Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

General warning
In general, Xadago may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms. In particular, the concomitant use of Xadago and fluoxetine or fluvoxamine should be avoided, or if concomitant treatment is necessary these medicinal products should be used at low doses (see section 4.5). A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with Xadago.

At least 7 days must elapse between discontinuation of Xadago and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).

When Safinamide is co-administered with products that are BCRP substrates, please refer to the SmPC for that particular medicinal product.

Hepatic impairment
Caution should be exercised when initiating treatment with Xadago in patients with moderate hepatic impairment. In case patients progress from moderate to severe hepatic impairment, treatment with Xadago should be stopped (see sections 4.2, 4.3 and 5.2).

Potential for retinal degeneration in patients with prior history of retinal disease Xadago should not be administered to patients with ophthalmological history that would put them at increased risk for potential retinal effects (e.g., family history of hereditary retinal disease, or history of uveitis) see sections 4.3 and 5.3.


XADAGO-SPC-0820-V1                                 Page 2 of 14
Impulse control disorders (ICDs)
Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments. Some reports of ICDs have also been observed with other MAO-inhibitors. Safinamide treatment has not been associated with any increase in the appearance of ICDs.

Patients and carers should be made aware of the behavioural symptoms of ICDs that were observed in patients treated with MAO-inhibitors, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.

Dopaminergic side effects
Safinamide used as an adjunct to levodopa may potentiate the side effects of levodopa, and pre- existing dyskinesia may be exacerbated, requiring a decrease of levodopa. This effect was not seen when safinamide was used as an adjunct to dopamine agonists in early stage PD patients.

Effects on Driving

4.7   Effects on ability to drive and use machines

XADAGO-SPC-0820-V1                                Page 4 of 14
Somnolence and dizziness may occur during Xadago treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that Xadago does not affect them adversely.