Ropimax 1 mg Tablet (Ropinirole Hydrochloride)

Adult dose

1. An appropriate dose should be determined individually, taking efficacy and tolerability into consideration. (1) Idiopathic Parkinson's disease It is preferable to take the medicine 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: Week 1: Dose per administration (mg) 0.25, daily dose (mg) 0.75 Week 2: Dose per administration (mg) 0.5, daily dose (mg) 1.5 Week 3: Dose per administration (mg) 0.75, daily dose (mg) 2.25 Week 4: Dose per administration (mg) 1.0, daily dose (mg) 3.0 Maintenance treatment: After the initial treatment, the dose may be increased at 1-week intervals up to 3mg per day. Therapeutic effects are seen at doses of 3-9mg per day. If symptoms are not adequately controlled or symptom control cannot be maintained, the ropinirole dose may be increased until a clear therapeutic effect is achieved, but it should not exceed 24mg per day. 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 guidelines for discontinuing the other medicine 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 before bedtime, 1-3 hours before going to bed. 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 the initial treatment, the daily dose may be increased according to the following schedule until an optimal therapeutic response is achieved. Week 2: Dose per administration (mg) 1 Week 3: Dose per administration (mg) 1.5 Week 4: Dose per administration (mg) 2 Week 5: Dose per administration (mg) 2.5 Week 6: Dose per administration (mg) 3 Week 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 medicine should be discontinued gradually by reducing the daily dose. If treatment with this medicine has been interrupted substantially, 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 medicine 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 medicine 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 65 years of age and older, but the dose for older 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 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 disease. Care should be taken when taken with antihypertensives or antiarrhythmics, as it may cause heart problems such as hypotension, bradycardia, or arrhythmias. Patients with significant mental disorders should only use this medication when the therapeutic benefits outweigh the risks. Drowsiness may occur suddenly during the day, so care should be taken to avoid driving or operating hazardous machinery if such symptoms occur. This medication should not be taken by individuals allergic to it, pregnant women, or nursing mothers. Patients with certain genetic disorders such as lactose intolerance should also avoid this medication. Side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur; consult your doctor if abnormal symptoms appear. Patients with Parkinson's disease should be cautious as they may experience drug-induced movement disorders, hallucinations, or confusion. This medication can be harmful to pregnant women, and it is advisable not to use it during breastfeeding. Safety and effectiveness in children under 18 years of age have not been established, so it is not recommended for use in this population. In case of overdose, symptoms such as vomiting, hallucinations, lethargy, palpitations, drowsiness, and confusion may occur, and medical assistance should be sought immediately. It is safest to avoid alcohol while taking this medication and not to combine it with other dopamine agonists. During treatment with this medication, regular check-ups with the physician are necessary, and impulse control disorders or psychiatric symptoms should be monitored closely.

• Dizziness
• drowsiness
• leg edema
• abdominal pain
• vomiting
• syncope
• movement disorders
• hallucinations
• confusion
• lightheadedness

This medication should be stored in a cool place below 25 degrees Celsius and kept in a tightly sealed container to prevent light exposure. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance

Pale green pentagonal film-coated tablet

Package unit

21 tablets/PTP