Parkinolphide Tablets 8 mg (Ropinirole Hydrochloride)

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 drug should be used with caution in patients with severe cardiovascular diseases. Additionally, when taken with antihypertensive agents or antiarrhythmics, hypotension, bradycardia, and arrhythmias may occur, so special care is required. Patients with significant mental disorders should only use this drug when the therapeutic effect outweighs the risks. During treatment with this drug, sudden drowsiness or sleep may occur, so activities requiring alertness, such as driving or operating machinery, should be avoided. Patients with allergies to ropinirole or any component of this drug, those with severely impaired kidney or liver functions, and women who are pregnant or breastfeeding should not take this medication. Patients with lactose intolerance should also avoid taking this drug. Patients with cardiovascular diseases should carefully monitor blood pressure, especially in the early stages of treatment, and should use this drug cautiously if allergic to specific pigments contained in it. Side effects such as hallucinations, drowsiness, dizziness, hypotension, constipation, peripheral edema, etc., may occur, so if unusual symptoms are experienced, medical consultation should be sought immediately. Psychological issues or impulse control disorders may arise, so regular symptom checks and dosage adjustments may be necessary. This drug can provoke sudden sleep, so if excessive drowsiness occurs during daily activities, discontinue use and consult a healthcare professional. Caution is advised regarding drug interactions, especially not to take it alongside other dopamine agonists or antagonists. If smoking is started or stopped, dosage adjustments may be necessary. Pregnant or breastfeeding women should not take this drug, and it is not recommended for individuals under 18 years of age. In case of overdose, dopamine-related symptoms may appear, necessitating immediate medical assistance. Finally, store this medication out of reach of children and do not transfer it to other containers for safety.

Hallucinations, drowsiness, akathisia, 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 shopping, binge eating, aggression, syncope, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, liver reactions, increased liver enzymes, lower limb edema

This drug may be sensitive to air or moisture, so it must be stored in a sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Brownish-red, bilaterally convex, film-coated prolonged-release tablet

Package unit

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