Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following frequencies are the basis for assessing undesirable effects: 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 (cannot be estimated from the available data).


Very common          Common        Uncommon             Rare      Not known Blood and                                                                          Thrombocytopen lymphatic                                                                          ia system disorders
Immune system                                        Hypersensitivit disorders                                            y
Psychiatric                                          Nervousness,                  Mood changes disorders                                            insomnia                      (including depression)
Nervous system                       Headache,                                     Extrapyramidal disorders                            dizziness                                     syndrome Cardiac                              Atrioventricula Bradycardia                   Sinoatrial block, disorders                            r block (may                                  congestive heart be of first,                                  failure second or third degree; bundle branch block may occur),
palpitations
Vascular                             Flushing        Orthostatic                   Vasculitis disorders                                            hypotension                   (including leukocytoclastic vasculitis),
hypotension
Gastrointestina                      Constipation,   Vomiting,         Dry mouth   Gingival l disorders                          dyspepsia,      diarrhoea                     hyperplasia gastric pain,
nausea
Hepatobiliary                                        Hepatic                       Hepatitis disorders                                            enzymes increase (AST,
ALT, LDH,
ALP increase)
Skin and                             Erythema,                         Urticaria   Photosensitivity subcutaneous                         pruritus                                      (including tissue                                                                             lichenoid disorders                                                                          keratosis at sun exposed skin areas),
angioneurotic


oedema, rash,
erythema multiforme
(including
Steven-Johnson syndrome and toxic epidermal necrolysis),
hyperhidrosis,
exfoliative dermatitis, acute generalised exanthematous pustulosis,
desquamative erythema with or without fever,
allergic dermatitis,
lupus-like syndrome
Reproductive                                                                   Gynaecomastia system and breast disorders
General         Peripheral           Malaise,
disorders and oedema                 fatigue administration site conditions


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/