Adverse reactions : תופעות לוואי

4.8. Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: 
Not known: frequency cannot be estimated from the available data 
System organ               Frequency                Adverse reactions class
Blood and lymphatic        Not known                Thrombocytopenia, system                                              leukopenia, aplastic disorders                                           anaemia, bone marrow depression,
pancytopenia,
agranulocytosis****
Metabolism and nutrition   Not known                Metabolic acidosis, disorder                                            electrolyte imbalance* and thirst**
Psychiatric disorders      Not known                Depression, irritability, reduced libido, occasional instances of confusion
Nervous system             Not known                Paraesthesia, particularly disorders                                           a “tingling” feeling in the extremities, dizziness,
headache, occasional instances of drowsiness,
convulsions, flaccid paralysis
Eye disorders              Not known                Transient myopia*** choroidal effusion,

                                                           choroidal detachment
Ear and labyrinth           Not known                 Impaired hearing disorders                                             and tinnitus Gastrointestinal            Not known                 Melaena, taste disorders                                             disturbance, nausea, vomiting, diarrhoea
Hepatobiliary               Not known                 Fulminant hepatic disorders                                             necrosis****, hepatitis or cholestatic jaundice
Skin and subcutaneous       Not known                 Urticaria, rash (including tissue                                                erythema multiforme, disorders                                             Stevens-Johnson syndrome, toxic epidermal necrolysis)****,
thrombocytic purpura,
photosensitivity, acute generalised exanthematous pustulosis
(AGEP)
Renal and urinary           Not known                 Haematuria, disorders                                             crystalluria****, renal and ureteral colic****, renal lesions, renal failure,
calculus formation****,
glycosuria, polyuria
General disorders and       Not known                 Fever****, fatigue, administration site                                   anaphylaxis****, conditions                                            flushing Investigations              Not known                 Abnormal liver function

* During long-term therapy, metabolic acidosis and electrolyte imbalance may occasionally occur. This can usually be corrected by the administration of bicarbonate.

**Adverse reactions during short-term therapy are usually non-serious.

***This condition invariably subsides upon diminution or withdrawal of the medication.

****Acetazolamide is a sulphonamide derivative and therefore some side-effects similar to those caused by sulphonamides have occasionally been reported.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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