Posology : מינונים

4.2    Posology and method of administration

Posology
Treatment with Xadago should be started at 50 mg per day. This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
If a dose is missed the next dose should be taken at the usual time the next day.

Elderly
No change in dose is required for elderly patients.
Experience of use of safinamide in patients over 75 years of age is limited.

Hepatic impairment
Xadago use in patients with severe hepatic impairment is contraindicated (see section 4.3). No dose adjustment is required in patients with mild hepatic impairment. The lower dose of 50 mg/day is XADAGO-SPC-0820-V1                              Page 1 of 14
recommended for patients with moderate hepatic impairment. If patients progress from moderate to severe hepatic impairment Xadago should be stopped (see section 4.4).

Renal impairment
No change in dose is required for patients with renal impairment.

Paediatric population
Xadago is not indicated for use in children and adolescents under 18 years of age since the safety and efficacy of safinamide in this population have not been established. No data are available.

Method of administration

For oral use.
Xadago should be taken with water.
Xadago may be taken with or without food.