Pancrex V 125 mg hard capsules - Summary of Product Characteristics (SmPC) (2024)

Each hard capsule contains 125 mg pancreatin to provide enzymatic activity per capsule not less than:

For the full list of excipients, see section 6.1.

Hard capsule.

A white or buff coloured powder in clear hard gelatin capsules.

Pancrex V 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.

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.

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.

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

Pharmacotherapeutic group: Digestives, incl. enzymes, enzyme preparations, ATC code: A09AA02.

Mechanism of action

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.

Capsule shell

Gelatin

Capsule content

Aluminium oxide

Magnesium stearate

Microcrystalline cellulose

The drug product is contained in a polypropylene securitainer with low density polyethylene cap.

Securitainer: 300 and 500 capsules.

Not all pack sizes may be marketed.

Essential Pharmaceuticals Limited

8a Crabtree Road, Egham,

Surrey, TW20 8RN, UK.

Date of first authorisation: 13/11/1985

Date of latest renewal: 04/11/2003