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Patientstheir caregiversand families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depressionany unusual changes in mood or behavioror the emergence of suicidal thoughtsbehavioror thoughts about selfharmBehaviors of concern should be reported immediately to healthcare providers.

The administration of levetiracetam to patients with renal impairment may require dose adjustmentIn patients with severely impaired hepatic functionassessment of renal function is recommended before dose selectionsee section 4.2

Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal productsphenytoincarbamazepinevalproic acidphenobarbitallamotriginegabapentin and primidoneand that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.

Table 9Adverse Reactions in a Placebo-ControlledAdd-On Study in Patients 4 Years of Age and Older with PGTC Seizures.

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