Rikiron Tablets 2mg (Ropinirole Hydrochloride)

Adult dose

1. An individualized optimal dose is recommended, taking efficacy and tolerability into account. (1) Idiopathic Parkinson's disease It is preferable to take the drug 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: 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 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 control is not maintained, the ropinirole dose may be increased until a definite 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 by up to approximately 20% of the total dose. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidance for discontinuation before starting ropinirole. ③ As with other dopamine agonists, when discontinuing ropinirole, gradually stop treatment 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 (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 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 the optimal therapeutic response is reached. 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 above 4mg/day have not been established in patients with restless legs syndrome. As with other dopamine agonists, treatment with this drug should be discontinued gradually while reducing the daily dose. If administration of this drug has been interrupted significantly, it is recommended that treatment be restarted using the dose adjustment schedule described above. 2. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), since ropinirole clearance is unchanged. Use of this drug in 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 drug 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; however, the dose for elderly patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

④ 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 medication should be used with caution in patients with severe cardiovascular disease. Care should be taken when taken with other antihypertensive or antiarrhythmic drugs as hypotension or arrhythmias may occur. Patients with severe mental illness should only use this medication after carefully considering its therapeutic effects and risks. Since sudden drowsiness or sleep may occur during use, patients should avoid driving or operating machinery. This medication should not be used in patients with hypersensitivity to it or in pregnant or breastfeeding women. Patients with lactose intolerance are also advised not to take this medication. Patients with a history of allergy to Tartrazine (FD&C Yellow No. 5) should use it cautiously. Side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and peripheral edema may occur, and if any unusual symptoms arise, consultation with a physician is necessary. Particularly, patients with Parkinson’s disease should carefully observe for symptoms of motor disturbances or psychiatric symptoms, and changes in blood pressure. This medication should not be used in combination with other dopamine agonists, and its efficacy may decrease when used with dopamine antagonists. Patients with liver or kidney function issues or those taking other medications should inform healthcare professionals. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should also exercise caution. Safety and efficacy in children under 18 years have not been established, so it is not recommended for this age group. In cases of overdose, serious symptoms such as nausea, dizziness, hallucinations, and cardiac irregularities may occur, requiring immediate medical attention. This medication should be stored out of the reach of children and in a cool, dry place below 25 degrees Celsius. If unusual behaviors such as drowsiness, impulse control issues, or hallucinations occur during treatment, immediate consultation with a physician is required, and dosage adjustment or discontinuation may be necessary.

• Nausea
• drowsiness
• leg edema
• abdominal pain
• vomiting
• fainting
• dyskinesia
• hallucinations
• confusion
• dizziness

This medication is sensitive to light, so it should be stored in a special container that does not allow light to enter. Additionally, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Pink pentagonal film-coated tablets

Package unit

21 tablets/box [21 tablets/PTP*1]