Ropinirole Sustained-Release Tablets 8 mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The appropriate dose should be determined individually, taking efficacy and tolerability into consideration. This medicine should be taken once daily at the same time each day. It may be taken with or without food. Swallow this medicine whole. Do not chew, crush, or split it. 1) Initial therapy For the first week, administer 2mg of this medicine (extended-release tablet) once daily. Starting in the second week of treatment, increase the dose to 4mg once daily. A treatment response may occur starting at 4mg daily. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptoms are not adequately controlled or control is not maintained with 4mg once daily, gradually increase the dose by 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptoms are not adequately controlled or control is not maintained with 8mg once daily, gradually increase the daily dose by 2mg or 4mg at intervals of 2 weeks or longer. The maximum daily dose of this medicine is 24mg. If treatment is interrupted for 1 day or more, restarting treatment should be considered according to the initial therapy dosing schedule. When ropinirole is administered concomitantly with levodopa, the levodopa dose may be gradually reduced according to the clinical response. In clinical trials, the levodopa dose was gradually reduced by up to approximately 30% in patients receiving this medicine (extended-release tablet) concomitantly with levodopa. Dyskinesia may occur early in treatment with this medicine (extended-release tablet) when administered with levodopa in patients with advanced Parkinson's disease. In such cases, the levodopa dose should be reduced. If ropinirole is to be used as a substitute for another dopamine agonist, the other dopamine agonist should be discontinued according to its recommended instructions before starting ropinirole. As with other dopamine agonists, ropinirole should be discontinued by gradually reducing the daily dose over 1 week. 3) Switching from immediate-release ropinirole tablets to this medicine (extended-release tablet) Immediate-release ropinirole tablets may be replaced with this medicine (extended-release tablet) overnight. The dose of this medicine should be selected based on the patient's total daily dose of immediate-release ropinirole tablets, according to the following dosage table. Total daily dose of immediate-release ropinirole tablets (mg) 0.75-2.25: Total daily dose of ropinirole extended-release tablets (mg) 2 Total daily dose of immediate-release ropinirole tablets (mg) 3-4.5: Total daily dose of ropinirole extended-release tablets (mg) 4 Total daily dose of immediate-release ropinirole tablets (mg) 6: Total daily dose of ropinirole extended-release tablets (mg) 6 Total daily dose of immediate-release ropinirole tablets (mg) 7.5-9: Total daily dose of ropinirole extended-release tablets (mg) 8 Total daily dose of immediate-release ropinirole tablets (mg) 12: Total daily dose of ropinirole extended-release tablets (mg) 12 Total daily dose of immediate-release ropinirole tablets (mg) 15-18: Total daily dose of ropinirole extended-release tablets (mg) 16 Total daily dose of immediate-release ropinirole tablets (mg) 21: Total daily dose of ropinirole extended-release tablets (mg) 20 Total daily dose of immediate-release ropinirole tablets (mg) 24: Total daily dose of ropinirole extended-release tablets (mg) 24 After switching from immediate-release ropinirole tablets to this medicine (extended-release tablet), adjust the dose according to the treatment response. 2. Administration to elderly patients Since ropinirole clearance is decreased in patients aged 65 years and older, the dose should be increased more gradually according to the clinical response. In very elderly patients, consider increasing the dose even more gradually during the initial period of treatment. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min), as ropinirole clearance is unchanged.

This medication should be used with caution in patients with severe cardiovascular diseases. Additionally, when used with medications that lower blood pressure or antiarrhythmics, there may be side effects such as hypotension or bradycardia, so caution is advised. Patients with significant mental illness should only use this medication when its therapeutic benefits are deemed greater than the risks. Patients taking this medication may experience sudden drowsiness or sleep during treatment, so activities that require alertness, such as driving or operating machinery, should be avoided. Patients with allergic reactions, significantly impaired kidney or liver function, pregnant or breastfeeding women, and those with lactose intolerance should not take this medication. For patients with cardiovascular diseases, it is advisable to frequently monitor blood pressure, especially during the initial treatment phase, and caution is required if there is an allergy to any of the dyes included in this medication. During treatment, adverse reactions such as hallucinations, confusion, drowsiness, dizziness, hypotension, nausea, constipation, edema, delusions, obsessions, impulse control disorders, hypersexuality, compulsive spending, binge eating, aggressiveness, fainting, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, increased liver enzymes, and peripheral edema may occur, and patients should consult a healthcare professional if symptoms are severe. Particularly, since this medication acts on dopamine, there may be behavioral changes such as impulse control disorders, pathological gambling, excessive sexual desire, and compulsive spending, which require regular monitoring. Dosage should not be suddenly reduced or stopped, as serious side effects may occur, and adjustments should be made gradually. This medication should not be taken with other dopamine agonists, and dosage adjustments may be necessary depending on certain antibiotics or smoking habits. Pregnant or breastfeeding women should not take this medication, and it is not recommended for children or adolescents under 18 due to insufficient safety data. In the case of overdose, symptoms related to dopamine may appear; appropriate treatment and cardiovascular monitoring are required. This medication should be kept out of reach of children and should not be transferred to other containers.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, and pruritus), confusion, delusions, hallucinations, including paranoid reactions, impulse control disorders, hypersexuality, pathological gambling, increased libido, compulsive shopping, binge eating, aggression, syncope, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, liver reactions, elevated liver enzymes, lower limb edema

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. By doing so, the efficacy of the medication can be maintained for a long time.

Appearance

Brownish-red, bilaterally convex, rectangular film-coated sustained-release tablet

Package unit

28 tablets/box [14 tablets/PTP * 2]