Abbott Healthcare Products Limited

Creon 25000 Capsules

Each capsule contains 300 mg Pancreatin equivalent to:

For a full list of excipients, see section 6.1

Gastro-resistant capsule, hard.

Size 0, hard gelatin capsules with opaque orange caps and colourless transparent bodies filled with gastro-resistant brown granules.

For the treatment of pancreatic exocrine deficiency.

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.

The daily dose of pancreatic enzymes for most patients should remain below 2500 units of lipase per kilogram per meal (10,000 units per kilogram per day), and that higher doses should be used with caution and only if quantitative measures demonstrate substantially improved absorption with such treatment. This particularly applies to young children.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon 25000.

The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with fluid or soft food. If the granules are mixed with food, it is important that they are taken immediately, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed.

Colonic damage has been reported in patients with cystic fibrosis taking high doses of pancreatic enzyme supplements (see 4.8 Undesirable Effects).

Patients with known hypersensitivity to porcine proteins.

The product is of porcine origin.

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

None known.

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 sections 4.2 and 4.8.)

None expected.

1. Rarely, cases of hyper-uricosuria and hyper-uricaemia have been reported with very high doses of pancreatin.

2. Meconium ileus type obstructive symptoms and cases of colonic stricture resulting in bowel re-section, have been seen with high doses of pancreatic enzyme supplements. Similar problems have not occurred to date with this product. However, unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage.

3. The following unwanted effects have been reported with Creon: diarrhoea, constipation, stomach pains, feeling sick, and skin reactions (rash, itching).

Most cases respond to supportive measures including stopping enzyme therapy, ensuring adequate rehydration.

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.

None stated.

Granules:

Macrogol 4000

Hypromellose Phthalate

Cetyl alcohol

Triethyl citrate

Dimeticone

Capsules:

Gelatin

Red and Yellow Iron Oxides (E172)

Titanium dioxide (E171)

Sodium lauryl sulphate

Not applicable.

2 years.

Do not store above 30°C.

HDPE container with polypropylene closure,: containing 50 or 100 capsules.

No special requirements.

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

S018 3JD

United Kingdom

PA 108/25/2

Date of first authorisation: 24th April 1997

Date of last renewal: 21st March 2007

June 2011