lowering the serum LDL-cholesterol concentration.

List of Excipients

Tablet core:

Purified water
Hydroxypropylcellulose
Silica, colloidal anhydrous
Castor oil, hydrogenated

Film-coating:

Hypromellose
Acetic acid esters of mono- and diglycerides of fatty acids
Polysorbate 80

Printing ink:

Shellac
Indigo carmine aluminium lake (E132)
Carnauba wax

Pack sizes and marketing

High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.

Aluminium/polychlorotrifluoroethylene/PVC blister.

Pack sizes of 45, 99, 198, 270 or 297 tablets per carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Mitsubishi Tanabe Pharma Europe Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom
Tel: +44 (0)207 065 5000
Fax: +44 (0)207 065 5050
Email: info@mt-pharma-eu.com

Marketing authorization dates and numbers

EU/1/12/804/001-010

Date of first authorisation: 21 January 2013

Drugs

Drug Countries
BINDREN Estonia

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