TRIMBOW® 100/6/10 and 200/6/10

Beclometasone dipropionate 100 or 200 micrograms, formoterol (eformoterol) fumarate dihydrate 6 micrograms
and glycopyrronium (as bromide) 10 micrograms per spray

Consumer Medicine Information

What is in this leaflet ways to relax the muscles in your Before you use
airways, helping to open the airways TRIMBOW
This leaflet answers some of the wider and allowing you to breathe
more common questions about more easily.
When you must not use it
TRIMBOW. It does not contain all Regular treatment with this medicine
the available information. It does not Do not take this medicine if you
helps to relieve and prevent
take the place of talking to your have an allergy to:
symptoms such as shortness of
doctor or pharmacist. breath, wheezing and cough in adult • any medicine containing
All medicines have risks and patients with chronic obstructive beclometasone dipropionate,
benefits. Your doctor has weighed pulmonary disease (COPD) and formoterol (eformoterol)
the risks of you being given this asthma. fumarate dihydrate or
medicine against the benefits this glycopyrronium bromide
COPD is a serious long-term disease
medicine is expected to have for you. (glycopyrrolate)
in which the airways become blocked
and air sacs inside the lungs become • any of the other ingredients listed
If you have any concerns about
taking this medicine, ask your damaged, leading to difficulty in at the end of this leaflet.
doctor or pharmacist. breathing. Some of the symptoms of an allergic
Keep this leaflet with the medicine. reaction may include:
Asthma is a serious, long-term
You may need to read it again. disease where the muscles • shortness of breath
surrounding the airways become tight • wheezing or difficulty breathing
(bronchoconstriction), and swollen • swelling of the face, lips, tongue,
and irritated (inflammation). or other parts of the body
What TRIMBOW is Symptoms can come and go, which • rash, itching or hives on the skin.
used for can include shortness of breath,
Do not give this medicine to
wheezing, chest tightness and cough. children and adolescents below the
TRIMBOW is a pressurised metered-
Do not use this medicine to relieve age of 18 years.
dose inhaler that contains medicines a sudden attack of breathlessness
to help you breathe. Do not use this medicine after the
or wheezing. expiry date printed on the pack or
TRIMBOW contains the three active You will use TRIMBOW every day if the packaging is torn or show
ingredients: and not only when you have signs of tampering.
• beclometasone dipropionate, breathing problems or other If it has expired or is damaged, return
• formoterol (eformoterol) symptoms of COPD and asthma. to your pharmacist for disposal.
fumarate dihydrate This will ensure that it controls your If you are not sure whether you
• glycopyrronium bromide symptoms properly. should start using this medicine,
(glycopyrrolate). Ask your doctor if you have any talk to your doctor.
Beclometasone dipropionate belongs questions about why this medicine
has been prescribed for you. Before you start to use it
to a group of medicines called
corticosteroids which act to reduce This medicine is available only with Tell your doctor if you have or
the swelling and irritation in your a doctor’s prescription. have had any of the following
lungs. medical conditions:
TRIMBOW is unlikely to affect your
Formoterol (eformoterol) fumarate ability to drive and use machines. • heart problems (heart pain, pain
dihydrate and glycopyrronium in the chest, recent heart attack,
bromide (glycopyrrolate) are heart failure, narrowing of the
medicines called long-acting arteries around your heart, disease
bronchodilators. They act in different

TRIMBOW® 100/6/10 and 200/6/10

Published by MIMS July 2022 1
 of your heart valves or any other your pharmacy, supermarket or How to use TRIMBOW
abnormalities of your heart) health food shop.
• heart condition known as Some medicines and TRIMBOW Follow all directions given to you
hypertrophic obstructive may interfere with each other. These by your doctor or pharmacist
cardiomyopathy (also known as include: carefully.
HOCM, a condition where the They may differ from the
• medicines for HIV such as
heart muscle is abnormal) information contained in this leaflet.
ritonavir, cobicistat
• heart rhythm disorders such as If you do not understand the
• medicines for treating high blood
irregular heart rate, a fast pulse instructions in this leaflet, ask your
pressure, heart conditions and doctor or pharmacist for help.
rate or palpitations or abnormal abnormal heart rhythms (such as
heart trace (ECG) digoxin, quinidine, disopyramide, How much to use
• high blood pressure or swelling procainamide)
and weakening of blood vessels Always use this medicine exactly as
• medicines to treat glaucoma
• an overactive thyroid gland your doctor or pharmacist has told
• medicines to treat migraines you. Check with your doctor or
• low blood levels of potassium • other medicines to treat COPD or pharmacist if you are not sure.
• disease of your liver or kidneys asthma (such as theophylline,
The recommended dose is two puffs
• diabetes or high blood sugars aminophylline or corticosteroids) in the morning and two puffs in the
• a tumour of the adrenal gland • medicines used to treat allergic evening at the same time every day.
• tuberculosis (TB) reactions (antihistamines)
Do not use more than your doctor
• viral or fungal chest infection • medicines to treat depression or tells you to use.
• eye problems called narrow-angle mental disorders such as
monoamine oxidase inhibitors TRIMBOW is not used for initial
glaucoma therapy. TRIMBOW is used as a
(phenelzine, isocarboxazid,
• prostate problems or difficulty maintenance treatment for your
furazolidone and procarbazine),
passing urine COPD or asthma.
tricyclic antidepressants
• an infection of the mouth or (amitriptyline and imipramine),
throat.
or phenothiazines How to use the inhaler
Tell your doctor if you are • L-dopa, a medicine used to treat TRIMBOW is for inhalation use.
pregnant or plan to become
Parkinson’s Disease You should inhale the medicine
pregnant or are breastfeeding.
You should only use TRIMBOW • L-thyroxine, a medicine used to through your mouth and this takes
during pregnancy if you are advised treat an underactive thyroid gland the medicine directly into your lungs.
to do so by your doctor. It is • oxytocin, used to bring on This medicine is contained in a
preferable to avoid the use of (induce) labour pressurised container enclosed in a
TRIMBOW during labour as it may • medicines containing alcohol plastic inhaler with a mouthpiece.
impact contractions of the uterus. • fluid or water tablets Each container provides 60 puffs or
You should not use TRIMBOW • anaesthetics used during surgery 120 puffs or 180 puffs.
during breast-feeding. You and your • disulfiram, a medicine used to If you have been prescribed a
doctor will decide whether to treat drinking problems container providing 60 puffs or 120
discontinue breast-feeding or to puffs:
• metronidazole, an antibiotic to
discontinue TRIMBOW taking into treat infection in your body. There is a counter on the back of the
account the benefit of breast-feeding inhaler, which corresponds to the
Your doctor and pharmacist have
for your child and the benefit of number of puffs left in the container.
more information on medicines to be
therapy for you. Each time you press the pressurised
careful with or avoid while taking
If you have not told your doctor this medicine. container, a puff of medicine is
about any of the above, speak with released and the counter will count
your doctor before you start using down by one. Take care not to drop
TRIMBOW. the inhaler as this may cause the
counter to count down.
Taking other medicines
If you have been prescribed a
Tell your doctor or pharmacist if container providing 180 puffs:
you are taking any other There is an indicator on the back of
medicines, including any that you
the inhaler, which tells you how
get without a prescription from
many doses are left. Each time you

TRIMBOW® 100/6/10 and 200/6/10

Published by MIMS July 2022 2
press the pressurised container, a puff
of medicine is released, and the dose
indicator rotates by a small amount.
The number of puffs remaining is
displayed in intervals of 20. Take
care not to drop the inhaler as this
may cause the dose indicator to count
down.
Testing your inhaler
How to use your inhaler
Before using the inhaler for the first
time, you should test your inhaler to Stand or sit up when inhaling.
make sure that it is working properly, IMPORTANT: Do not perform steps
as follows. 2 to 5 too quickly.
1. Depending on the inhaler size 1. Remove the protective cap from
prescribed for you, check that the the mouthpiece and check that the
dose counter reads 61 or 121 or mouthpiece is clean and free from
180 dust and dirt.
2. Remove the protective cap from 2. Breathe out as slowly and deeply
the mouthpiece as possible, in order to empty
3. Hold your inhaler upright with your lungs.
the mouthpiece at the bottom 3. Hold the inhaler upright with the
4. Direct the mouthpiece away from mouthpiece at the bottom and
place the mouthpiece between For the second puff, keep the inhaler
yourself and firmly press the
your teeth without biting it. Then in the upright position for about half
pressurised container to release
place your lips around the a minute, then repeat steps 2 to 5.
one puff
mouthpiece, with the tongue flat If you see 'mist' coming from the top
5. Check the dose counter. If you
under it. of the inhaler or the sides of your
are testing your inhaler for the
first time, the counter should 4. Breathe in slowly and deeply mouth, this means that TRIMBOW
read: through your mouth to fill your will not be getting into your lungs as
lungs with air (this should take it should. Take another puff,
60 - when using the container
about 4-5 seconds). Just after following the instructions starting
providing 60 puffs.
starting to breathe in, press down again from step 2.
firmly on the top of the After use
pressurised container to release
Replace the protective cap.
one puff.
5. Hold your breath for as long as To prevent a fungal infection in the
possible and, finally, remove the mouth and throat, rinse your mouth
inhaler from your mouth and or gargle with water without
breathe out slowly. Do not swallowing it or brush your teeth
breathe out into the inhaler. after each use of your inhaler.
6. Check that the dose counter has When to get a new inhaler
120 - when using the container
moved down by one (for 60 and You should get a replacement when
providing 120 puffs
120 puff inhalers) or that the dose the counter or indicator shows the
indicator has rotated by a small number 20. Stop using the inhaler
amount (180 puff inhaler). when the counter or indicator shows
0, as any medicine left in the inhaler
may not be enough to give you a full
puff.
If you have a weak grip, it may be
easier to hold the inhaler with both
hands. Hold the upper part of the
180 - when using the container inhaler with both index fingers and
providing 180 puffs its lower part with both thumbs.

TRIMBOW® 100/6/10 and 200/6/10

Published by MIMS July 2022 3
If you find it difficult to use the not take the dose you have missed, may include short of breath or
inhaler while starting to breathe in, but just take the next dose at the start wheezing (breathing with an
you may use a suitable spacer correct time. audible whistling sound) straight
device. Ask your doctor or after using TRIMBOW.
pharmacist about this device. Do not use a double dose to make up
for the dose that you missed. Things you must not do
It is important that you read the
package leaflet which is supplied If you use too much Do not take TRIMBOW to treat
with your spacer device and that you any other complaints unless your
(overdose)
carefully follow the instructions on doctor tells you to.
how to use the spacer device and Immediately telephone your doctor Do not give your medicine to
how to clean it. or Poisons Information Centre anyone else, even if they have the
(telephone 13 11 26) or go to same condition as you.
Cleaning the TRIMBOW inhaler
Accident and Emergency at your
You should clean your inhaler once a nearest hospital if you think that Do not stop taking your medicine
week. you or anyone else may have taken or lower the dosage without
or been given too much checking with your doctor.
1. Do not remove the pressurised
TRIMBOW. Do this even if there
container from the inhaler and do Things to be careful of
are no signs of discomfort or
not use water or other liquids to poisoning.
clean your inhaler. TRIMBOW contains ethanol
You may need urgent medical
2. Remove the protective cap from attention. TRIMBOW contains 8.856 mg of
the mouthpiece by pulling it away ethanol absolute (alcohol) in each
If you use more TRIMBOW than you actuation, which is equivalent to
from your inhaler.
should, side effects may occur (see 17.712 mg per dose of two
3. Wipe inside and outside of the “Side Effects”).
mouthpiece and the inhaler with a actuations. The amount in two
clean, dry cloth or tissue. actuations of this medicine is
equivalent to less than 1 mL of wine
4. Replace the mouthpiece cap.
or beer. The small amount of alcohol
While you are using in this medicine will not have any
When to use it TRIMBOW noticeable effects.
You should use TRIMBOW every
day, even when your COPD or Things you must do
asthma is not troubling you. If you are about to be started on
If you feel that the medicine is not any new medicine, remind your Side effects
working or you are getting breathless doctor and pharmacist that you
are taking TRIMBOW. Tell your doctor or pharmacist as
or wheezy, talk to your doctor. Do
soon as possible if you do not feel
not use this medicine to relieve or Contact your doctor if you well while you are using
treat a sudden attack of experience blurred vision or other TRIMBOW.
breathlessness or wheezing. visual disturbances.
All medicines can have side effects.
Tell any other doctors, dentists,
How long to use it and pharmacists who treat you Sometimes they are serious, most of
that you are taking this medicine. the time they are not. You may need
Continue using TRIMBOW for as medical treatment if you get some of
long as your doctor tells you. If you are going to have surgery,
the side effects.
tell the surgeon or anaesthetist that
Do not stop using TRIMBOW or Do not be alarmed by the list of
you are taking this medicine.
lower the dose, even if you are possible side effects. You may not
It may affect other medicines used
feeling better or have no symptoms. experience any of them.
during surgery.
It is important to use TRIMBOW If you become pregnant while Ask your doctor or pharmacist to
every day. taking this medicine, tell your answer any questions you may
doctor immediately. have.
If you have any further questions on
the use of this medicine, ask your Keep all of your doctor's Tell your doctor or pharmacist if
doctor or pharmacist. appointments so that your progress you notice any of the following and
can be checked. they worry you:
If you forget to use it Stop taking TRIMBOW, use your • sore, raised patches in the mouth,
quick-acting “reliever” inhaler and throat or oesophagus (food pipe)
Use it as soon as you remember. If it
seek medical help immediately if caused by a fungal infection (oral
is almost time for your next dose, do
your breathing gets worse, this thrush). Rinsing your mouth out

TRIMBOW® 100/6/10 and 200/6/10

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 with water immediately after mucus colour, or increased cough • clouding of the lens of your eyes
using the inhaler may prevent this or increased breathing difficulties (cataracts)
side effect. • severe chills, sore throat or mouth • depression, mental disorders,
• dry mouth, sore mouth, burning ulcers. feeling worried, nervous, over-
sensation of the lips, tooth decay The above list includes serious side excited or irritable
• sore, dry or irritated throat, effects that may require medical • growth retardation and changes in
swallowing difficulties attention. behaviour (children and
• flu-like symptoms If any of the following happen, tell adolescents).
• runny or stuffy nose and your doctor immediately or go to
sneezing, nose bleeds Accident and Emergency at your
nearest hospital:
• feeling of tension or fullness in
your sinuses • worsening shortness of breath and After using TRIMBOW
• hoarseness of the voice wheezing immediately after using
TRIMBOW Storage
• cough
• sudden signs of allergy such as Keep it where children cannot
• abnormal or reduced sense of
rash, itching or hives on the skin, reach it.
taste
swelling of the face, lips, tongue Do not expose to temperatures higher
• headache or other parts of the body
than 50°C.
• inflammation of the ear • eye pain or discomfort, temporary
• skin rash, hives, itchy skin Do not pierce the pressurised
blurring of vision, visual halos or
container.
• increased sweating, flushing of coloured images in association
the skin with red eyes (signs of an acute TRIMBOW 100/6/10
• bleeding or bruising more easily attack of narrow-angle glaucoma) 60, 120 or 180 puff inhalers:
than normal, bleeding into the • crushing chest pain often Store below 30°C for a maximum of
tissues spreading to the arms or neck and 2 months. Your pharmacist will enter
• painful, difficult or frequent sometimes to the shoulders and the dispensing date on a label affixed
urination (may be a sign of a back (angina). to the inhaler.
urinary tract infection or The above list includes very serious From a multipack:
problems) side effects. You may need urgent
medical attention or hospitalisation. Store the unused inhaler(s) in a
• fungal infection of the vagina
refrigerator (2°C-8°C) until you are
with itching, burning and white Tell your doctor or pharmacist if
discharge (thrush) ready to use. Do not freeze.
you notice anything else that is
• diarrhoea, feeling sick, upset making you feel unwell. Before use, take one inhaler out of
stomach, stomach discomfort Other side effects not listed above the refrigerator for some minutes to
after meals may occur in some patients. Some of allow for the solution to warm up.
these side effects (for example, After first use, store the inhaler
• decreased appetite
changes in blood pressure, changes in below 30°C for a maximum of 2
• muscle cramps or pain, pain in
blood levels of sugars, electrolytes, months. Enter the date of first use on
arms, legs or chest muscles
hormones, blood cells, cells to help the removable label and affix to the
• swelling of the hands and feet inhaler. Do not put the inhaler back
your blood clot, fatty acids, ketones
• restlessness, trembling, or proteins in the blood) can only be into the refrigerator.
numbness, weakness found when your doctor does tests TRIMBOW 200/6/10
• dizziness, fatigue, sleep disorders from time to time to check your
60 puff inhaler:
• irregular heartbeat, sensation of progress.
fast, slow or missed heart beats, Store the inhaler below 30°C for a
Using high-dose inhaled
palpitations. maximum of 1 month. Your
corticosteroids over a long time can
pharmacist will enter the dispensing
The above list includes less serious cause other very rare side effects.
date on a label affixed to the inhaler.
side effects of your medicine. TRIMBOW does not contain a high
dose of corticosteroids, however, 120 puff inhaler:
Tell your doctor as soon as possible
if you notice any of the following: your doctor will monitor you for Store the inhaler below 30°C for a
• symptoms of a lung infection other rare side effects such as: maximum of 2 months. Your
such as fever or chills, increased • problems with how your adrenal pharmacist will enter the dispensing
mucus production, change in glands work date on a label affixed to the inhaler.
• thinning of your bones From a multipack:

TRIMBOW® 100/6/10 and 200/6/10

Published by MIMS July 2022 5
Store the unused inhaler(s) in a Not all pack sizes may be marketed.
refrigerator (2°C-8°C) until you are
ready to use. Do not freeze. Ingredients
Before use, take one inhaler out of The active ingredients of TRIMBOW
the refrigerator for some minutes to are beclometasone dipropionate,
allow for the solution to warm up. formoterol (eformoterol) fumarate
After first use, store the inhaler dihydrate and glycopyrronium
below 30°C for a maximum of 2 bromide (glycopyrrolate).
months. Enter the date of first use on
Each metered dose (the dose leaving
the removable label and affix to the
the mouthpiece) contains 100
inhaler. Do not put the inhaler back
micrograms of beclometasone
into the refrigerator.
dipropionate, 6 micrograms of
formoterol fumarate dihydrate and 10
Disposal
micrograms of glycopyrronium (as
If your doctor tells you to stop 12.5 micrograms glycopyrronium
using this medicine or the expiry bromide).
date has passed, ask your
pharmacist what to do with any Each metered dose (the dose leaving
medicine that is left over. the mouthpiece) contains 200
micrograms of beclometasone
dipropionate, 6 micrograms of
formoterol fumarate dihydrate and 10
Product Description micrograms of glycopyrronium (as
12.5 micrograms glycopyrronium
bromide).
What it looks like
The other ingredients are:
TRIMBOW is a pressurised
• ethanol absolute (alcohol)
inhalation solution.
• hydrochloric acid
TRIMBOW comes in a pressurised
• norflurane as the propellant.
container (coated aluminium), with a
metering valve. The pressurised
container is inserted in a grey plastic
Supplier
inhaler. This incorporates a TRIMBOW is supplied by:
mouthpiece provided with a plastic
Chiesi Australia Pty Ltd
protective red cap (TRIMBOW
Suite 3, 22 Gillman Street,
100/6/10) or green cap (TRIMBOW
Hawthorn East, VIC 3123
200/6/10) and a dose counter.
E: [email protected]
TRIMBOW 100/6/10 W: www.chiesi.com.au
Pack of 1 container with either 60, This leaflet was prepared in May
120 or 180 puffs. 2022.
Multipack containing 240 puffs (2 TRIMBOW 100/6/10:
containers of 120 puffs each). AUST R 314166
Multipack containing 360 puffs (3 TRIMBOW 200/6/10:
containers of 120 actuations each). AUST R 368010
Not all pack sizes may be marketed.
TRIMBOW 200/6/10
Pack of 1 container with either 60 or
120 puffs.
Multipack containing 240 puffs (2
containers of 120 puffs each).
Multipack containing 360 puffs (3
containers of 120 puffs each).

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Published by MIMS July 2022 6