Ropimak Speed Table 4 mg (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 should be used cautiously in patients with severe cardiovascular diseases. In cases of severe heart-related illnesses, the dopamine action of this medication can burden the heart, so caution is needed. Additionally, caution should be exercised when used in conjunction with other medications that lower blood pressure or affect heart rhythm as hypotension or arrhythmias may occur. In patients with severe mental disorders, careful consideration of the therapeutic effects and risks of this medication should be made. During treatment, sudden drowsiness or sleep episodes may occur, so it is advisable to avoid dangerous activities such as driving or operating machinery. Especially when taken with sedatives that induce drowsiness, these symptoms may worsen. Patients who are allergic to this medication or have severe renal or hepatic function impairment should not take it. Women who are pregnant or breastfeeding, and women who may become pregnant should also avoid using this medication. Patients with certain genetic issues such as lactose intolerance should avoid taking this medication due to its components. In patients with severe cardiovascular disease, frequently checking blood pressure at the beginning of treatment is crucial. This medication contains specific pigments, so patients with a history of allergies should exercise caution. Side effects such as hallucinations, dizziness, orthostatic hypotension, nausea, constipation, peripheral edema, and other symptoms may occur, so patients should consult with healthcare providers if symptoms arise. Particularly, in patients with Parkinson’s disease, abnormal motor symptoms may arise, which may necessitate dosage adjustment. Mental symptoms such as confusion, impulse control disorders, increased libido, and obsessive behaviors have also been reported, so patients should be aware of these changes. Sudden decrease or discontinuation of dosage can cause severe side effects, so adjustments must be made gradually according to the healthcare provider's instructions. It should not be taken with other dopamine agonists, and possible interactions with specific antibiotics or smoking should be reported to healthcare providers. If pregnant or breastfeeding, this medication should not be used as it may harm the fetus or newborn. The safety and efficacy of this medication have not been verified for children or adolescents under 18 years old. In the case of overdose, symptoms related to dopamine action may occur, requiring immediate hospital treatment. This medication should be stored out of reach of children, and it is safe to avoid transferring it to another container.

Hallucinations, drowsiness, movement disorders, dizziness, sudden sleep, orthostatic hypotension, low blood pressure, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusions, illusions, paranoid reactions, impulse control disorders, hypersexuality, pathological gambling, compulsive buying, binge eating, aggression, fainting, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, liver reactions, increased liver enzymes, lower limb edema

This medication should be stored in a sealed container to prevent air or moisture ingress, preferably at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance

A light brown, double convex, rectangular film-coated sustained-release tablet with 'KDC' on one side and '4' embossed on the other side.

Package unit

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