Hyberol Extended-release Tablet 50 mg (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”). Category: renal impairment(1), severity: mild, strong CYP3A inhibitor(3), no inhibitor: 50 mg, with inhibitor: 25 mg Category: renal impairment(1), severity: moderate, strong CYP3A inhibitor(3), no inhibitor: 50 mg, with inhibitor: 25 mg Category: renal impairment(1), severity: severe, strong CYP3A inhibitor(3), no inhibitor: 25 mg, with inhibitor: not recommended Category: hepatic impairment(2), severity: mild, strong CYP3A inhibitor(3), no inhibitor: 50 mg, with inhibitor: 25 mg Category: hepatic impairment(2), severity: moderate, strong CYP3A inhibitor(3), 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 by patients who are allergic to the active ingredient or any other components. Patients with very high, uncontrolled blood pressure or serious heart disease may see their condition worsen with this medication, so it should be avoided. Patients with diseases that prolong the QT interval or those taking medications that can prolong the QT interval should take special care when using this medication. It is not recommended for use in patients with end-stage renal disease or severe liver impairment. Patients with severe renal impairment or moderate liver impairment who are taking strong CYP3A4 enzyme inhibitors should also avoid this medication. Patients with bladder outlet obstruction or those taking antimuscarinic agents for the treatment of overactive bladder should exercise caution when using this medication. This medication contains Yellow No. 4 and Yellow No. 5 colors, so patients allergic to these substances should use it with caution. Taking this medication may increase heart rate or blood pressure, so hypertension patients should regularly monitor their blood pressure and heart rate. Side effects such as urinary tract infections or tachycardia may occur, and in some cases, serious adverse reactions like atrial fibrillation may manifest. Pregnant women or women who may become pregnant are advised not to take this medication. Breastfeeding women should also avoid taking this medication. Children under 19 have not established the safety and efficacy of this medication, so it is not used in this age group. In case of overdose, heart rate and blood pressure may significantly increase, and immediate medical treatment should be sought. This medication should be kept out of reach of children and should not be transferred to other containers.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, hypertension, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukopenic vasculitis, purpura, joint swelling, vulvar pruritus, 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, urinary obstruction, hematuria, malignant neoplasm of the male reproductive system, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, diabetes exacerbation, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, increased frequency of urination, decreased urine flow, chest pain, facial swelling, bladder discomfort, abnormal urination, nocturia, back pain, asthenia, altered temperature sensation, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastroenteritis, lip dryness, periodontal destruction, thirst, dry eye, 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, musculoskeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, loss of appetite, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain its effectiveness and safety.

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