Patient Leaflet Updated 24-Jun-2025 | Astellas Pharma Ltd
Mirabegron Astellas 25mg & 50mg prolonged-release tablets
Mirabegron Astellas 25 mg prolonged-release tablets
Mirabegron Astellas 50 mg prolonged-release tablets
mirabegron
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
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:
Talk to your doctor or pharmacist before taking Mirabegron Astellas
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.
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.
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.
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.
There is no information to suggest that this medicine affects your ability to drive or use machines.
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 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.
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 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 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.
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.
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)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1 000 people)
Very rare (may affect up to 1 in 10 000 people)
Not known (frequency cannot be estimated from the available data)
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.
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.
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.
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.
This leaflet was last revised in 09/2024.
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