This information is intended for use by health professionals
1. Name of the medicinal product
2. Qualitative and quantitative composition
Pancreatin BP to provide enzymatic activity per gram not less than:
|Free protease||300 BP units|
|Lipase||5000 BP units|
|Amylase||4000 BP units|
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Pancrex is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states.It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis and pancreatic steatorrhoea following pancreatectomy. It may also be indicated following gastrectomy as an aid to digestion.
4.2 Posology and method of administration
Dosage should be adjusted according to the needs of the individual patient and the amount and type of food consumed.The following dosage ranges provide a suitable basis for adjustment.Adults, the Elderly, and Children 5 g - 10 g swallowed dry or mixed with a little water or milk just before meals
Hypersensitivity to the active ingredient (porcine pancreatin) or any of the excipients.
4.4 Special warnings and precautions for use
Unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.It is possible that some irritation of the skin of the mouth may occur if the granules are chewed or retained in the mouth. Irritation of the anus may also occur. A barrier cream may prevent this local irritation.If the granules are mixed with liquids the resulting mixture should not be allowed to stand for more than one hour prior to use.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
Pancrex should not be used in pregnancy and lactation unless clearly necessary but if required should be used in doses sufficient to provide adequate nutritional status.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Rare cases of hyperuricosuria and hyperuricaemia have been reported when extremely high doses of pancreatin have been taken.Strictures of the ileo-caecum and large bowel, and colitis, have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date Pancrex and Pancrex V presentations have not been implicated in the development of colonic damage. 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/kg/day of lipase.Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pancreatin is derived from porcine pancreas and contains the enzymes, amylase, protease and lipase. The enzymes have the same actions as pancreatic juice and when administered to patients with pancreatic insufficiency improve the ability to metabolise starches, proteins and fats.
5.2 Pharmacokinetic properties
Pancreatin hydrolyses fats to glycerol and fatty acids, changes proteins into proteases and derived substances, and converts starch into dextrins and sugars.
5.3 Preclinical safety data
No relevant pre-clinical safety data has been generated.
6. Pharmaceutical particulars
6.1 List of excipients
Lactose, acacia (E414), Opaseal P17-0200 containing IMS, polyvinyl acetate phthalate and stearic acid (E570).This medicinal product contains approximately 70g of lactose per 100g. When taken according to the dosage recommendations each dose supplies up to 7g of lactose.
6.3 Shelf life
6.4 Special precautions for storage
Store at a temperature not exceeding 15°C.
6.5 Nature and contents of container
Securitainer; 100, 300 and 500 g.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Essential Pharmaceuticals LimitedUnit 7, Egham Business VillageCrabtree RoadEghamSurrey TW20 8RB,UK.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
01/05/1987 / 28/11/2003
10. Date of revision of the text