PANCREX V

Posology These low dose capsules may be used when small amounts of Pancrex V are required, for example for neonates. Dosage should be adjusted according to the needs of the individual patient and the amount of food consumed. The following dosage scale provides a suitable basis for adjustment.

Paediatric population Neonates:

The contents of 1-2 capsules mixed with feeds. Method of administration Oral use. The capsules should be taken with each feed or before a meal. 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.

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. uk/yellocard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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