Sun Rhythm Capsule 50 mg (Flecainide Hydrochloride Hydrate)

Adult dose

The usual adult dose is 50 milligrams of pilsicainide hydrochloride hydrate orally three times daily. The dose may be adjusted according to age and symptoms, but may be increased to 75 milligrams three times daily only in severe cases or when the effect is insufficient. Patients with renal impairment: Reduce the dose or extend the dosing interval. In particular, because high blood concentrations may persist in patients with renal impairment requiring dialysis, administer cautiously while monitoring the patient's condition, starting, for example, at 25 mg daily. (See section 4, General Precautions, under Precautions for Use)

This medication affects heart function and should not be used in patients with heart failure due to the risk of worsening arrhythmia or further deterioration of heart function. It is also prohibited in patients with advanced atrioventricular block or sinus block, which can worsen their condition. Additionally, this medication contains lactose, so patients with lactose intolerance or genetic lactose metabolism disorders should not take it. It should be administered with caution to patients with a history of basic heart disease or heart failure, conduction disorders, pronounced bradycardia, renal or liver function impairment, elderly patients, and those with low serum potassium levels. This medication may cause various adverse reactions such as arrhythmia, heart rhythm abnormalities, gastrointestinal disorders, headaches, rashes, etc., and serious side effects like ventricular fibrillation or heart failure may occur, requiring regular ECG tests and physical examinations. If there is any deterioration in heart condition or abnormal signals are detected, medication should be stopped immediately, and appropriate treatment should be administered. As this medication is excreted by the kidneys, dosage adjustment is needed in patients with decreased renal function, and caution is required for patients using permanent or temporary cardiac pacemakers. Elderly patients are advised to start with low doses and use it carefully, as they may experience drug side effects more easily due to weakened liver and kidney functions. Pregnant women or women of childbearing potential should use this medication only after thoroughly considering its risks and benefits, and its use during breastfeeding should be avoided. The safety and efficacy of this medication in children have not been sufficiently established, so its use is not recommended. In case of overdose, serious heart problems and psychiatric neurological abnormalities may occur, thus if an overdose is suspected, medication should be stopped immediately, and appropriate treatment should be provided. When taking the medicine, it should be taken out from the packaging, and care should be taken not to swallow the packaging. The use of this medication is generally not recommended in patients with asymptomatic or mild symptoms after myocardial infarction, as it is associated with increased mortality. Caution is needed while driving or operating dangerous machinery, as dizziness and other symptoms may appear.

• Atrioventricular block
• increased QRS duration
• chest discomfort
• abdominal pain
• dry mouth
• QT prolongation
• headache
• rash
• dizziness
• nausea

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. Storage temperature should be maintained at room temperature between 1°C and 30°C.

Appearance

This medicine is a blue and white hard capsule with a white powder inside.

Package unit

100 capsules (10 capsules/PTP X 10)/carton