Therapeutic indications: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.¹

Pharmacotherapeutic group: Urologicals, urinary antispasmodics (G04BD12).

Therapeutic indications: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.

^*Posology and administration: For adults with OAB (≥ 18 years and elderly): 50 mg once daily, with or without food. For paediatric patients 3 to less than 18 years of age with NDO: Only for administration to patients weighing 35 kg or more. Starting dose is 25 mg once daily with food. The dose may be increased to a maximum dose of 50 mg once daily with food after 4 to 8 weeks if needed. For patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m²) or with moderate hepatic impairment (Child-Pugh Class B), a maximum dose of 25 mg is recommended.
To be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed.

Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients.
Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg

^*Special warnings and precautions for use: Renal and hepatic impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m²), patients requiring haemodialysis or patients with severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations. Betmiga is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m²) or patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors. Hypertension: Can increase blood pressure in both adults and paediatric patients. Blood pressure increases may be larger in children (3 to less than 12 years of age) than in adolescents (12 to less than 18 years of age). Blood pressure should be measured at baseline and periodically during treatment, especially in hypertensive patients. Administer with caution to patients with congenital or acquired QT prolongation, patients with clinically significant bladder outlet obstruction and patients on antimuscarinic treatment of OAB. Pregnancy, lactation and fertility: Is not recommended in women of childbearing potential not using contraception, nor during pregnancy or breast feeding. The effect of mirabegron on human fertility has not been established.

^*Undesirable effects: The most common (< 10 %) adverse drug reactions (ADRs) are tachycardia, urinary tract infection, headache, dizziness, nausea, constipation and diarrhoea. Insomnia and confusional state have been reported at an unknown frequency. Overall, the safety profile in children and adolescents is similar to that observed in adults. In the paediatric patients with NDO, no severe adverse reactions have been reported. The most commonly reported adverse reactions observed in the paediatric population are urinary tract infection, constipation, and nausea.

Marketing authorisation holder: Astellas Pharma Europe B.V., The Netherlands.

Country specific information

Sweden: Status of the product: Rx. Reimbursement: Only reimbursed for patients that have tried but cannot tolerate antimuscarinic pharmaceuticals. Local representative: Astellas Pharma AB, Tel: +46 (0)40 650 15 00. For more information, pack size and price see www.fass.se.

^*The section has been rewritten and/or abbreviated compared to the authorised SmPC.