CORTIMENT Prolonged release tablet Ref.[116526] Active ingredients: Budesonide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS

Product name and form

Cortiment 9 mg, prolonged release tablets.

Pharmaceutical Form

Prolonged release tablet.

White to off-white, round, biconvex, film-coated, gastro-resistant tablet, approximately 9.5 mm diameter, approximately 4.7 mm thickness, debossed on one side with "MX9".

Qualitative and quantitative composition

One tablet contains 9 mg of budesonide.

Excipients with known effect:

Lactose monohydrate 50 mg.

Contains lecithin, derived from soya oil.

For a full list of excipients, see section 6.1.

Active Ingredient

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

Tablet core:

Stearic acid (E570)
Lecithin (soya) (E322)
Microcrystalline cellulose (E460)
Hydroxypropylcellulose (E463)
Lactose monohydrate
Silica, colloidal hydrated (E551)
Magnesium stearate (E470b)

Tablet film-coating:

Methacrylic acid – methyl methacrylate copolymer (1:1)
Methacrylic acid – methyl methacrylate copolymer (1:2)
Talc (E553b)
Titanium dioxide (E171)
Triethyl citrate

Pack sizes and marketing

The tablets are packaged in polyamide/ aluminium/PVC foil blister packs with aluminium push through foil, contained in a cardboard carton.

Packs contain 10, 20, 30, 50, 60 or 80 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS

Marketing authorization dates and numbers

PL 03194/0113

November 2014

Drugs

Drug Countries
CORTIMENT Austria, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

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