BETMIGA Prolonged-release tablet Ref.[7511] Active ingredients: Mirabegron

Posology

Overactive bladder

Adults (including elderly patients)

The recommended dose is 50 mg once daily.

Neurogenic detrusor overactivity in the paediatric population

Paediatric patients 3 to less than 18 years of age with NDO may be administered Betmiga prolonged-release tablets or Betmiga granules for prolonged-release oral suspension based on the body weight of the patient. The prolonged-release tablets may be administered to patients weighing 35 kg or more; the granules for prolonged-release oral suspension are recommended for patients below 35 kg. Patients administered 6 ml oral suspension dose may be switched to 25 mg tablet dose and patients administered 10 ml oral suspension dose may be switched to 50 mg tablet dose.

The recommended starting dose of Betmiga prolonged-release tablets is 25 mg once daily with food. If needed, the dose may be increased to a maximum dose of 50 mg once daily with food after 4 to 8 weeks. During long-term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated.

Patients should be instructed to take any missed doses, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.

Special populations

Renal and hepatic impairment

Betmiga has not been studied in patients with end stage renal disease (ESRD) (estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m²), patients requiring haemodialysis, or patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in these patient populations (see sections 4.4 and 5.2).

The following table provides the daily dosing recommendations for adult OAB patients with renal or hepatic impairment (see sections 4.4, 4.5 and 5.2).

Table 1. Daily dosing recommendations for adult OAB patients with renal or hepatic impairment:

¹ Mild/Moderate: eGFR 30 to 89 ml/min/1.73 m²; Severe: eGFR 15 to 29 ml/min/1.73 m²; ESRD: eGFR <15 ml/min/1.73 m².
² Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B; Severe: Child-Pugh Class C.
^* In patients with mild to moderate renal impairment or mild hepatic impairment concomitantly
receiving strong CYP3A inhibitors, the recommended dose is no more than 25 mg.
^** Not recommended for use in patients with severe renal impairment or moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors.

The following table provides the daily dosing recommendations for paediatric NDO patients aged 3 to less than 18 years with renal or hepatic impairment weighing 35 kg or more (see sections 4.4 and 5.2).

Table 2. Daily dosing recommendations for paediatric NDO patients aged 3 to less than 18 years with renal or hepatic impairment weighing 35 kg or more:

¹ Mild/Moderate: eGFR 30 to 89 ml/min/1.73 m²; Severe: eGFR 15 to 29 ml/min/1.73 m²; ESRD: eGFR <15 ml/min/1.73 m². No dose adjustment is necessary for patients with mild to moderate renal impairment.
² Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B; Severe: Child-Pugh Class C.
^* In patients with mild to moderate renal impairment or mild hepatic impairment concomitantly receiving strong CYP3A inhibitors, the recommended dose is no more than the starting dose.
^** Not recommended for use in patients with severe renal impairment or moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors.

Gender

No dose adjustment is necessary according to gender.

Paediatric population

Overactive bladder:

The safety and efficacy of mirabegron in children below 18 years of age with OAB have not yet been established. No data are available.

Neurogenic detrusor overactivity:

The safety and efficacy of mirabegron in children below 3 years of age have not yet been established.

Method of administration

Overactive bladder in adults

The tablet is to be taken with liquids, swallowed whole, and is not to be chewed, divided, or crushed. It may be taken with or without food.

Neurogenic detrusor overactivity in the paediatric population

The tablet is to be taken with liquids, swallowed whole, and is not to be chewed, divided, or crushed. It should be taken with food.

Mirabegron has been administered to healthy adult volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy adult volunteers.

Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.

3 years.

This medicinal product does not require any special storage conditions.

Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.