Pakinol Tablet 0.25 mg (Ropinirole Hydrochloride)

Adult dose

1. The appropriate dose should be determined individually, taking efficacy and tolerability into consideration. (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 to 3mg daily. Therapeutic effects are 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; however, it should not exceed 24mg daily. ① When administered as adjunctive therapy to levodopa, the total levodopa dose may be gradually reduced by approximately 20%. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidelines for discontinuation of the other medication before starting ropinirole. ③ As with other dopamine agonists, ropinirole should be discontinued gradually 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 (1 week): The initial recommended 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 of treatment). 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 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 above 4mg/day have not been established in patients with restless legs syndrome. As with other dopamine agonists, treatment with this medication should be discontinued gradually 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 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, ropinirole is not recommended for these patients. 3. Patients with hepatic impairment: Use of this medication has not been studied in patients with hepatic impairment; therefore, ropinirole is not recommended for these patients. 4. Administration to older adults: Ropinirole clearance is reduced in patients aged 65 years and older, but the dose for older patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

Must not be administered to children.

This medication requires caution in patients with severe cardiovascular diseases. Care should be taken as hypotension or irregular heartbeats may occur when taken with other antihypertensive agents or antiarrhythmic drugs. Patients with mental disorders should only use this drug when its benefits are deemed greater than its risks. Severe drowsiness or sudden sleepiness may occur while taking this medication, hence dangerous activities such as driving or operating machinery should be avoided. Patients with hypersensitivity to this medication, pregnant or breastfeeding women, and those with specific genetic lactose intolerance should not use it. Common side effects include nausea, vomiting, dizziness, drowsiness, edema, and in severe cases, hallucinatory or confusional psychiatric symptoms may develop. Particularly in Parkinson's disease patients, there is a risk of movement disorders or symptoms of hypotension. Safety and efficacy have not been established in children, thus its use is not recommended in this population. In case of an overdose, serious symptoms such as vomiting, drowsiness, low blood pressure, and cardiac issues may arise, necessitating immediate consultation with healthcare professionals. During treatment, it is advised not to combine this medication with other dopaminergic agents, and its effectiveness may decrease when used with neuroleptics. Additionally, this drug is metabolized in the liver; hence, dosage adjustments may be needed when taken with certain antibiotics or antidepressants. It is best for pregnant or breastfeeding women to avoid this medication, and those planning a pregnancy should refrain from using it as well. When discontinuing the medication, tapering is necessary rather than abrupt cessation, as severe symptoms such as high fever or muscle rigidity may occur during the process. Impulsive control disorders may appear while taking this medication, so patients and caregivers should carefully monitor for behavioral changes. Store in a cool, dry place out of the reach of children, and avoid transferring to other containers.

• Nausea
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• syncope
• movement disorders
• hallucinations
• confusion
• dizziness

This medication should be stored in a container that is lightproof and airtight to prevent exposure to light and air. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its efficacy.

Appearance

White, convex, pentagonal film-coated tablet.

Package unit

30 tablets/bottle