Oniror Tablet 2 mg (Ropinirole Hydrochloride)

Adult dose

It is preferable to take this medication 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 (weeks) 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 the initial treatment, the dose may be increased at 1-week intervals up to 3mg daily. Therapeutic effects occur 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 clear therapeutic effect is achieved, but must 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 discontinuing 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 the course of 1 week. Ropinirole should be taken once daily at 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 starting on day 3 and continuing 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 3 4 5 6 7 Dose per administration (mg) 1 1.5 2 2.5 3 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 discontinued gradually while 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 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 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. Use in older adults: Ropinirole clearance is reduced in patients aged 65 years or 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 of ropinirole use in this population have been reported, and it should not be administered to children.

This drug should be used with caution in patients with serious heart or vascular problems. Use with medications that lower blood pressure or affect heart rhythm may cause hypotension, slow heart rate, or arrhythmias, so caution is advised. In patients with severe mental illnesses, this medication should only be used if the benefits outweigh the risks. Patients may suddenly experience daytime sleepiness or fall asleep while taking this drug; if these symptoms occur, avoid driving or operating hazardous machinery. Individuals allergic to this medication, pregnant or breastfeeding women, and those with lactose intolerance should not use this medication. Side effects such as nausea, drowsiness, leg swelling, abdominal pain, vomiting, dizziness, hallucinations, confusion, hypotension, and others may occur; patients should consult a doctor if any unusual symptoms appear. Particularly, side effects may be more common in patients with Parkinson's disease or restless legs syndrome. Do not abruptly stop taking this medication; taper the dosage gradually, as sudden discontinuation may cause serious symptoms. Impulse control disorders may occur while taking this medication; report any gambling, excessive sexual urges, compulsive spending, or eating behaviors to your doctor. Taking this medication in conjunction with other dopamine agonists or neuroleptics may alter its effectiveness, so consult a doctor. This medication is metabolized in the liver, so taking it with certain antibiotics, antidepressants, or hormone treatments may alter drug concentrations and require dosage adjustments. Avoid use during pregnancy as it may be harmful to the fetus, and do not use while breastfeeding as this medication can pass into breast milk and affect the baby. Safety and efficacy have not been established for children under 18 years of age, so it is not recommended for this group. In case of overdose, symptoms such as nausea, dizziness, hallucinations, abnormal heartbeat, and drowsiness may occur; seek medical attention immediately in such cases. Store this medication out of the reach of children and in a cool, dry place away from direct sunlight.

• Nausea
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• syncope
• akathisia
• hallucinations
• delirium
• dizziness

This medication should be stored in a cool place below 25 degrees Celsius and in an airtight container that does not allow light or air exposure. Proper storage will maintain the medication's efficacy and prevent deterioration.

Appearance

Pale pink pentagonal film-coated tablets

Package unit

30 tablets/bottle