INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CREON 25 000 capsules
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CREON 25 000 capsules

COMPOSITION
Per capsule: pancreatin 300 mg.
The enzyme activities per capsule are:
Amylase         : 18 000 FIP units*
Lipase         : 25 000 FIP units
Protease         : 1 000 FIP units
* FIP = Fédération Internationale Pharmaceutique

PHARMACOLOGICAL CLASSIFICATION
A. 11.1 Digestants.

PHARMACOLOGICAL ACTION
Creon 25 000 (pancreatin) substitutes pancreatic enzymes if they are deficient. The capsule dissolves rapidly in the stomach releasing the enzymes in micro-encapsulated pellets. The enteric coating of the pellets has been formulated to resist inactivation by gastric acid, but is rapidly dissolved in the alkaline pH of the duodenum, thus releasing the enzymes at the appropriate site. The enzymes become dispersed in the duodenum and digest fats, proteins and carbohydrates.

INDICATIONS
Supplement for pancreatic exocrine insufficiency which may be caused by:
- chronic pancreatitis
- cystic fibrosis
- partial pancreatectomy

CONTRA-INDICATIONS
- Patients with a known hypersensitivity to pig proteins.
- Early stages of acute pancreatitis (due to the fact that patients are not allowed to eat for the first two to three days).
Safety of Creon 25 000 in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE
The dose of pancreatin must be adjusted according to the needs of the individual patient.
Initially one Creon 25 000 capsule should be taken, with liquid, with meals. If necessary, the dosage can be increased.
Children with cystic fibrosis who are taking, or have been given in excess of 10 000 units of lipase/kg/day are at risk of developing colon damage.
The capsule should be swallowed whole, without chewing. Alternatively the capsule may be opened and the pellets administered without the shell from a spoon. The pellets should not be chewed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The following side effects may occur:
- Allergy to pancreatin which includes symptoms like sneezing, lachrymation or skin rashes;
- Hyperuricosuria and hyperuricaemia with high doses;
- Oral and peri-anal soreness.
Cases of intestinal stricture and blockage requiring surgical decompression have been reported in patients taking high lipase activity pancreatic enzyme preparations.
Stricture of the ileo-caecum and large bowel and colitis have been reported in children with cystic fibrosis taking high strength pancreatic enzyme supplements. 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is supportive and symptomatic.

IDENTIFICATION
Bi-coloured hard gelatin capsules size 0 with Swedish orange opaque cap and colourless transparent body filled with brownish minimicrospheres.

PRESENTATION
Packs of 100 capsules.

STORAGE INSTRUCTIONS
Store below 25°C, protected from light. Keep out of reach of children.

REGISTRATION NUMBER
28/11.1/0645

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/09072/07)
106 Sixteenth Road
Randjespark
Midrand 1685
P O Box 5278
Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 June 1997

Updated on this site: December 2000

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