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ENERZAIR® BREEZHALER®
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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
ENERZAIR BREEZHALER contains the active ingredients indacaterol, glycopyrronium and
mometasone furoate. ENERZAIR BREEZHALER is used as a maintenance treatment of asthma
in adult patients.
For more information, see Section 1. Why am I using ENERZAIR BREEZHALER? in the full CMI.
Do not use if you have ever had an allergic reaction to ENERZAIR BREEZHALER or any
of the ingredients listed at the end of the 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.
For more information, see Section 2. What should I know before I use ENERZAIR BREEZHALER? in the full CMI.
Some medicines may interfere with ENERZAIR BREEZHALER and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will advise you of the appropriate dose.
Inhale the contents of one capsule once daily.
More instructions can be found in Section 4. How do I use ENERZAIR BREEZHALER? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ENERZAIR BREEZHALER
Use this medicine exactly as prescribed by your doctor or pharmacist
Tell your doctor immediately if you become pregnant or intend to become pregnant
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Things you should not do
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Do not stop using this medicine suddenly
Do not use this medicine to treat any other problems unless your doctor tells you
to
Do not swallow ENERZAIR BREEZHALER capsules
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how ENERZAIR
BREEZHALER affects you
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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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Do not store above 30°C
The capsules must always be stored in the blister pack to protect them from moisture
and light
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For more information, see Section 5. What should I know while using ENERZAIR BREEZHALER? in the full CMI.
Less serious side effects include headache, rash, hives, itchiness, dry mouth, fever,
feeling tired, muscle cramps, abnormal heart rhythm, throat irritation, cough, hoarse
voice, white tongue, pain in muscles, bones, joints, muscle cramp, back pain, neck
pain, aching muscles, muscle weakness, frequent urge to urinate, pain or burning when
urinating, vomiting or feeling sick. Serious side effects include trouble breathing,
wheezing, swelling of face, tongue, eyes, difficulty swallowing, blisters on face,
changes to vision, tightness in chest, chest pain, fast heart rate.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
ENERZAIR® BREEZHALER®
Active ingredient(s):
Indacaterol/glycopyrronium/mometasone furoate
Consumer Medicine Information (CMI)
This leaflet provides important information about using ENERZAIR BREEZHALER. 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 ENERZAIR BREEZHALER.
Where to find information in this leaflet:
ENERZAIR BREEZHALER contains the active ingredients
indacaterol, glycopyrronium and mometasone furoate
.
Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators.
They help to relax the muscles around your airways in the lungs. This makes breathing
easier in asthma patients.
Mometasone furoate belongs to a group of medicines called corticosteroids which help
to reduce swelling and irritation in your airways in the lungs. It also helps to prevent
asthma attacks.
ENERZAIR BREEZHALER is used as a maintenance treatment of asthma in adult patients.
It is used in patients who have not achieved adequate control with a maintenance combination
of a long-acting beta2-agonist drug and an inhaled corticosteroid medicine who have
experienced one or more asthma attacks in the previous year.
Asthma is a chronic lung disorder characterised by narrowing and swelling of airways
which can cause difficulty in breathing. Its symptoms include wheezing, cough and
shortness of breath.
Do not use ENERZAIR BREEZHALER if:
you are allergic to indacaterol, glycopyrronium, mometasone furoate, or any of the
ingredients listed at the end of this leaflet. Always check the ingredients to make
sure you can use this medicine.
Allergic reaction symptoms include swelling of the tongue, lips, and face; difficulty
in breathing or swallowing, hives, or skin rash.
you have acute asthma symptoms or acute episodes of bronchospasm (constriction of
the airways).
Do not give this medicine to a child or adolescent under 18 years of age.
Check with your doctor if you:
have any liver problems
have any kidney problems, severe renal impairment or end-stage renal disease.
have any heart problems including symptoms such as increase in pulse rate, high blood
pressure
take any medicines for diabetes or have a high blood sugar level
have eye problems such as narrow-angle glaucoma (an eye disorder that causes damage
to the optic nerve of the eye)
have any problems regarding your urinary bladder (urinary retention)
have pulmonary tuberculosis or any chronic or untreated infections
have a low level of potassium in your blood
have any thyroid problems
suffer from fits/seizures
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
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor will advise you regarding the possible risks and benefits of using ENERZAIR
BREEZHALER during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is unknown whether the active ingredients in ENERZAIR BREEZHALER pass into breast
milk.
Your doctor will advise you regarding the possible risks and benefits of using ENERZAIR
BREEZHALER during breast feeding.
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 ENERZAIR BREEZHALER and affect how it works.
Tell your doctor/pharmacist if you take any of the following medications:
Medicines used to treat depression such as monoamine oxidase inhibitors, tricyclic
antidepressants
Medicines used to treat high blood pressure or lower the level of potassium in your
blood such as diuretics.
Bronchodilator medications such as methylxanthines used to treat breathing problems
(e.g. theophylline) or steroids (e.g. prednisolone)
Medicines used to treat other heart problems, (e.g. propranolol) or to treat glaucoma
(e.g. timolol)
Medicines used to treat fungal infections (e.g., ketoconazole or itraconazole)
Medicines used in the treatment of HIV infection (e.g., ritonavir, nelfinavir or cobicistat)
Medicines that are used to treat low heart rate, respiratory problems (muscarinic
antagonists or long-acting beta2-adrenergic agonists)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ENERZAIR BREEZHALER.
How much to use
There are two dose strengths of ENERZAIR Breezhaler, 114/46/68 micrograms and 114/46/136
micrograms. Your doctor will decide which dose is appropriate for you
Follow the instructions provided and use ENERZAIR BREEZHALER until your doctor tells
you to stop
Inhale the contents of one capsule of ENERZAIR BREEZHALER each day
How to use ENERZAIR BREEZHALER
Follow the instructions provided by your doctor and use ENERZAIR BREEZHALER carefully
Use it only for inhalation
Do not swallow ENERZAIR BREEZHALER capsules.
The capsules must be used only using the ENERZAIR BREEZHALER inhaler
The inhaler is provided with each new prescription
Keep the capsules in the blister and only remove them before using
Peel the backing away from the blister to open it; do not push the capsule through
the foil
After inhalation, rinse your mouth with water without swallowing
If you do not understand how to use the inhaler, ask your doctor or pharmacist for
advice
If you forget to use ENERZAIR BREEZHALER
ENERZAIR BREEZHALER should be used regularly at the same time each day.
If you miss your dose at the usual time, inhale the dose as soon as possible. Then
inhale the next dose at the usual time.
Do not take more than one dose in a day.
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.
If you use too much ENERZAIR BREEZHALER
If you think that you have used too much ENERZAIR BREEZHALER, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Call your doctor straight away if you:
Develop any allergic reaction to ENERZAIR BREEZHALER.
Experience any side effects to ENERZAIR BREEZHALER or have any asthma attacks.
Are pregnant or intend to become pregnant.
Have any liver, kidney or heart problems.
Use this medicine exactly as prescribed by your doctor or pharmacist.
Only use the inhaler provided in the pack. You will receive a new inhaler each time
you refill your script.
You may discard your old inhaler when the capsules are finished.
Remind any doctor, dentist or pharmacist you visit that you are using ENERZAIR BREEZHALER.
Things you should not do:
Do not stop using this medicine suddenly
Do not swallow ENERZAIR BREEZHALER capsules
Do not use this medicine to treat any other problems unless your doctor tells you
to
Do not give your medicine to anyone else (especially children), even if they have
the same condition as you
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ENERZAIR
BREEZHALER affects you.
Looking after your medicine
Follow the instructions provided in the user leaflet on how to properly clean and
take care of your ENERZAIR BREEZHALER
Do not store above 30°C
Dispose of each BREEZHALER inhaler after 30 days of use
The capsules must always be stored in the blister to protect them from moisture and
light.
Remove the capsules only before use
Follow the instructions in the carton on how to take care of your medicine properly
Store in a cool dry place away from moisture, heat or sunlight; for example, do not
store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Discard your ENERZAIR BREEZHALER when you have no capsules left.
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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
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Less serious side effects
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What to do
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General problems:
Headache
Rash
Hives, itchiness
Dry mouth
Fever
Feeling tired, muscle cramps, abnormal heart rhythm (could be low level of potassium
in your blood)
Respiratory problems:
Throat irritation
Cough
Hoarse voice
White tongue
Muscle problems:
Pain in muscles, bones, joints
Muscle cramp
Back pain
Neck pain
Aching muscles, muscle weakness not caused by exercise
Infections:
A frequent urge to urinate and pain or burning when urinating (signs of urinary tract
infection)
Tummy problems:
Vomiting, feeling sick, pain in tummy
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Speak to your doctor if you have any of these less serious side effects 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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Signs of an allergic reaction
Trouble breathing, wheezing
Swelling of face, tongue, eyes
Difficulty swallowing.
Blisters on face, lips that are spreading.
Eye problems
Changes to vision or blurred vision
Heart problems:
Tightness in chest, chest pain
Fast heart rate that may make you feel faint
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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 here may occur in some people.
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.
This medicine is only available with a doctor's prescription.
What ENERZAIR BREEZHALER contains
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Active ingredient
(main ingredient)
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Indacaterol/glycopyrronium/mometasone furoate
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Other ingredients
(inactive ingredients)
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Capsule fill: Lactose monohydrate, Magnesium stearate.
Capsule shell components: Hypromellose, Purified water, Carrageenan, Potassium chloride.
Colourants: Iron oxide yellow, Indigotine.
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Potential allergens
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lactose (as monohydrate)
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Do not take this medicine if you are allergic to any of these ingredients.
What ENERZAIR BREEZHALER looks like
The pack contains a white plastic BREEZHALER inhaler device together with capsules
in blister cards.
ENERZAIR BREEZHALER has two strengths based on the amount of medicine in each:
ENERZAIR BREEZHALER 114/46/68 micrograms, inhalation powder, hard capsules have green
transparent cap and uncoloured transparent body containing a white to practically
white powder, with the product code “IGM150-50-80” printed in black on the body and
with a logo printed in white on the cap (AUST R 319002)
ENERZAIR BREEZHALER 114/46/136 micrograms, inhalation powder, hard capsules have green
transparent cap and uncoloured transparent body containing a white to practically
white powder, with the product code “IGM150-50-160” printed in black above two black
bars on the body and with a logo printed in black and surrounded by one black bar
on the cap (AUST R 319001)
Who distributes ENERZAIR BREEZHALER
ENERZAIR BREEZHALER is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
Web site: www.novartis.com.au
This leaflet was prepared in June 2025.
(ene211221c_V2 based on PI ene211221i)
