NUTRIZYM

Posology Adults (including elderly) and Paediatric population 1-2 capsules with meals and 1 capsule with snacks. Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms and at the discretion of the physician.

Dose increase, if required should be added slowly with careful monitoring of response and symptomatology. Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. The dose of Nutrizym 22 should usually not exceed this dose.

Where a patient is already receiving a lower unit dose enteric coated pancreatic supplement, then Nutrizym 22 may be substituted at 1/2 of the number of capsules normally consumed with the previous preparation. Method of administration Capsules should be swallowed whole with water.

Where swallowing of capsules proves to be difficult, the minitablets may be removed and taken with water or with a small amount of acidic fluid or soft food, but without chewing. g. apple, orange or pineapple juice. If the minitablets are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result.

In order to protect the enteric coating, it is important that the minitablets are not crushed or chewed. Crushing and chewing of the minitablets or mixing with food or fluid with alkaline pH can disrupt the protective enteric coating.

This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth. Adequate patient hydration should be ensured at all times whilst treating with Nutrizym 22.

In clinical trials, more than 900 patients were exposed to pancreatin. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity. 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 ≥ 1/1000 to < 1/100 Frequency not known Gastrointestinal disorders abdominal pain* nausea, vomiting, constipation, abdominal distention, diarrhoea strictures of the ileo-caecum and large bowel (fibrosing colonopathy) including children with cystic fibrosis**, oral mucosa irritation Skin and subcutaneous tissue disorders rash pruritus, urticaria Immune system disorders hypersensitivity (anaphylactic reactions including urticaria and angioedema) Metabolism and nutrition disorders Hyperuricemia Renal and urinary disorders Hyperuricosuria* ** *Gastrointestinal disorders are mainly associated with the underlying disease.

Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea. 4 - Special warnings and precautions for use *** Hyperuricosuria has been reported when high doses of pancreatin have been taken Allergic reactions mainly, but not exclusively, limited to the skin have been observed and identified as adverse reactions during post-approval use.

Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency. As with any pancreatin extract, high doses may cause buccal and perianal irritation, in some cases resulting in inflammation.

4). Abdominal symptoms (those not usually experienced by the patient) 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 of lipase/kg/day.

Paediatric population No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

In several patients with cystic fibrosis (including children), high doses of pancreatin caused fibrosing colonopathy (narrowing of the colon and ileocecal part of the intestine). If symptoms of ileus occur in patients taking pancreatin, fibrosing colonopathy should be considered as potential cause.

Hyperuricaemia and hyperuricosuria have been reported to occur in cystic fibrosis patients; pancreatin extracts contain a small amount of purine which might, in high doses, contribute to this condition. Important information about the ingredients of Nutrizym 22 Nutrizym 22 contains castor oil which may cause stomach upset and diarrhoea.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

In children aged 15 years and under with cystic fibrosis. 1.