Pracup Tablet 2 mg (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 this 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 (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 are seen at daily doses of 3-9mg. 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 daily. ① When administered as adjunctive therapy to levodopa, the levodopa dose may be gradually reduced by approximately 20% of the total dose. 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 before bedtime, 1-3 hours before bedtime. Initial treatment (week 1): The initially 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 (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 medicine should be discontinued gradually while reducing the daily dose. If this medicine has been discontinued for a significant period, it is recommended that treatment be restarted using the dose-adjustment schedule 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 medicine 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 medicine in patients with hepatic impairment has not been studied; therefore, ropinirole is not recommended in these patients. 4. Use in the elderly: Ropinirole clearance is decreased in patients 65 years of age or older, but 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 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. Caution is also required when used in combination with antihypertensive drugs or antiarrhythmic agents, as it may cause cardiac issues such as hypotension or bradycardia. It should only be administered to patients with severe psychiatric disorders when the benefits outweigh the risks. Patients should be careful to avoid driving or operating machinery since drowsiness or sudden sleep may occur during treatment. Women who are allergic to this medication, pregnant, or breastfeeding should not take it. Patients with a known allergy to the dye included in this medication should use it carefully. During treatment, side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and peripheral edema may occur. If these symptoms are severe, consulting a doctor is recommended. Particularly in Parkinson's disease patients, caution is needed as movement disorders, hallucinations, and confusion may occur. Regular monitoring for symptom exacerbation or sudden drowsiness should be conducted, and if abnormal signs appear, dosage adjustments or discontinuation should be considered. This medication should not be used in combination with other dopamine agonists, and since it may interact with some drugs, it is essential to consult a healthcare provider before starting any new medications. Women who are pregnant or breastfeeding should not take this drug, and its safety and efficacy have not been established in children under 18 years of age. An overdose may lead to nausea, dizziness, hallucinations, and cardiac issues, so it is critical to adhere to the prescribed dosage and seek immediate medical attention if any abnormal symptoms occur. This medication should be stored out of reach of children, away from direct sunlight, and in a dry place at or below 25 degrees Celsius.

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

This medication should be stored in a cool place at or below 25 degrees Celsius, in a tightly sealed container that is protected from light and well-ventilated. This will help maintain the effectiveness of the medication for a longer period.

Appearance

Pink pentagonal film-coated tablet

Package unit

21 tablets (21 tablets/PTPX1)