Requip 1mg (Ropinirole Hydrochloride)

Adult dose

1. The appropriate dose should be determined for each patient based on efficacy and tolerability. (1) Idiopathic Parkinson's disease It is preferable to take the medication 3 times daily with food 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 initial treatment, the daily dose may be increased to 3mg at 1-week intervals. A therapeutic effect is seen at doses of 3-9mg per day. If symptoms are not adequately controlled or symptom control is not maintained, the dose of ropinirole may be increased until a clear therapeutic effect is achieved; however, the dose 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 previous treatment 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. (See section ‘4. General precautions’ under Precautions for use.) (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 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 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 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 by reducing the daily dose. (See section ‘4. General precautions’ under Precautions for use.) If treatment with this medication has been interrupted for a significant period, it is recommended that treatment be restarted using the dose-adjustment schedule 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 required. The use of this medication in patients with severe renal impairment (creatinine clearance ＜30mL/min) has not been studied; therefore, ropinirole is not recommended in these patients. 3. Patients with hepatic impairment: The use of this medication 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 decreased in patients aged 65 years 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 Administration to 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 taking it with blood pressure-lowering medications or antiarrhythmics, as hypotension or arrhythmias may occur. Patients with mental illness should only use this medication when its benefits outweigh the risks. Patients may suddenly feel drowsy or fall asleep while taking this medication, so if severe drowsiness or sudden sleep occurs, driving or operating hazardous machinery should be avoided. This medication should not be used in individuals with hypersensitivity to it, pregnant or breastfeeding women, or certain genetically lactose-intolerant patients. Adverse effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur; if symptoms are severe, consult a physician. If the dosage is suddenly reduced or stopped, symptoms such as insomnia, depression, and fatigue may appear, so it should be adjusted gradually. Avoid taking this medication with other dopamine agonists and be mindful of potential interactions with certain antibiotics and hormone therapies; inform your doctor when starting or stopping new medications. Pregnant or breastfeeding women should not take this medication, and safety and efficacy in children under 18 years have not been established. In case of overdose, symptoms such as severe drowsiness, hallucinations, and hypotension may occur, and immediate medical attention is required. This medication should be stored in a dry, cool place away from direct sunlight, and kept out of reach of children.

Nausea, drowsiness, leg edema, abdominal pain, vomiting, fainting, movement disorders, hallucinations, confusion, dizziness, sudden sleep, dyspepsia, constipation, orthostatic hypotension, hypotension, peripheral edema, agitation, symptom exacerbation, early morning rebound, upper respiratory tract infection, fatigue, arthralgia, injury, dry mouth, pain, diarrhea, myalgia, sensory disturbances, increased sweating, cough, viral infection, migraine, rhinitis, sinusitis, hypersensitivity reaction, delirium, paranoia, delirium tremens, psychiatric adverse reactions, impulse control disorder, increased libido, hypersexuality, pathological gambling, compulsive buying, binge eating, aggression, mania, extreme drowsiness, drug withdrawal syndrome, insomnia, indifference, anxiety, depression, sweating, tremors, confusion, fever, chest pain, vertigo, dyspepsia, movement disorders, anxiety, delusion, rash, dysuria, facial edema, peripheral ischemia, loss of appetite, dyspnea, weight loss, sleep disorders, air trapping in the gastrointestinal tract, urine discoloration, blisters, visual hallucinations, excessive sweating, claustrophobia, chorea, palpitations, weakness, nightmares, vasovagal syncope, agitation, chest pain, vasovagal syncope

This medication should be stored in a cool place below 25 degrees Celsius, and it is important to keep it in a tightly sealed container that does not allow light or air in. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

Film-coated tablets which are light green in color, pentagonal in shape, and have 'SB' on one side and '4892' embossed on the other side with both sides being convex.

Package unit

21 tablets/PTP