Healthcare professionals are asked to report any suspected adverse reactions. Therefore, their concomitant use should be considered with appropriate caution. Patient factors Opicapone enhances the effects of levodopa.
Thus, their concomitant use should be considered with appropriate caution. Opicapone appears to be safe and well-tolerated and is not associated with relevant electrocardiographic or hepatic adverse events. Method of administration The capsules should be swallowed whole with water. To reduce levodopa-related dopaminergic adverse reactions e. This will allow quick identification of new safety information.
The choice of treatment will depend on the person's clinical and lifestyle characteristics, and their preferences, after an informed discussion about the benefits and risks of treatment. Therefore, caution should be exercised when driving or using machines. Bial is seeking partners for the development of opicapone.
All of these metabolites are inactive except the reduced derivative. The patient should not take an extra dose to make up for the missed dose.
Most participants were also taking other Parkinson's disease medicines, most commonly a dopamine agonist. 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. More levodopa reaches the brain, where it is activated to dopamine. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys.
Date of revision of the text This information is intended for use by health professionals This medicinal product is subject to additional monitoring. There are limited data on the use of opicapone as a first choice adjunct therapy to levodopa. Paediatric population There is no relevant use of Ongentys in the paediatric population with Parkinson's disease and motor fluctuations.
Breast-feeding should be discontinued during treatment with Ongentys. Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations. Opicapone enhances the effects of levodopa. Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used. Sulphation was the main metabolic pathway.
Dose adjustment of levodopa therapy within the first days to first weeks after initiating treatment with opicapone will often be necessary. Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. Fertility The effects of opicapone on fertility in humans have not been studied. Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence.
Therefore, their combination with opicapone can result in increased catecholamine concentrations in the body and corresponding adverse effects. Dyskinesia was the most commonly reported adverse event. If Ongentys 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.
Opicapone was well tolerated. Missed dose If one dose is missed, the next dose should be taken as scheduled.
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