Table 11 lists treatment-emergent adverse events that occurred in at least 5 of idiopathic generalized epilepsy patients experiencing pgtc seizures treated with keppra and were numerically more common than in patients treated with placebo.
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Available data in children did not suggest impact on growth and pubertyHoweverlong term effects on learningintelligencegrowthendocrine functionpuberty and childbearing potential in children remain unknown.
The extent of absorption of levetiracetam was not altered by foodbut the rate of absorption was slightly reduced.
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 4Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Placebo-Controlled Studies in Adult Patients Experiencing Partial Onset Seizures.
Howeverif levetiracetam treatment is needed during breastfeedingthe benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
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