Regulatory pharmaceutical product information detailing composition, indications, dosing, contraindications, warnings, interactions, and safety profile of Miraba-S Tablets for the treatment of overactive bladder.
Name of the medicinal product:
Miraba-S Tablets
Active substances:
Mirabegron (Extended-Release) 25 mg; Solifenacin succinate 5 mg
Pharmaceutical form:
Film coated tablet
Description:
Yellow coloured, round, biconvex, film coated tablet
Therapeutic indications:
Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Posology:
One tablet daily; may increase to two tablets daily after 4 to 8 weeks based on efficacy and tolerability
Dose adjustments:
Maximum once daily in severe renal impairment (CLcr 15–29 mL/min or eGFR 15–29 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh Class B); not recommended in ESRD or severe hepatic impairment
Method of administration:
Swallowed whole with water, with or without food; not chewed, divided, or crushed
Contraindications:
Hypersensitivity to mirabegron, solifenacin succinate, or any excipients
Special warnings and precautions:
Risk of increased blood pressure, urinary retention, angioedema, and interactions with CYP2D6 substrates
Drug interactions:
CYP2D6 substrates (e.g., metoprolol, desipramine, thioridazine, flecainide, propafenone); digoxin; warfarin
Fertility:
No human data available; no treatment-related effects observed in animals
Pregnancy:
No adequate studies in pregnant women
Lactation:
No information on presence in human milk or effects on breastfed child
Effects on ability to drive and use machines:
Mirabegron has negligible influence; solifenacin may cause blurred vision, somnolence, and fatigue
Undesirable effects:
Dry mouth, urinary tract infection, constipation, tachycardia, hypertension, urinary retention, angioedema
Reporting of suspected adverse reactions:
Healthcare professionals advised to report adverse reactions
