Ropimax Tablet 2 mg (Ropinirole Hydrochloride)

Adult dose

1. The appropriate dose should be determined individually, considering efficacy and tolerability. (1) Idiopathic Parkinson's disease It is preferable to take this medication with food three times daily to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg three times daily. The treatment schedule for the first 4 weeks is as follows: Week 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 daily dose may be increased at weekly intervals up to 3mg three times daily. Therapeutic effects occur at doses of 3-9mg per day. If symptoms are not adequately controlled or symptom control is not maintained, the ropinirole dose may be increased until a clear therapeutic effect is achieved, but should not exceed 24mg per day. 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 before starting ropinirole. ③ As with other dopamine agonists, ropinirole should be discontinued gradually by reducing the number of daily doses over the course of 1 week. (2) Primary restless legs syndrome Ropinirole should be taken once daily at bedtime, 1~3 hours before bedtime. Initial treatment (week 1): 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). 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 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 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 it be restarted using the dose titration 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, 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, ropinirole is not recommended in these patients. 4. Use in older adults: Ropinirole clearance is reduced in patients over 65 years of age, but dosage in older patients may be adjusted in the usual manner according to their clinical response.

Child dose

Do not administer to children.

This medication should be used with caution in patients with severe cardiovascular disease. If taken with antihypertensives or antiarrhythmics, hypotension, bradycardia, and other arrhythmias may occur. It should only be used if the benefits of treatment outweigh the risks in patients with significant mental disorders. During treatment with this medication, sudden severe daytime drowsiness or sudden sleep may occur; therefore, patients should avoid dangerous activities such as driving or operating machinery. It should not be used in patients with hypersensitivity to this medication or in pregnant or breastfeeding women, as well as in certain genetically lactose-intolerant patients. Nausea, vomiting, drowsiness, dizziness, hypotension, peripheral edema, and other side effects may occur; if unusual symptoms arise, consult a doctor. Particularly in Parkinson's disease patients, movement disorders, mental confusion, hallucinations, etc., may occur, so caution is needed. As a dopamine agonist, this medication may cause symptoms related to blood pressure lowering, psychiatric abnormalities, impulse control disorders, etc., so regular monitoring of the condition is necessary. Pregnant or breastfeeding women should not take this medication as it may harm the fetus or newborn, and it is not recommended for children under 18 years of age due to the establishment of safety and efficacy not being confirmed. In cases of overdose, symptoms such as vomiting, dizziness, hallucinations, and heart abnormalities may occur, and immediate medical attention is required. Drug interactions with other dopamine antagonists or drugs affecting the CYP1A2 enzyme may occur; therefore, consult a doctor or pharmacist before taking new medications. This medication should be kept out of the reach of children and stored in a dry place below 25 degrees Celsius, and it is advisable not to transfer it to another container.

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

This medication should be stored in a cool place below 25 degrees Celsius, in a tightly sealed container that is not exposed to light and well-ventilated. By storing it this way, the effectiveness of the medication can be preserved for a long time and deterioration can be prevented.

Appearance

Pink pentagonal film-coated tablet

Package unit

21 tablets/PTP