Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Frequency         Very common Common            Uncommon       Rare          Very rare     Not known (≥1/10)     (≥1/100 to        (≥1/1,000 to   (≥1/10,000 to (<1/10,000) Organ system                        <1/10)            <1/100)        <1/1,000) Blood and lymphatic                 changes in system disorders                    primary haemostasis


Immune system                       hypersensitivit disorders                           y reactions
Psychiatric disorders                                                anxiety                     confusion, depression
Nervous system                      insomnia,   trembling,                                       irritability disorders                           nervousness sweating,
migraine
Frequency        Very common Common       Uncommon        Rare          Very rare     Not known (≥1/10)     (≥1/100 to   (≥1/1,000 to    (≥1/10,000 to (<1/10,000) Organ system                      <1/10)       <1/100)         <1/1,000) Eye disorders         episodes of angle-closure glaucoma in patients who are anatomically predisposed
Cardiac disorders                              tachycardia,    cardiac palpitations    arrhythmias,
hypertension,
precordial pain
Gastrointestinal                               nausea,
disorders                                      vomiting
Musculoskeletal and                                                                        muscle connective tissue                                                                          weakness disorders
Renal and urinary                              acute urinary disorders                                      retention

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