Pakinolpid Tablet 2 mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The optimal dose should be individualized, taking efficacy and tolerability into consideration. This medication should be taken once daily at the same time each day. It may be taken with or without food. Swallow this medication whole; do not chew, crush, or split it. 1) Initial therapy During the first week, administer this medication (extended-release tablet) 2mg once daily. Starting in the second week of treatment, increase the dose to 4mg once daily. A treatment response may occur starting at 4mg/day. 2) Maintenance therapy When administering this medication (extended-release tablet), continue treatment at the minimum dose that controls symptoms. If symptoms are inadequately controlled or not maintained with 4mg once daily, increase the dose in 2mg increments each week (or over a longer period) until the daily dose reaches 8mg. If symptoms are inadequately controlled or 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 medication is 24mg. If treatment is interrupted for 1 day or longer, restarting treatment at the initial therapy dose should be considered. When ropinirole is administered concomitantly with levodopa, the levodopa dose may be reduced gradually according to the clinical response. In clinical trials, the levodopa dose was gradually reduced by up to approximately 30% in patients receiving this medication (extended-release tablet) concomitantly with levodopa. In patients with advanced Parkinson’s disease receiving concomitant levodopa, dyskinesia may occur early in treatment with this medication (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 immediate-release ropinirole to this medication (extended-release tablet) Immediate-release ropinirole may be replaced with this medication (extended-release tablet) overnight. The dose of this medication should be selected according to the following dosage table, based on the patient’s total daily dose of immediate-release ropinirole. Total daily dose of immediate-release ropinirole (mg) → Total daily dose of extended-release ropinirole (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 to this medication (extended-release tablet), adjust the dose according to the treatment response. 2. Use in elderly patients Ropinirole clearance is reduced in patients aged 65 years or older; therefore, increase the dose 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 because ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min).

This medication should be used cautiously in patients with severe cardiovascular diseases. Caution is advised when taken with antihypertensive medications or antiarrhythmic drugs, as it may cause heart problems such as hypotension or bradycardia. Patients with significant mental disorders should use this medication only when the benefits of treatment are deemed greater than the risks. During the use of this medication, sudden excessive drowsiness or falling asleep unexpectedly during the day may occur, so patients should avoid dangerous activities such as driving or operating machinery. Patients who have experienced hypersensitivity reactions to this drug, or those with severe renal or hepatic dysfunction, pregnant or breastfeeding women, as well as those with lactose intolerance or specific genetic metabolic disorders, should not take this medication. Patients with severe cardiovascular disease should take this medication cautiously while frequently checking their blood pressure, and patients allergic to the pigments included in the medication should also be careful. Side effects such as drowsiness, dizziness, hallucinations, orthostatic hypotension, constipation, nausea, swelling, etc., may occur; therefore, consultation with a doctor is required if any unusual symptoms appear. Mental changes or impulse control disorders may occur, so both patients and caregivers should closely monitor for these symptoms. If sudden sleepiness or sleep occurs while taking this medication, immediate consultation with a doctor and avoidance of risky activities is necessary. Sudden discontinuation of this medication may result in serious side effects, so the dosage should be gradually reduced according to a doctor's instructions. There may be drug interactions, so healthcare providers must be notified when starting new medications. Pregnant or breastfeeding women should not take this drug, and it is not recommended for children or adolescents under 18 years of age. In case of overdose, heart problems or other symptoms may arise, and immediate medical attention is required. This medication should be stored out of reach of children and not transferred to other containers for safety.

Hallucination, drowsiness, extrapyramidal symptoms, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusion, hallucination, psychiatric reactions including paranoia, impaired impulse control, hypersexuality, pathological gambling, compulsive spending, binge eating, aggression, syncope, excessive daytime sleepiness, vomiting, chest pain, abdominal pain, liver reactions, increased liver enzymes, lower limb edema

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

Appearance

Pink, convex-shaped, film-coated controlled release tablet

Package unit

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