Pancrex V Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pancrex V Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pancreatin BP to provide enzymatic activity per capsule not less than:
Free protease 430 BP units
Lipase 8000 BP units
Amylase 9000 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
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.
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.
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 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.
Pharmacokinetic properties
5.2
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
Aluminium oxide, magnesium stearate, microcrystalline cellulose, gelatin, titanium dioxide, yellow iron oxide (E172), quinoline yellow (E104).
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store at a temperature not exceeding 15°C.
6.5 Nature and contents of container
Securitainer; 100, 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.
8 MARKETING AUTHORISATION NUMBER(S)
PL 41094/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/11/1985 / 31/05/2001
10 DATE OF REVISION OF THE TEXT
26/11/2015