Equfina Special Precautions

Hepatic impairment: Caution should be exercised when initiating treatment with safinamide in patients with moderate hepatic impairment. In case patients progress from moderate to severe hepatic impairment, treatment with safinamide should be stopped (see Dosage & Administration, Contraindications and Pharmacology: Pharmacokinetics under Actions).
Potential for retinal degeneration in patients with prior history of retinal disease: Safinamide 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 Contraindications and Pharmacology: Toxicology: Preclinical safety data under Actions.
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 ability to drive and use machines: Somnolence and dizziness may occur during safinamide treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that safinamide does not affect them adversely.