Tamiga Sustained-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. Recommended daily doses for patients with renal or hepatic impairment Mild renal impairment(1): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Moderate renal impairment(1): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Severe renal impairment(1): without strong CYP3A inhibitors 25 mg, with inhibitors Not recommended Mild hepatic impairment(2): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Moderate hepatic impairment(2): without strong CYP3A inhibitors 25 mg, with inhibitors 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 with allergies to the active ingredient or other components. Administration should also be avoided in patients with severe uncontrolled hypertension or serious heart disease. Patients with a history of prolonged QT interval or those taking QT prolonging medications should use this drug cautiously. It is not recommended for patients with end-stage renal disease or severe liver impairment. Caution is advised when administering to patients with severe renal impairment or moderate liver impairment who are taking strong CYP3A4 inhibitors. Patients with bladder outlet obstruction and those taking anticholinergics for overactive bladder should also be careful. This medication contains certain colorants; use with caution if allergic to them. It is important to regularly monitor blood pressure and heart rate during treatment with this drug. Some patients may experience side effects such as tachycardia, urinary tract infections, dry mouth, and serious adverse reactions such as atrial fibrillation have also been reported. Use of this drug is not recommended for pregnant women, women of childbearing potential, nursing mothers, or children under 19 years of age. In case of overdose, an increase in heart rate and blood pressure may occur; if overdose is suspected, consult a healthcare professional immediately. Store this medication out of reach of children and take care not to transfer it to another container. Additionally, due to potential interactions with other medications, it is crucial to inform your healthcare provider of any other medications being taken. It has minimal effects on driving or operating machinery, but caution is needed as it may vary by individual.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• palpitations
• 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. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow oval film-coated sustained-release tablets

Package unit

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