Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using BETMIGA?
BETMIGA contains mirabegron, a beta 3-adrenoceptor agonist, which is used to treat
symptoms of an overactive bladder.
2. What should I know before I use BETMIGA?
Do not use if you have ever had an allergic reaction to BETMIGA or any of the ingredients
listed at the end of the CMI.
Do not take BETMIGA if you have very high blood pressure (systolic greater than or
equal to 180mmHg and /or diastolic greater than or equal to 110mmHg).
3. What if I am taking other medicines?
Some medicines may interfere with BETMIGA and affect how it works.
4. How do I use BETMIGA?
The usual dose is 25 mg tablet once a day. Based upon your response and tolerability,
your doctor may increase your dose to 50 mg once daily. The maximum dose for BETMIGA
is 50 mg once daily.
5. What should I know while using BETMIGA?
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Things you should do
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If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking BETMIGA.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not take BETMIGA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or alter the dosage without checking with your doctor.
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Driving or using machines
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There is no information to suggest that BETMIGA affects your ability to drive or use
machinery. Be careful driving or operating machinery until you know how BETMIGA affects
you. It may cause dizziness in some people. If this occurs, do not drive or use machinery.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store BETMIGA or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
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6. Are there any side effects?
There are a number of side effects associated with this medicine. It is important
to be aware of them so that you can identify any symptoms if they occur (see the full
CMI for more details). The most common and serious side effects are fast or irregular
heartbeats; swelling of the face, eyelid, lips, tongue, throat, airways or joints;
rash, itchiness or hives.
Active ingredient(s):
Mirabegron (my-ra-BEG-ron)
Full Consumer Medicine Information (CMI)
This leaflet answers some common questions about BETMIGA.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
BETMIGA against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
Where to find information in this leaflet:
1. Why am I using BETMIGA?
BETMIGA contains mirabegron, a beta 3-adrenoceptor agonist, which is used to treat
symptoms of an overactive bladder.
Overactive bladder occurs when you cannot control your bladder contractions. When
these muscle contractions happen too often or cannot be controlled, you can get symptoms
such as:
suddenly needing to empty your bladder (urgency)
having to empty your bladder more than usual (increased urinary frequency)
not being able to control when you empty your bladder (urgency incontinence).
BETMIGA works by reducing the activity of an overactive bladder and treats the related
symptoms.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. (UP TO HERE**)
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription.
The safety and effectiveness of BETMIGA in children and adolescents under the age
of 18 years have not been established.
2. What should I know before I use BETMIGA?
Warnings
Do not use BETMIGA if:
you have an allergy to any medicine containing mirabegron or any of the ingredients
listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take BETMIGA if you have very high blood pressure (systolic greater than or
equal to 180mmHg and/or diastolic greater than or equal to 110mmHg).
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have or have had any of the following medical conditions:
kidney problems
liver problems
high blood pressure
heart disorders, including an irregular heartbeat, an abnormal electrical signal in
the heart that can cause an irregular heart rhythm called "prolongation of the QT
interval", or if you are taking any medicine known to cause irregular heart rhythm
(see Section 3. What if I am taking other medicines?)
trouble emptying your bladder or you have a weak urine stream
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start
taking BETMIGA.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and BETMIGA may interfere with each other. These include:
thioridazine (a medicine for mental illness), propafenone or flecainide (medicines
for abnormal heart rhythm), metoprolol (a medicine for high blood pressure or heart
problems), imipramine or desipramine (medicines used for depression). These specific
medicines may require dose adjustment by your doctor.
some anti-fungal medicines (e.g. itraconazole, ketoconazole)
ritonavir (a medicine used to treat HIV/AIDS)
digoxin (a medicine for heart failure or abnormal heart rhythm). Blood levels of digoxin
are measured by your doctor. If the blood level is out of range, your doctor may adjust
the dose of digoxin
medicines used for the management of overactive bladder (e.g. solifenacin, tolterodine,
oxybutynin, darifenacin, trospium, fesoterodine) and medicines used for the management
of enlarged prostate (e.g. tamsulosin)
some medicines that are known to prolong QT interval, such as quinidine, sotalol,
amiodarone (medicines used for abnormal heart rhythm), mesoridazine, haloperidol (medicines
for mental illness), or erythromycin, clarithromycin (anti-infectives)
These medicines may be affected by BETMIGA or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
4. How do I use BETMIGA?
Follow directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
The usual dose is 25 mg tablet once a day. Based upon your response and tolerability,
your doctor may increase your dose to 50 mg once daily. The maximum dose for BETMIGA
is 50 mg once daily.
How to take it
Swallow the tablet whole with a full glass of water. Do not crush or chew the tablet.
You can take the tablet with or without food.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will help you remember when to take it.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
Do not stop treatment with BETMIGA early if you do not see an immediate effect. Your
bladder might need some time to adapt.
Do not stop taking BETMIGA when your bladder condition improves.
This medicine helps to control your condition, but does not cure it. Stopping treatment
may result in a recurrence of symptoms of an overactive bladder.
If you forget to take it
If it is 6 hours or less before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much (overdose)
If you think that you have used too much BETMIGA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much BETMIGA, you may feel a fast heart rate.
5. What should I know while using BETMIGA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking BETMIGA.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Things you should not do
Do not take BETMIGA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or alter the dosage without checking with your doctor.
Driving or using machines
There is no information to suggest that BETMIGA affects your ability to drive or use
machinery. Be careful driving or operating machinery until you know how BETMIGA affects
you. It may cause dizziness in some people. If this occurs, do not drive or use machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store BETMIGA or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking BETMIGA.
This medicine helps most people with overactive bladder but it may have unwanted side
effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not.
You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Ask your doctor or pharmacist to answer any questions you may have.
Less serious side effects
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Less serious side effects
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What to do
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indigestion (dyspepsia)
common cold symptoms (nasopharyngitis)
headache
dizziness
nausea (feeling sick) or vomiting
fatigue
constipation
stomach, back or joint pain
urinary tract infection, including signs such as burning or pain when passing urine,
or an urge to pass urine frequently. Urine may have a strong smell, looks cloudy or
contains blood
vaginal discharge, itching or burning
increased blood pressure
increase in liver enzymes
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Tell your doctor or pharmacist if you notice any of the following and they worry you.
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Serious side effects
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Serious side effects
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What to do
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fast or irregular heartbeats
swelling of the face, eyelid, lips, tongue, throat, airways or joints
rash, itchiness or hives
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects (for example, changes in blood test results, blood pressure
or liver enzymes) can only be found when your doctor does tests from time to time
to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What BETMIGA contains
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Active ingredient
(main ingredient)
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BETMIGA contains 25 mg or 50 mg of mirabegron as the active ingredient.
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Other ingredients
(inactive ingredients)
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macrogols
hyprolose
butylated hydroxytoluene
magnesium stearate
hypromellose
iron oxide yellow
iron oxide red (25 mg tablet only)
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What BETMIGA looks like
BETMIGA is available in 25 mg or 50 mg strengths:
25 mg tablet (AUST R 199664) is an oval, brown film-coated tablet, debossed with the
(Astellas logo) and "325"
50 mg tablet (AUST R 199668) is an oval, yellow film-coated tablet, debossed with
the (Astellas logo) and "355"
Both strengths are available in packs of 30 tablets.
Who distributes BETMIGA
BETMIGA is supplied in Australia by:
Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road
Macquarie Park NSW 2113
Medical Information:
1800 751 755
® = Registered Trademark
This leaflet was prepared in July 2021.