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 BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE contains three active ingredients in the one puffer: budesonide,
glycopyrronium, and formoterol (eformoterol) fumarate dihydrate. BREZTRI AEROSPHERE
is used to treat chronic obstructive pulmonary disease (COPD).
2. What should I know before I use BREZTRI AEROSPHERE?
Do not use if you have ever had an allergic reaction to BREZTRI AEROSPHERE or any
of the ingredients listed at the end of CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with BREZTRI AEROSPHERE and affect how it works.
4. How do I use BREZTRI AEROSPHERE?
The recommended dose is 2 puffs (actuations) of BREZTRI AEROSPHERE twice a day (2
puffs in the morning, 2 puffs at night)
Each pack of BREZTRI AEROSPHERE contains an instruction leaflet that tells you the
correct way to use your inhaler. Please read this carefully.
5. What should I know while using BREZTRI AEROSPHERE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using BREZTRI AEROSPHERE
See your doctor regularly to make sure that your COPD is not getting worse. If you
find that your symptoms are worsening or not as well controlled as usual contact your
doctor as it's important that your COPD is controlled properly
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Things you should not do
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Do not stop taking BREZTRI AEROSPHERE, or lower the number of puffs or times you take
it each day, unless your doctor tells you to (even if you are feeling well)
Do not use BREZTRI AEROSPHERE to relieve an acute attack of breathlessness or wheezing.
BREZTRI AEROSPHERE is for regular long-term use only. You should have a separate
reliever inhaler to treat sudden episodes or flare-ups of breathlessness or wheezing,
as recommended by your doctor
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Looking after your medicine
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Store BREZTRI AEROSPHERE in a cool dry place away from moisture, heat or sunlight
where the temperature stays below 30°C. Do not expose to temperatures higher than
50°C and do not freeze
Store in the original carton and foil until you are ready to use it for the first
time to protect it from moisture
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6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and
temporary. The most common side effects are headache, painful and/or frequent urination,
muscle cramps/spasms, thrush, feeling anxious, problems sleeping, cough and/or hoarse
voice, and feeling sick. The more serious side effects are chest pain, fast/irregular
heartbeat, fever or chills and increased phlegm/sputum production or a change in colour,
difficulty breathing, swelling of face, chest tightness or shortness of breath.
Active ingredient(s): budesonide, glycopyrronium, and formoterol (eformoterol) fumarate dihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BREZTRI AEROSPHERE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BREZTRI AEROSPHERE.
Where to find information in this leaflet:
1. Why am I using BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE is used to treat chronic obstructive pulmonary disease (COPD).
COPD (which includes chronic bronchitis and emphysema) is a serious long-term lung
disease that slowly gets worse. COPD can cause difficulty in breathing (breathlessness,
wheezing or chest tightening/discomfort), constant coughing and coughing up of mucus
(phlegm/sputum).
BREZTRI AEROSPHERE contains three active ingredients in the one puffer: budesonide,
glycopyrronium, and formoterol (eformoterol) fumarate dihydrate.
budesonide – an inhaled corticosteroid which works by reducing and preventing inflammation
in your lungs
glycopyrronium – a long-acting muscarinic antagonist (or LAMA)
formoterol – a fast and long-acting beta-2-agonist (or LABA)
Glycopyrronium and formoterol belong to a group of medicines called bronchodilators,
and work together in different ways to stop the tightening of the muscles in the lungs,
making it easier for air to get in and out of the lungs.
When used regularly, BREZTRI AEROSPHERE helps to make breathing easier and also helps
to prevent flare-ups of symptoms (exacerbations).
BREZTRI AEROSPHERE should not be used to relieve a sudden episode or flare-up of breathlessness
or wheezing. If this occurs, you should use your reliever medicine recommended by
your doctor or pharmacist (e.g. Ventolin puffer).
2. What should I know before I use BREZTRI AEROSPHERE?
Warnings
Do not use BREZTRI AEROSPHERE if:
you are allergic to budesonide, glycopyrronium, or formoterol (eformoterol) fumarate
dihydrate or any of the ingredients listed at the end of this leaflet
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have allergies to any other medicines or foods
have any other medical conditions such as asthma, high blood pressure (hypertension)
or heart problems, thyroid problems (thyrotoxicosis), low potassium in your blood
(hypokalaemia), diabetes or high blood glucose (hyperglycaemia), prostate problems,
problems passing urine, eye problems (glaucoma), severe kidney or liver problems
take any medicines for any other condition
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?
BREZTRI AEROSPHERE is not recommended for use in children or adolescents under 18 years
of age.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take BREZTRI AEROSPHERE if you are pregnant or breastfeeding unless your doctor
says so.
It is not known if it is safe for you to take BREZTRI AEROSPHERE while you are pregnant.
It may affect your baby.
It is not known if your baby can take in BREZTRI AEROSPHERE from breast milk if you
are breastfeeding.
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 may interfere with BREZTRI AEROSPHERE and affect how it works.
This includes:
other medicines used regularly to treat your breathing problems that contain glycopyrronium,
formoterol or other bronchodilators (such as ipratropium, tiotropium, aclidinium,
umeclidinium, salmeterol, indacaterol, vilanterol, olodaterol)
medicines that lower the amount of potassium in your blood such as diuretics (e.g.
frusemide or hydrochlorothiazide)
medicines used to treat heart problems or high blood pressure such as beta-blockers
(e.g. atenolol, propranolol), antiarrhythmics (e.g. amiodarone) and diuretics
medicines used to treat glaucoma such as beta-blockers (e.g. timolol)
medicines used to treat depression or other mood/mental disorders such as tricyclic
antidepressants and monoamine oxidase inhibitors
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole)
medicines used to treat HIV (e.g. cobicistat and protease inhibitors such as ritonavir)
medicine to use stomach ulcers (e.g. cimetidine)
These medicines may be affected by BREZTRI AEROSPHERE of may affect how well it works.
You may need different amounts of your medicine or you may need to take different
medicines. Your doctor can tell you what to do if you are taking other medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BREZTRI AEROSPHERE.
4. How do I use BREZTRI AEROSPHERE?
How much to take
The recommended dose is 2 puffs (actuations) of BREZTRI AEROSPHERE twice a day (i.e.
2 puffs in the morning and 2 puffs at night)
Your doctor should tell you the best way to manage your COPD symptoms and any flare-ups.
This may include additional medicines (such as reliever medicines) to use when you
have sudden episodes or flare-ups of breathlessness or wheezing
If you are using more puffs of your reliever medicine or you are wheezing or breathless
more than usual tell your doctor
If your COPD gets worse, your doctor may give you some additional medicines (such
as oral corticosteroids or antibiotics)
When to take BREZTRI AEROSPHERE
Take BREZTRI AEROSPHERE at about the same time each day (i.e. 2 puffs in the morning
and 2 puffs at night)
BREZTRI AEROSPHERE is a regular long-term medicine used to help control your COPD
symptoms. You need to use it every day even if you are feeling well
BREZTRI AEROSPHERE helps control your COPD symptoms and prevent flare-ups, but does
not cure COPD
Follow the instructions provided and use BREZTRI AEROSPHERE until your doctor tells
you to stop
How to take BREZTRI AEROSPHERE
BREZTRI AEROSPHERE is for oral inhalation only
Each pack of BREZTRI AEROSPHERE contains an instruction leaflet that tells you the
correct way to use your inhaler. Please read this carefully.
If you are not sure how to use your inhaler, ask your doctor or pharmacist to show
you how
If you find it difficult breathing in and pressing the inhaler at the same time talk
to your doctor or pharmacist. You may be able to use a spacer with your inhaler.
A spacer is a holding chamber shaped like a football or a tube, which can attach to
your inhaler.
If you forget to use BREZTRI AEROSPHERE
BREZTRI AEROSPHERE should be used regularly at the same time each day. If you miss
your dose at the usual time, take it as soon as you remember, and then go back to
taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed. Do not take more than
two puffs twice a day on the same day.
This may increase the chance of getting an unwanted side effect.
If you use too much BREZTRI AEROSPHERE
If you think that you have used too much BREZTRI AEROSPHERE, 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. You may
need urgent medical attention.
Symptoms of an overdose may include blurred vision, dry mouth, nausea, muscle cramps,
shaking, headache, fast or irregular heartbeat, and changes in blood pressure.
5. What should I know while using BREZTRI AEROSPHERE?
Things you should do
Take BREZTRI AEROSPHERE exactly as your doctor has prescribed
If you are about to be started on any new medicine (including any for COPD or other
lung/breathing problems), remind your doctor and pharmacist that you are taking BREZTRI
AEROSPHERE.
Tell your doctor if you become pregnant while you are taking BREZTRI AEROSPHERE
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine
It may affect other medicines used during surgery
Tell your doctor if you need to have any medical tests while you are taking BREZTRI
AEROSPHERE
Have your reliever medicine with you at all times.
Rinse your mouth out with water after taking your daily morning and evening dose of
BREZTRI AEROSPHERE and spit this out. This helps to reduce the chance of you developing
thrush (fungal infection) in your mouth
Call your doctor straight away if you:
Find that your symptoms are worsening or not as well controlled as usual as it's important
that your COPD is controlled properly
See your doctor regularly to make sure that your COPD is not getting worse
Remind any doctor, dentist or pharmacist you visit that you are using BREZTRI AEROSPHERE.
Things you should not do
Do not stop taking BREZTRI AEROSPHERE, or lower the number of puffs or times you take
it each day, unless your doctor tells you to
Do not take BREZTRI AEROSPHERE to treat any other conditions unless your doctor tells
you to
Do not give BREZTRI AEROSPHERE to anyone else, even if their symptoms are similar
to yours
Do not use BREZTRI AEROSPHERE to relieve an acute attack of breathlessness or wheezing.
BREZTRI AEROSPHERE is for regular long-term use only. You should have a separate
reliever inhaler to treat sudden episodes or flare-ups of breathlessness or wheezing,
as recommended by your doctor or pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BREZTRI
AEROSPHERE affects you.
BREZTRI AEROSPHERE is unlikely to affect your ability to drive or operate machinery.
Looking after your medicine
Store in the original carton and foil until you are ready to use it for the first
time to protect it from moisture
Always replace the mouthpiece cap after using BREZTRI AEROSPHERE
Follow the instructions in the carton on how to clean and take care of your medicine
properly.
Store BREZTRI AEROSPHERE in a cool dry place away from moisture, heat or sunlight
where the temperature stays below 30°C. For example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills
Keep BREZTRI AEROSPHERE where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store it.
When to discard your medicine
Discard BREZTRI AEROSPHERE within 3 months (120 actuations pack) or 3 weeks (28 actuations
sample pack) after removal from the foil pouch.
WARNING
The canister in BREZTRI AEROSPHERE contains a pressurised liquid. Do not expose to
temperatures higher than 50°C and do not freeze. Do not pierce the canister. The
canister should not be broken, punctured or burnt, even when it seems empty. If exposed
to freezing temperatures, the inhaler should be kept at room temperature for 1 hour
prior to taking a dose.
Getting rid of any unwanted medicine
Your BREZTRI AEROSPHERE should always be returned to your pharmacist for disposal,
including:
when you have taken all your puffs and the dose indicator reaches zero ('0') - see
instructions in the pack, or
3 months (120 actuations pack) or 3 weeks (28 actuations sample pack) after removal
from the foil pouch. Note: When you first opened the foil pouch to remove your inhaler, you may have written
the date you opened it onto the carton to remind you when to stop using the inhaler,
or
it is damaged or past its expiry date, or
your doctor has told you to stop using it
Do not use this BREZTRI AEROSPHERE after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Serious side effects
The above list includes serious side effects that require medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Tell your doctor if you notice any issues with your eyes such as blurred vision or
other problems with your eyesight.
Your doctor may need to send you to an ophthalmologist (eye doctor) to check that
you don’t have eye problems such as cataracts (clouding of the eye lens), glaucoma
(increased pressure in your eyeballs) or other rare eye conditions reported with corticosteroid
use.
Some side effects (for example, changes in thyroid function, blood sugar levels or
blood potassium levels) 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 BREZTRI AEROSPHERE contains
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Active ingredients
(main ingredients)
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budesonide, glycopyrronium (as glycopyrronium bromide), and formoterol (eformoterol)
fumarate dihydrate
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Other ingredients
(inactive ingredients)
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propellant (norflurane (HFA-134a)), calcium chloride dihydrate and distearoylphosphatidylcholine
(DSPC)
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Each actuation (puff) contains:
160 micrograms of budesonide
7.2 micrograms of glycopyrronium
5 micrograms of formoterol fumarate dihydrate
Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
What BREZTRI AEROSPHERE looks like
BREZTRI AEROSPHERE is a pressurised metered dose inhaler (pMDI). There are two types
of pMDIs registered*:
Bespak / Trudell device
This inhaler comes as a pressurised canister with a dose indicator on top inside a
white plastic actuator body and mouthpiece. The mouthpiece is covered with a removable
grey protective dust cap.
DFP-EvoCap XS / EvoCap XS device
This inhaler comes as a pressurised canister with a dose indicator on top inside a
yellow plastic actuator body and white mouthpiece. The mouthpiece is covered with
a removable grey protective dust cap.
The 120 actuations (puffs) pack size also contains a plastic collar inside the actuator
body.
Each inhaler is individually wrapped in a foil laminate pouch (containing a sachet
of drying agent).
BREZTRI AEROSPHERE 160/7.2/5 (AUST R 339070) and BREZTRI AEROSPHERE 160/7.2/5 DFP-EvoCap
(AUST R 386646) come in two pack sizes* - 120 actuations (puffs) inhaler and a 28
actuations (puffs) inhaler (sample pack).
* Not all pMDIs or pack sizes may be available in Australia.
Who distributes BREZTRI AEROSPHERE
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
Macquarie Park NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in August 2022.
BREZTRI and BREZTRI AEROSPHERE are registered trademarks of the AstraZeneca group
of companies.
© AstraZeneca 2022
Doc ID-004627123 V3.0