Betmiga®

Betmiga<sup>®</sup>

Betmiga®

Mirabegron

Betmiga®

Mirabegron 50 mg

Tablets for oral use

 

Product leaflet summary

Therapeutic Indications

Betmiga contains the active substance mirabegron. It is a bladder muscle relaxant (a so-called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.

Betmiga is used to treat the symptoms of an overactive bladder in adults such as:

– Suddenly needing to empty your bladder (called urgency)

– Having to empty your bladder more than usual (called increased urinary frequency)

– Not being able to control when to empty your bladder (called urgency incontinence)

 

Dosage and Administration

The recommended dose is one 50 mg tablet by mouth once daily. You should take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food.

 

Contraindications

Do not use Betmiga 50 mg:

– If you are allergic to mirabegron or any of the other ingredients of this medicine.

– If you have very high uncontrolled blood pressure.

– If you have mild or moderate renal impairment and taking a Strong CYP3A inhibitor.

– If you have severe renal impairment.

– If you have mild hepatic impairment and taking a Strong CYP3A inhibitor.

– If you have moderate hepatic impairment.

 

Pregnancy and Lactation

If you are pregnant, think you may be pregnant or are planning to have a baby you should not use Betmiga.

If you are breast feeding, ask your doctor or pharmacist for advice before using this medicine. It is likely that this medicine passes into your breast milk. You and your doctor should decide if you should use Betmiga or breastfeed. You should not do both.

 

Pediatric Population:

Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Betmiga in this age group has not been established.

 

Ability to Drive and Use Machinery

There is no information to suggest that this medicine affects your ability to drive or use machines.

 

Package Presentation:

Betmiga is available in packs containing 30 film coated tablets.