Patient leaflet - Mirabegron Astellas 50 mg prolonged-release tablets
1. What Mirabegron Astellas is and what it is used for
Mirabegron Astellas 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 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)
- 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 (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.
If the tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist who will advise you what to do.
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 contains
The active substance is mirabegron.
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)
What Mirabegron looks like and contents of the pack
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 is available in aluminium-aluminium blister in packs containing 30 tablets. Other strengths are available.
Manufacturer
Delpharm Meppel B.V., Hogemaat 2, 7942 JG Meppel, The Netherlands or Astellas Pharma Europe B.V., Hogemaat 2, 7942 JG Meppel, The Netherlands.
Procured within the EU. Product Licence Holder: Ecosse Pharmaceuticals Limited, 3 Young Place, East Kilbride, G75 0TD, United Kingdom. Re-packaged by Munro Wholesale Medical Supplies,
3 Young Place, East Kilbride, G75 0TD, United Kingdom.
PL 19065/0934
This leaflet was last revised: 28.07.2025
E0934/2 09.24
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Astellas® is the registered trademark of Astellas Pharma Inc.