Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Frequencies of undesirable effects are given as follows:
Very common (1/10); common (1/100, 1/10); uncommon (1/1,000, 1/100); rare (1/10,000, 1/1,000); very rare (1/10,000) and not known (frequency cannot be estimated from the data available).

The most commonly reported side effects are local skin reactions.

System organ class                     Frequency
Immune System disorders                Not known                               Anaphylactic shock, angioedema (Quincke-edema), hypersensitivity reactions.
Skin and      subcutaneous     tissue Uncommon                                 Local skin reactions such as disorders                                                                      erythema, eczema, pruritus and burning sensations.
Rare                                    Dermatological: Photosensitisation, urticaria. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized.
Renal and urinary disorders            Very rare                               Cases of aggravation of previous renal insufficiency.
Gastrointestinal                       Very rare                               Stomach ulcer, gastrointestinal disorders                                                                      bleeding, diarrhea 
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. 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