Requip PD 2 mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The appropriate dose should be determined individually based on efficacy and tolerability. This medicine is 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 During 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 response to treatment may occur at 4mg per day. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the minimum dose that controls symptoms. If symptom control is insufficient or cannot be maintained with 4mg once daily, increase the dose gradually by 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptom control is insufficient or cannot be maintained with 8mg once daily, increase the daily dose gradually 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 longer, restarting treatment should be considered according to the initial therapy dosing schedule. 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 reduced gradually 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 replacement 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. (See section ‘5. General Precautions’ under Precautions for Use.) 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 according to the following dosage table, based on the patient's total daily dose of immediate-release ropinirole tablets. 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 response to treatment. 2. Administration to elderly patients Because ropinirole clearance is reduced in patients aged 65 years or older, 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 Since ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min), dose adjustment is not necessary.

This medication should be used with caution in patients with severe cardiovascular diseases. Caution is necessary when taken in conjunction with antihypertensive or antiarrhythmic medications, as side effects such as hypotension and bradycardia may occur. Patients with severe mental disorders should only use this medication if the therapeutic effect outweighs the risks. Sudden drowsiness or sleep may occur while taking this medication, so patients should avoid driving or operating hazardous machinery if extreme drowsiness occurs. Patients who are hypersensitive to this medication, those with severely impaired renal function, diminished liver function, pregnant or breastfeeding women, and those with lactose intolerance should not take this medication. Patients with severe cardiovascular disease should have their blood pressure monitored frequently during the initial dosing, and caution is warranted if there is an allergy to any colorants included in this medication. Side effects such as hallucinations, drowsiness, dizziness, orthostatic hypotension, nausea, constipation, and peripheral edema may occur during use, and if symptoms are severe, the patient should consult a physician. Especially in patients with Parkinson's disease, movement disorders may occur in the initial dosing phase, and dosage should be adjusted according to a physician's guidance. Patients with a history of mental illness may experience impulse control disorders or manic symptoms while taking this medication, and should regularly monitor their condition. The medication may be less effective when used in conjunction with neuroleptics, so co-administration should be avoided. Concomitant use with certain antibiotics or smoking may alter blood concentration levels of this medication, necessitating dose adjustments. This medication should not be taken during pregnancy as it may harm the fetus, nor during breastfeeding due to its suppression of milk secretion. It is not recommended for children or adolescents under 18 years old as safety and efficacy have not been established. In the case of overdose, side effects related to dopamine activity may occur, requiring immediate notification to healthcare providers and appropriate treatment. Lastly, this medication should be stored out of reach of children and should not be transferred to other containers.

Hallucinations, drowsiness, movement disorders, 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, mania, syncope, excessive daytime drowsiness, vomiting, heartburn, abdominal pain, liver reactions, increased liver enzymes, lower limb edema, drug withdrawal syndrome, insomnia, apathy, anxiety, depression, fatigue, sweating, pain

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is also important to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Pink, double-convex, rectangular, film-coated controlled-release tablet

Package unit

28 tablets (14 tablets/PTP X 2)