Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Reported side effects have generally been infrequent, mild and self-limiting.
The reported undesirable effects are listed below according to MedDRA system organ class classification and frequency. Within each frequency category, the ADRs are presented in the order of clinical importance. Frequency categories are expressed as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (the frequency cannot be estimated from the available data).

System Organ Class                             Common                            Not known 
Blood and the lymphatic system disorders                                         Leukopenia 
Immune system disorders                                                          Drug hypersensitivity 
Metabolism and nutrition disorders             Decreased appetite

Nervous system disorders                       Headache                          Convulsions 
Neuropathy peripheral

Paraesthesia
Hypoaesthesia

Sensory disturbances

Ataxia
Dizziness

Dysgeusia

Ear and labyrinth disorders                    Vertigo
Vascular disorders                                                               Flushing 
Gastrointestinal disorders                     Vomiting                          Glossitis 
Diarrhoea                         Stomatitus

Nausea                            Tongue discolouration
Abdominal pain
Skin and subcutaneous tissue disorders          Dermatitis allergic               Angioedema 
Pruritis                          Urticaria

Renal and urinary disorders                                                       Chromaturia 
General disorders and administration site                                         Pyrexia conditions
Fatigue


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/( 
Additionally, you can report to “Unipharm Ltd”.