LACOSAMIDE G.L. PHARMA GMBH

1. - Known second- or third-degree atrioventricular (AV) block. Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic medicinal products in several indications. A meta-analysis of randomised placebo controlled clinical studies of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

8). Cardiac rhythm and conduction Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. g. 5), as well as in elderly patients. In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400 mg/day and after lacosamide is titrated to steady- state.

In the placebo-controlled clinical studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open- label epilepsy studies and in post-marketing experience. In post-marketing experience, AV block (including second degree or higher AV block) has been reported.

In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions. g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting).

Patients should be counselled to seek immediate medical advice if these symptoms occur. Dizziness Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. 8). Potential for new onset or worsening of myoclonic seizures New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients with PGTCS, in particular during titration.

In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type. Potential for electro-clinical worsening in specific paediatric epilepsy syndromes The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.