BRIMICA GENUAIR 340/12 User manual

BRIMICA® GENUAIR® 340/12
aclidinium bromide / formoterol (eformoterol) fumarate dihydrate
Consumer Medicine Information
BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 1
What is in this leaflet
This leaflet answers some common
questions about BRIMICA
GENUAIR 340/12.
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
BRIMICA GENUAIR 340/12.
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 BRIMICA
GENUAIR 340/12 is
used for
BRIMICA GENUAIR 340/12
contains two different medicines
called aclidinium bromide and
formoterol (eformoterol) fumarate
dihydrate.
Both belong to a group of
medicines known as
bronchodilators. Bronchodilators
relax airways and help keep
bronchioles open.
BRIMICA GENUAIR 340/12 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.
BRIMICA GENUAIR 340/12 is
used to help open the airways and
relieve symptoms of COPD, a
serious long-term lung disease
characterised by breathing
difficulties. Regular use of
BRIMICA GENUAIR 340/12 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.
BRIMICA GENUAIR 340/12 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 BRIMICA
GENUAIR 340/12 has been
prescribed for you.
This medicine is only available with
a doctor
’
s prescription.
It is not addictive.
Before you use
BRIMICA GENUAIR
340/12
When you must not use it
Do not use BRIMICA GENUAIR
340/12 if you have an allergy to:
•
aclidinium bromide, formoterol
(eformoterol) fumarate
dihydrate or any of the other
ingredient of this medicine listed
at the end of 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 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 have epilepsy
•
if you have thyroid gland
problems (thyrotoxicosis)
•
if you have a tumour in one of
your adrenal glands
(phaeochromocytoma)
•
if you have difficulty passing
urine
•
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 rare hereditary
galactose intolerance, the total
lactase deficiency or glucose-
galactose malabsorption.
Your doctor may want to take
special precautions if you have any
of the above conditions.
BRIMICA GENUAIR 340/12 may
cause dryness in the mouth, which

BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 2
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.
BRIMICA GENUAIR 340/12 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
discuss with you the benefits and
risks involved.
Children and adolescents
BRIMICA GENUAIR 340/12 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 BRIMICA
GENUAIR 340/12 may interfere
with each other. These include:
•
other medicines used to treat
breathing difficulties
•
medicines that lower the amount
of potassium in your blood.
These include:
- steroids that you take by mouth
(such as prednisolone)
- diuretics (such as furosemide
(frusemide) or
hydrochlorothiazide)
- certain medicines used to treat
breathing conditions (such as
theophylline).
•
medicines called beta blockers
that may be used to treat high
blood pressure or other heart
problems (such as atenolol or
propranolol) or to treat
glaucoma (such as timolol)
•
medicines which can cause a
change in your heart trace
(electrocardiogram) known as
QT interval prolongation. These
include medicines for the
treatment of:
- depression, such as
monoamine oxidase inhibitors
or tricyclic antidepressants
- bacterial infections (such as
erythromycin, clarithromycin,
telithromycin)
- allergic reaction anti-
histamines).
You may need to take different
amounts of your medicines or you
may need to take different
medicines. Your doctor and
pharmacist will advise you.
If you have not told your doctor
about any of these things, tell
him/ her before you start using
BRIMICA GENUAIR 340/12.
How to use BRIMICA
GENUAIR 340/12
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, 12 hours apart.
The effects of BRIMICA
GENUAIR 340/12 last for 12 hours;
therefore, you should try to use your
BRIMICA GENUAIR 340/12
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 the booklet
contained within the carton for
instructions on how to use the
BRIMICA GENUAIR 340/12
inhaler.
If you are not sure of how to use
BRIMICA GENUAIR 340/12, 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
BRIMICA 340/12, 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 BRIMICA GENUAIR
340/12. Do this even if there are
no signs of discomfort or
poisoning.

BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 3
While you are using
BRIMICA GENUAIR
340/12
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
BRIMICA 340/12 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 BRIMICA GENUAIR
340/12.
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.
Things to be careful of
Be careful driving, operating
machinery or doing jobs that
require you to be alert until you
know how BRIMICA GENUAIR
340/12 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
BRIMICA GENUAIR 340/12.
All medicines may have some
unwanted side effects. Sometimes
they are serious, but 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
•
increased mucous (sputum)
•
diarrhoea, vomiting or nausea
•
dry mouth
•
changes in voice
•
changes in sense of taste
•
sore mouth or throat from
inhaling the powder or irritation
in the throat
•
painful swelling and sores inside
the mouth
•
cellulitis
•
itchy rash
•
being unable to sleep
•
fatigue
•
dizziness
•
muscle aching, cramps or
spasms
•
chest pain
•
trembling, shakiness or agitation
•
nervousness or anxiety
•
infection in the tissues at the
base of a tooth (tooth abscess)
•
blurred vision
Tell your doctor as soon as
possible if you notice any of the
following:
•
palpitations (feeling that your
heartbeat is unusually fast or
irregular)
•
painful and/or frequent urination
–
these may be signs of a
urinary tract infection
•
difficulty passing urine (urinary
retention)
•
difficulty in breathing.
The above list includes side effects
that may require medical attention.
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, eyes or
other part of the body; difficulty
in breathing, palpitations, severe
dizziness or fainting; 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
paradoxical bronchospasm.
Your doctor may consider other
treatment for your COPD.
Tell your doctor or pharmacist if
you notice anything else that is
making you feel unwell.

BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 4
After using BRIMICA
GENUAIR 340/12
Storage
Keep the BRIMICA GENUAIR
340/12 inhaler protected in the
sealed pouch until you need to
start using it.
The inhaler must be used within 60
days of opening the pouch.
Keep your inhaler in a cool dry
place where the temperature
stays below 30°C.
Do not store BRIMICA
GENUAIR 340/12 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
BRIMICA 340/12 is a white or
almost white powder.
The BRIMICA GENUAIR 340/12
inhaler device is white coloured
with an integral dose indicator and
an orange dosage button. The
mouthpiece is covered with an
orange removable protective cap. It
is supplied in a sealed pouch.
Ingredients
Active Ingredients
Each delivered dose contains 396
micrograms aclidinium bromide
(equivalent to 340 micrograms
aclidinium) and 12 micrograms of
formoterol (eformoterol) fumarate
dihydrate.
Inactive Ingredient
BRIMICA GENUAIR 340/12 also
contains lactose monohydrate.
Supplier
BRIMICA GENUAIR 340/12 is
supplied in Australia by:
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Avenue
Chatswood NSW 2067
Medical Information: 1800 644 542
® = Registered Trademarks of
Almirall, S.A. and AstraZeneca AB
Australian Registration Number(s):
AUST R 224899
This leaflet was revised in March
2021.
For the most up to date version of
this document, please go to
www.menarini.com.au/cmi
[vA06-0]
Instructions for Use
Getting Started
Before using the BRIMICA
GENUAIR 340/12 inhaler, please
read the full instructions.
You should become familiar with
the parts of your inhaler (see image
1).
Before Use
•
Before first use, tear the sealed
pouch along the notch and
remove the inhaler.
•
Do not press the orange 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).
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).
1.3 Hold the inhaler horizontally
with the mouthpiece towards you
and the orange button facing
straight up (see image 4).
Make sure the orange button is
on top. DO NOT TILT.

BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 5
1.4 Press the orange 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 orange button (see
image 6).
Make sure you release the orange
button so the inhaler can work
correctly.
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
ORANGE BUTTON ALL THE
WAY DOWN, GO BACK TO
'STEP 1 ACTIVATE YOUR
INHALER' AND REPEAT
STEPS 1.1 TO 1.6.
Step 2: Inhale your dose
Read steps 2.1 to 2.7 fully before
use. DO NOT HOLD THE
ORANGE 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 ORANGE BUTTON
DOWN WHILE YOU ARE
INHALING. DO NOT TILT.
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
orange button before inhaling or
may not have inhaled correctly.
If that happens, try again.
Make sure you have RELEASED
the orange 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.
•
Once the control window has
turned red, replace the
protective cap by pressing it
back onto the mouthpiece (see
image 10). This will prevent

BRIMICA® GENUAIR® 340/12
Published by MIMS May 2021 6
moisture from getting inside the
mouthpiece of your inhaler.
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 orange 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).
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
orange button will not return to
its full upper position, but will
be locked in a middle position
(see image 12). Even though the
orange 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 BRIMICA
GENUAIR 340/12 inhaler.