Betmiga 50 mg prolonged-release tablets

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Betmiga is and what it is used for
2. What you need to know before you take Betmiga
3. How to take Betmiga
4. Possible side effects
5. How to store Betmiga
6. Contents of the pack and other information

Do not take Betmiga:

• if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6)
• if you have very high uncontrolled blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking Betmiga:

• if you have trouble emptying your bladder or you have a weak urine stream or if you take other medicines for the treatment of overactive bladder such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce your dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Tell your doctor about the medicines that you take.
• if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this such as
  • medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
  • medicines used for allergic rhinitis;
  • antipsychotic medicines (medicines for mental illness) such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
  • anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking Mirabegron

Children and adolescents

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.

Other medicines and Betmiga

Tell your doctor or pharmacist if you are taking, have recently used or might use any other medicines.

Betmiga may affect the way other medicines work, and other medicines may affect how this medicine works.

• Tell your doctor if you use thioridazine (a medicine for mental illness), propafenone or flecainide (medicines for abnormal heart rhythm), imipramine or desipramine (medicines used for depression). These specific medicines may require dose adjustment by your doctor.
• Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm). Blood levels of this medicine are measured by your doctor. If the blood level is out of range, your doctor may adjust the dose of digoxin.
• Tell your doctor if you use dabigatran etexilate (a medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot formation in adult patients with an abnormal heart beat (atrial fibrillation) and additional risk factors). This medicine may require dose adjustment by your doctor.

Pregnancy and breast-feeding

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

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

Driving and using machines

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

If you take more Betmiga than you should

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately.

Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an increased blood pressure.

If you forget to take Betmiga

If you forget to take your medicine, take the missed dose as soon as you remember. If it is less than 6 hours before your next scheduled dose, skip the dose and continue to take your medicine at the usual time.

Do not take a double dose to make up for a forgotten dose. If you miss several doses, tell your doctor and follow the advice given to you.

If you stop taking Betmiga

Do not stop treatment with Betmiga early if you do not see an immediate effect. Your bladder might need some time to adapt. You should continue taking your tablets. Do not stop taking them when your bladder condition improves. Stopping treatment may result in recurrence of symptoms of overactive bladder.

Do not stop taking Betmiga without talking to your doctor first, as your overactive bladder symptoms may come back.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Betmiga contains

• The active substance is mirabegron.
  Betmiga 25 mg prolonged-release tablets
  Each tablet contains 25 mg of mirabegron.
  Betmiga 50 mg prolonged-release tablets
  Each tablet contains 50 mg of mirabegron.
• The other ingredients are:
  Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate
  Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).

What Betmiga looks like and contents of the pack

Betmiga 25 mg prolonged release film-coated tablets are oval, brown film-coated tablets, debossed with the company logo and “325” on the same side.

Betmiga 50 mg prolonged release film-coated tablets are oval, yellow film-coated tablets, debossed with the company logo and “355” on the same side.

Betmiga is available in aluminium-aluminium blister in packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets and in high density polyethylene (HDPE) bottles with silica gel desiccant and child-resistant closures containing 90 tablets.

Not all pack sizes may be available in your country. The bottle may not be available in your country.

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