Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The following adverse reactions have been observed.
The frequencies are unknown, unless listed under one of the following classifications: 
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)

Blood and lymphatic system disorders
Bone marrow depression with agranulocytosis ,aplastic anemia and thrombocytopenia.
Nervous system disorders
Peripheral neuritis, neuropathy, drowsiness, dizziness.
Gastrointestinal disorders
Common: abdominal pain, nausea, vomiting and diarrhea
Hepatobiliary disorders
Hepatotoxicity
Skin and subcutaneous tissue disorders
Alopecia, rash

Musculoskeletal and connective tissue disorders
Myopathy and rhabdomyolysis

Reproductive system and breast disorders
Amenorrhoea, dysmenorrhoea, oligospermia, azoospermia
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain

Metabolism and nutrition disorders
Vitamin B12 deficiency

Paediatric population
No long-term safety data are available in paediatric patients.
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