Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Zambon S.p.A., Via Lillo del Duca 10, 20091, Bresso (MI) - Italy, Tel: +39 02 665241, Fax: +39 02 66501492, Email: info.zambonspa@zambongroup.com
Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Treatment with safinamide 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.
No change in dose is required for elderly patients.
Experience of use of safinamide in patients over 75 years of age is limited.
Safinamide 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 recommended for patients with moderate hepatic impairment. If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4).
No change in dose is required for patients with renal impairment.
The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established. No data are available.
For oral use.
Safinamide should be taken with water.
Safinamide may be taken with or without food.
In one patient suspected of consuming more than the daily prescribed dose of 100 mg for one month, symptoms of confusion, sleepiness, forgetfulness and dilated pupils were reported. These symptoms resolved on discontinuing the medicinal product, without sequelae.
The expected pattern of events or symptoms following intentional or accidental overdose with Safinamide would be those related to its pharmacodynamic profile: MAO-B inhibition with activity-dependent inhibition of Na+ channels. The symptoms of an excessive MAO-B inhibition (increase in dopamine level) could include hypertension, postural hypotension, hallucinations, agitation, nausea, vomiting, and dyskinesia.
There is no known antidote to safinamide or any specific treatment for safinamide overdose. If an important overdose occurs, safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated.
4 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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