Creon

1. Name Of The Medicinal Product

Creon® 10000 Capsules

Creon® 25000 Capsules

Creon® 40000 Capsules

2. Qualitative And Quantitative Composition

Creon 10000

Each capsule contains pancreatin 150 mg equivalent to:

Lipase 10,000 PhEur units

Amylase 8,000 PhEur units

Protease 600 PhEur units

Creon25000

Each capsule contains pancreatin PhEur 300 mg equivalent to:

Lipase 25,000 PhEur units

Amylase 18,000 PhEur units

Protease 1,000 PhEur units

Creon40000

Each capsule contains pancreatin PhEur 400 mg equivalent to:

Lipase 40,000 PhEur units

Amylase 25,000 PhEur units

Protease 1,600 PhEur units

3. Pharmaceutical Form

Creon 10000

Brown/clear capsules containing gastro-resistant granules.

Creon25000

Orange/colourless capsules filled with brownish minimicrospheres.

Creon 40000

Brown/clear size 00 capsules containing light brown, gastro-resistant granules.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of pancreatic exocrine insufficiency.

4.2 Posology And Method Of Administration

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. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

Creon 10000 and 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.

Creon 40000 only

The capsules should be swallowed whole.

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

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

4.3 Contraindications

Patients with known hypersensitivity to porcine proteins.

4.4 Special Warnings And Precautions For Use

The product is of porcine origin.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in use during pregnancy and lactation. However, as enzymes are not absorbed, it is unlikely that there would be any effect on the nursing infant.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

Diarrhoea, constipation, gastric discomfort, nausea and skin reactions have been reported occasionally in patients receiving enzyme replacement therapy.

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

Stricture of the ileo-caecum and large bowel and colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date, Creon 10000 and 25000 have not been implicated in the development of colonic damage. Experience with Creon 40000 in clinical use is limited. However, 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.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The ATC code is A09A A (Enzyme preparations).

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

5.2 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.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Granules: Macrogol 4000, liquid paraffin, hypromellose phthalate, dibutyl phthalate, dimeticone.

Capsule shell: Gelatin, iron oxide (E172), titanium dioxide (E171).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Creon 10000 and 25000:

2 years

Creon 40000: 3

years

6.4 Special Precautions For Storage

Creon 10000:

Do not store above 30°C

Creon 25000:

Store below 25°C.

Creon 40000:

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

6.5 Nature And Contents Of Container

Creon 10000, 25000 and 40000: HDPE tablet container with LDPE closure. Each container contains 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

6.5

No special instructions.

Administrative Data

7. Marketing Authorisation Holder

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

Creon 10000:

PL 00512/0149

Creon 25000:

PL 00512/0150

Creon 40000:

PL 00512/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

Creon 10000 and 25000:

1 January 2001

Creon 40000:

5 July 2002

10. Date Of Revision Of The Text

Creon 10000: May 2002

Creon 25000: June 2003

Creon 40000: October 2002

Legal Category

Creon 10000: P

Creon 25000 and 40000: POM