CREON

Adults (including the elderly) and children:

Initially one or two capsules during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.

g. apple, orange or pineapple juice. If the granules 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 granules are not crushed or chewed.

5 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.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon. 4).

In clinical trials, more than 900 patients were exposed to Creon. 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) Skin and subcutaneous tissue disorders rash pruritus, urticaria Immune system disorders Hypersensitivity (anaphylactic reactions).

*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. 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. 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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

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.

Creon is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg) per dose (2 mg). Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.