Onzentis Capsule 25 mg (Opicapone)

Adult dose

1. The recommended dose of this medicine is 50mg once daily. Administer this medicine orally at bedtime, at least 1 hour apart from levodopa/dopa decarboxylase inhibitors (benserazide or carbidopa). Maintain a fasting state from 1 hour before to 1 hour after taking this medicine. 2. Adjustment of antiparkinsonian medication doses This medicine is administered as an adjunct to standard levodopa therapy and enhances the efficacy of levodopa. Therefore, to reduce levodopa-related dopaminergic adverse effects, including dyskinesia, hallucinations, nausea, vomiting, and orthostatic hypotension, the levodopa dose may need to be adjusted after starting this medicine, according to the patient's clinical status, by reducing the amount of levodopa per dose or increasing the interval between doses (see section ‘2. Precautions’). 3. If you forget to take this medicine If you forget to take this medicine, take the next dose as scheduled. Do not take more than the recommended dose to make up for a missed dose. 4. Elderly patients: No dose adjustment is required for elderly patients (see section ‘8. Information for Healthcare Professionals’). Use with caution in patients aged 85 years or older because clinical experience is limited. 6. Patients with renal impairment: Since only a small amount of this medicine is excreted by the kidneys (see section ‘8. Information for Healthcare Professionals’), no dose adjustment is required in patients with renal impairment. 7. Patients with hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A). Clinical experience with this medicine in patients with moderate hepatic impairment (Child-Pugh B) is limited, so dose adjustment may be necessary. Use of this medicine is not recommended in patients with severe hepatic impairment (Child-Pugh C), as there is no clinical experience (see section ‘8. Information for Healthcare Professionals’).

Child dose

Children: Use of this medicine in children is not recommended.

This medication should not be used by individuals who are allergic to the active ingredient, excipients, or capsule materials. Patients with chromaffin cell tumors, adrenal medullary tumors, or other catecholamine-secreting tumors should not take this medication. Patients with neuroleptic malignant syndrome or non-traumatic rhabdomyolysis may also be at risk when taking this medication. It is safe to avoid concomitant use with specific monoamine oxidase inhibitors other than Parkinson’s disease medications. Pregnant or breastfeeding women are advised not to use this medication. This medication contains lactose, so individuals with genetic conditions such as lactose intolerance, galactose intolerance, or lactose deficiency should avoid taking it. Patients undergoing treatment for Parkinson's disease should be aware that this medication enhances the effects of levodopa, necessitating adjustments to the dosage and timing of levodopa intake. Moreover, patients and caregivers should closely monitor any emerging impulse control disorders while on this medication. Since this medication can interfere with the metabolism of certain drugs in the liver, individuals taking drugs like adrenaline or dopamine should proceed with caution. Elderly patients over 85 years old, or those with moderate to severe liver impairment, should use this medication with enhanced caution. This medication is very low in sodium and poses no significant burden for those requiring sodium restriction. Commonly observed side effects during treatment may include movement disorders, dry mouth, constipation, and insomnia, with dizziness, headaches, and drowsiness also possible. Rarely, muscle cramps, blood pressure fluctuations, and digestive disturbances may occur; immediate consultation with healthcare professionals is advised if unusual symptoms arise. This medication can rarely cause severe muscle-related side effects such as myasthenia gravis or rhabdomyolysis, necessitating immediate reporting of any muscle pain or weakness. Additionally, abrupt cessation of this medication may exacerbate symptoms, so it should be tapered off gradually under medical supervision. Caution is required when driving or operating machinery, as drowsiness or dizziness may occur. Special care is needed for patients with ischemic heart disease when using this medication. When this medication is taken with another Parkinson's treatment, levodopa, it is advisable to maintain at least a 1-hour interval between doses. When combined with certain antidepressants or other dopamine-related medications, interactions may arise, so consultation with healthcare professionals is crucial. It is safest for pregnant or breastfeeding women to avoid this medication, and particularly for nursing mothers to discontinue breastfeeding while on this medication. In cases of overdose, as there is no specific antidote, symptomatic treatment and supportive therapy are needed, with gastric lavage or administration of activated charcoal considered.

• Movement disorders
• dry mouth
• constipation
• insomnia
• reduced appetite
• hypertriglyceridemia
• abnormal dreams
• hallucinations
• anxiety
• depression

This medication should be stored in a tightly sealed container to prevent air exposure at room temperature between 1 degrees and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and safety.

Appearance

A bright blue hard capsule containing a yellow powder

Package unit

10 capsules/bottle, 30 capsules/bottle, 90 capsules/bottle