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.
1. Why am I using ATECTURA BREEZHALER?
ATECTURA BREEZHALER contains the active ingredients indacaterol and mometasone furoate.
ATECTURA BREEZHALER is used to treat the symptoms of asthma attack in patients over
12 years of age.
2. What should I know before I use ATECTURA BREEZHALER?
Do not use if you have ever had an allergic reaction to indacaterol and mometasone
furoate or any of the ingredients listed at the end of the CMI. ATECTURA BREEZHALER
also contains lactose monohydrate.
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 ATECTURA BREEZHALER and affect how it works.
4. How do I use ATECTURA BREEZHALER?
Carefully read the "Instructions for use" leaflet that comes with the medicine as
well as this leaflet.
You must only use the capsules with the inhaler you receive when you fill your script.
5. What should I know while using ATECTURA BREEZHALER?
Things you should do
|
Remind any doctor, dentist, or pharmacist you visit that you are using ATECTURA BREEZHALER.
You must only use the capsules with the inhaler you receive when you fill your script.
Inhale the medicine as demonstrated by your doctor or pharmacist.
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not give this medicine to someone else (especially children under the age of 12).
Do not swallow the capsules.
|
Driving or using machines
|
Be careful driving or using machinery until you know how ATECTURA 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
|
Do not store above 25°C.
The capsules must always be stored in the blister pack to protect them from moisture
and light.
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6. Are there any side effects?
Less serious side effects include itchiness, rash, sore throat, white tongue, harsh
or croaky voice, pain in muscles, bones or joints, muscle spasm, headache, feeling
or being sick. Serious side effects include trouble breathing, wheezing, swelling
of face, tongue, eyes, difficulty swallowing, blisters on face, lips that are spreading;
changes to vision, tightness in chest, chest pain or fast heart rate that may make
you feel faint.
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 .
Active ingredient(s):
Indacaterol (as acetate)/mometasone furoate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ATECTURA 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 ATECTURA BREEZHALER.
Where to find information in this leaflet:
1. Why am I using ATECTURA BREEZHALER?
ATECTURA BREEZHALER contains the active ingredients indacaterol and mometasone furoate.
Indacaterol belongs to a group of medicines called bronchodilators that help relax the muscles
of the small airways in the lungs making it easier for air to get in and out.
Mometasone furoate belongs to a group of medicines called corticosteroids that reduce swelling and irritation
in the small airways in the lungs and gradually ease breathing problems and prevent
asthma attacks.
ATECTURA BREEZHALER is used to treat asthma in adults and adolescents 12 years of
age and older where the combination of a long-acting beta-2 agonist (indacaterol)
and inhaled corticosteroid (mometasone furoate) is appropriate. Asthma is a condition
that narrows your airways making it difficult to breathe and can be brought on by
a number of things including exercise, smoke, cold air or allergens such as pollen
or dust.
2. What should I know before I use ATECTURA BREEZHALER?
Warnings
Do not use ATECTURA BREEZHALER if:
you are allergic to indacaterol, mometasone furoate, or any of the ingredients listed
at the end of this leaflet.
you are allergic to lactose or milk protein
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have heart problems including an irregular or fast heartbeat
have thyroid gland problems
have diabetes or high blood sugar
suffer from seizure or fits
have low potassium
have liver problems
have tuberculosis of the lung or any longstanding or untreated infections
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?
Monitoring before and during treatment
Your doctor may send you for tests on your liver, heart, or lung function. They may
also send you for blood tests from time to time to check on how your body is responding
to treatment. It is important that you attend these appointments and get all your
testing done. If you are diabetic, you may also need to monitor your blood sugar closely.
Effects of corticosteroids
Your doctor may wish to start you on the lowest available dose to see how your body
responds to treatment first. Taking higher doses of therapy, particularly for a longer
period of time may have unwanted effects on your body and is especially more dangerous
in children under 12.
Using your ATECTURA BREEZHALER
You should ensure that you know how to use the device correctly so that you get the
best benefit from the medicine. You may also get white residue on the back of your
throat from the medicine.
Children (patients under 12)
There is not enough information about whether this medicine is safe or effective in
children under the age of 12.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, think you may be pregnant, or intend to
become pregnant. There is not enough information on the use of this medicine in pregnancy
and so may harm your unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Indacaterol
and/or mometasone furoate may pass into breastmilk and harm your unborn baby.
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 ATECTURA BREEZHALER and affect how it works.
Medicines to treat depression
Medicines like ATECTURA BREEZHALER; these may increase the risk of possible side effects
Medicines that decrease the level of potassium in your blood
Medicines to treat high blood pressure, other heart problems, or glaucoma
Medicines to treat fungal infections
Medicines to treat HIV infection
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ATECTURA BREEZHALER.
4. How do I use ATECTURA BREEZHALER?
How much to use
There are three dose strengths of ATECTURA BREEZHALER, 125/62.5 micrograms, 125/127.5
micrograms and 125/260 micrograms. Your doctor will decide which dose strength is
appropriate for you.
The usual dose is to inhale the contents of one capsule each day. You only need to
use this medicine once a day because its effect lasts for 24 hours. Do not use more
than your doctor tells you to use.
You should inhale the contents of one capsule of ATECTURA BREEZHALER every day and
continue to use it even when you are not experiencing asthma symptoms.
Follow the instructions provided and use ATECTURA BREEZHALER until your doctor tells
you to stop.
When to use ATECTURA BREEZHALER
ATECTURA BREEZHALER should be used at the same time each day.
How to use the BREEZHALER
Carefully read the full Instructions for use provided in the package leaflet before
use
Only use the capsules with the inhaler provided in the pack. You will receive a new
inhaler each time you refill your script. The capsules should remain in the blister
until you need to use them.
Peel the backing away from the blister to open it, do not push the capsule through
the foil
Do not swallow the capsules
Ensure you rinse your mouth out with water after each use.
Make sure you understand how to use the BREEZHALER device properly. If you are not
sure, ask your doctor or pharmacist.
If you forget to use ATECTURA BREEZHALER
ATECTURA 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.
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 ATECTURA BREEZHALER
If you think that you have used too much ATECTURA BREEZHALER, 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.
Signs that you might have taken too much include faster heart rate, shaking, being
sick.
5. What should I know while using ATECTURA BREEZHALER?
Things you should do
Only use the inhaler contained in the pack. You will receive a new inhaler each time
you refill your script so you may discard your old inhaler when the capsules are all
gone (see section "Getting rid of any unwanted medicine")
Ensure you know how to use the inhaler properly otherwise the device may not work
as well
Keep all of your appointments and get all blood tests done so that your condition
and your response to treatment can be monitored
If you are diabetic or have high blood sugar, monitor your blood sugar closely while
on treatment.
Always use this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Call your doctor straight away if you
Become pregnant or think you may be pregnant
Experience tightness of the chest, coughing, wheezing or shortness of breath immediately
after inhaling ATECTURA BREEZHALER
Have difficulty breathing or swallowing, swelling of your tongue, lips or face, rash,
itchy skin or hives as these could be signs of an allergic reaction
Remind any doctor, dentist or pharmacist you visit that you are using ATECTURA BREEZHALER.
Things you should not do
Do not swallow the capsules
Do not stop using this medicine suddenly
Do not use ATECTURA BREEZHALER to treat any other complaints 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 ATECTURA
BREEZHALER affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions in the user leaflet on how to properly clean and take care
of your ATECTURA BREEZHALER
Keep your capsules in the original blister to protect them from moisture and light,
and do not remove them until immediately before use
Dispose of each BREEZHALER inhaler after 30 days of use
Do not store above 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store it 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
When you have no more capsules, you can discard your ATECTURA BREEZHALER inhaler as
you receive a new one when you get your script refilled.
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.
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
Serious side effects
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.
7. Product details
This medicine is only available with a doctor's prescription.
What ATECTURA BREEZHALER contains
Active ingredients
(main ingredients)
|
Indacaterol and mometasone furoate
|
Other ingredients
(inactive ingredients)
|
Lactose monohydrate and gelatin
|
Potential allergens
|
Lactose monohydrate and gelatin
|
Do not take this medicine if you are allergic to any of these ingredients.
What ATECTURA BREEZHALER looks like
ATECTURA BREEZHALER contains a white plastic BREEZHALER inhaler device together with
capsules in blister cards. ATECTURA BREEZHALER has three strengths based on the amount
of medicine in each:
ATECTURA BREEZHALER 125/62.5 microgram capsules have a natural transparent cap and
uncoloured transparent body containing a white to practically white powder, with the
product code "IM150-80" printed in blue above one blue bar on the body and with a
logo printed in blue and surrounded by two blue bars on the cap (AUST R 319076)
ATECTURA BREEZHALER 125/127.5 microgram capsules have a natural transparent cap and
uncoloured transparent body containing a white to practically white powder, with the
product code "IM150-160" printed in grey on the body and with a logo printed in grey
on the cap (AUST R 319075)
ATECTURA BREEZHALER 125/260 microgram capsules have a natural transparent cap and
uncoloured transparent body containing a white to practically white powder, with the
product code "IM150-320" printed in black above two black bars on the body and with
a logo printed in black and surrounded by two black bars on the cap (AUST R 319074)
Who distributes ATECTURA BREEZHALER
ATECTURA 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
This leaflet was prepared in June 2025.
(ate160720c_V3 based on PI ate160720i)