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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.
KEPPRA tablets should be swallowed wholeKEPPRA tablets should not be chewed or crushed.
Somnolence and asthenia occurred most frequently within the first 4 weeks of treatmentIn generalthe incidences of somnolence and fatigue in the pediatric partial onset seizure studiesand in pediatric and adult myoclonic and primary generalized tonic-clonic seizure studies were comparable to those of the adult partial onset seizure studies.
Table 9 lists adverse reactions that occurred in at least 5of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with KEPPRA and were numerically more common than in patients treated with placeboIn this studyeither KEPPRA or placebo was added to concurrent AED therapy.
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