Onzentis Capsule 50 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

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

This medication should not be used by individuals allergic to certain ingredients. This medication should not be administered to patients with specific hormone-secreting tumors. Patients with severe muscle diseases or neurological disorders may be at risk when using this medication. Patients currently taking certain Parkinson's disease treatments should exercise caution as this medication may interact with them. Pregnant or nursing women should avoid taking this medication, as it is safer not to do so. This medication contains lactose, so it should not be taken by patients who are lactose intolerant. Patients undergoing treatment for Parkinson's disease may need to adjust the dosage of existing medications when taking this medication. During the use of this medication, careful observation for mental health issues such as impulse control disorders should be conducted. This medication can affect certain enzymes in the body, thereby altering the effects of other medications; therefore, consultation with a physician is necessary if other medications are being taken. There is limited experience with this medication in patients aged 85 years and older, so it should be used with caution. Patients with moderate liver dysfunction should closely monitor the effects and side effects of this medication while taking it. This medication has a very low sodium content and is not a concern for patients requiring sodium restriction. This medication may cause various side effects such as neurological symptoms, gastrointestinal issues, and muscle pain, so any symptoms should be reported to a healthcare professional immediately. Serious symptoms such as severe muscle weakness, high fever, or changes in mental state may occur during the use of this medication, requiring attention. Abrupt discontinuation of this medication can worsen symptoms, so it should be tapered off gradually as per a physician's directions. Caution is advised while driving or operating machinery, as dizziness or drowsiness may be experienced. Patients with heart disease require special attention when using this medication. Interactions may occur with other specific medications, so must consult with a physician or pharmacist. Pregnant or nursing women should not take this medication, and in cases of nursing, it is safest to stop breastfeeding.

• Movement disorders
• dry mouth
• constipation
• insomnia
• decreased appetite
• hypertriglyceridemia
• abnormal dreams
• visual hallucinations
• hallucinations
• anxiety

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best kept at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance

Dark blue hard capsule containing yellow powder

Package unit

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