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 ULTIBRO BREEZHALER?
ULTIBRO BREEZHALER contains the active ingredients indacaterol and glycopyrronium
bromide (glycopyrrolate). ULTIBRO BREEZHALER is used to treat chronic obstructive
pulmonary disease. This is a serious lung condition caused by damage to the lungs.
For more information, see Section
1. Why am I using ULTIBRO BREEZHALER? in the full CMI.
2. What should I know before I use ULTIBRO BREEZHALER?
Do not use if you have ever had an allergic reaction to ULTIBRO 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 ULTIBRO BREEZHALER? in the full CMI.
3. What if I am taking other medicines?
4. How do I use ULTIBRO BREEZHALER?
Your doctor will decide which dose is appropriate for you
Inhale the contents of one capsule once daily.
Do not take more than one dose in a day.
5. What should I know while using ULTIBRO BREEZHALER?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ULTIBRO BREEZHALER.
Use this medicine exactly as prescribed by your doctor or pharmacist.
Tell your doctor immediately if you experience difficulties in breathing.
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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 ULTIBRO 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 ULTIBRO
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 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 headache, dizziness, dry mouth, fever, indigestion,
blocked nose, difficulty in swallowing, throat irritation, cough, pain in muscles,
bones, joints, pain in arms or legs. Serious side effects include difficulty in breathing
or swallowing, swelling of tongue, lips and face, skin rash, itching and hives, difficulty
breathing with wheezing or coughing, fast or irregular heart beats, chest pain, eye
pain or discomfort, temporary blurring of vision, visual halos or coloured images
in association with red eyes, frequent urination, difficulty passing urine or painful
urination.
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.
Active ingredients:
Indacaterol/ Glycopyrronium bromide (glycopyrrolate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ULTIBRO 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 ULTIBRO BREEZHALER.
Where to find information in this leaflet:
1. Why am I using ULTIBRO BREEZHALER?
ULTIBRO BREEZHALER contains the active ingredients indacaterol and glycopyrronium
bromide (glycopyrrolate). ULTIBRO BREEZHALER belongs to a group of medicines called bronchodilators. They help
to relax the muscles around your airways in the lungs and keep them open. This makes
breathing easier.
ULTIBRO BREEZHALER is used to treat chronic obstructive pulmonary disease (COPD).
It is a serious lung condition caused due to damage to the lungs. The damage results
in irritation and swelling inside the airways. This limits the airflow into and out
of the lungs. ULTIBRO BREEZHALER helps improve and reduce symptom flare-ups from occurring.
2. What should I know before I use ULTIBRO BREEZHALER?
Warnings
Do not use ULTIBRO BREEZHALER if:
you are allergic to indacaterol and glycopyrronium bromide (glycopyrrolate), or any
of the ingredients listed at the end of this leaflet. Always check the ingredients
to make sure you can use this medicine.
Symptoms of an allergic reaction include difficulty in breathing or swallowing, swelling
of the tongue, lips, face, other parts of the body, hives and skin rash.
Check with your doctor if you:
have asthma
have any heart problems
have any thyroid gland problems
have diabetes
are taking similar medicines for your lung disease
have any kidney problems
have any liver problems
have an eye problem including narrow-angle glaucoma
have difficulty passing urine
Do not give this medicine to a child or adolescent under 18 years of age.
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.
ULTIBRO BREEZHALER is not recommended for use during pregnancy.
Your doctor will advise you regarding the possible risks and benefits of using ULTIBRO
BREEZHALER during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is unknown whether the active ingredients in ULTIBRO BREEZHALER passes into breast
milk.
Your doctor will advise you regarding the possible risks and benefits of using ULTIBRO
BREEZHALER during breast feeding.
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 ULTIBRO BREEZHALER and affect how it works.
Tell your doctor or pharmacist if you take any of the following:
medicines used in the treatment of depression
any other medicines for your lung disease. Use of these may increase the risk of experiencing
possible side effects
medicines that decrease the level of potassium in your blood
medicines for high blood pressure and heart problems or in the treatment of glaucoma
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ULTIBRO BREEZHALER.
4. How do I use ULTIBRO BREEZHALER?
How much to use
Your doctor will decide which dose is appropriate for you.
The dose for adults is inhaling the contents of one capsule once daily.
Follow the instructions provided and use ULTIBRO BREEZHALER until your doctor tells
you to stop.
Do not take more than one dose in a day.
Ask your doctor if you do not understand your dose.
When to use ULTIBRO BREEZHALER
ULTIBRO BREEZHALER should be used at about the same time each day.
How to use ULTIBRO BREEZHALER
Carefully read the instructions and follow the diagrams inside the carton that show
you how to use the BREEZHALER properly.
Use ULTIBRO capsules only for oral inhalation using BREEZHALER inhaler.
Do not swallow ULTIBRO BREEZHALER capsules.
Keep the capsules in the blister pack and only remove them before using.
Peel the backing away from the blister pack to open it; do not push the capsule through
the foil.
If you do not understand how to use the inhaler, ask your doctor or pharmacist for
advice.
If you forget to use ULTIBRO BREEZHALER
ULTIBRO BREEZHALER should be used regularly at the same time each day. If you miss
your dose at the usual time, take it as soon as possible.
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 ULTIBRO BREEZHALER
If you think that you have used too much ULTIBRO 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.
5. What should I know while using ULTIBRO BREEZHALER?
Things you should do
Call your doctor straight away if you:
develop any allergic reaction to ULTIBRO BREEZHALER
are pregnant or intend to become pregnant.
experience any contraction in the airways causing difficulty in breathing.
have any difficulty passing urine.
have any heart issues including pain or rapid heartbeat.
experience eye pain, discomfort or temporary blurring of vision.
Remind any doctor, dentist or pharmacist you visit that you are using ULTIBRO BREEZHALER.
Things you should not do
Do not stop using this medicine suddenly.
Do not swallow ULTIBRO BREEZHALER capsules.
Do not use this medicine to treat any other problems unless your doctor tells you
to.
Do not take more than one dose in a day.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ULTIBRO
BREEZHALER affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions provided in the user leaflet on how to properly clean and
take care of your ULTIBRO BREEZHALER
Store below 25°C
Always store ULTIBRO BREEZHALER capsules in the blister pack to protect from moisture.
Remove the capsules only before use.
Dispose of each BREEZHALER inhaler after 30 days of 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 ULTIBRO 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.
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
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Less serious side effects
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What to do
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General problems:
Headache
Dizziness
Dry mouth
Fever
Indigestion
Respiratory problems:
Blocked nose
Difficulty in swallowing
Throat irritation
Cough
Muscle problems:
Pain in muscles, bones, joints
Pain in arms or legs
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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:
Difficulty in breathing or swallowing, swelling of tongue, lips and face, skin rash,
itching and hives
Difficulty breathing with wheezing or coughing
Heart problems:
Fast or irregular heart beats
Chest pain
Eye problems:
Eye pain or discomfort, temporary blurring of vision, visual halos or coloured images
in association with red eyes; these may be signs of an acute attack of narrow-angle
glaucoma.
Other problems:
Excessive thirst or hunger and frequent urination (symptoms of high blood sugar levels)
Difficulty passing urine or painful urination
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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.
7. Product details
This medicine is only available with a doctor's prescription.
What ULTIBRO BREEZHALER contains
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Active ingredient
(main ingredient)
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Indacaterol and glycopyrronium bromide (glycopyrrolate)
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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, CI Food Yellow 4/Tartrazine.
Black Printing Ink: Shellac, ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium
hydroxide, potassium hydroxide, water purified, iron oxide black
Blue Printing Ink: Shellac, ethyl alcohol, FD&C Blue 2, n-butyl alcohol, titanium dioxide, propylene
glycol, isopropyl alcohol
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Potential allergens
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Lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What ULTIBRO BREEZHALER looks like
Inhalation powder, hard capsule
Transparent yellow cap and natural transparent body capsules containing a white to
practically white powder, with the product code IGP110.50 printed in blue under two
blue bars on the body and the company logo printed in black on the cap (AUST R 206449).
Breezhaler
A white plastic BREEZHALER inhalation device is also supplied in the pack.
Who distributes ULTIBRO BREEZHALER
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
® = Registered Trademark
This leaflet was prepared in June 2025.
(ulb081220c_V2 based on PI ulb081220i)