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                            Uncommon                Frequency not common            Common >1/100 >1/1000 to              known
>1/10             to <1/10      <1/100
Gastrointestinal    abdominal         nausea,                               strictures of the disorders           pain*             vomiting,                             ileo-caecum and constipation,                         large bowel abdominal                             (fibrosing distention,                           colonopathy) diarrhea*
Skin and                                            rash                    pruritus, subcutaneous                                                                urticaria 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 diarrhea.

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 postapproval use. Because these reactions were reported spontaneously form a population of uncertain size, it is not possible to reliably estimate their frequency.

Paediatric population
No specific adverse reactions were identified in the pediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.


Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL)