Pakinol 1 mg (Ropinirole Hydrochloride)

Adult dose

1. An appropriate dose for each individual is recommended, taking efficacy and tolerability into consideration. (1) Idiopathic Parkinson's disease It is advisable to take this medicine with food 3 times daily to improve gastrointestinal tolerability. Initial therapy: 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 therapy: After initial therapy, the dose may be increased at 1-week intervals up to 3mg daily. The therapeutic effect is seen at doses of 3-9mg daily. If symptoms are not adequately suppressed or symptom control is not maintained, the ropinirole dose may be increased until a clear 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 to approximately 20% of the total dose. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidelines for discontinuation 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 therapy (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 starting on day 3 through the last day of the first week of treatment (day 7). Maintenance therapy (from week 2): After initial therapy, 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 medicine should be discontinued gradually by reducing the daily dose. If administration of this medicine has been interrupted significantly, it is recommended that treatment be restarted using the dose adjustment 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), no dose adjustment is necessary. Use of this medicine in patients with 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 medicine 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, but the dose for elderly patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

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 drug must be used cautiously in patients with severe cardiovascular diseases. Caution is also needed when taken with other antihypertensives or antiarrhythmics due to the risk of side effects such as hypotension or bradycardia. Patients with significant mental illnesses should only use it after careful consideration of the treatment benefits and risks. Sudden drowsiness or sleepiness may occur during treatment, so particular care should be taken when driving or operating machinery. Patients hypersensitive to this drug, pregnant or nursing women, and those with certain genetic lactose intolerance should not take it. Various side effects such as nausea, drowsiness, dizziness, hypotension, peripheral edema, etc., may occur; if abnormal symptoms arise, consultation with a doctor should be made immediately. Parkinson's disease patients should pay special attention to neurological side effects like dyskinesias or hallucinations, and dosage adjustments may be necessary. It is advisable not to take this drug with other dopaminergic agents and to inform of any medications being taken due to potential interactions with certain antibiotics or hormonal therapies. It should be avoided during pregnancy or breastfeeding as it may affect the fetus or newborn, and safety and efficacy have not been established for children under 18.

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

This medicine is sensitive to light, so it should be stored in a light-protected container. In addition, it is important to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Light green, convex on both sides, pentagonal film-coated tablet

Package unit

30 tablets/bottle