Ropinirole Extended-Release Tablets 4 mg (Ropinirole Hydrochloride)

Adult dose

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) → Total daily dose of ropinirole extended-release tablets (mg) 0.75-2.25 → 2 3-4.5 → 4 6 → 6 7.5-9 → 8 12 → 12 15-18 → 16 21 → 20 24 → 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. Caution is also necessary if taken with antihypertensives or antiarrhythmics as hypotension or arrhythmias may occur. It should only be used in patients with severe mental illnesses when the benefits outweigh the risks. During the use of this medication, sudden drowsiness or sleep may occur, and patients should avoid driving or operating hazardous machinery. Patients with hypersensitivity to this medication, severe renal or hepatic impairment, pregnant or nursing women should not use this. Patients with lactose intolerance should also avoid this medication. Patients with cardiovascular diseases are advised to check blood pressure frequently, especially during the initial doses. Caution is necessary if allergic to any of the dyes in this medication. This medication may cause side effects such as drowsiness, dizziness, hallucinations, orthostatic hypotension, etc. Mental symptoms or impulse control disorders may occur, and in such cases, consultation with a physician is necessary. If severe drowsiness or sudden sleep occurs while taking this medication, it should be discontinued immediately and a healthcare provider should be consulted. This medication should not be stopped suddenly and the dosage should be gradually reduced to prevent serious side effects such as neuroleptic malignant syndrome. It should not be used in conjunction with other dopaminergic agents, and dosage adjustments may be needed according to certain antibiotics or smoking habits. Pregnant or nursing women should not take this, and it is not recommended for children or adolescents under 18 years of age. In case of overdose, cardiovascular status should be closely monitored, and appropriate treatment should be provided if necessary. The product should be stored out of reach of children, and it is recommended not to change the container in which it is stored.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusions, hallucinations, including psychiatric responses, impulse control disorders, hypersexuality, pathological gambling, compulsive shopping, binge eating, aggression, fainting, excessive daytime sleepiness, vomiting, chest pain, abdominal pain, liver reactions, elevated liver enzymes, lower limb edema

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will ensure the safety and efficacy of the medication.

Appearance

Light brown, bilaterally convex, rectangular, film-coated extended-release tablet

Package unit

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