Rickyrol Tablet 0.25mg (Ropinirole Hydrochloride)

Adult dose

1. An individualized optimal dose is recommended, taking efficacy and tolerability into account. (1) Idiopathic Parkinson's disease It is preferable to take the drug with food 3 times daily to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment regimen for the first 4 weeks is as follows: Weeks 1 2 3 4 Dose per administration (mg) Daily dose (mg) 0.25 0.75 0.5 1.5 0.75 2.25 1.0 3.0 Maintenance treatment: After initial treatment, the dose may be increased at 1-week intervals up to 3mg daily. Therapeutic effects occur at doses of 3-9mg daily. If symptoms are not adequately controlled or control is not maintained, the ropinirole dose may be increased until a definite therapeutic effect is achieved, but should not exceed 24mg daily. ① When administered as adjunctive therapy to levodopa, the levodopa dose may be gradually reduced by up to approximately 20% of the total dose. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidance for discontinuation before starting ropinirole. ③ As with other dopamine agonists, when discontinuing ropinirole, gradually stop treatment by reducing the number of daily doses over 1 week. (2) Primary restless legs syndrome Ropinirole should be taken once daily before bedtime, 1~3 hours before bedtime. Initial treatment (week 1): The recommended initial dose is 0.25mg once daily for 2 days, taken 1~3 hours before bedtime. If this dose is well tolerated, it may be increased to 0.5mg once daily from day 3 through the last day of the first week of treatment (day 7). Maintenance treatment (from week 2): After initial treatment, the daily dose may be increased according to the following schedule until the optimal therapeutic response is reached. Weeks 2 3 4 5 6 7 Dose per administration (mg) 1 1.5 2 2.5 3 4 The safety and efficacy of doses above 4mg/day have not been established in patients with restless legs syndrome. As with other dopamine agonists, treatment with this drug should be discontinued gradually while reducing the daily dose. If administration of this drug has been interrupted significantly, it is recommended that treatment be restarted using the dose adjustment schedule described above. 2. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), since ropinirole clearance is unchanged. Use of this drug in severe renal impairment (creatinine clearance ＜30mL/min) has not been studied; therefore, ropinirole is not recommended in these patients. 3. Patients with hepatic impairment: Use of this drug in patients with hepatic impairment has not been studied; therefore, ropinirole is not recommended in these patients. 4. Use in elderly patients: Ropinirole clearance is reduced in patients aged 65 years and older; however, the dose for elderly patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

④ Use in children: Parkinson's disease does not occur in children. Therefore, no studies of ropinirole use in this population have been reported, and it should not be administered to children.

This medication should be used with caution in patients with severe cardiovascular diseases. \nIt should be used carefully when taken with antihypertensive medications or antiarrhythmics as it may cause heart problems such as hypotension, bradycardia, or arrhythmias. \nPatients with significant mental illness should only use this medication when the treatment benefits outweigh the risks. \nThis medication may cause sudden drowsiness or sleep, so caution is necessary when engaging in activities such as driving or operating machinery. \nIt should not be used in individuals with allergies to this medication, pregnant or breastfeeding women, or patients with certain genetic lactose intolerance conditions. \nNausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur upon taking this medication, so consult a doctor if any unusual symptoms appear. \nPatients with Parkinson's disease may experience movement disorders or psychiatric symptoms such as hallucinations and confusion, so caution is required. \nIt is best not to use this medication in combination with other dopaminergic drugs, and dose adjustments may be necessary when used with certain antibiotics or hormonal medications. \nIt should not be used during pregnancy as it may harm the fetus, and breastfeeding women should also avoid its use. \nIt is not recommended for children under 18 years of age as safety and efficacy have not been established. \nIn the event of overdose, symptoms such as vomiting, dizziness, hallucinations, or heart problems may occur, requiring an immediate visit to a medical facility. \nThis medicine should be kept out of the reach of children and stored in a dry and cool place.

• nausea
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• fainting
• movement disorders
• hallucinations
• confusion
• dizziness

This medicine should be stored in a container that does not allow light and air, preferably in a cool place at temperatures below 25 degrees. \nStoring it this way can help maintain the effectiveness of the medication for a longer period.

Appearance

White pentagonal film-coated tablet

Package unit

21 tablets/box [21 tablets/PTP*1]