Creon 10000 Adverse Reactions

Over 900 patients have been treated with Creon in clinical studies. The most commonly reported adverse events were mostly mild to moderate gastrointestinal disorders.
The following adverse reactions were observed during clinical studies.
The following categories are used to assess the frequency of adverse reactions: Very common: can affect more than 1 in 10 of those treated; Common: can affect up to 1 in 10 of those treated; Uncommon: can affect up to 1 in 100 of those treated; Rare: can affect up to 1 in 1,000 of those treated; Very rare: can affect up to 1 in 10,000 of those treated; Not known: frequency cannot be estimated from the available data. (See table.)

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Strictures in the ileocaecal region and the ascending colon (fibrosing colonopathy) have been reported in cystic fibrosis patients receiving high doses of pancreatin preparations - see Precautions.
Periodic Safety Update Reports have highlighted allergic reactions limited mainly, but not exclusively, to the skin.
Paediatric population: No specific adverse reactions have been observed in the paediatric population. The frequency, nature and severity of the adverse reactions in children with cystic fibrosis were similar to those documented in adults.
Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allowed continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Drug Office, Department of Health via link http://www.drugoffice.gov.hk/eps/do/en/healthcare_providers/adr_reporting/adr_report_form.html.