Active ingredient
- mirabegron
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
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.
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:
2. What you need to know before you take Betmiga
Do not take Betmiga:
Warnings and precautions
Talk to your doctor or pharmacist before taking Betmiga:
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.
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)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known side effects (frequency cannot be estimated from the available data)
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
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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.
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