Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Sulthiame should not be administered, or only administered with special caution and adequate monitoring
-     in patients with impaired renal function
-     in patients with a history of psychiatric disorders

Note:
The patient respectively the parentsshould be instructed to consult the attending doctor immediately if fever, sore throat, allergic skin reactions with lymph node swelling and/or flu-like symptoms occur during treatment with Ospolot. Progressive thrombocytopenias or leukopenias that are accompanied by clinical symptoms, such as fever or sore throat, require interruption of treatment. In cases of severe allergic reactions, Ospolot must be discontinued immediately.
Treatment should also be interrupted if a lasting increase in creatinine occurs. The blood count, liver enzymes and urine should be checked regularly (see also section 4.2).

Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose- galactose malabsorption should not take Ospolot®.

Suicidal ideation and suicidal behaviour
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for sulthiame.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Ospolot®.

Effects on Driving

4.7 Effects on ability to drive and use machines

Even when used as directed, these medicinal products can affect reactions to such an extent - especially at the start of treatment - that the ability to drive a vehicle or use machines may be impaired. This applies to a greater extent in combination with alcohol.