Rikirolpidi Tablet 4 mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The appropriate dose should be determined individually, taking efficacy and tolerability into consideration. 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 treatment response may occur starting at 4mg daily. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptoms are not adequately controlled or control is not maintained with 4mg once daily, gradually increase the dose by 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptoms are not adequately controlled or control is not maintained with 8mg once daily, gradually increase the daily dose 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 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. Dyskinesia may occur early in treatment with this medicine (extended-release tablet) when administered with levodopa in patients with advanced Parkinson's disease. 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 instructions 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 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 based on the patient's total daily dose of immediate-release ropinirole tablets, according to the following dosage table. 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 treatment response. 2. Administration to elderly patients Since ropinirole clearance is decreased in patients aged 65 years and older, the dose should be increased 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 in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min), as ropinirole clearance is unchanged.

This medication should be used with caution in patients with severe cardiovascular diseases. Particularly, when used with blood pressure-lowering agents or antiarrhythmic drugs, there is a risk of heart problems such as hypotension or bradycardia. It should only be used in patients with significant mental illness when the benefits outweigh the risks. Patients may unexpectedly fall asleep or become very drowsy while taking this medication, and dangerous activities such as driving or operating machinery should be avoided. It should not be used by patients with hypersensitivity to this medication, severe renal or liver dysfunction, pregnant or breastfeeding women, or patients with certain genetic lactose metabolism disorders. Patients with severe cardiovascular diseases should frequently monitor their blood pressure due to the increased risk of hypotension. This medication contains certain dyes and should be used with caution in case of allergic reactions. Side effects such as drowsiness, dizziness, hallucinations, orthostatic hypotension, dyspepsia, peripheral edema, confusion, delusions, illusions, paranoid reactions, impulse control disorders, hypersexuality, compulsive consumption, binge eating, aggression, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, increased liver enzymes, and lower limb edema may occur, so consult a doctor if symptoms are severe. Patients and caregivers should closely monitor for signs of mental confusion or symptoms such as impulse control disorders and obsessive behaviors. This medication has been reported to cause sudden sleep attacks, so if extreme drowsiness occurs during the day, use should be discontinued, and dangerous activities should be avoided. This medication is not used to treat certain symptoms caused by muscle relaxants. The drug is released slowly over 24 hours; thus, if gastrointestinal transit is rapid, some medications may be excreted in feces. Dosage should be gradually reduced when discontinuing treatment, as sudden cessation may cause serious side effects. It is best to avoid using this medication with other dopamine agonists, as there may be interactions with certain antibiotics, smoking, and hormone therapy, so inform your doctor. This medication should not be used during pregnancy or breastfeeding, and safety has not been established for children or adolescents under 18 years of age. In case of overdose, symptoms related to dopamine may appear, requiring appropriate treatment and cardiac status monitoring. This medication should be kept out of reach of children and should not be transferred to other containers.

Hallucination, 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, syncope, excessive daytime drowsiness, vomiting, chest pain, abdominal pain, liver reactions, primarily increased liver enzymes, lower limb edema

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Light brown, film-coated, oblong tablet with both sides convex

Package unit

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