Creon 40000 Capsules

Each capsule contains 400 mg pancreatin equivalent to:

For excipients, see 6.1.

Capsule, hard.

Brown/clear Size 00 hard gelatin capsule containing light brown, gastro-resistant granules.

For the treatment of pancreatic exocrine insufficiency.

Adults (including the elderly) and children:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products.

Initially one or two capsules with meals. The capsules should be swallowed whole. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon 40000.

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section 4.8).

Patients with known hypersensitivity to porcine proteins or to any of the excipients.

The product is of porcine origin.

Oral medications should not be administered during the early stages of acute pancreatitis.

There are no reports of interactions with other drugs or other forms of interaction.

There are no adequate data from the use of Creon in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonal/foetal development, parturition/and postnatal development. The potential risk for humans is unknown. Creon should not be used during pregnancy or lactation unless clearly necessary, but if required should be used in doses providing adequate nutritional status (see warnings about high dose in sections 4.2 & 4.8).

There is no evidence that Creon 40000 has any effect on the ability to drive or operate machines and therefore no adverse effects would be expected.

1. Stricture of the ileocaecum and large bowel and colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. Similar problems have not occurred to date with this product. Unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

2. The following unwanted effects have been reported with Creon:

Gastrointestinal disorders: Abdominal pain (common); constipation (uncommon); abnormal stool (uncommon); diarrhoea (uncommon); and nausea/vomiting (uncommon).

Skin and subcutaneous tissue disorders: Allergic or hypersensitivity reactions (uncommon).

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.

Most cases of overdose respond to supportive measures including stopping enzyme therapy and ensuring adequate rehydration.

Pharmacotherapeutic class: digestive agent, multienzyme, ATC code is A09A A02.

Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.

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 data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity, carcinogenicity or toxicity to reproduction have not been performed.

Not applicable.

3 years.

Do not store above 30°C.

Keep container tightly closed.

HDPE tablet container with polypropylene closure. Each container contains 50 or 100 capsules.

Not all pack sizes may be marketed.

No special requirements.

Abbott Healthcare Products Ltd.

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

PA 108/25/5

8^th September 2006

June 2011