Hyundai Ropinirole Sustained-release Tablet 8mg (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) → 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 drug has dopamine agonist activity and must be used with caution in patients with severe heart or vascular problems. Be careful when used in conjunction with medications that lower blood pressure or affect heart rhythm, as they may cause side effects such as hypotension or bradycardia. Patients with severe mental illness should only use this medication when the therapeutic effects outweigh the risks, and should avoid dangerous activities such as driving or operating machinery due to the risk of sudden drowsiness or sleep. Patients allergic to any components of this drug, those with severely impaired kidney or liver function, and pregnant or breastfeeding women should not use it. Moreover, patients with certain genetic disorders such as lactose intolerance should not take this medication. Patients with heart disease should regularly check their blood pressure, especially when starting treatment, and should be cautious if allergic to any dyes contained in this drug. Side effects such as hallucinations, drowsiness, dizziness, blood pressure drops, digestive disturbances, and swelling may occur during use, so consult a doctor immediately if any abnormal symptoms arise. Abruptly reducing or stopping the dosage can lead to serious side effects, so it should be adjusted gradually, and mental health or impulse control issues should also be monitored regularly. Do not take this medication with other dopamine-agents, and be sure to inform your doctor about other medications or lifestyle habits that may interact, such as certain antibiotics, smoking, or hormone therapy. Pregnant or breastfeeding women should not take this drug, and its safety has not been confirmed in children and adolescents, so it is not recommended for them. In the case of overdose, problems may arise in the heart and nervous system, so immediate medical treatment is necessary. Finally, this medication should be kept out of reach of children, and should not be transferred to other containers for safety.

hallucinations, drowsiness, abnormal movements, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusions, illusions, paranoid reactions, impulse control disorders, hypersexuality, pathological gambling, compulsive buying, 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 sealed container to protect it from air and moisture, and kept at a cool temperature below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

Brownish-red, double convex, film-coated sustained-release tablet in rectangular shape

Package unit

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