Adverse reactions : תופעות לוואי

4.8. Undesirable effects
The adverse reactions reported from clinical studies and post-marketing experience are listed below according to system organ class.

Tabulated list of adverse reactions
Adverse reactions reported are presented in table below. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Frequencies were defined as follows: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not know (cannot be estimated from the available data).
MedDRA                            Frequency                     Undesirable Effects System Organ Class


Skin and subcutaneous tissues     Uncommon                      - Dermatitis allergic disorders


Gastrointestinal disorders        Common                        - Diarrhoea - Vomiting
- Nausea



Nervous system disorders          Not known                     - Dizziness, Convulsions particularly in case of misuse (refer to sections 4.3 and 4.4)

Eye disorders                     Not known                     - Visual disturbances including impaired colour vision


Vascular disorders                Not known                     - Malaise with hypotension, with or without loss of consciousness
(generally following a too fast intravenous injection, exceptionally after oral administration)
- Arterial or venous thrombosis at any sites



Immune system disorders           Not known                     - Hypersensitivity reactions including anaphylaxis



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/.