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SPC, UK: CREON Gastro-resistant granules (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Creon 10000 Capsules.

Qualitative and quantitative composition

Each capsule contains: Lipase 10,000 PhEur units. Amylase 8,000 PhEur units. Protease 600 PhEur units.

Pharmaceutical form

Brown/clear capsules containing gastro-resistant granules.

Therapeutic indications

For the treatment of pancreatic exocrine insufficiency.

Posology and method of administration

Adults (including the elderly) and children Initially one or two capsules during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response ...

Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

Special warnings and precautions for use

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Pregnancy and lactation

Pregnancy For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental ...

Effects on ability to drive and use machines

Creon has no or negligible influence on the ability to drive or use machines.

Undesirable effects

In clinical trials, more than 900 patients were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity. The following ...

Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia. Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are ...

Pharmacodynamic properties

Multienzymes (amylase, lipase, protease) ATC code: A09AA02 Creon contains porcine pancreatin formulated as enteric-coated (acid-resistant) minimicrospheres within gelatine capsules. The capsules dissolve ...

Pharmacokinetic properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

Preclinical safety data

None stated.

List of excipients

Granules: Macrogol 4000 Hypromellose phthalate Dimeticone Cetyl alcohol Triethyl citrate Capsule shell: Gelatin Anhydrous iron (III) oxide, E172 Hydrated iron (III) oxide, E172 Iron (II, III) oxide (E172) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years. Once opened, use within 3 months.

Special precautions for storage

Do not store above 25°C. Keep container tightly closed.

Nature and contents of container

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

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

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

Marketing authorization number(s)

PL 46302/0028

Date of first authorization / renewal of the authorization

01 January 2001

Date of revision of the text

19 January 2017

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