Requip PD Tablet 8 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 requires special caution in patients with severe cardiovascular disease. Care should be taken when used in combination with antihypertensive or antiarrhythmic drugs due to the potential for hypotension or arrhythmias. It should only be used in patients with severe mental illness when the treatment benefits outweigh the risks. Patients taking this medication may experience sudden drowsiness or sleep; therefore, activities such as driving or operating machinery should be avoided. Those with an allergic reaction, severe kidney or liver dysfunction, pregnant or breastfeeding women, and patients with certain hereditary lactose intolerance should avoid this medication. Patients with severe heart disease should frequently monitor their blood pressure and use it cautiously, and those allergic to the dye contained in the medication should also exercise caution. Side effects such as drowsiness, hallucinations, dizziness, hypotension, nausea, constipation, edema may occur; if unusual symptoms arise, consult a doctor. Particularly, changes in mental state or impulse control disorders may occur, necessitating regular monitoring and dosage adjustment if symptoms are severe. It should not be used concurrently with other dopamine agonists and caution should be exercised due to potential interactions with certain antibiotics, smoking, and hormone treatments. Pregnant or breastfeeding women should not take this medication, and it is not recommended for children or adolescents under 18 as safety and efficacy have not been established. In case of overdose, serious symptoms may occur, so immediate contact with healthcare professionals is necessary, and this medication should be kept out of reach of children.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, and pruritus), confusion, delusions, illusions, paranoid reactions, impulsivity disorders, hypersexuality, compulsive gambling, compulsive spending, binge eating, aggression, mania, fainting, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, liver reactions, increased liver enzymes, lower extremity edema, drug withdrawal syndrome

This medication should be stored in a tightly sealed container to protect it from air and moisture, preferably at a cool temperature below 25 degrees Celsius. Storing it this way helps maintain the medication's efficacy and safety.

Appearance

A reddish-brown, biconvex, rectangular film-coated extended-release tablet

Package unit

28 tablets (14 tablets/PTP X 2)