Adverse reactions : תופעות לוואי

4.8 Undesirable effects
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≥ 1/100 to <        Uncommon         Frequency not known common≥         1/10                      ≥ 1/1000 to <
1/10                                      1/100
Gastrointestinal       abdominal       nausea, vomiting,                          strictures of the ileo- disorders              pain*           constipation,                              caecum and large bowel abdominal distention,                      (fibrosing colonopathy) diarrhoea*
Skin and                                                         rash             pruritus, urticaria subcutaneous tissue disorders
Immune system                                                                     hypersensitivity disorders                                                                         (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.
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see section 4.4 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 authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/