Creon

/ Abbott

CREON 10000: Initially one to two capsules with each meal. Doses increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.
CREON 25000: It is recommended to take the enzymes during or immediately after each meal or snack.
Adults (including the elderly) and children: Initially one capsule with meals. Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. For infants and children a median lipase intake of 10,000 Ph. Eur. units per kg body weight a day is recommended. A daily lipase intake of 15,000 – 20,000 Ph.Eur. units per kg body weight should not be exceeded.
See prescribing information for full details.

For the treatment of pancreatic exocrine insuffficiency.

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

The product is of porcine origin. 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 symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

Abdominal pain nausea, vomiting, constipation, abdominal distention, diarrhea.
See prescribing information for full details.

No interaction studies have been performed.

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 toxicity is to be expected. Caution should be exercised when prescribing to pregnant women.
Lactation: No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding. If required during pregnancy and lactation, this medicinal product should be used in doses sufficient to provide adequate nutritional status.

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 recommended.