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Mirabegron Astellas 50 mg prolonged-release tablets

Active Ingredient:
mirabegron
Company:  
Astellas Pharma Ltd See contact details
ATC code: 
G04BD12
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 24 Jun 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 00166/0416.

{printer} Print patient leaflet as text only

Mirabegron Astellas 25mg & 50mg prolonged-release tablets

Package leaflet: Information for the user

Mirabegron Astellas 25 mg prolonged-release tablets

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

1. What Mirabegron Astellas is and what it is used for

Mirabegron Astellas contains the active substance mirabegron. It is a bladder muscle relaxant (also called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms and reduces neurogenic detrusor overactivity.

Mirabegron is used to:

  • treat the symptoms of a condition called overactive bladder in adults.
    These symptoms include: 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).
  • treat a condition called neurogenic detrusor overactivity in children aged 3 to less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a condition that you are born with or injury to the nerves, which control the bladder. If left untreated, neurogenic detrusor overactivity may lead to damage to your bladder and/or kidneys. Mirabegron is used to increase the amount of urine your bladder can hold and reduce urine leakage.

2. What you need to know before you take Mirabegron Astellas
Do not take Mirabegron Astellas
  • 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 Mirabegron Astellas

  • 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 or neurogenic detrusor overactivity 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 Mirabegron Astellas, 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 this medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age for the treatment of overactive bladder because the safety and efficacy of mirabegron in this population has not been established.

Mirabegron is not to be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.

Other medicines and Mirabegron Astellas

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

Mirabegron 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 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 must not take Mirabegron Astellas.

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 Mirabegron Astellas or breast-feed. 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 Mirabegron Astellas

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

Use in adults with overactive bladder

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 must take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Mirabegron can be taken with or without food.

Use in children and adolescents (age 3 to less than 18 years) with neurogenic detrusor overactivity

Take this medicine by mouth once daily. You must take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Mirabegron must be taken with food. Your doctor will tell you which dose you/your child should take. Your doctor will calculate the correct dose for a patient depending on his or her body weight. You should carefully follow their instructions.

If you take more Mirabegron Astellas 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 Mirabegron Astellas

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 Mirabegron Astellas

Do not stop treatment with Mirabegron Astellas 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 or neurogenic detrusor overactivity.

Do not stop taking Mirabegron Astellas without talking to your doctor first, as your symptoms of overactive bladder or neurogenic detrusor overactivity 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 (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1 000 people)

  • Swelling of the eyelid (eyelid oedema)
  • Swelling of the lip (lip oedema)
  • Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis)
  • Small purple spots on the skin (purpura)
  • 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)
  • Inability to completely empty the bladder (urinary retention)

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

  • Severely high blood pressure (hypertensive crisis)

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

  • Insomnia
  • Confusion

Mirabegron 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 Mirabegron Astellas

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 or blister after EXP. The expiry date refers to the last day of that month.

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 Mirabegron Astellas contains
  • The active substance is mirabegron.
    Mirabegron Astellas 25 mg prolonged-release tablets
    Each tablet contains 25 mg of mirabegron.
    Mirabegron Astellas 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 Mirabegron Astellas looks like and contents of the pack

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

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

Mirabegron Astellas is available in aluminium-aluminium blister in packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Astellas Pharma Ltd.
300 Dashwood Lang Road
Bourne Business Park
Addlestone
KT15 2NX
United Kingdom

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

This leaflet was last revised in 09/2024.

Astellas Pharma Ltd
Company image
Address
300 Dashwood Lang Road, Bourne Business Park, Addlestone, KT15 2NX, UK
Telephone
+44 (0) 203 379 8700
Medical Information Direct Line
0800 783 5018
Medical Information e-mail
[email protected]
Stock Availability
+44 (0) 203 379 8721