Genupharm Mirabegron Sustained-Release Tablets 50 mg

Adult dose

Adults (including elderly patients) should receive the recommended dose of 50 mg orally once daily. This medicine may be taken with or without food. It should be swallowed with water and must not be chewed or crushed. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without a strong CYP3A inhibitor (see “Precautions for Use 5) Drug Interactions”). Category | Severity | No inhibitor | With inhibitor Renal impairment(1) | Mild | 50 mg | 25 mg Renal impairment(1) | Moderate | 50 mg | 25 mg Renal impairment(1) | Severe | 25 mg | Not recommended Hepatic impairment(2) | Mild | 50 mg | 25 mg Hepatic impairment(2) | Moderate | 25 mg | Not recommended (1) Mild: GFR 60~89 mL/min/1.73m2; moderate: GFR 30~59 mL/min/1.73m2; severe: GFR 15~29 mL/min/1.73m2. (2) Mild: Child-Pugh Class A; moderate: Child-Pugh Class B. (3) For strong CYP3A inhibitors, see “5) Drug Interactions”

This medication should not be used in patients who are allergic to the active ingredient or other components. Patients with very high blood pressure or serious heart diseases may also experience worsening symptoms if they take this medication, so it should be avoided. Patients with a history of prolonged QT interval or those taking medications that prolong the QT interval should exercise caution when using this medication. It is not recommended for patients with end-stage renal disease or severe liver impairment. Particularly, it is advisable not to administer this medication to patients with severe renal or liver impairment who are taking strong CYP3A4 inhibitors. Patients with bladder outlet obstruction or those already taking specific medications for overactive bladder should use this medication with caution. This medication contains specific pigments, and patients allergic to these components should be careful. Taking this medication may lead to side effects like increased heart rate or urinary tract infections, and, rarely, cardiac abnormalities such as atrial fibrillation have been reported. Dry mouth may occur, but it is generally less pronounced compared to other medications. In case of overdose, increased heart rate or elevated blood pressure may occur, so caution is necessary, and immediate consultation with medical personnel is advised if symptoms occur. Use of this medication is not recommended in pregnant women, women who might become pregnant, nursing mothers, and children under 19 years of age. This medication can raise blood pressure, so hypertensive patients should check their blood pressure regularly, and it does not significantly affect driving or operating machinery. This medication can interact with other drugs, so consultation with a specialist is necessary, especially when taking CYP3A4 inhibitors or drugs that affect CYP2D6 metabolism. Store out of reach of children, and to maintain quality, care should be taken not to transfer it to another container.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• palpitations
• hypertension
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This medication should be stored in a tightly closed container to protect it from air and humidity, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness over time.

Appearance

Yellow oval film-coated sustained-release tablet

Package unit

PTP - 90 tablets/box [10 tablets/PTP X 9], bottle - 30 tablets/bottle, bottle - 100 tablets/bottle