SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Pancrex V Capsules 125 mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Free protease    160 BP units

Lipase    2950 BP units

Amylase    3300 BP units

3 PHARMACEUTICAL FORM

Capsule

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

These low dose capsules may be used when small amounts of Pancrex 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.

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

4.3 Contraindications

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

4.4 Special warnings and precautions for use

It is possible that some irritation of the skin of the mouth may occur if capsules 125mg 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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

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

None.

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.

4.9    Overdose

None stated.

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.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium oxide Magnesium stearate Microcrystalline cellulose Gelatin.

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store at temperature not exceeding 15°C.

6.5 Nature and contents of container

Securitainer; 300 and 500 capsules.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Essential Pharmaceuticals Limited Unit 7, Egham Business Village Crabtree Road Egham

Surrey TW20 8RB,

UK.

MARKETING AUTHORISATION NUMBER(S)

PL 41094/0005

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/11/1985 / 04/11/2003

DATE OF REVISION OF THE TEXT

26/11/2015