PANCREX V

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.

5- 2 grams swallowed dry or mixed with a little water or milk before each snack or meal. 5 grams with each feed. 25 ml spoonful. 5 ml spoonful. Method of administration (1) Oral use (2) Pancrex V Powder may be administered via a nasogastric tube or a gastrostomy tube.

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Rare cases of hyperuricosuria and hyperuricaemia have been reported when extremely high doses of pancreatin have been taken. 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 ≥ 1/1,000 to < 1/100 Frequency not known (cannot be estimated from the available data) 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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 10,000 units 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. A barrier 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 to use. When Pancrex V Powder 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 glucose- galactose malabsorption should not take this medicine.

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