Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following frequency categories are used for the evaluation of 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 (frequency cannot be estimated from the available data)

Metabolism and nutrition disorders
Common:                weight loss, lack of appetite

Psychiatric disorders
Uncommon:                 hallucinations, anxiety, lack of drive
Not known:                depressive mood/depression, personality change and behavioural anomaly (e.g. aggressiveness, irritability, mood swings)


Nervous system disorders
Common:               paraesthesias in the extremities and in the face*, dizziness, headache Uncommon:             myasthenic phenomena, grand-mal status, increased seizure activity Not known:            polyneuritis

Eye disorders
Common:                   double vision

Cardiac disorders
Common:                   stenocardia, tachycardia
Respiratory, thoracic and mediastinal disorders
Common:                 tachypnoea*, hyperpnoea*, dyspnoea, singultus 
Gastrointestinal disorders
Very common:            gastric complaints like e.g. nausea, vomiting (in about 10% of patients) Not known:              diarrhoea

Hepatobiliary disorders
Not known:              hepatotoxic reactions, increase of liver enzymes 
Skin and subcutaneous disorders

Not Known: Stevens-Johnson syndrome, Lyell's syndrome
Musculoskeletal and connective tissue disorders
Uncommon:             joint pain
Renal and urinary disorders
Not known:             acute renal failure

*Dose-dependent, if necessary the dose has to be adapted.

In one case, administration of Ospolot® led to progressive weakness of the limbs, hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated within hours of Ospolot® being discontinued.

Sulthiame is a carbonic anhydrase inhibitor. Therefore, undesirable effects of carbonic anhydrase inhibition, such as renal stone formation, metabolic acidosis, tiredness/exhaustion, haemodilution and changes in serum electrolyte values (e.g. hypocalcaemia), may occur during administration of sulthiame (see also section 4.5).


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