Ropinirole Hydrochloride 2 mg Tablet

Adult dose

1. Adults The recommended dose should be individualized based on efficacy and tolerability. 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 therapeutic response may occur at 4mg per day. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptom control is inadequate or is not maintained with 4mg once daily, increase the dose in increments of 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptom control is inadequate or is not maintained with 8mg once daily, increase the daily dose in increments of 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. In patients with advanced Parkinson's disease receiving concomitant levodopa, dyskinesia may occur early in treatment with this medicine (extended-release tablet). 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 method before starting ropinirole. As with other dopamine agonists, ropinirole should be discontinued by gradually reducing the daily dose over 1 week. 3) Switching from ropinirole immediate-release tablets to this medicine (extended-release tablet) Ropinirole immediate-release tablets may be replaced with this medicine (extended-release tablet) overnight. The dose of this medicine should be selected according to the following dosage table, based on the patient's total daily dose of ropinirole immediate-release tablets. Total daily dose of ropinirole immediate-release 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 ropinirole immediate-release tablets to this medicine (extended-release tablet), the dose should be adjusted according to the therapeutic response. 2. Administration to elderly patients Because ropinirole clearance is decreased in patients aged 65 years or older, the dose should be increased more gradually according to the clinical response. In very elderly patients, slower dose escalation during the initial period of treatment should be considered. 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 disease. Care should be taken when used in conjunction with antihypertensive drugs or antiarrhythmic agents due to the risk of side effects such as hypotension or bradycardia. Patients with severe psychiatric disorders should only take this medication when the therapeutic benefit outweighs the risks. Sudden drowsiness or sleep may occur during treatment, so activities such as driving or operating machinery should be avoided. Patients with allergic reactions, severely impaired kidney or liver function, pregnant or nursing women should not take this medication. Patients with lactose intolerance should also refrain from using this medication. Cardiovascular disease patients should closely monitor blood pressure, especially during initial dosing, and use cautiously if allergic to the colorants contained in the medication. Side effects may include drowsiness, dizziness, hallucinations, orthostatic hypotension, nausea, constipation, peripheral edema, confusion, delusions, illusions, paranoia, impulse control disorder, hypersexuality, compulsive buying, binge eating, aggression, fainting, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, elevated liver enzymes, and lower limb edema, so if any abnormal symptoms occur, consult a healthcare professional. Mental changes or impulse control disorders may arise, thus both patient and caregiver should be aware of these symptoms and regularly check the patient's condition. If extreme drowsiness or sudden sleep occurs, immediate consultation with a doctor is advised and driving or engaging in risky activities should be avoided. This medication should not be abruptly discontinued and should be gradually tapered off, as there may be potential interactions with other medications. Before starting any new medications, consulting with a healthcare provider is essential. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. In case of overdose, cardiovascular monitoring and treatment to alleviate symptoms are necessary, so immediate medical attention is required. Finally, this medication should be stored out of reach of children, and it's important not to transfer it to other containers.

Hallucinations, drowsiness, dyskinesia, dizziness, sudden sleep, orthostatic hypotension, low blood pressure, 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, increased liver enzymes, lower limb edema

This medication must be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Pink, biconvex, rectangular film-coated sustained release tablet

Package unit

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