ENTOCORT CR Capsule Ref.[27516] Active ingredients: Budesonide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom

Product name and form

Entocort CR 3 mg Capsules.

Pharmaceutical Form

Hard gelatin capsules for oral administration with an opaque, light grey body and opaque, pink cap marked CIR 3mg in black radial print.

Each capsule contains budesonide 3 mg as gastro-resistant, prolonged-release granules.

Qualitative and quantitative composition

Each capsule contains budesonide 3 mg.

Excipient(s) with known effect: Sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Budesonide

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

List of Excipients

Ethylcellulose
Tributyl acetylcitrate
Methacrylic acid copolymer
Triethylcitrate, Antifoam M
Polysorbate 80
Talc
Sucrose
Maize starch
Gelatine
Titanium dioxide (E171)
Iron oxide (E172)

Pack sizes and marketing

White polyethylene bottles of 50 or 100 capsules, having either a tamper-evident or child-resistant polypropylene screw cap, with an integral desiccant.

Marketing authorization holder

Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom

Marketing authorization dates and numbers

PL 36633/0006

Date of first authorisation: 31st January 1996
Date of latest renewal: 4th June 2002

Drugs

Drug Countries
ENTOCORT Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Malta, Mexico, Netherlands, New Zealand, Poland, Turkey, United Kingdom

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