Adverse reactions : תופעות לוואי

4.8. Undesirable effects

Tabulated summary of undesirable effects
The undesirable effects are listed in the table below according to the MedDRA system/organ classes and frequency categories. The CIOMS frequencies are defined 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 (cannot be estimated from the available data).


System/Organ     Common          Uncommon        Rare Very rare            Not known class
Blood and                                                                  Neutropoenia lymphatic                                                                  Thrombocytopaenia system disorders
Nervous          Weakness;    Sleepiness;                                  Cerebral ischaemic disorders in system           fatigue;     Syncope.                                     patients with underlying disorders        sensation of                                              cerebrovascular disorders (see vertigo;                                                  section 4.4).
vertigo;
headache;
dizziness.
Eye disorders                 Abnormal                                     Intraoperative floppy iris syndrome vision                                       (see section 4.4)
Cardiac                       Tachycardia;               Angina pectoris Atrial fibrillation disorders                     palpitations               in     coronary patients     (see section 4.4)
Vascular         Hypotension Hot flushes disorders        (orthostatic)

System/Organ      Common          Uncommon           Rare Very rare            Not known class
(see section 4.4)
Respiratory                       Rhinitis system disorders
Gastrointestinal Nausea;          Vomiting disorders        abdominal pain;
stomach pain;    dry mouth; and diarrhoea
Hepatobiliary                                                                  Hepatocellular   injury;   cholestatic disorders                                                                      liver disease.
Skin        and                   Skin       rash;          Urticaria; and subcutaneous                      itching                   angioedema tissue disorders
Reproductive                                                                   Priapism system      and breast disorders
General          Asthenia;        Chest pain;
disorders        malaise          oedema.


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 at https://sideeffects.health.gov.il