Rickyrol Tablets 1 mg (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 cautiously in patients with severe cardiovascular diseases. Caution is needed when taken with other antihypertensives or antiarrhythmics as it may cause hypotension or cardiac irregularities. It should only be administered to patients with psychiatric disorders when the therapeutic benefit is judged to outweigh the risks. Sudden drowsiness or sleepiness may occur during treatment; therefore, activities such as driving or operating machinery should be avoided. It should not be taken by individuals allergic to any component of this medication, by pregnant or breastfeeding women, or by patients with certain genetic lactose intolerance. Side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur; if any unusual symptoms arise, consult a doctor. Dosage adjustments are particularly necessary, and sudden discontinuation should be avoided; tapering off is recommended. This medication should not be combined with other dopamine agonists, and taking it together with dopamine antagonists such as antipsychotics may reduce its effectiveness. This medication is primarily metabolized in the liver, which may lead to interactions with certain drugs; dose adjustments may also be needed for smokers or those undergoing hormone therapy. During pregnancy, it may be harmful to the fetus; therefore, it should not be taken, and breastfeeding women should also avoid this medication. It is not recommended for children under 18 years, as safety and efficacy in this age group have not been established. In cases of overdose, symptoms such as nausea, dizziness, hallucinations, and heart problems may occur, requiring immediate medical assistance. When stored, it should be kept out of reach of children, in a dry and cool place.

• dizziness
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• fainting
• dyskinesia
• hallucinations
• confusion
• dizziness

This medication is sensitive to light, therefore it should be stored in a container that does not allow light in. Additionally, to maintain the medication's effectiveness, it is important to store it in a cool place below 25 degrees Celsius.

Appearance

Pale green pentagonal film-coated tablet

Package unit

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