ONBREZ BREEZHALER capsules for inhalation by hjkuiw354


capsules for inhalation
Indacaterol maleate
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
                                                                                 • epilepsy
                                                                                 • thyroid gland problems
                                                                                 • diabetes
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
involved.                               Breezhaler
                                                                                 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.
   antidepressants, monoamine
                                        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
   methylxanthines (e.g.
                                        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
Onbrez Breezhaler
                                                                               • 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
be checked.
                                       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
                                         cardboard carton.

After using Onbrez                       A white plastic Breezhaler inhalation
Breezhaler                               device is also supplied in the pack.

Cleaning and storage
                                         Active Ingredient
• 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
                                         Telephone 1-800-671-203
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
cardboard carton.

Indacaterol 300 microgram
Clear colourless hard capsules with
blue imprints. The capsules are
marked with “IDL 300” and a
Onbrez® Breezhaler®                                                                                4

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