Mirabegron Extended-Release Tablets 50 mg (Mirabegron)

Adult dose

Adults (including elderly patients): The recommended dose is 50mg orally once daily. This medicine may be taken with or without food. Swallow it with water; do not chew or crush it. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without strong CYP3A inhibitors (see “Precautions for Use, 5) Drug Interactions”). Category / Severity / Strong CYP3A inhibitor(3) absent / Strong CYP3A inhibitor(3) present 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 by patients who are allergic to the active ingredient or any other ingredients of this product. It should not be administered to patients with severe hypertension that is not controlled and patients with significant heart disease as it may worsen their symptoms. Use with caution in patients with a history of QT interval prolongation or those taking drugs that may prolong the QT interval. It is not recommended for patients with end-stage renal disease or severe liver impairment. Additionally, administration is not recommended for patients with severe renal impairment taking strong CYP3A4 inhibitors and those with moderate liver impairment. Patients with bladder outlet obstruction or those taking antimuscarinic agents should be cautious when using this medication. This product contains certain yellow pigments, so patients with hypersensitivity or a history of allergy to these components should use caution. Common side effects may include tachycardia and urinary tract infections, while rare cases of adverse cardiac events such as atrial fibrillation have been reported. Dry mouth may occur with this medication; however, it is less frequent compared to other antimuscarinic agents. In case of overdose, symptoms such as increased heart rate and elevated blood pressure may occur, thus immediate consultation with a healthcare professional is necessary if these symptoms arise. This medication can raise blood pressure, so patients with hypertension should monitor and manage their blood pressure regularly. In patients with bladder outlet obstruction or those taking antimuscarinic agents, urinary retention may occur, necessitating caution. This medication is known not to significantly affect driving or machine operation, but individual responses may vary, hence caution is warranted. This product may interact with other medications, so inform your healthcare provider if you are taking any other medications. It is advisable for women who are pregnant or may become pregnant to avoid this medication, and nursing mothers should also refrain from using it. Safety and efficacy in children under 19 years have not been established, hence its use is not recommended. This medication should be stored out of reach of children, and transferring it to another container should be avoided.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• palpitations
• increased blood pressure
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This medication should be stored in a tightly closed container to protect it from air and moisture and kept at room temperature between 1 to 30 degrees Celsius. Proper storage ensures that the medication retains its effectiveness and prevents degradation.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

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