TEVA Airomir Autohaler Owner's manual

Airomir™ Autohaler™ and Inhaler
Salbutamol sulfate (sal-bute-a-mol sull-fate)
Consumer Medicine Information
Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014 1
What is in this leaflet
This leaflet answers some common
questions about Airomir Autohaler
and Airomir Inhaler. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Airomir
Autohaler or Airomir Inhaler against
the benefits they expect it will have
for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
Keep this leaflet with your
medicine.
You may need to read it again.
What's in Airomir
Autohaler and Inhaler
The name of your medication is
Airomir Autohaler or Airomir
Inhaler. It contains a medicine called
salbutamol sulfate. Salbutamol
sulfate belongs to the beta-agonist
family of medicines. The amount of
medicine in each puff of Airomir
Autohaler or Inhaler is the same as
100 micrograms of salbutamol. Each
Airomir Autohaler or Inhaler
contains at least 200 puffs.
What Airomir Autohaler
and Inhaler are used for
Airomir Autohaler and Inhaler are
designed so the medicine can be
inhaled (breathed in) into the lungs to
treat asthma and other conditions
where breathing is difficult.
Salbutamol sulfate opens up the
airways to your lungs, thereby
relieving wheezing and the feeling of
tightness in your chest, and helps you
breathe more easily. Airomir
Autohaler and Airomir Inhaler are
therefore known as a RELIEVER
medicine.
Your medicine may also help prevent
wheezing and chest tightness in some
situations that cause narrowing of the
airways to your lungs, like exercise.
That's why your doctor or pharmacist
may advise you to take one or two
puffs of Airomir Autohaler or
Airomir Inhaler before exercise.
Your Airomir Autohaler or Inhaler is
designed to be just one part of a
general plan to help you manage your
asthma. Every asthma patient is
different. Ask your doctor or
pharmacist for an ASTHMA
MANAGEMENT PLAN that suits
you. Make sure you visit your doctor
or pharmacist regularly to check
whether your plan needs to be
changed.
Perhaps you have been prescribed
Airomir Autohaler or Inhaler for
something other than asthma.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
What's different about
Airomir Autohaler and
Airomir Inhaler?
If you have been using an older type
of inhaler you will find that Airomir
Autohaler or Inhaler has a different
taste and a warm, soft spray. But it is
still just as effective.
Each spray from Airomir Autohaler
or Inhaler contains exactly the same
dose of salbutamol sulfate active
ingredient as a spray from the older
type of inhaler.
Before you use Airomir
Autohaler or Airomir
Inhaler
When you must not use it
Do not use Airomir Autohaler or
Airomir Inhaler if you are allergic
to:
•salbutamol and similar drugs
•any of the ingredients listed under
"Product description" later in this
leaflet
Some of the symptoms of an allergic
reaction may include:
•shortness of breath
•wheezing or difficulty breathing
•swelling of the face, lips, tongue
or other parts of the body
•rash, itching or hives on the skin
Do not take this medicine after the
expiry date printed on the canister
or if the packaging is torn or shows
signs of tampering.

Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014 2
If it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should start using this medicine,
talk to your doctor.
Before you start to take it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor or pharmacist if
you have or have had any of the
following medical conditions:
•heart problems
•liver or kidney problems
•diabetes (high blood sugar)
•high blood pressure
•problems with your thyroid gland
•hypoxia (less oxygen in the
tissues)
Tell your doctor or pharmacist if
you are pregnant or plan to
become pregnant or are breast-
feeding.
Your doctor or pharmacist can
discuss with you the risks and
benefits involved.
If you have not told your doctor or
pharmacist about any of the above,
tell them before you start using
Airomir Autohaler or Airomir
Inhaler.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
medicines, including any that you
get without a prescription from
your pharmacy, supermarket or
health food shop.
Some medicines and Airomir
Autohaler or Airomir Inhaler may
interfere with each other.
These include:
•any medications for high blood
pressure or angina (for example
atenolol, metoprolol, propranolol
or pindolol)
•theophylline or any steroids
•fluid tablets (diuretics), (for
example frusemide or
chlorothiazide)
These medicines may be affected by
Airomir Autohaler or Airomir Inhaler
or may affect how well they work.
You may need different amounts of
your medicines, or you may need to
take different medicines.
Your doctor and pharmacist have
more information on medicines to be
careful with or avoid while taking
this medicine.
How to use Airomir
Autohaler and Airomir
Inhaler
Carefully follow all directions
given to you by your doctor or
pharmacist.
They may differ from the
information contained in this leaflet.
Even if you have been using
another type of inhaler or
autohaler, please read the
instructions for use in this leaflet
before you start.
Your Airomir Autohaler or Airomir
Inhaler may not help you as much as
it should if not used correctly.
If you do not understand the
instructions, ask your doctor or
pharmacist for help.
Airomir Autohaler Instructions
for Use
If your Airomir Autohaler is new or
has not been used for two weeks or
more, you must test fire it by
releasing four puffs into the air away
from your face.
1. REMOVE COVER AND
SHAKE
Remove the mouthpiece cover by
unclipping it from the back.
Check that the mouthpiece is
clean before use.
Hold the autohaler unit upright
between your thumb and index
finger and shake well.
2. HOLD UPRIGHT AND PUSH
LEVER UP
Hold the autohaler unit upright.
Push the lever up so that it stays
up. Keep holding the autohaler
unit upright, making sure that
your hand is not blocking the air
vent at the bottom.
3. BREATHE OUT AND
POSITION MOUTHPIECE.
Breathe out as far as you
comfortably can and immediately
close your lips around the
mouthpiece.
4. BREATHE IN
slowly and deeply through the
mouthpiece.
Do not stop breathing in when
you hear the click and whoosh
and feel the puff in your mouth. It
is important that you keep
breathing in after the puff is
released
5. HOLD YOUR BREATH
for 10 seconds, then breathe out
slowly.
6. PUSH LEVER DOWN
After each puff return the lever to
the down position whilst holding
the autohaler unit upright.
If your doctor has prescribed
more than one puff, repeat steps 2
to 6. Replace the mouthpiece
cover after use.
Remember to push the lever up
before each puff, and gently back
down afterwards, always holding
the autohaler upright. This
prepares the autohaler for your
next dose. The lever should be
left down between treatments and
the mouthpiece cover replaced to
keep your Airomir Autohaler
clean.
How to test fire or tell if your
Airomir Autohaler is empty
1. REMOVE THE
MOUTHPIECE COVER
by unclipping it from the back.
Shake the Autohaler.

Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014 3
2. Hold your Airomir Autohaler
upright and point the mouth-
piece away from you so that the
puffs of medicine will go into
the air.
PUSH THE LEVER UP
so that it stays up.
3. RELEASE A PUFF
by pushing the dose release slide
on the bottom of the Autohaler
unit in the direction of the arrow.
4. TO RELEASE THE SECOND
PUFF
first return the lever to its down
position, then repeat steps 2 and 3
above. Repeat until you have
released four puffs altogether.
5. ALWAYS PUSH THE LEVER
BACK DOWN
after test firing. This prepares the
autohaler for your next dose.
6. If your Airomir Autohaler is
empty you will not feel or hear
a puff being discharged when
you test fire
Do not use the dose release slide to
take your medicine.
Your Airomir Autohaler will
automatically release a dose when
you begin to breathe in from the
mouthpiece.
Airomir Autohaler is designed for
ease of use. To make it work you just
breathe in through the mouthpiece.
There is no need to press and
breathe in at the same time.
A click and whoosh tells you that
Airomir Autohaler has automatically
released the correct dose of medicine.
Airomir Inhaler Instructions for
Use
If your Airomir Inhaler is new or you
have not used the inhaler for two
weeks or more, it must be tested
before use by releasing four puffs
into the air away from your face.
1. REMOVE COVER AND
SHAKE
If the mouthpiece of your inhaler
is fitted with a cover; remove the
cover. Check that the mouthpiece
is clean before use.
Hold the inhaler unit upright
between your thumb and index
finger and shake well.
2. BREATHE OUT
3. POSITION MOUTHPIECE,
START TO BREATHE IN
AND PRESS
Still holding the inhaler unit
upright between your thumb and
forefinger, place the mouthpiece
in the mouth and close your lips
firmly around it.
As you start to breathe in slowly,
use your forefinger to firmly
press the metal canister
downwards until a puff is
released.
4. FINISH BREATHING IN AND
HOLD
Check that the mouthpiece is
clean before use. Hold your
breath for 10 seconds before
breathing out slowly.
If you need another puff, repeat
steps 2 to 4.
Replace the mouthpiece cover after
use and put the inhaler unit away
in a safe place.
If your Airomir Autohaler
or Airomir Inhaler does
not work properly
When your inhaler is blocked little or
no medicine comes out when you
press down on the metal canister.
This may be for one of the following
reasons:
•A dirty or clogged mouthpiece:
Wash the mouthpiece as
described in Step 1 and air dry
thoroughly as described in Step 2.
•It may be empty. Check by
shaking.
•It may be put together wrongly.
It is important that the canister in the
correct position in your inhaler. The
narrow stem of the metal canister
should be fitted into the small socket.
If the stem of the metal canister is
not in the small socket, your
inhaler will not work.
Do not take your Airomir Autohaler
or Airomir Inhaler apart.
Do not drop or hit your Airomir
Autohaler or Airomir Inhaler because
it could be damaged.
How much to use
Use Airomir Autohaler or Inhaler
only as directed by your doctor or
pharmacist.
Adults
The usual dose is one or two puffs to
relieve wheezing, or before exercise.
You should not use more than 16
puffs per day without consulting
your doctor.
Do not use Airomir Autohaler or
Airomir Inhaler more often than
your doctor or pharmacist tells
you, or as stated in this leaflet.
Children
As for adults, or as directed by your
doctor.
Children using Airomir Autohaler
or Airomir Inhaler should be
supervised by a responsible adult.
Elderly
Older people should use Airomir
Autohaler or Airomir Inhaler as
directed by their doctor.
How to take it
Carefully follow the instructions
above under "How to use Airomir
Autohaler and Airomir Inhaler".

Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014 4
If you use too much
(overdose)
Do not use more than the
recommended dose unless your
doctor tells you to.
Too much use of any asthma
medication may be dangerous. If you
use more puffs than those
recommended you may suffer
unwanted effects. You may feel tense
and shaky and your heart may beat
faster than usual.
Immediately telephone your doctor
or the Poisons Information Centre
(in Australia call 131126; in New
Zealand call 0800 764 766) for
advice, or go to Accident and
Emergency at the nearest hospital,
if you think you or anyone else
may have used too much Airomir
Autohaler or Inhaler Do this even
if there are no signs of discomfort
or poisoning.
You may need medical attention.
While you are using
Airomir Autohaler or
Airomir Inhaler
Things you must do
If you are about to be started on
any new medicine remind your
doctor and pharmacist that you
are taking Airomir Autohaler or
Airomir Inhaler.
Tell any other doctors, dentists,
and pharmacists who treat you
that you are using this medicine.
If your usual dose of Airomir
Autohaler or Airomir Inhaler does
not seem to be working or it is not
lasting as long as before, contact
your doctor urgently.
If you are going to have surgery,
tell the surgeon or anaesthetist that
you are taking this medicine.
It may affect other medicines used
during surgery.
If you become pregnant while
taking this medicine, tell your
doctor immediately.
Things you must not do
Do not use Airomir Autohaler or
Airomir Inhaler to treat any other
complaints unless your doctor tells
you to.
Do not give your medicine to
anyone else even if they have the
same condition as you.
Side effects
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are using Airomir
Autohaler or Airomir Inhaler.
This medicine helps most people
with asthma, but it may have
unwanted side effects in a few people
and may occur with the normal use
of your Airomir Autohaler or
Airomir Inhaler.
All medicines can have side effects.
Sometimes they are serious, most of
the time they are not. You may need
medical attention if you get some of
the side effects.
Do not be alarmed by the following
lists of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may have.
Tell your doctor or pharmacist if you
notice any of the following and they
worry you:
•fine shaking in the hands
•headache
•feeling tense
•nausea
•light headedness
•leg cramps
•dizziness
•chest pain
•palpitations (when your heart
beats faster and harder than
normal)
•lowering of the potassium level in
the blood
•minor irritation to your mouth
and throat
The above list includes the more
common side effects of your
medicine. They are usually mild and
short-lived.
Tell your doctor or pharmacist if
you notice anything that is making
you feel unwell.
Other side effects not listed above
may also occur in some people.
After using Airomir
Autohaler or Airomir
Inhaler
Care and Cleaning
Keeping the plastic mouthpiece clean
is very important to prevent the
inhaler from becoming dirty and
clogged.
Your inhaler should be cleaned at
least once a week as follows:
•STEP 1.
WASH MOUTHPIECE UNDER
WARM RUNNING WATER.
Remove the canister and put aside
in a safe place. Never immerse
the canister in water.
Wash the mouthpiece through the
top and bottom with warm
running water for 30 seconds.
Wash the mouthpiece cover as
well.

Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014 5
•STEP 2.
SHAKE OFF EXCESS WATER
AND AIR DRY.
To dry, shake off excess water
and leave the mouthpiece and
cover in a safe place to air dry
thoroughly, such as overnight.
When the mouthpiece is dry,
replace the canister and the
mouthpiece cover.
If you need to use your inhaler
before it is completely dry, shake
off excess water, replace the
canister and remove most of the
water remaining in the
mouthpiece by test spraying twice
into the air away from your face.
Then take your dose as
prescribed. After such use, wash
the inhaler again and air dry
thoroughly as recommended
above.
NOTE:
Blockage from medication build-up
is more likely to occur if the
mouthpiece is not allowed to air-dry
thoroughly.
Storage
Keep your Airomir Autohaler or
Airomir Inhaler in a cool dry place
where the temperature stays below
30°C.
Do not store Airomir Autohaler or
Airomir Inhaler or any other
medicine in the bathroom or near a
sink. Do not leave it on a
windowsill or in the car.
Heat and dampness can destroy some
medicines.
Keep it (together with the
mouthpiece cover) in a place where
children cannot reach.
A locked cupboard at least one-and-
one-half metres above the ground is a
good place to store medicines.
Disposal
If your doctor tells you to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
medicine that is left over.
Dispose of your Airomir Autohaler
or Airomir Inhaler thoughtfully,
remembering that the metal
canister is pressurised. Do not
burn or puncture the metal
canister even when empty, as it
may explode.
Product description
What it looks like
•Airomir Autohaler (AUST R
67257) consists of a metal
canister sealed inside a plastic
autohaler unit. At the bottom of
the autohaler unit there is a
mouthpiece with a plastic cover.
At the top of the autohaler unit is
a lever. Available in pack sizes of
100* & 200 doses.
•Airomir Inhaler (AUST R
64799) consists of a metal
canister inside a plastic inhaler
unit. At one end of the inhaler
there is a mouthpiece with a
plastic cover. Available in pack
sizes of 100* & 200 doses.
* Not currently marketed
Ingredients
Airomir Autohaler and Airomir
Inhaler release 100 micrograms of
salbutamol in each puff.
Airomir Autohaler and Airomir
Inhaler also contain:
•ethanol (0.0036 mL per puff)
•oleic acid
•norflurane - a non-CFC
propellant that does not deplete
ozone from the atmosphere.
Sponsor/Supplier
Airomir Autohaler and Airomir
Inhaler are supplied by:
iNova Pharmaceuticals (Aust) Pty
Ltd
(ABN 88 000 222 408)
L10, 12 Help Street
Chatswood NSW 2067
Australian Toll Free: 1800 630 056
New Zealand Toll Free: 0508 375
394
Developed and manufactured by:
3M Health Care Limited
Loughborough UK
™ = Trademark
3M and Airomir are trademarks.
AeroChamberPlus is a registered
trademark of Trudell Medical.
This leaflet was prepared in March
2014.