Adults w/ idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination w/ other PD medicinal products in mid- to late-stage fluctuating patients.
Discontinue use in case patients progress from moderate to severe hepatic impairment. Increased risk for potential retinal effects in patients w/ ophthalmological history. Impulse control disorders may occur in patients treated w/ dopamine agonists &/or dopaminergic treatments. May potentiate levodopa side effects & exacerbate existing dyskinesia. Avoid concomitant use w/ fluoxetine or fluvoxamine. Consider at least 7 days must elapse between discontinuation of safinamide & initiation of treatment w/ MAOIs or pethidine. Concomitant use of pethidine & MAOIs may cause serious adverse reactions as this may be a class-effect, concomitant administration w/ pethidine is contraindicated. May affect ability to drive & use machines. Not to be given to women of childbearing potential. Not recommended during pregnancy & in women of childbearing potential not using contraception. Not to be used during lactation. Childn & adolescents <18 yr. Elderly >75 yr.
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