What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/12/809/001, EU/1/12/809/002, EU/1/12/809/003, EU/1/12/809/004, EU/1/12/809/005, EU/1/12/809/006, EU/1/12/809/007, EU/1/12/809/008, EU/1/12/809/009, EU/1/12/809/010, EU/1/12/809/011, EU/1/12/809/012, EU/1/12/809/013, EU/1/12/809/014, EU/1/12/809/015, EU/1/12/809/016, EU/1/12/809/017, EU/1/12/809/018.

Betmiga 25mg & 50mg prolonged-release tablets

Package leaflet: Information for the patient

Betmiga 25 mg prolonged-release tablets

Betmiga 50 mg prolonged-release tablets

mirabegron

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

1. What Betmiga is and what it is used for

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)

2. What you need to know before you take Betmiga

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.

3. How to take Betmiga

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 50 mg tablet by mouth once daily. If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 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.

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects may include irregular heart beat (atrial fibrillation). This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately stop taking the medicine and seek urgent medical advice.

If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor. These may be signs of severely elevated blood pressure.

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

  • Increased heart rate (tachycardia)
  • Infection of the structures that carry urine (urinary tract infections)
  • Nausea
  • Constipation
  • Headache
  • Diarrhoea
  • Dizziness

Uncommon side effects (may affect up to 1 in 100 people)

  • Bladder infection (cystitis)
  • Feeling your heartbeat (palpitations)
  • Vaginal infection
  • Indigestion (dyspepsia)
  • Infection of the stomach (gastritis)
  • Swelling of the joints
  • Itching of the vulva or vagina (vulvovaginal pruritus)
  • Increased blood pressure
  • Increase in liver enzymes (GGT, AST and ALT)
  • Itching, rash or hives (urticaria, rash, rash macular, rash papular, pruritus)

Rare side effects (may affect up to 1 in 1,000 people)

  • Swelling of the eyelid (eyelid oedema)
  • Swelling of the lip (lip oedema)
  • Swelling of the deeper layers of the skin caused by a build-up of fluid, which can affect any part of the body including the face, tongue or throat and may cause difficulty in breathing (angioedema)
  • Small purple spots on the skin (purpura)
  • Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis)
  • Inability to completely empty the bladder (urinary retention)

Very rare side effects (may affect up to 1 in 10,000 people)

  • Hypertensive crisis

Not known side effects (frequency cannot be estimated from the available data)

  • Insomnia
  • Confusion

Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

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.

5. How to store Betmiga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP. The expiry date refers to the last day of that month.

After first opening of the bottle, the tablets can be stored for 6 months.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

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.

Marketing Authorisation Holder and Manufacturer

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Astellas Pharma Ltd.
Tel: +44 (0) 203 379 8700

This leaflet was last revised in 04/2019

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.