Ropimax Speed Tablets 8mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The recommended dose should be individualized based on efficacy and tolerability. 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 therapeutic response may occur at 4mg per day. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptom control is inadequate or is not maintained with 4mg once daily, increase the dose in increments of 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptom control is inadequate or is 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 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. 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 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 ropinirole immediate-release tablets to this medicine (extended-release tablet) Ropinirole immediate-release 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 ropinirole immediate-release tablets. Total daily dose of ropinirole immediate-release 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 ropinirole immediate-release tablets to this medicine (extended-release tablet), the dose should be adjusted according to the therapeutic response. 2. Administration to elderly patients Because ropinirole clearance is decreased in patients aged 65 years or older, the dose should be increased more gradually according to the clinical response. In very elderly patients, slower dose escalation during the initial period of treatment should be considered. 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 requires special caution in patients with severe cardiovascular diseases. Caution is also advised when taken with other medications that may lower blood pressure or affect heart rhythm, as hypotension or arrhythmias may occur. Patients with significant mental disorders should only use this medication when the therapeutic effect is judged to outweigh the risks. Sudden sleepiness or drowsiness may occur during treatment; therefore, it is advisable to avoid dangerous activities such as driving or operating machinery. Patients with allergic reactions, severely impaired kidney or liver function, pregnant or breastfeeding women, and those with certain genetic lactose intolerance should not take this medication. Patients with cardiovascular diseases should closely monitor blood pressure changes at the beginning of treatment, and caution should be taken if there is an allergy to certain pigments. During treatment, side effects such as hallucinations, drowsiness, dizziness, hypotension, indigestion, swelling, etc., may occur, and if symptoms are severe, patients should consult a physician. Patients with a history of mental health issues should be regularly monitored for impulse control disorders or abnormal behaviors while taking this medication. This medication should be titrated slowly, and abrupt discontinuation may cause severe side effects, so caution is necessary. It is advised to avoid the concomitant use with other dopaminergic medications, and interactions may occur with some antibiotics, smoking, hormone treatments, etc.; therefore, patients must inform their healthcare provider about other medications being taken. Pregnant or breastfeeding women should not take this medication, and it is not recommended for children or adolescents under the age of 18 due to safety concerns. In cases of overdose, cardiac and neurological symptoms may appear, and immediate medical treatment is needed; it should be stored in a safe place out of reach of children.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusions, hallucinations, paranoia including psychotic responses, impulse control disorders, hypersexuality, pathological gambling, compulsive spending, binge eating, aggression, syncope, excessive daytime drowsiness, vomiting, chest pain, abdominal pain, hepatic reactions, primarily increased liver enzymes, lower limb edema

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is advisable to keep the storage temperature between 1 to 30 degrees Celsius. Proper storage helps to maintain the efficacy of the medication over time.

Appearance

Brownish red, bilaterally convex film-coated prolonged-release tablet with 'KDC' embossed on one side and '8' on the other side.

Package unit

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