BETMIGA ® PROLONGED-RELEASE TABLETS 25MG
4.1 Therapeutic indications
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
4.3 Contraindications
Mirabegron is contraindicated in patients with
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
- Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
4.2 Posology and method of administration
Posology
Adults (including elderly patients)
The recommended starting dose of Betmiga is 25 mg once daily. Based on individual patient efficacy and tolerability the dose may be increased to 50mg once daily.
Betmiga can be taken with or without food.
Special populations
Renal and hepatic impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2 as estimated by MDRD). In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), the recommended dose is 25 mg dose once daily with or without food. Betmiga has not been studied in patients with End Stage Renal Disease (eGFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). In patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dose is 25 mg once daily with or without food. Betmiga has not be studied in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Gender
No dose adjustment is necessary according to gender.
Paediatric population
The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.
Method of administration
The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.
