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               Uncommon           Rare    Not known common
Blood and                                                                      Thrombocytopenia lymphatic system disorders
Immune                                              Hypersensitivity system disorders

Psychiatric                                         Nervousness,               Mood changes disorders                                           insomnia                   (including depression)
Nervous                        Headache,                                       Extrapyramidal system                         dizziness                                       syndrome disorders
Cardiac                        Atrioventricular     Bradycardia                Sinoatrial block, disorders                      block (may be                                   congestive heart of first, second                                failure or third degree;
bundle branch block may occur),
palpitations
Vascular                       Flushing             Orthostatic                Vasculitis (including disorders                                           hypotension                leukocytoclastic vasculitis), hypotension

Very         Common              Uncommon         Rare        Not known common
Gastrointestin                Constipation,       Vomiting,        Dry         Gingival hyperplasia.
al disorders                  dyspepsia,          diarrhoea        mouth gastric pain,
nausea
Hepatobiliary                                     Hepatic                      Hepatitis disorders                                         enzymes increase (AST,
ALT, LDH,
ALP increase)
Skin and                      Erythema                             Urticaria   Photosensitivity subcutaneous                  Pruritus                                         (including lichenoid tissue                                                                         keratosis at sun exposed disorders                                                                      skin areas), angioneurotic oedema, rash, erythema multiforme (including
Steven-Johnson's syndrome and toxic epidermal necrolysis),
hyperhidrosis, exfoliative dermatitis, acute generalised exanthematous pustulosis, occasionally desquamative erythema with or without fever,
allergic dermatitis,
Lupus-like syndrome
Reproductive                                                                   Gynecomastia system and breast disorders
General       Peripheral      Malaise, fatigue disorders and oedema administratio n 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/