Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

The use of high dose levels of this medicine can result in dark colouration of the stools.

The following table presents the adverse reactions reported during the use of CARBOSYLANE® in clinical trials and while marketed. Adverse reactions are classified by organ system and frequency using the following convention: very frequent (1/10), frequent (1/100 to 1/10), infrequent (1/1,000 to 1/100), rare (1/10,000 to 1/1,000), very rare (1/10,000), indeterminate frequency (cannot be estimated on the basis of available data).


Adverse Reactions
System Class         Frequent          Uncommon               Rare                Undetermined Organ                                                                              frequency Skin         and                                                            Urticaria subcutaneous tissue disorders
Immune system                                                               Anaphylactic-like allergic disorders                                                                   reaction Gastro-                                                                     Pain,              vomiting, intestinal                                                                  discomfort,     constipation conditions                                                                  or diarrhea 
Reporting of suspected undesirable effects

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. .
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/ Side effects can also be reported to the following email: safety@trima.co.il