CREON Capsule containing gastro-resistant granules Ref.[8466] Active ingredients: Pancreatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK

Product name and form

Creon 10000 Capsules.

Pharmaceutical Form

Brown/clear capsules containing gastro-resistant granules.

Qualitative and quantitative composition

Each capsule contains:

Lipase 10,000 PhEur units.

Amylase 8,000 PhEur units.

Protease 600 PhEur units.

Active Ingredient Description

Pancreatin when reaching the small intestine disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.

List of Excipients


Macrogol 4000
Hypromellose phthalate
Cetyl alcohol
Triethyl citrate

Capsule shell:

Anhydrous iron (III) oxide, E172
Hydrated iron (III) oxide, E172
Iron (II, III) oxide (E172)
Titanium dioxide (E171)
Sodium lauryl sulfate

Pack sizes and marketing

HDPE container with tamper-evident PP cap. Containers hold 100, 250 or 300 capsules.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK

Marketing authorization dates and numbers

PL 46302/0028

01 January 2001


Drug Countries
CREON Australia, Brazil, Canada, Cyprus, Ecuador, Finland, France, Hong Kong, Ireland, Israel, Malta, Mexico, Netherlands, New Zealand, Singapore, Tunisia, United Kingdom, United States, South Africa

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