Betamix Prolonged Release 50mg (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. 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”). Renal impairment(1), mild: no inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1), moderate: no inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1), severe: no inhibitor 25 mg, with inhibitor not recommended Hepatic impairment(2), mild: no inhibitor 50 mg, with inhibitor 25 mg Hepatic impairment(2), moderate: 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 who are allergic to the active ingredient or other components. Patients with severely elevated or uncontrolled blood pressure and those with serious heart conditions may worsen their symptoms by taking this medication and should avoid it. Patients with a history of prolonged QT interval or those taking medications that prolong the QT interval should exercise caution when using this medication. The use of this medication is not recommended in patients with end-stage kidney disease or severe liver dysfunction. Patients with severe renal impairment or moderate liver dysfunction taking strong CYP3A4 inhibitors should also avoid using this medication. Patients with bladder outlet obstruction or those currently taking antimuscarinic agents for overactive bladder should be cautious when using this medication. This medication should also be administered with caution in patients who are allergic to certain coloring agents. Common side effects may include tachycardia, urinary tract infections, dry mouth, and increased blood pressure, while rare adverse effects such as atrial fibrillation have also been reported. It is important to regularly monitor blood pressure and heart rate to check for any irregularities. Women who are pregnant or may become pregnant should avoid taking this medication, and nursing mothers should also refrain from using it. The safety and effectiveness of this medication in children and adolescents under the age of 19 have not yet been confirmed. In cases of overdose, increased heart rate and elevated blood pressure may occur; immediate medical assistance should be sought. This medication should be stored out of reach of children and should not be transferred to another container for safety. While the impact on driving or operating machinery is minimal, individual responses may vary, so caution is advised. This medication may interact with other drugs; therefore, especially when taking medications related to CYP3A4 or CYP2D6, consultation with a physician or pharmacist is necessary.

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

This medication should be stored in a sealed container that protects it from air and moisture. Additionally, it is best to store the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold places. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow oval film-coated prolonged-release tablet

Package unit

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