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"Potential for an Increase in Risk of Suicidal Thoughts or Behaviours".
Discontinuation: In accordance with current clinical practice, if Levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in children and adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Suicide: Suicide, suicide attempt and suicide ideation have been reported in patients treated with Levetiracetam. Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
FC tablet: There is potential for an increased risk of suicidal thoughts or behaviours with antiepileptic drugs (AEDs) including Levetiracetam.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Due to possible different individual sensitivity, some patients might experience, somnolence or other central nervous system related symptoms, at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Renal or Hepatic Impairment: The administration of Levetiracetam to patients with renal impairment may require dose adaptation. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.
Acute kidney injury: The use of levetiracetam has been rarely associated with acute kidney injury, with a time to onset ranging from few days to several months.
