Nutamiga Extended-Release Tablets 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”). Mild renal impairment(1): 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Moderate renal impairment(1): 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Severe renal impairment(1): 25 mg without a strong CYP3A inhibitor; with a strong CYP3A inhibitor, not recommended Mild hepatic impairment(2): 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Moderate hepatic impairment(2): 25 mg without a strong CYP3A inhibitor; with a strong CYP3A 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 medicine should not be used in certain patients. Persons who are allergic to the active ingredient or other components of this medication should not take it. Additionally, patients with uncontrolled severe hypertension or severe heart disease should not be administered this medication. This medication should be used cautiously in some patients. Particularly, attention is required for patients with congenital or acquired abnormalities in cardiac electrical signals. It is not recommended for patients with end-stage renal disease or severe hepatic impairment. Furthermore, patients with renal or liver dysfunction taking certain enzyme inhibitors should avoid this medication. Patients with obstructed bladder outlets or those currently taking other medications for overactive bladder should also exercise caution. This medication contains specific dyes, so patients who are allergic to them should take it with caution. When taking this medication, various side effects may occur. The most common side effects include tachycardia and urinary tract infections. Rarely, cardiac side effects such as atrial fibrillation have been reported. Dry mouth, headache, dyspepsia, and skin rashes may also occur. If abnormal symptoms appear, immediate consultation with a physician is necessary. This medication can affect heart rate and blood pressure, so patients with hypertension should regularly monitor their blood pressure. Additionally, patients with a history of QT interval prolongation or those taking medications that prolong the QT interval should be particularly cautious. It is known to have little effect on driving or operating machinery. This medication can interact with other drugs, so it is important to inform your doctor or pharmacist if you are currently taking any medications. Especially when taken with drugs that inhibit or induce specific enzymes, dosage adjustments may be necessary. When taken in combination with certain drugs like digoxin, monitoring blood concentration is required. Women who are pregnant or may become pregnant should avoid taking this medication. Breastfeeding women should also refrain from using this medication. Safety and efficacy in children under 19 years of age have not been established. In the event of overdose, tachycardia and elevated blood pressure may occur, so appropriate treatment at a hospital should be sought immediately. This medication should be kept out of the reach of children, and it is advisable not to transfer it to another container to maintain quality.

tachycardia, urinary tract infection, atrial fibrillation, palpitations, increased blood pressure, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, pruritus, leukocytoclastic vasculitis, purpura, joint swelling, vulvar pruritus, cystitis, increased γ-GTP, increased SGOT, increased SGPT, dry mouth, urinary retention, nausea, constipation, diarrhea, angioedema, insomnia, delirium, dizziness, headache, pyuria, bladder stones, kidney stones, ureteral stricture, hematuria, malignant neoplasm of male genital organs, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, exacerbation of diabetes mellitus, cataracts, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, frequent urination, decreased urine flow, chest pain, facial edema, bladder discomfort, abnormal urination, back pain, asthenia, changes in temperature sensation, generalized edema, abdominal pain, colitis, stomatitis, gastroesophageal reflux, gastroenteritis, dry lips, periodontal destruction, thirst, dry eyes, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, loss of ejaculation function, inguinal hernia, prostatic hyperplasia, visual disturbances, upper respiratory tract infection, pharyngitis, dyspnea, skeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, appetite loss, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly sealed container to avoid effects from air or moisture. It is recommended to maintain a storage temperature between 1°C and 30°C, as this helps preserve the effectiveness and safety 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, bottle - 100 tablets/bottle