Summary Of Lacosamide Accord Product Characteristics.pdf

Medicinal Product: Lacosamide Accord in various strengths (50mg, 100mg, 150mg, 200mg) film-coated tablets.

Qualitative & Quantitative Composition: Each tablet contains a specific dose of lacosamide and a trace amount of lecithin (soya) as an excipient.

Pharmaceutical Form: Film-coated tablets in different colors and sizes to differentiate strengths.

Clinical Use:
- Monotherapy for partial-onset seizures with or without secondary generalisation in adults, adolescents, and children from 2 years old with epilepsy.
- Adjunctive therapy for the same conditions, as well as primary generalized tonic-clonic seizures in older children with idiopathic generalised epilepsy.

Posology & Administration:
- Adults, Adolescents, & Children ≥ 2 years: Start with a suitable dose based on weight and adjust weekly.
- Monotherapy: 50mg or 100mg twice daily (100mg/day or 200mg/day).
- Adjunctive therapy: 50mg twice daily (100mg/day) at first, increasing as needed.
- Children < 2 years: Use Lacosamide 10 mg/ml syrup initially.
- Special Dosage Instructions: A loading dose of 200mg followed by 100mg twice daily may be considered for some patients under medical supervision due to potential side effects (not recommended in acute conditions).

Important Notes:
- Lacosamide must be taken twice daily, approximately 12 hours apart.
- Missed doses should be taken immediately if within 6 hours of the next dose; otherwise, wait until the regular time.
- Do not double the dose.