What is Betmiga - Mirabegron?
Betmiga is a medicine that contains the active substance mirabegron. It is available as prolonged-release tablets (25 mg, 50 mg). The term "prolonged release" means that mirabegron is released from the tablet slowly over a few hours.
What is Betmiga - Mirabegron used for?
Betmiga is used in adults with overactive bladder syndrome. It is indicated in the treatment of some symptoms of this condition: urination urgency (sudden and urgent urination to urinate), increase in voiding frequency (need to urinate frequently) and urgency incontinence (involuntary loss of urine from the bladder following imperious urination).
The medicine can only be obtained with a prescription.
How is Betmiga - Mirabegron used?
The recommended dose of Betmiga is 50 mg once a day. In patients with impaired renal or hepatic function, the doctor may prescribe a lower dose or avoid the use of Betmiga, especially if patients take other medicines.
For more detailed information, see the package leaflet (also included with the EPAR).
How does Betmiga - Mirabegron work?
The active substance in Betmiga, mirabegron, is an beta-3 adrenergic receptor agonist. It works by binding and activating beta-3 receptors in the bladder muscle cells. Experimental studies have shown that, once activated, beta-3 receptors cause a relaxation of the bladder muscles. It is believed that this causes an increase in the capacity of the bladder and induces a change in the way it contracted, with a consequent reduction in bladder contractions and, consequently, a more limited number of undesired urination.
What studies have been carried out on Betmiga - Mirabegron?
The effects of Betmiga were first tested in experimental models before being studied in humans.
Betmiga has been studied in three main studies involving 4, 611 patients with overactive bladder syndrome. Patients were treated with Betmiga (25 mg, 50 mg or 100 mg) or placebo (an ineffective substance on the body) every day for 3 months. The main measure of effectiveness was the change in the frequency of urination and the daily incontinence episodes after 3 months of treatment.
What benefit has Betmiga - Mirabegron shown during the studies?
Treatment with Betmiga 50 mg once a day has been shown to be effective in reducing the frequency of urination and incontinence episodes. After 3 months of treatment, Betmiga 50 mg reduced the number of daily micturitions by 1.8, while the placebo induced a reduction of 1.2 per day.
Betmiga 50 mg contributed to a reduction of 1.5 incontinence episodes per day compared to placebo, which favored a 1.1 reduction in such events.
What is the risk associated with Betmiga - Mirabegron?
The most common side effects of Betmiga are tachycardia (acceleration of the heartbeat), observed in just over 1 in 100 patients, and infection of the urinary tract (infection of the structures that carry urine), observed in just under 3 patients out of 100. Serious but infrequent side effects include atrial fibrillation (abnormal heart rhythm). For the full list of all side effects reported with Betmiga, see the package leaflet.
Betmiga should not be used in people who may be hypersensitive (allergic) to mirabegron or any of the other ingredients.
Why has Betmiga - Mirabegron been approved?
The CHMP noted that the beneficial effects seen with Betmiga, although modest, are comparable to the benefits of other medicines authorized for this condition. Regarding safety, side effects are mostly comparable to the effects observed with other medicines used
in the treatment of overactive bladder syndrome. In the product information, the potential risk of hypersensitivity (allergic reactions) and the effects on the heart were adequately considered. The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Betmiga - Mirabegron
On December 20, 2012, the European Commission issued a marketing authorization valid throughout the European Union.
For the full EPAR for Betmiga, see the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Betmiga therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12/2012.
