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Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adultsadolescentschildren and infants from 1 month of age with epilepsy.

Levetiracetam has minor or moderate influence on the ability to drive and use machinesDue to possible different individual sensitivitysome patients might experience somnolence or other central nervous system related symptomsespecially at the beginning of treatment or following a dose increaseThereforecaution is recommended in those patients when performing skilled taskse.gdriving vehicles or operating machineryPatients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.

Levetiracetam is excreted in human breast milkThereforebreast-feeding is not recommended.

Table 3 lists adverse reactions that occurred in at least 1of adult epilepsy patients receiving KEPPRA in placebocontrolled studies and were numerically more common than in patients treated with placeboIn these studieseither KEPPRA or placebo was added to concurrent AED therapy.

Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adultsadolescentschildren and infants from 1 month of age with epilepsy.

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Thereforepatients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be consideredPatientsand caregivers of patientsshould be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.

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

In all of these studiesthe main measure of effectiveness was the change in the number of seizures before and during treatment.

Thereforepatients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be consideredPatientsand caregivers of patientsshould be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.

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table 9 lists treatment-emergent adverse events that occurred in at least 5 of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with keppra and were numerically more common than in patients treated with placebo.

In these studies, 904 patients were randomized to placebo, keppra 1000 mg, keppra 2000 mg, or keppra 3000 mg day.

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Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsyto treat partial-onset seizuresfitswith or without secondary generalisationThis is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as suddenjerky movements of one part of the bodydistorted hearingsense of smell or visionnumbnessor a sudden sense of fearSecondary generalisation occurs when the overactivity later reaches the whole brain.

Keppra injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

There was about a 22increase of apparent total body clearance of levetiracetam when it was co-administered with enzyme-inducing AEDsDose adjustment is not recommendedLevetiracetam had no effect on plasma concentrations of carbamazepinevalproatetopiramateor lamotrigine.

There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetamThereforemacrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.

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patients, their caregivers, and families should be counseled that aeds, including keppra, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.