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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 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 (Vimpat).
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge (see Adverse Reactions).
Cardiac rhythm and conduction: Dose-related prolongations in PR interval with lacosamide (Vimpat) have been observed in clinical studies. Lacosamide (Vimpat) should be used with caution in patients with underlying proarrhythmic conditions such as patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and sodium channel blocking antiepileptic medicinal products (see Interactions), 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 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.
Patients should be made aware of the symptoms of cardiac arrhythmia (e.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 (Vimpat) has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine (see Adverse Reactions).
Potential for new onset or worsening of myoclonic seizures: New onset or worsening of myoclonic seizures has been reported in 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.
Effects on ability to drive and use machines: Lacosamide (Vimpat) has minor to moderate influence on the ability to drive and use machines. Lacosamide (Vimpat) treatment has been associated with dizziness or blurred vision. Accordingly, patients should be advised not to drive or to operate other potentially hazardous machinery until they are familiar with the effects of Lacosamide (Vimpat) on their ability to perform such activities.
Vimpat Injection: Excipients: This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
