capsules for inhalation
Consumer Medicine Information
a serious lung condition that can Onbrez Breezhaler is not suitable
cause difficulty in breathing, and for use in the treatment of asthma.
constant coughing. Symptoms of Onbrez Breezhaler is not suitable
What is in this leaflet COPD include shortness of breath, for people who have both asthma
cough, chest discomfort and and COPD. Its use may lead to an
coughing up phlegm. overdose of bronchodilator
This leaflet answers some common
medication, commonly found in
questions about Onbrez Breezhaler. Onbrez capsules for inhalation asthma medications.
It does not contain all the available belong to a group of medicines called
information. It does not take the bronchodilators. These medicines are
used to keep the air passages in the Do not use Onbrez Breezhaler if
place of talking to your doctor or you have ever had an allergic
lungs open and make breathing
pharmacist. reaction to indacaterol maleate
The information in this leaflet was (the active ingredient) or to any of
Onbrez capsules make breathing the other ingredients listed at the
last updated on the date listed on the
easier by opening the small air end of this leaflet.
final page. More recent information
passages in the lungs and helping Some of the symptoms of an allergic
on the medicine may be available.
them to remain relaxed and open. reaction may include shortness of
You should ensure that you speak breath, wheezing or difficulty
to your pharmacist or doctor to Onbrez is a long acting breathing; swelling of the face, lips,
obtain the most up-to-date bronchodilator. Each dose of Onbrez tongue or other parts of the body;
information on the medicine. You will keep your air passages open and rash, itching or hives on the skin.
can also download the most up-to- relieve chest tightness and wheezing
for 24 hours. Do not breast-feed while you are
date leaflet from
using this medicine.
www.novartis.com.au. Onbrez capsules for inhalation It is not known if the active
Those updates may contain important contain the active ingredient, ingredient passes into the breast milk
information about the medicine and indacaterol maleate in a capsule and could affect your baby.
its use of which you should be form.
aware. Do not use this medicine after the
The capsules are for oral inhalation expiry date printed on the pack or
All medicines have risks and only. The powder from the capsule is if the packaging is torn or shows
benefits. Your doctor has weighed inhaled (breathed into the lungs), signs of tampering.
the risks of you having Onbrez using the Breezhaler® inhalation In that case, return it to your
Breezhaler against the benefits they device provided with the medicine. pharmacist.
expect it will have for you.
Ask your doctor if you have any
If you have any concerns about questions about why Onbrez Before you start to use it
having this medicine, ask your Breezhaler has been prescribed for
doctor or pharmacist. you. Tell your doctor if you have any of
This medicine is only available with the following medical conditions:
Keep this leaflet. a doctor's prescription. • asthma
You may need to read it again. It is not addictive. • heart problems
• thyroid gland problems
What Onbrez Before you use
Onbrez Breezhaler Your doctor may want to take special
Breezhaler is used for
precautions if you have any of the
Onbrez capsules are for the treatment above conditions.
of chronic obstructive pulmonary When you must not use it
disease, also called COPD. COPD is
Onbrez® Breezhaler® 1
Tell your doctor if you are If you have not told your doctor carton that show you how to use
pregnant or intend to become about any of these things, tell the Breezhaler properly.
pregnant. him/her before you start using
Onbrez Breezhaler. Make sure you understand how to
Onbrez is not recommended for use
use the device properly. If you are
during pregnancy. If it is necessary
not sure, ask your doctor or
for you to use this medicine during pharmacist for help.
pregnancy, your doctor will discuss
with you the benefits and risks How to use Onbrez How long to use it
Continue to use this medicine for
as long as your doctor tells you to.
Taking other medicines You may have been given a
treatment plan by your doctor to If it helps your breathing problems,
help you manage your COPD and your doctor may want you to keep
Tell your doctor or pharmacist if to know what to do when it using it for a long time. This
you are taking any other worsens. Make sure that you medicine helps to control your
medicines, including medicines understand this plan by talking to condition but it does not cure it. You
that you buy without a your doctor and pharmacist about will need to use other medications as
prescription from a pharmacy, it. In particular, do not stop other well and this will be outlined in your
supermarket or health food shop. medications that are used to treat COPD management plan.
Some medicines and Onbrez may COPD even if you feel well. Only
interfere with each other. These stop other prescribed medications
include: on medical advice. If you still smoke, you should stop.
If have not taken advice about an
• some similar medicines used to
Follow all directions given to you exercise program, consider asking
treat your lung disease
by your doctor and pharmacist for it.
• medicines for high blood pressure
and heart problems (beta These directions may differ from the
blockers e.g. propanolol)
If you forget to use it
information contained in this leaflet.
• medicines used to treat If it is almost time for your next
depression and other mental If you do not understand the dose, skip the one you missed and
disorders (e.g. tricyclic instructions on the label or in the use the next dose when you are
carton, ask your doctor or meant to.
pharmacist for help.
oxidase inhibitors) Otherwise, use it as soon as you
• medicines for glaucoma, remember, and then go back to
including eye drops (e.g. using it as you would normally.
How much to use
Do not use a double dose to make
• medicines that decrease the level The usual dose for adults is the
up for the one that you missed.
of potassium in the blood inhalation (puff) of the content of
one capsule each day, everyday. This may increase the chance of you
• medicines for hay fever, coughs, getting an unwanted side effect.
colds and runny nose Only two daily doses are possible,
150 or 300 micrograms. There is no If you have trouble remembering
• other bronchodilators such as
gain to be had from exceeding these when to use your medicine, ask
doses. Most people with COPD your pharmacist for some hints.
theophylline) or steroids (e.g.
benefit from 150 micrograms per
day. If you use too much
• diuretic medicines, also called
fluid or water pills used to treat Take your puff at the same time each (Overdose)
high blood pressure (e.g. day to help minimise your symptoms
throughout the day and night. It will Immediately telephone your doctor
hydrochlorothiazide) or Poisons Information Centre
also help you remember to use your
You may need to take different (telephone 13 11 26) for advice, or
amounts of your medicines or you go to Accident and Emergency at
may need to take different medicines. your nearest hospital if you think
Your doctor and pharmacist have How to use the Breezhaler that you or anyone else may have
more information. used too much Onbrez. Do this
Carefully read the instructions and even if there are no signs of
follow the diagrams inside the discomfort or poisoning.
Onbrez® Breezhaler® 2
Some of the symptoms of an Do not take any other medicines • crushing chest pain (heart
overdose may include nausea for your breathing problems problems)
(feeling sick), vomiting, shakiness, without checking with your doctor. • neck pain
sleepiness, headache and fast or Do not give this medicine to • palpitations (feeling that your
irregular heartbeat. anyone else, even if their condition heartbeat is unusually fast or
seems similar to yours. irregular)
Do not use it to treat any other • headache
complaints unless your doctor tells • sore throat
While you are using you to. • cough
• runny nose
Things to be careful of • blocked nose
Things you must do
Be careful driving, operating • dry mouth
Only use the inhalation device machinery or doing jobs that • feeling pressure or pain in the
contained in this pack. require you to be alert until you cheeks and forehead
Use this medicine exactly as your know how Onbrez affects you. (inflammation of the sinuses)
doctor has prescribed. Try not to This medicine may cause dizziness in
miss any doses and use it even if • chest pain
some people. Make sure you know
you feel well. how you react before you drive a car, • chest discomfort
If you don not follow your doctor's operate machinery, or do anything • pain in muscles, bones or joints
instructions, you may not get relief else that could be dangerous. If you • excessive thirst, high urine
from your breathing problems or you are dizzy, do not drive. output, increase appetite with
may have unwanted side effects. weight loss and tiredness, high
If you find that the usual dose of level of sugar in the blood (that
Onbrez Breezhaler is not giving as are signs of a disease called
much relief as before, or does not Side effects diabetes)
last as long as usual, contact your • tingling and numbness
doctor so that your condition can
Tell your doctor or pharmacist as Some people occasionally cough
soon as possible if you do not feel soon after inhaling the medicine.
This is important to ensure your
well while you are using Onbrez Cough is a common symptom in
COPD is controlled properly. Breezhaler. COPD patients. If you experience
If you become pregnant while All medicines can have side effects. coughing briefly after inhaling the
using this medicine, tell your Sometimes they are serious, most of medicine, do not worry, as long as
doctor. the time they are not. You may need the capsule is empty, you have
Your doctor can discuss with you the medical treatment if you get some of received the full dose.
risks of using it while you are the side effects.
Do not be alarmed by these lists of Tell your doctor immediately or go
If you are about to be started on possible side effects. You may not to Accident and Emergency at
any new medicine, remind your experience any of them. Ask your your nearest hospital if any of the
doctor and pharmacist that you doctor or pharmacist to answer following happen:
are using Onbrez Breezhaler. any questions you may have.
• crushing chest pain (heart
Tell any other doctor, dentist or Tell your doctor if you notice any problems)
pharmacist who treats you that of the following side effects and • you develop signs of allergy such
you are using this medicine. they worry you:
as swelling of the face, lips,
• combination of sore throat, runny tongue or other part of the body;
Things you must not do nose, blocked nose, sneezing, severe dizziness or fainting;
coughing, headache with or redness, itching or rash on the
Do not exceed the recommended without fever skin
daily dose – it will not help you to
• sneezing Tell your doctor if you notice
do this. Instead, check your
COPD management plan and seek • muscle pain anything else that is making you
medical attention. Do not swallow • muscle spasm feel unwell.
the capsules. • swollen hands, ankles and feetSome people may have other side
effects not yet known or mentioned
in this leaflet. Some side effects may
Onbrez® Breezhaler® 3
only be found when your doctor Novartis logo. The capsules come in
orders blood tests from time to time. foil packs containing 30 capsules in a
After using Onbrez A white plastic Breezhaler inhalation
Breezhaler device is also supplied in the pack.
Cleaning and storage
• Follow the instructions in the
Each capsule contains either 150 or
carton on how to properly clean 300 micrograms of indacaterol as
and take care of your Onbrez indacaterol maleate.
• Store it in a cool dry place away Inactive ingredients
from moisture. Onbrez capsules also contain lactose.
The capsule shell is made of gelatin,
• Do not store the device or any
an edible material.
other medicine in the bathroom
or near a sink.
• Do not leave it in the car or on
window sills. Onbrez Breezhaler is supplied in
Australia by: Novartis
Keep this medicine where children
Pharmaceuticals Australia Pty
cannot see or reach it.
A locked cupboard at least one-and- ABN 18 004 244 160
a-half metres above the ground is a
54 Waterloo Road
good place to store medicines.
North Ryde NSW 2113
Disposal Web site: www.novartis.com.au
If your doctor tells you to stop
using this medicine or the expiry ® = Registered Trademark
date has passed, ask your This leaflet was prepared in August
pharmacist how to dispose of it 2010
Australian Registration Numbers.
Onbrez Breezhaler 150 microgram:
AUST R 160172
Product description Onbrez Breezhaler 300 microgram:
AUST R 160177
What it looks like
Indacaterol 150 microgram
Clear colourless hard capsules with
black imprints. The capsules are
marked with “IDL 150” and a
Novartis logo. The capsules come in
foil packs containing 30 capsules in a
Indacaterol 300 microgram
Clear colourless hard capsules with
blue imprints. The capsules are
marked with “IDL 300” and a
Onbrez® Breezhaler® 4