Pancrex Granules.

Pancreatin BP to provide enzymatic activity per gram not less than:

Granules.

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.

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.

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.

None known.

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.

None.

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.

None stated.

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.

Pancreatin hydrolyses fats to glycerol and fatty acids, changes proteins into proteases and derived substances, and converts starch into dextrins and sugars.

No relevant pre-clinical safety data has been generated.

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.

None known.

2 years.

Store at a temperature not exceeding 15°C.

Securitainer; 100, 300 and 500 g.

Not applicable.

Paines and Byrne Limited

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

PL0051/5003R

First authorisation granted 1 May 1987 / October 2003

25 October 2007

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