Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Dose adjustments of antiparkinsonian therapy
Ongentys 50 mg is to be administered as an adjunct to levodopa treatment. Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys 50 mg. Opicapone enhances the effects of levodopa. To reduce levodopa-related dopaminergic adverse reactions (e.g.
dyskinesia, hallucinations, nausea, vomiting and orthostatic hypotension), it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with Ongentys 50 mg, according to the clinical condition of the patient (see section 4.2).

If Ongentys 50 mg is discontinued it is necessary to adjust the dosing of the other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the symptoms.

Psychiatric disorders

Patients and care-givers should be made aware that impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic 

treatments. Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.

Others

Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-O- methyltransferase (COMT). For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.

Excipients

Ongentys 50 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Ongentys 50 mg contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7    Effects on ability to drive and use machines

Opicapone in association with levodopa may have major influence on the ability to drive and use machines. Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence. Therefore, caution should be exercised when driving or using machines.