BRETARIS GENUAIR Owner's manual

BRETARIS®GENUAIR®1
BRETARIS® GENUAIR®
aclidinium bromide
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common
questions about BRETARIS
GENUAIR.
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 pharmacist or doctor
will be able to advise you about the
risks and benefits of using
BRETARIS GENUAIR.
If you have any concerns about
using this medicine, ask your
pharmacist or doctor.
Keep this leaflet with the medicine.
You may need to read it again.
What BRETARIS
GENUAIR is used for
The active ingredient of BRETARIS
GENUAIR is aclidinium bromide,
which belongs to a group of
medicines called bronchodilators.
Bronchodilators relax airways and
help keep bronchioles open.
BRETARIS GENUAIR is a dry
powder inhaler that uses your breath
to deliver the medicine directly into
your lungs. This makes it easier for
chronic obstructive pulmonary
disease (COPD) patients to breathe.
BRETARIS GENUAIR is indicated
to help open the airways and relieve
symptoms of COPD, a serious, long-
term lung disease characterised by
breathing difficulties. Regular use of
BRETARIS GENUAIR can help you
when you have ongoing shortness of
breath related to your disease and
will help you to minimise the effects
of the disease on your everyday life.
BRETARIS GENUAIR is indicated
for maintenance treatment of your
COPD; it should not be used to treat
a sudden attack of breathlessness or
wheezing. If your COPD symptoms
(breathlessness, wheezing, cough) do
not improve or get worse you should
contact your doctor for advice as
soon as possible.
Ask your doctor if you have any
questions about why BRETARIS
GENUAIR has been prescribed for
you.
This medicine is only available with
a doctor's prescription.
It is not addictive.
Before you use
BRETARIS GENUAIR
When you must not use it
Do not use BRETARIS GENUAIR
if you have an allergy to:
aclidinium bromide or any of the
other ingredients of this medicine
listed at the end of this leaflet
atropine or related bronchodilator
medicines, for example
ipratropium, tiotropium or
oxitropium.
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 use this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
In that case, return it to your
pharmacist.
Before you start to use it
Tell your doctor if you have any of
the following medical conditions:
if you have asthma
if you have had heart problems
recently
if you see halos around lights and
coloured images, have eye pain or
discomfort or temporary blurring
of vision (narrow angle
glaucoma)
if you have an enlarged prostate,
problems passing urine, or a
blockage in your bladder
if you have rare hereditary
galactose intolerance, the Lapp
lactase deficiency or glucose-
galactose malabsorption.
Your doctor may want to take special
precautions if you have any of the
above conditions.
BRETARIS GENUAIR may cause
dryness in the mouth, which may
cause tooth decay after using your
medicine for a long time. Therefore,
please remember to pay attention to
oral hygiene.
Tell your doctor if you are
pregnant, intend to become
pregnant or are breastfeeding.
BRETARIS GENUAIR is not
recommended for use during
pregnancy or while breastfeeding. If
it is necessary for you to use this
medicine during pregnancy or while
breastfeeding, your doctor will

BRETARIS®GENUAIR®2
discuss with you the benefits and
risks involved.
Children and adolescents
BRETARIS GENUAIR is not for use
in children or adolescents below 18
years of age.
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 BRETARIS
GENUAIR may interfere with each
other. These include other medicines
used to treat breathing difficulties,
such as tiotropium, ipratropium or
oxitropium (called anticholinergics).
You may need to take different
amounts of your medicines or you
may need to take different medicines.
Your doctor and pharmacist have
more information.
If you have not told your doctor
about any of these things, tell him/
her before you start using
BRETARIS GENUAIR.
How to use BRETARIS
GENUAIR
Follow all directions given to you
by your doctor and pharmacist
carefully.
These directions may differ from the
information contained in the leaflet.
If you do not understand the
instructions, ask your doctor or
pharmacist for help.
How much to use
The recommended dose is one
inhalation twice a day in the morning
and night.
The effects of BRETARIS
GENUAIR last for 12 hours;
therefore, you should try to use your
BRETARIS GENUAIR inhaler at the
same time every morning and at
night. This ensures that there is
always enough medicine in your
body to help you breathe more easily
throughout the day and night. It will
also help you to remember to use it.
How to use
See instructions at the end of this
leaflet or refer to booklet contained
within the carton for instructions on
how to use the BRETARIS
GENUAIR inhaler.
If you are not sure of how to use
BRETARIS GENUAIR, ask your
doctor or pharmacist.
How long to use
Continue to use this medicine for
as long as your doctor tells you to.
If it helps your breathing problems,
your doctor may want you to keep
using it for a long time.
This medicine helps to control your
condition but it does not cure it.
If you want to stop treatment, first
talk to your doctor, as your
symptoms may worsen.
If you forget to use it
If you forget to have a dose of
BRETARIS, inhale the dose as
soon as you remember. However, if
it is nearly time for your next dose,
skip the missed dose.
Do not take a double dose to make
up for the one that you missed.
This may increase the chance of you
getting an unwanted side effect.
If you have trouble remembering
when to use your medicine, ask
your pharmacist for some hints.
If you use too much
(overdose)
Immediately telephone your doctor
or the Poisons Information Centre
(telephone 13 11 26) for advice, or
go to Accident and Emergency at
the nearest hospital, if you think
that you or anyone else may have
used too much BRETARIS. Do this
even if there are no signs of
discomfort or poisoning.
While you are using
BRETARIS GENUAIR
Things you must do
Use this medicine exactly as your
doctor has prescribed. Try not to
miss any doses and use it even if
you feel well.
If you do not follow your doctor's
instructions, you may not get relief
from your breathing problems or you
may have unwanted side effects.
If you find that the usual dose of
BRETARIS is not giving as much
relief as before, or does not last as
long as usual, contact your doctor
so that your condition can be
checked.
This is important to ensure your
COPD is controlled properly.
If you become pregnant while
using this medicine, tell your
doctor.
Your doctor can discuss with you the
risks of using it while you are
pregnant.
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are using BRETARIS GENUAIR.
Tell any other doctors, dentists,
and pharmacists who treat you
that you are using this medicine.
Things you must not do
Do not exceed the recommended
daily dose –it will not help you to
do this.
Do not take any other medicines
for your breathing problems
without checking with your doctor.
Do not give this medicine to anyone
else, even if their condition seems
similar to yours.
Do not use it to treat any other
complaints unless your doctor tells
you to.

BRETARIS®GENUAIR®3
Things to be careful of
Be careful driving, operating
machinery or doing jobs that
require you to be alert until you
know how BRETARIS GENUAIR
affects you.
This medicine may cause headache,
dizziness or blurred vision. If you are
affected by either of these side
effects do not drive or use machinery
until the headache has cleared and
your vision has returned to normal.
Side effects
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are using
BRETARIS GENUAIR.
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 these lists of
possible 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:
headache
inflammation of the sinuses
(sinusitis)
runny nose or sneezing (rhinitis)
common cold or flu symptoms
cough
diarrhoea, vomiting, nausea or
abdominal discomfort
dry mouth
changes in voice
fungal infection in the mouth
(candidiasis)
dizziness
toothache or infection in the
tissues at the base of a tooth
(tooth abscess)
inflammation of the mouth
(stomatitis)
blurred vision
fall
heart failure, diabetes, arthritis
itchy rash.
Tell your doctor as soon as possible
if you notice any of the following:
palpitations (feeling your
heartbeat is unusually fast or
irregular)
difficulty passing urine (urinary
retention).
Tell your doctor immediately or go
to Accident and Emergency at
your nearest hospital if any of the
following happen:
you develop signs of an allergic
reaction such as swelling of the
face, lips, tongue, throat or other
part of the body; severe dizziness
or fainting, faster heart rate,
redness, itching or rash on the
skin
if you get tightness of the chest,
coughing, wheezing or
breathlessness immediately after
using the medicine. These may be
signs of a condition called
bronchospasm.
Tell your doctor or pharmacist if
you notice anything else that is
making you feel unwell.
After using BRETARIS
GENUAIR
Storage
Keep the BRETARIS GENUAIR
inhaler protected in the sealed
pouch until you need to start using
it.
The inhaler must be used within 90
days of opening the pouch.
Keep your inhaler in a cool dry
place where the temperature stays
below 30°C.
Do not store BRETARIS
GENUAIR or any other medicine
in the bathroom or near a sink. Do
not leave it on a window sill or in
the car.
Heat and dampness can destroy some
medicines.
Keep it where children cannot
reach it.
A locked cupboard at least one-and-
a-half metres above the ground is a
good place to store medicines.
Disposal
If your doctor tells you to stop
using the inhaler or the expiry date
has passed, ask your pharmacist
how to dispose of it properly.
Product description
What it looks like
BRETARIS is a white or almost
white powder.
The BRETARIS GENUAIR inhaler
device is white coloured with an
integral dose indicator and a green
dosage button. The mouthpiece is
covered with a removable green
protective cap. It is supplied in a
sealed pouch.
Ingredients
Active Ingredient
Each delivered dose contains 375
micrograms aclidinium bromide
(equivalent to 322 micrograms of
aclidinium).
Inactive Ingredient
BRETARIS also contains lactose
monohydrate.
Supplier
BRETARIS GENUAIR is supplied
in Australia by:
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Avenue
Chatswood NSW 2067
Medical Information: 1800 644 542

BRETARIS®GENUAIR®4
® = Registered Trademarks of
Almirall, S.A. and AstraZeneca AB
Australian Registration Number(s):
AUST R 206071
This leaflet was revised in February
2020.
For the most up to date version of
this document, please go to
www.menarini.com.au/cmi
[vA04-0]
Instructions for Use
Getting Started
Before using the BRETARIS
GENUAIR inhaler, please read the
full instructions.
You should become familiar with the
parts of your inhaler (see image 1).
IMAGE 1
Before Use
Before first use, tear the sealed
pouch along the notch and
remove the inhaler.
Do not press the green button
until you are ready to take a dose.
When you are about to take your
dose of medicine, remove the
protective cap by LIGHTLY
SQUEEZING THE ARROWS
marked on each side and pulling
outwards (see image 2).
IMAGE 2
Step 1: Activate your inhaler
1.1 Look to see that nothing is
blocking the mouthpiece (see image
3).
1.2 Look at the coloured control
window and it should be red (see
image 3).
IMAGE 3
1.3 Hold the inhaler horizontally with
the mouthpiece towards you and the
green button facing straight up (see
image 4).
Make sure the green button is on
top. DO NOT TILT.
IMAGE 4
1.4 Press the green button all the way
down to load your dose (see image
5). When you press the button all the
way down, the control window
changes from red to green.
1.5 Release the green button (see
image 6).
Make sure you release the green
button so the inhaler can work
correctly.
IMAGE 5 IMAGE 6
Stop and Check: Make sure
your dose is ready for
inhalation
1.6 Make sure the coloured control
window has changed to GREEN (see
image 7).
The green control window
confirms that your medicine is
ready for inhalation.
IF THE COLOURED CONTROL
WINDOW STAYS RED AFTER
PRESSING THE GREEN
BUTTON ALL THE WAY
DOWN, GO BACK TO 'STEP 1
ACTIVATE YOUR INHALER'
AND REPEAT STEPS 1.1 TO 1.6.
IMAGE 7
Step 2: Inhale your dose
Read steps 2.1 to 2.7 fully before
use. DO NOT HOLD THE
GREEN BUTTON DOWN
WHILE INHALING. Do not tilt.
2.1 Before bringing the inhaler to
your mouth, breathe out completely
away from the mouthpiece. Do not
breathe out into the mouthpiece of
the inhaler.
2.2 Hold your head upright and close
your lips tightly around the
mouthpiece of the inhaler.
2.3 Breathe in STRONGLY and
DEEPLY through your mouth (see
image 8). This strong, deep breath
pulls the medicine through the
inhaler into your lungs.
While you breathe in you will hear
a “CLICK” which signals that you
are inhaling correctly. Keep
breathing in for as long as possible
even after you have heard the
“CLICK” to be sure you get the
full dose.
ATTENTION: DO NOT HOLD
THE GREEN BUTTON DOWN
WHILE YOU ARE INHALING.
DO NOT TILT.
IMAGE 8

BRETARIS®GENUAIR®5
2.4 Remove the inhaler from your
mouth.
2.5 Hold your breath for as long as is
comfortable.
2.6 Breathe out slowly through your
nose, away from the mouthpiece.
Some patients may experience a
grainy sensation in their mouth, or a
slightly sweet or bitter taste when
inhaling the medicine. Do not take an
extra dose if you do not taste or feel
anything after inhaling.
Stop and Check: Make sure
you have inhaled correctly
2.7 Make sure the control window is
now RED (see image 9). This
confirms that you have inhaled your
full dose correctly.
IF THE COLOURED CONTROL
WINDOW IS STILL GREEN,
THIS MEANS YOU HAVE NOT
INHALED YOUR FULL DOSE
CORRECTLY. GO BACK TO
'STEP 2 INHALE YOUR DOSE'
AND REPEAT STEPS 2.1 TO 2.7.
If the control window still does
not change to RED, you may
have forgotten to release the
green button before inhaling or
may not have inhaled correctly. If
that happens, try again.
Make sure you have RELEASED
the green button and take a
STRONG DEEP breath in through
the mouthpiece.
Note: If you are unable to inhale
correctly after several attempts,
consult your doctor.
IMAGE 9
Once the control window has
turned red, replace the protective
cap by pressing it back onto the
mouthpiece (see image 10). This
will prevent moisture from
getting inside the mouthpiece of
your inhaler.
IMAGE 10
Additional Information
What should you do if you
accidentally prepared a dose?
Store your inhaler with the protective
cap in place until it is time to inhale
your dose, then remove the cap and
start at Step 1.6.
How should you clean the inhaler?
You DO NOT NEED to clean your
inhaler. However, if you wish to
clean it you should do so by wiping
the outside of the mouthpiece with a
dry tissue or paper towel.
NEVER use water to clean the
inhaler, as this may damage your
medicine.
How does the dose indicator work?
The inhaler is equipped with a
dose indicator to show you
approximately how many doses
are left in the inhaler.
On first use, every inhaler
contains at least 60 doses, or at
least 30 doses, depending on the
pack size.
Each time you load a dose by
pressing the green button all the
way down, the dose indicator
moves down slowly displaying
intervals of 10 (60, 50, 40, 30, 20,
10, 0) (see image 11).
IMAGE 11
When should you get a new
inhaler?
You should get a new inhaler:
When a RED STRIPED BAND
appears in the dose indicator (see
image 11); this means you are
nearing your last dose, or
If your inhaler appears to be
damaged or if you lose the cap, or
If your inhaler is empty (see 'How
do you know that your inhaler is
empty?').
How do you know that your
inhaler is empty?
When 0 (zero) appears in the
middle of the dose indicator, you
should continue using any doses
remaining in the inhaler.
When the last dose has been
prepared for inhalation, the green
button will not return to its full
upper position, but will be locked
in a middle position (see image
12). Even though the green button
is locked, your last dose may still
be inhaled. After that, the inhaler
cannot be used again and you
should start using a new
BRETARIS GENUAIR inhaler.
IMAGE 12