Ropinirole Hydrochloride Extended-Release Tablets 4 mg

Adult dose

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 disease. When used with antihypertensive or antiarrhythmic medications, there may be a risk of hypotension, bradycardia, or arrhythmias. It should only be used in patients with severe mental disorders when the therapeutic effect outweighs the risks. This medication can cause sudden drowsiness or sleep, so caution is advised when engaging in hazardous activities such as driving or operating machinery. Patients with hypersensitivity to this drug, impaired kidney or liver function, pregnant or nursing women, and patients with specific genetic lactose intolerance should not take this medication. Severe cardiovascular patients should frequently monitor their blood pressure due to the risk of hypotension. This medication contains a dye that can cause allergies, so sensitive individuals should be cautious. Various side effects, including hallucinations, drowsiness, dizziness, hypotension, nausea, constipation, peripheral edema, confusion, delusions, paranoia, impulse control disorders, hypersexuality, compulsive buying, binge eating, aggression, syncope, chest pain, abdominal pain, increased liver enzymes, limb edema, and withdrawal syndrome may occur while taking this medication. In particular, Parkinson's disease patients may experience movement disorders during the initial dosage adjustment period, so they should follow their physician's instructions. Symptoms such as mental confusion, delusions, and impulse control disorders may appear, so regular monitoring of their condition is necessary. If this medication is abruptly discontinued, symptoms such as insomnia, depression, and fatigue may arise, so it should be tapered off gradually. Do not combine this medication with other dopamine agonists, and dosage adjustments may be necessary when used with certain antibiotics or medications. Dosage adjustments may also be required if smoking is initiated or discontinued. Pregnant or nursing women should not take this medication, and its safety has not been established for children or adolescents under 18 years old. In case of overdose, appropriate treatment and cardiovascular monitoring are necessary.

• Hallucinations
• drowsiness
• extrapyramidal symptoms
• dizziness
• sudden sleep
• orthostatic hypotension
• hypotension
• nausea
• constipation
• peripheral edema

This medication should be stored in a tightly sealed container, as it may be sensitive to air and moisture. Additionally, it is important to store it in a cool place at temperatures below 25 degrees Celsius to maintain its efficacy.

Appearance

The film-coated, prolonged-release tablet is bright brown, convex on both sides, and rectangular in shape.

Package unit

28 tablets (14 tablets/PTP x 2)