Pancrex V Capsules.

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

Capsule.

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.

Infants: the contents of 1 - 2 capsules mixed with feeds.

Older Children and Adults: the contents of 2 - 6 capsules with each snack or meal. The capsules may be swallowed.

The capsules may provide a suitable alternative to the enteric coated presentations in cases where the pH of the duodenum is not sufficiently alkaline to dissolve the enteric coat.

Capsules provide a simple and convenient method of dose measurement of pancreatin for administration to younger children requiring a low dose.

Hypersensitivity to the active ingredient (porcine pancreatin) or any of the excipients.

It is possible that some irritation of the skin of the mouth may occur if capsules are chewed or the contents retained in the mouth. Irritation of the anus may also occur. A barrier cream may prevent this local irritation.

Allergic/asthmatic reactions have occasionally occurred on handling the capsule contents.

If the capsule contents are mixed with liquids or feeds 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.

Aluminium oxide, magnesium stearate, microcrystalline cellulose gelatin, titanium dioxide, yellow iron oxide (E172), quinoline yellow (E104).

None known.

2 years.

Store at a temperature not exceeding 15°C.

Securitainer; 100, 300 and 500 capsules.

Not applicable.

Paines and Byrne Limited

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PL0051/5043R

First authorisation granted 13 November 1985

Renewal granted 31^st May 2001

13^th December 2010

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