Newmiga Extended-release Tablet 50 mg (Mirabegron)

Adult dose

In adults (including elderly patients), the recommended dose is 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. Recommended daily doses for patients with renal and hepatic impairment: Renal impairment(1), mild: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Renal impairment(1), moderate: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Renal impairment(1), severe: without a strong CYP3A inhibitor 25 mg, with an inhibitor not recommended Hepatic impairment(2), mild: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Hepatic impairment(2), moderate: without a strong CYP3A inhibitor 25 mg, with an 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) See “5) Drug Interactions” for strong CYP3A inhibitors.

This medication should not be administered to certain patients. Patients who are allergic to the active ingredient or other components of this medication should not take it. Taking this medication can be risky for patients with severe hypertension or uncontrolled hypertension. Also, patients with serious heart disease should be cautious as symptoms may worsen with this medication. This medication must be used cautiously in some patients. Patients who have a congenital or acquired abnormality of the cardiac electrical signal that prolongs the QT interval should take this medication with care. This medication is not recommended for patients with end-stage renal disease or severe liver dysfunction. Additionally, patients with severe renal or liver impairment who are taking certain enzyme inhibitors need to be cautious with this medication. Patients with bladder outlet obstruction and those taking specific medications for overactive bladder should also be careful when taking this medication. This medication contains certain pigments, so it should be administered cautiously to patients who are allergic to such components. Side effects that may appear when taking this medication include rapid heartbeat and urinary tract infections. Most side effects are mild or moderate, while some patients have reported serious side effects such as atrial fibrillation. Dry mouth may also occur frequently, but it is relatively less compared to other medications. This medication may slightly increase heart rate and blood pressure, so patients with hypertension should regularly monitor their blood pressure. Changes in heart rate and blood pressure may recover upon discontinuation of the medication. Pregnant women or women who may become pregnant are advised to avoid taking this medication, and breastfeeding women are also advised not to use it. The safety and efficacy in children under 19 years of age have not yet been confirmed. In case of overdose, the heart rate may increase, necessitating monitoring of blood pressure and electrocardiogram, and appropriate treatment based on symptoms should be carried out. This medication should be kept out of reach of children, and it is important to avoid transferring it to another container to maintain quality. This medication may interact with other medications, so especially if you are taking certain enzyme inhibitors or other heart-related medications, consult your doctor or pharmacist. It is known to have little effect on driving or operating machinery.

Tachycardia, urinary tract infection, atrial fibrillation, elevated blood pressure, palpitations, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukocytoclastic vasculitis, purpura, joint swelling, vulvar itching, cystitis, increased γ-GTP, increased SGOT, increased SGPT, dry mouth, urinary retention, nausea, constipation, diarrhea, angioedema, insomnia, confusion, 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, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fractures, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, frequent urination, decreased urine flow, chest pain, facial swelling, bladder discomfort, abnormal urination, back pain, weakness, changes in temperature sensation, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastroenteritis, chapped lips, periodontal destruction, thirst, dry eye, unspecified disorder of lipid metabolism, 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, muscle spasms, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, decreased appetite, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance

Yellow, oval-shaped film-coated extended-release tablet

Package unit

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