CREON CAPSULES
SCHEDULING STATUS:
S1
PROPRIETARY NAME
(and dosage form):
CREON CAPSULES
COMPOSITION
Per capsule: pancreatin 300mg.
The enzyme activities per capsule are:
|
Amylase |
: 9000 FIP units* |
|
Lipase |
: 8000 FIP units |
|
Protease |
: 450 FIP units |
* FIP = Fédération Internationale Pharmaceutique
PHARMACOLOGICAL CLASSIFICATION
A. 11.1 Digestants.
PHARMACOLOGICAL ACTION
Creon (pancreatin) substitutes pancreatic enzymes if they are deficient. The capsule dissolves rapidly in the stomach releasing pellets, ie the granulated form of pancreatin. The enzymes are micro-encapsulated in the pellets, the stability of which is set at pH 5,5 so that the enzymes are not inactivated in the stomach. In the duodenum the enzymes become dispersed 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
Pancreatic preparations are contra-indicated in the early stages of acute pancreatitis due to the fact that patients are not allowed to eat for the first two to three days.
DOSAGE AND DIRECTIONS FOR USE
One Creon capsule should be taken three times a day with liquid during main meals. If necessary, the dosage can be increased.
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. |
Safety of Creon in pregnancy has not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is supportive and symptomatic.
IDENTIFICATION
Hard gelatin capsule with a transparent yellow body and brown opaque cap. The capsule contains brownish pellets.
PRESENTATION
100 capsules in blister packs.
STORAGE INSTRUCTIONS
Store below 25°C, protected from light. Keep out of reach of children.
REGISTRATION NUMBER
W/11.1/372
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
4 May 1992
Updated on this site: December 2000 |
