Miracron Extended-Release Tablets 50 mg (Mirabegron)

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. Mild renal impairment(1): no inhibitor 50 mg, with inhibitor 25 mg Moderate renal impairment(1): no inhibitor 50 mg, with inhibitor 25 mg Severe renal impairment(1): no inhibitor 25 mg, with inhibitor not recommended Mild hepatic impairment(2): no inhibitor 50 mg, with inhibitor 25 mg Moderate hepatic impairment(2): no inhibitor 25 mg, with inhibitor 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 allergic to the active ingredient or any other components. Care should be taken when administering this medication to patients with very high blood pressure or serious heart disease, as symptoms may worsen. Patients with a history of prolonged QT interval or those taking medications that can prolong the QT interval should use this medication with caution. This medication is not recommended for patients with end-stage renal disease or severe liver impairment. It is advisable to avoid administering this medication to patients with severe renal impairment or moderate liver impairment when taking strong CYP3A4 inhibitors. Patients with bladder outlet obstruction or those taking antimuscarinics for overactive bladder treatment should use this medication with caution. This medication contains certain dyes, and caution should be exercised if allergic to these dyes. In clinical trials, tachycardia and urinary tract infections were the most commonly reported side effects, and rarely, cardiac adverse reactions such as atrial fibrillation can occur. Dry mouth was commonly reported in Asian patients, but it was not serious and similar in level to the placebo group. During treatment with this medication, blood pressure and pulse rate may increase slightly, so it is important for hypertensive patients to monitor their blood pressure regularly. This medication is not recommended for women who are pregnant or may become pregnant, nursing mothers, or children under 19 years of age as its safety has not been established. In case of overdose, increased heart rate and palpitations may occur, and in such cases, monitoring of blood pressure and electrocardiogram is necessary. Keep this medication out of reach of children and it is best to store it in its original container to maintain quality. This medication may interact with other drugs, so it is important to consult with a healthcare professional or pharmacist, especially if taking CYP3A4 inhibitors or drugs related to CYP2D6. It is known not to have a significant impact on driving or machinery operation.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• palpitation
• elevated blood pressure
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage ensures the safety and effectiveness of the medication.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

PTP - 90 tablets/box [10 tablets/PTP x 9], Bottle - 30 tablets/bottle