Summary of Product Characteristics (SmPC) - Pancrex V capsules 125 mg
1 NAME OF THE MEDICINAL PRODUCT
Pancrex V 125 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 125 mg pancreatin to provide enzymatic activity per capsule not less than:
Free protease 160 BP units
Lipase 2950 BP units
Amylase 3300 BP units
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule).
A white or buff coloured powder in clear hard gelatin capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for 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.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pancrex V 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
Pancrex V has no or negligible influence on the ability to drive and use machines.
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/yellocard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
None stated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule shell
Gelatin
Capsule content
Aluminium oxide
Magnesium stearate
Microcrystalline cellulose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Essential Pharmaceuticals Limited 8a Crabtree Road, Egham, Surrey, TW20 8RN,
UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 41094/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 13/11/1985
Date of latest renewal: 04/11/2003
10 DATE OF REVISION OF THE TEXT
10/06/2022