Ongentys

Posology The recommended dose is 50 mg of opicapone. Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations. Dose adjustments of antiparkinsonian therapy Ongentys is to be administered as an adjunct to levodopa treatment and enhances the effects of levodopa.

4). Missed dose If one dose is missed, the next dose should be taken as scheduled. The patient should not take an extra dose to make up for the missed dose. 2). Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.

2). Hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B). 2). 2). Paediatric population There is no relevant use of Ongentys in the paediatric population with Parkinson’s disease and motor fluctuations.

Method of administration Oral use. The capsules should be swallowed whole with water.

Summary of the safety profile The most common adverse reactions reported were nervous system disorders. 7%). Tabulated list of adverse reactions In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.

Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Table 1 – Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class Very common Common Uncommon Metabolism and nutrition disorders Decreased appetite, Hypertriglyceridaemia Psychiatric disorders Abnormal dreams, Hallucination, Hallucination visual, Insomnia Anxiety, Depression, Hallucination auditory, Confusional state, Nightmare, Sleep disorder Nervous system disorders Dyskinesia Dizziness, Headache, Somnolence Dysgeusia, Hyperkinesia, Syncope Eye disorders Dry eye Ear and labyrinth disorders Ear congestion Cardiac disorders Palpitations Vascular disorders Orthostatic Hypotension Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Constipation, Dry mouth, Nausea, Vomiting Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia Musculoskeletal and connective tissue disorders Muscle spasms Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity Renal and urinary disorders Chromaturia, Nocturia General disorders and administration site conditions Fatigue Investigations Blood creatine phosphokinase increased Weight decreased 7 Injury, poisoning and procedural complications Fall Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Dose adjustments of antiparkinsonian therapy Ongentys 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. Opicapone enhances the effects of levodopa.

g. 2). 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. 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 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 contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium- free’.

1. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis. g. 5).