Parkinole Tablet 2 mg (Ropinirole Hydrochloride)

Adult dose

1. An individualized dose is recommended based on efficacy and tolerability. (1) Idiopathic Parkinson's disease It is preferable to take the medication 3 times daily with food to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment regimen for the first 4 weeks is as follows: Week (weeks) 1: Dose per administration (mg) 0.25, daily dose (mg) 0.75 Week (weeks) 2: Dose per administration (mg) 0.5, daily dose (mg) 1.5 Week (weeks) 3: Dose per administration (mg) 0.75, daily dose (mg) 2.25 Week (weeks) 4: Dose per administration (mg) 1.0, daily dose (mg) 3.0 Maintenance treatment: After initial treatment, the dose may be increased at 1-week intervals up to 3mg daily. A therapeutic effect is observed at doses of 3-9mg daily. If symptoms are not adequately controlled or symptom 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 approximately 20% of the total dose. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidelines for discontinuing the other medication before starting ropinirole. ③ As with other dopamine agonists, ropinirole should be gradually discontinued by reducing the number of daily doses over the course of 1 week. (2) Primary restless legs syndrome Ropinirole should be taken once daily before bedtime, 1~3 hours before bedtime. Initial treatment (1 week): 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 beginning on day 3 of treatment 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 an optimal therapeutic response is achieved. Week (weeks) 2: Dose per administration (mg) 1 Week (weeks) 3: Dose per administration (mg) 1.5 Week (weeks) 4: Dose per administration (mg) 2 Week (weeks) 5: Dose per administration (mg) 2.5 Week (weeks) 6: Dose per administration (mg) 3 Week (weeks) 7: Dose per administration (mg) 4 The safety and efficacy of doses greater than 4mg/day have not been established in patients with restless legs syndrome. As with other dopamine agonists, treatment with this medication should be gradually discontinued by reducing the daily dose. If treatment with this medication has been interrupted for a significant period, it is recommended that treatment be restarted using the dose adjustment schedule described above. 2. Patients with renal impairment: Since ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), dose adjustment is not necessary. Use of this medication has not been studied in patients with severe renal impairment (creatinine clearance ＜30mL/min); therefore, administration of ropinirole is not recommended in these patients. 3. Patients with hepatic impairment: Use of this medication has not been studied in patients with hepatic impairment; therefore, administration of ropinirole is not recommended in these patients. 4. Use in elderly patients: Ropinirole clearance is reduced in patients aged 65 years or older, but the dose for elderly patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

④ Administration to children: Parkinson's disease does not occur in children. Therefore, no studies on the use of ropinirole 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 problems. Caution is required when taken with drugs that lower blood pressure or antiarrhythmics, as this can lead to hypotension or irregular heartbeats. Patients with significant mental health conditions must consider the therapeutic effects and risks of this drug carefully before use. This medication can cause sudden drowsiness or sleepiness during daily activities, so caution is especially needed when driving or operating hazardous machinery. Patients with a hypersensitivity to this drug, or women who are pregnant or breastfeeding, as well as patients with lactose intolerance, should not take this medication. Various side effects such as nausea, vomiting, dizziness, drowsiness, hypotension, and edema may occur during use, and if symptoms are severe, consultation with a physician is required. This drug is not recommended for children under 18, as its safety and efficacy have not been established in this age group. When combined with other dopamine agonists or antipsychotics, there may be interactions, so it is essential to consult an expert. Use should be avoided during pregnancy and breastfeeding, as it may affect the fetus or newborn. Overdose may result in severe side effects, so prescribed doses must be followed, and any abnormal symptoms should be immediately reported to healthcare personnel. This medication should be stored out of reach of children, away from direct sunlight, and in a cool, dry place.

• Nausea
• drowsiness
• leg edema
• abdominal pain
• vomiting
• syncope
• dyskinesia
• hallucinations
• confusion
• dizziness

This medication is sensitive to light, so it should be stored in a container that does not allow light to pass through. Additionally, it is essential to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Pink, convex, pentagonal film-coated tablet on both sides

Package unit

30 tablets/bottle