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FOBUMIX EASYHALER 80 MICROGRAMS/4.5 MICROGRAMS INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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1. Shake 2. Click 3. Inhale
3-5x

Scan this code or visit www.oeh.fi/bfgb to see instructions on
how to use Easyhaler

Package leaflet: Information for the patient

Fobumix Easyhaler
80 micrograms/ 4.5 micrograms,
Inhalation Powder
Budesonide/formoterol fumarate dihydrate
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Fobumix Easyhaler 80/4.5 is and what it is used for
2. What you need to know before you use Fobumix Easyhaler
80/4.5
3. How to use Fobumix Easyhaler 80/4.5
4. Possible side effects
5. How to store Fobumix Easyhaler 80/4.5
6. Contents of the pack and other information
1. What Fobumix Easyhaler 80/4.5 is and what it is used for
Fobumix Easyhaler is an inhaler that is used to treat asthma in
adults aged 18 years and older. It contains two different medicines:
budesonide and formoterol fumarate dihydrate.
• Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and preventing swelling
and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of
medicines called ‘long-acting beta2adrenoceptor agonists’
or ‘bronchodilators’. It works by relaxing the muscles in your
airways. This helps you to breathe more easily.
This medicine is not suitable for people with severe asthma.
Fobumix Easyhaler is indicated for use in adults 18 years of age
and older only.
Fobumix Easyhaler is NOT indicated for use in children 12 years of
age and younger or adolescents 13
to 17 years of age.
2. What you need to know before you use Fobumix
Easyhaler 80/4.5
Do not use Fobumix Easyhaler 80/4.5:
- if you are allergic to budesonide, formoterol or to the other
ingredient of this medicine (listed in section 6) which is lactose
(which contains small amounts of milk protein).
Warnings and precautions
Talk to your doctor or pharmacist before using Fobumix Easyhaler
if you:
• are diabetic
• have a lung infection
• have high blood pressure or you have ever had a heart problem
(including an uneven heart beat, a very fast pulse, narrowing of
the arteries or heart failure)
• have problems with your thyroid or adrenal glands
• have low levels of potassium in your blood
• have severe liver problems.
Rinse your mouth after inhaling your dose in order to avoid fungal
infection in the mouth.
Children and adolescents
This medicine should not be used in children or adolescents under
the age of 18 years.
Other medicines and Fobumix Easyhaler
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
Some medicines may increase the effects of Fobumix Easyhaler
and your doctor may wish to monitor you carefully if you are
taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:
• Beta-blocker medicines (such as atenolol or propranolol for
high blood pressure), including eyedrops (such as timolol for
glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide).
These are used to treat high blood pressure.
• Steroid medicines that you take by mouth (such as
prednisolone).
• Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and
prochlorperazine).
• Medicines to treat infections (such as ketoconazole,
itraconazole, voriconazole, posaconazole, clarithromycin and
telithromycin).
• Medicines for Parkinson’s disease (such as leva-dopa).
• Medicines for thyroid problems (such as levo‑thyroxine).
• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as
phenelzine)
If any of the above applies to you, or if you are not sure, talk to
your doctor or pharmacist before using Fobumix Easyhaler.
Also tell your doctor or pharmacist if you are going to have a
general anaesthetic for an operation or for dental work.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine
• Do not use Fobumix Easyhaler unless your doctor tells you to.
• If you get pregnant while using Fobumix Easyhaler, do not stop
using Fobumix Easyhaler but talk to your doctor immediately.
Driving and using machines
Fobumix Easyhaler has no or negligible effect on your ability to
drive or to use tools or machines.
Fobumix Easyhaler contains lactose which is a type of sugar. If
you have been told by your doctor that you have an intolerance
to some sugars, talk to your doctor before using this medicine.
The amount of lactose in this medicine does not normally cause
problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins,
which may cause allergic reaction.
3. How to use Fobumix Easyhaler 80/4.5
• Each delivered (inhaled) dose contains 80 micrograms of
budesonide and 4.5 micrograms of formoterol fumarate
dihydrate. This dose corresponds to that received from other
budesonide/formoterol combination products which have
a metered dose of 100 micrograms of budesonide and 6
micrograms of formoterol fumarate dihydrate but similar
delivered doses to Fobumix Easyhaler.

• Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• It is important to use Fobumix Easyhaler every day, even if you
have no asthma symptoms at the time.
• Your doctor will want to regularly check your asthma symptoms.
If you have been taking steroid tablets for your asthma , your
doctor may reduce the number of tablets that you take, once
you start to use Fobumix Easyhaler. If you have been taking oral
steroid tablets for a long time, your doctor may want you to have
blood tests from time to time. When reducing oral steroid tablets,
you may feel generally unwell even though your chest symptoms
may be improving. You might experience symptoms such as a
stuffy or runny nose, weakness or joint or muscle pain and rash
(eczema). If any of these symptoms bother you, or if symptoms
such as headache, tiredness, nausea (feeling sick) or vomiting
(being sick) occur, please contact your doctor immediately. You
may need to take other medication if you develop allergic or
arthritic symptoms. Speak to your doctor if you are concerned as
to whether you should continue to use Fobumix Easyhaler.
Your doctor may consider adding steroid tablets to your usual
treatment during periods of stress (for example, when you have a
chest infection or before an operation).
Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using
Fobumix Easyhaler, you should continue to use Fobumix Easyhaler
but go to see your doctor as soon as possible, as you may need
additional treatment.
Contact your doctor immediately if:
• your breathing is getting worse or you often wake up at night
with asthma.
• your chest starts to feel tight in the morning or your chest
tightness lasts longer than usual.
These signs could mean that your asthma is not being properly
controlled and you may need different or additional treatment
immediately.
ASTHMA
Fobumix Easyhaler 80/4.5 can be prescribed for asthma in two
different ways. The amount of Fobumix Easyhaler to use and when
to use it depends on how it has been prescribed for you.
a) If you have been prescribed Fobumix Easyhaler and a separate
reliever inhaler, read the section called ‘A) Using Fobumix
Easyhaler and a separate reliever inhaler’.
b) If you have been prescribed Fobumix Easyhaler as your only
inhaler, read the section called ‘B) Using Fobumix Easyhaler as
your only asthma inhaler’.
A) Using Fobumix Easyhaler and a separate reliever inhaler
Use your Fobumix Easyhaler every day. This helps to prevent
asthma symptoms from happening.
Adults (18 years and above)
• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may increase this to 4 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you
to take your medicine once a day.
Your doctor (or asthma nurse) will help you to manage your
asthma. They will adjust the dose of this medicine to the lowest
dose that controls your asthma. However, do not adjust the dose
without talking to your doctor (or asthma nurse) first.
Use your separate ‘reliever inhaler’ to treat asthma symptoms
when they happen. Always keep your ‘reliever inhaler’ with you
to use when you need it. Do not use Fobumix Easyhaler to treat
asthma symptoms - use your reliever inhaler.
B) Using Fobumix Easyhaler as your only asthma inhaler
Only use Fobumix Easyhaler in this way if your doctor has told
you to.
Use your Fobumix Easyhaler 80/4.5 every day. This helps to
prevent asthma symptoms from happening. You can take:
• 1 inhalation in the morning and 1 inhalation in the evening
or
• 2 inhalations in the morning
or
• 2 inhalations in the evening.
Also use Fobumix Easyhaler 80/4.5 as a ‘reliever inhaler’ to
treat asthma symptoms when they happen.
• If you get asthma symptoms, take 1 inhalation and wait a few
minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.
Always keep your Fobumix Easyhaler with you, so you can use it
when you need it.
A total daily dose of more than 8 inhalations is not normally
needed. However, your doctor may allow you to take up to
12 inhalations a day for a limited period.
If you regularly need to use 8 or more inhalations a day, make
an appointment to see your doctor or nurse. They may need to
change your treatment.
Do not use more than 12 inhalations in total in 24 hours.
If you are doing exercise and you get asthma symptoms, use
Fobumix Easyhaler as described here. However, do not use
Fobumix Easyhaler just before exercise to stop asthma symptoms
from happening.
Preparing your new Fobumix Easyhaler
Fobumix Easyhaler is easy to use. Read through these instructions
first: they tell you what you should do and what to look out for.
UNPACK THE INHALER
Take the inhaler out of its
packaging. It comes in a foil
wrapping to keep the powder dry.
Only take it out of the bag when
you are ready to start using it.
Make sure you have all the parts
(Figure 1):
• An inhaler, with a dust cap on the
mouthpiece
• Possibly a protective cover.
If you don’t use a protective cover
move on to section “To take a dose
from Fobumix Easyhaler”.
Fit the inhaler into its protective
cover:
Open up the protective cover
(Figure 2). Make sure the dust
cap covers the mouthpiece of the
inhaler (this stops the inhaler going
off by accident). Insert the inhaler
into the protective cover to improve
durability of the product. If you are
not using the device immediately,
close the protective cover.

Figure 1.
Inhaler

Mouthpiece

Dust cap

Protective
cover

Figure 2.

TO TAKE A DOSE FROM FOBUMIX
EASYHALER
If you use a protective cover with
your Fobumix Easyhaler, open it.
Remove the dust cap.
Figure 3a.
A. Shake
• Shake the device vigorously up
and down three to five times
(Figure 3a or 3b).
This is to make sure the powder
flows properly and gives the
correct dose.

Figure 3b.

Make sure…
• you shake it up and down
• you don’t click it while you
shake it.

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B. Click
Figure 4a.
• Hold the inhaler upright,
gripping it between your
finger and thumb (Figure 4a or
4b).
• Squeeze until you hear a click,
and let it click back again.
This delivers powder into the
inhalation channel inside the
mouthpiece.

Figure 4b.

Make sure…
• the dust cap is not on the inhaler, it will stop you clicking it.
• you only click down once, just before you take the medicine.
If you click it more than once, see section “If you have problems
using the inhaler”.
• you keep the inhaler upright as you click it and inhale the dose.
C. Inhale
In the sitting or standing
position
• Breathe out normally
• Place the mouthpiece in your
mouth between your teeth
and close your lips tightly
around the mouthpiece
• Take a strong and deep breath
in (Figure 5a or 5b)
• Take the inhaler out of your
mouth, then breathe normally
away from the inhaler.

Figure 5a.

Figure 5b.

Uncommon (may affect up to 1 in 100 people)
• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which
causes wheezing). If the wheezing comes on suddenly after
using Fobumix Easyhaler stop using Fobumix Easyhaler and talk
to your doctor immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.

Make sure…
• the whole mouthpiece is well inside your mouth, so the powder
doesn’t go on your teeth
• your lips make a good seal around the mouthpiece
• you don’t breathe out into the inhaler. This is important: it could
clog up the inhaler. If you breathed out into the inhaler, see
section “If you have problems using the inhaler”.
If you have problems using the
inhaler
• Don’t rush things. It’s
Figure 6a.
important to breathe normally.
Practice a few times, in front of
the mirror if this helps.
• If you click the inhaler by
accident, or if you might have
clicked it more than once, or
if you breathe out into it, tap
the mouthpiece to empty the
powder onto a table top,or
the palm of your hand (Figure
6a or 6b). This ensures proper
dosing. Then start again with
steps A, B and C.

Figure 6b.

Very rare (may affect up to 1 in 10,000 people)
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.
Inhaled corticosteroids can affect the normal production of steroid
hormones in your body, particularly if you use high doses for a
long time. The effects include:
• changes in bone mineral density (thinning of the bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• a slowing of the rate of growth of children and adolescents
• an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled
corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme, www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.
5. How to store Fobumix Easyhaler 80/4.5

If you’re to take a second inhalation
• Start again with steps A, B and C (Note that you need to shake
the device again).
After you’ve used the inhaler
• Put the dust cap back on the mouthpiece. If you are using a
protective cover, close it.
• Rinse your mouth with water after your daily morning and/or
evening doses, and spit it out.
Cleaning the Easyhaler
Clean the Easyhaler’s mouthpiece at least once a week with a dry
cloth. Do not use water: the powder in the Easyhaler is sensitive to
moisture.
If you use a protective cover, you can take the Easyhaler out of it to
wipe it. When you are putting it back into its protective cover, put
the dust cap on the mouthpiece to stop it going off accidentally.
Getting a new Easyhaler
The inhaler has a dose counter
which shows how many doses
are left (Figure 7a or 7b). The
counter turns after every fifth
actuation. When the dose
counter starts turning red, there
are 20 doses left.
If you don’t already have a new
Easyhaler, contact your doctor
for a new prescription. When
the counter reaches 0, you need
to replace the Easyhaler even
though you can still observe the
powder in the clear window on
the back of the inhaler.
• Take the old Easyhaler out of
its protective cover (if you are
using one).
• Keep the protective cover and
dispose of the old inhaler (see
section 5 How to store Fobumix
Easyhaler) .
• Take the new inhaler out of
the bag. Insert the new inhaler
into the protective cover (if
you use one), with the dust
cap on.
Now you can use the new inhaler
as usual. See section 3 for more
details.

Other possible side effects:
Common (may affect up to 1 in 10 people)
• Palpitations (awareness of your heart beating), trembling or
shaking. If these effects occur, they are usually mild and usually
disappear as you continue to use Fobumix Easyhaler.
• Thrush (a fungal infection) in the mouth. This is less likely if
you rinse your mouth out with water after using your Fobumix
Easyhaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.

Figure 7.a

Figure 7b.

Dose
counter

Dose
counter

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on
the carton, bag and label of your inhaler after EXP. The expiry
date refers to the last day of that month.
• After opening the foil wrapping do not store above 25°C and
store protected from moisture. It is recommended to keep the
Easyhaler in its protective cover.
• If your Fobumix Easyhaler gets damp you need to replace it with
a new one.
• Replace Fobumix Easyhaler 4 months after you opened the foil
wrapping. Write down the date you opened the foil wrapping
here to help you remember
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to protect the
environment.
6. Contents of the pack and other information
What Fobumix Easyhaler 80/4.5 contains
- The active substances are budesonide and formoterol fumarate
dihydrate. Each inhaled dose contains 80 micrograms of
budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
- The other ingredient is lactose monohydrate (which contains
milk proteins).
What Fobumix Easyhaler 80/4.5 looks like and contents of the
pack
Fobumix Easyhaler 80/4.5 is an inhaler containing your medicine.
The inhalation powder is white to yellowish in colour. Each inhaler
contains 60 or 120 doses and has a white body with red upper
part.
Fobumix Easyhaler 80/4.5 is available in packs of 1 or 3 inhaler(s).
Not all pack sizes may be marketed.
Your pack may contain a protective cover. If you need a protective
cover, please contact the Marketing Authorisation Holder (details
given below).
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

If you use more Fobumix Easyhaler than you should
It is important that you take your dose as stated on the
pharmacist’s label or as advised by your doctor. You should not
exceed your prescribed dose without seeking medical advice.

Detailed and updated information on this product is available by
scanning the QR code included in the PIL, outer carton and device
label with a smartphone. The same information is also available on
the following URL: www.oeh.fi/bfgb.

The most common symptoms that may occur after if you use
more Fobumix Easyhaler 80/4.5 than you should are trembling,
headache or a rapid heart beat.

This leaflet was last revised in January 2017

If you forget to use Fobumix Easyhaler
• If you forget to take a dose, take it 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 a forgotten dose.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If either of the following happen to you, stop using Fobumix
Easyhaler and talk to your doctor immediately:
• Swelling of your face, particularly around your mouth (tongue
and/or throat and/or difficulty to swallow) or hives together
with difficulties to breath (angioedema) and/or sudden
feeling of faintness. This may mean that you are having an
allergic reaction. This happens rarely, affecting less than 1 in
1,000 people.
• Sudden acute wheezing or shortness of breath immediately
after using your inhaler. If either of these symptoms occur,
stop using your Fobumix Easyhaler inhaler straightaway
and use your ‘reliever’ inhaler. Contact your doctor
immediately as you may need to have your treatment
changed. This happens very rarely, affecting less than 1 in
10,000 people.

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