Summary of medicine characteristics - PANCREX V POWDER
SUMMARY OF PRODUCT CHARACTERISTICS1 NAME OF THE MEDICINAL PRODUCT
Pancrex VPowder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram powder contains pancreatin BP to provide enzymatic activity not lessthan:
Free protease 1400BP units
Lipase 25000BP units
Amylase 30000BP units
Excipient(s) with known effect
Lactose monohydrate
3 PHARMACEUTICAL FORM
Oral powder.
Awhite or buff coloured amorphous powder.
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
Posology
Dosage should be adjusted according to the needs of the individual patient and the amount and type of food consumed. The dosing may also require to be adjusted, as necessary, on the basis of the clinical outcome. The following dosage ranges provide a suitable basis for adjustment.
Adults, the Elderly, and Paediatric population
0.5– 2grams swallowed dry or mixed with a little water or milk before each snack ormeal.
New-born infants
0.25– 0.5grams with each feed.
1gram of Pancrex VPowder corresponds approximately to the volume of a 1.25ml spoonful.
2grams of Pancrex VPowder correspond approximately to the volume of a 2.5ml spoonful.
Method of administration
(1) Oral use
(2) Pancrex VPowder may be administered via a nasogastric tube or a gastrostomy tube. Refer to relevant local and national official guidelines (see section4.4).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section6.1.
4.4 Special warnings and precautions for use
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000units of lipase/kg/day.
It is possible that some irritation of the skin of the mouth may occur if the powder is retained in the mouth. Irritation of the anus may also occur. Abarrier cream may prevent this local irritation.
Allergic/asthmatic reactions have occasionally occurred on handling the powder.
If the powder is mixed with liquids or feeds the resulting mixture should not be allowed to stand for more than one hour prior touse.
When Pancrex VPowder is administered via a nasogastric tube or a gastrostomy tube then the internal diameter of the tube must be adequate and patency of the tube must be ensured. Refer to relevant local and national official guidelines.
Excipients
This medicine contains lactose monohydrate. Patients with rare hereditary problems of, galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of pancreatic enzymes in pregnant women. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.
Pancrex VPowder should be used with caution in pregnancy.
Lactation
No effects on the breastfed newborn/infant are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes.
If use during pregnancy and lactation is considered necessary, Pancrex VPowder should be used in doses sufficient to provide adequate nutritional status.
4.7 Effects on ability to drive and use machines
Pancrex VPowder has no or negligible influence on the ability to drive and use machines
4.8 Undesirable effects
4.8Undesirable effects
Rare cases of hyperuricosuria and hyperuricaemia have been reported when extremely high doses of pancreatin have beentaken.
The following adverse reactions have been observed during clinical trials with the below indicated frequencies:
| Organ system | Very common >1/10 | Common > 1/100 to <1/10 | Uncommon >1/1,000to <1/100 | Frequency not known (cannot be estimated from the availabledata) |
| Immune system disorders | hypersensitivity (anaphylactic reactions) | |||
| Gastrointestinal disorders | abdominal pain* | nausea, vomiting, constipation, abdominal distention, diarrhoea* | strictures of the ileo-caecum and large bowel (fibrosing colonopathy) | |
| Skin and subcutaneous tissue disorders | rash | pruritus, urticaria |
*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea.
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 Vpresentations 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 10,000units/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 or search for MHRA Yellow Card in the Google Play or Apple AppStore.
None stated.
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Digestives, incl. enzymes, enzyme preparations ATC code: A09AA02
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 andfats.
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
5.3Preclinical safety data
No relevant pre-clinical safety data has been generated.
PHARMACEUTICAL PARTICULARSPHARMACEUTICAL PARTICULARS
6.1
6.2
List of excipients
Lactose monohydrate.
Incompatibilities
Not applicable.
Shelf life
3years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
100g, 250g and 300g white polypropylene securitainer with a white polyethylene cap and a patient information label-leaflet attached.
A5ml graduated measuring spoon (PP resin) is included inside the container. The 5ml measuring spoon is graduated as 1.25ml, 2.5ml and 5ml, it can be used to measure the doses of 1.25ml and 2.5ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6Special precautions for disposal
No special requirements for disposal.
MARKETING AUTHORISATION HOLDER
Essential Pharmaceuticals Limited Unit 7, Egham Business Village CrabtreeRoad
Egham
Surrey TW20 8RB, United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 41094/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
Date of first authorisation: 13/11/1985
Date of latest renewal: 28/11/2003
