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SYMBICORT 400/12 TURBOHALER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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Reporting of side effects
If you get any side effects, talk to your
doctor, 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 at:
www.mhra.gov.uk/yellowcard. By reporting
side effects, you can help provide more
information on the safety of this medicine.

T05805

Symbicort® 400/12 Turbohaler®, Inhalation Powder
(budesonide/formoterol fumarate)
Patient Information Leaflet

This medicine is available using the above
name but will be referred to as Symbicort
Turbohaler throughout the Leaflet. Other
strengths of symbicort are available.

5. How to store Symbicort Turbohaler
• Keep out of the sight and reach of
children.
• Do not store above 30°C.
• Keep the container/ cap tightly closed,
in order to protect from moisture.
• Do not use Symbicort Turbohaler after
the expiry date printed on the carton or
on the label of your Turbohaler. The
expiry date refers to the last day of that
month.
• Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose of
medicines that are no longer required.
This will help to protect the
environment.
• If the medicine become discoloured or
show any other signs of deterioration,
you should seek the advice of your
doctor or pharmacist who will tell you
what to do.

Read all of this leaflet carefully before
you start using this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
What is in this leaflet:
1. What Symbicort Turbohaler is and
what it is used for
2. Before you use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Further information

6. Further information
What Symbicort Turbohaler contains
The active substances are budesonide and
formoterol fumarate dihydrate.
Each inhaled dose (the dose leaving the
mouthpiece) delivers 320 micrograms of
budesonide and 9 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 400 micrograms of
budesonide and 12 micrograms of
formoterol fumarate dihydrate.

1. What Symbicort Turbohaler is and
what it is used for
Symbicort Turbohaler is an inhaler. 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
adrenoceptor
‘long-acting
beta2
agonists’ or ‘bronchodilators’. It works
by relaxing the muscles in your
airways. This helps you to breathe
more easily.

What Symbicort Turbohaler looks like
and contents of the pack
Symbicort Turbohaler is a multidose
powder plastic inhaler with white body and
red turning grip and a dose counter. A
braille code '6' is embossed on the red
turning grip. The inhalation powder is white
in colour.
Symbicort Turbohaler is available in packs
of 1 Turbohaler and contains 60 doses.

Your doctor has prescribed this medicine to
treat asthma or chronic obstructive
pulmonary disease (COPD).

Manufacturer and Product Licence
Holder:
Symbicort Turbohaler is manufactured by
either of the following manufacturers.
• AstraZeneca AB, Södertälje, Sweden.
• AstraZeneca GmbH, Wedel, Germany.
• AstraZeneca UK Limited, Cheshire,
United Kingdom.
It is procured from within the EU by the
Product Licence Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon
CR0 4XS UK.

Asthma
For asthma, your doctor will prescribe two
asthma inhalers: Symbicort Turbohaler and
a separate ‘reliever inhaler’.
• Use Symbicort Turbohaler every day.
This helps to prevent asthma
symptoms from happening.
• Use your ‘reliever inhaler’ when you
get asthma symptoms, to make it
easier to breathe again.
Do not use Symbicort Turbohaler 400/12 as
a ‘reliever inhaler’.

POM

Chronic obstructive pulmonary disease
(COPD)
Symbicort Turbohaler can also be used to
treat the symptoms of COPD in adults.
COPD is a long-term disease of the airways
in the lungs, which is often caused by
cigarette smoking.

PL No: 10380/1594
Leaflet revision date: 10/12/2015
and
Turbohaler®
are
Symbicort®
trade marks of the AstraZeneca group of
companies, Sweden.

2. Before
you
Turbohaler

use

Symbicort

Do not use Symbicort Turbohaler if:
• You are allergic (hypersensitive) to
budesonide, formoterol, or the other
ingredient, which is lactose (which
contains small amounts of milk
proteins).

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Take special care with Symbicort
Turbohaler
Before you use Symbicort Turbohaler, tell
your doctor or pharmacist if:
• You are diabetic.
• You have a lung infection.
• You 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).
• You have problems with your thyroid or
adrenal glands.

• You have low levels of potassium in
your blood.
• You have severe liver problems.
Taking other medicines
Please tell your doctor or pharmacist if you
are using or have recently used any other
medicines. This includes medicines that
you buy without a prescription and herbal
medicines.
In particular, tell your doctor or pharmacist if
you are using 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).
medicines
(such as
• Xanthine
theophylline or aminophylline). These
are often used to treat asthma.
• Other bronchodilators (such as
salbutamol).
• Tricyclic anti-depressants (such as
amitriptyline) and the anti-depressant
nefazodone.
• Mono-Amine Oxidase Inhibitors, also
known
as
MAOIs
(such
as
phenelzine).
• Phenothiazine medicines (such as
chlorpromazine and prochlorperazine).
called ‘HIV-protease
• Medicines
inhibitors’ (such as ritonavir) to treat
HIV infection.
• 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).
If any of the above applies to you, or if you
are not sure, talk to your doctor or
pharmacist before using Symbicort
Turbohaler.
Also tell your doctor or pharmacist if you
are going to have a general anaesthetic for
an operation or for dental work.
Pregnancy, breast-feeding and fertility
• If you are pregnant, or planning to get
pregnant, talk to your doctor before
using Symbicort Turbohaler - do not
use Symbicort Turbohaler unless your
doctor tells you to.
• If you get pregnant while using
Symbicort Turbohaler, do not stop
using Symbicort Turbohaler but talk to
your doctor immediately.
• If you are breast-feeding, talk to your
doctor before using Symbicort
Turbohaler.
Driving and using machines
Symbicort Turbohaler has no or negligible
effect on your ability to drive or to use tools
or machines.
Important information about some of the
ingredients of Symbicort Turbohaler
Symbicort Turbohaler 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
an allergic reaction.

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3. How to use Symbicort Turbohaler
• Always use Symbicort Turbohaler
exactly as your doctor has told you.
Check with your doctor or pharmacist
if you are not sure.
• It is important to use Symbicort
Turbohaler every day, even if you
have no asthma or COPD symptoms
at the time.
• If you are using Symbicort Turbohaler
for asthma, your doctor will want to
regularly check your symptoms.
If you have been taking steroid tablets for
your asthma or COPD, your doctor may
reduce the number of tablets that you take,
once you start to use Symbicort Turbohaler.
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. You
should speak to your doctor if you are
concerned as to whether you should
continue to use Symbicort Turbohaler.
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 or COPD symptoms
If you feel you are getting breathless or
wheezy while using Symbicort Turbohaler,
you should continue to use Symbicort
Turbohaler 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
or COPD is not being properly controlled
and you may need different or additional
treatment immediately.
Asthma
Use your Symbicort Turbohaler 400/12
every day. This helps to prevent asthma
symptoms from happening.
Adults (18 years and above)
• The usual dose is 1 inhalation, twice a
day.
• Your doctor may increase this to 2
inhalations, twice a day.
• If your symptoms are well controlled,
your doctor may ask you to take your
medicine once a day.
Adolescents (12 to 17 years)
• The usual dose is 1 inhalation, twice a
day.
• If your symptoms are well controlled,
your doctor may ask you to take your
medicine once a day.
A lower strength of Symbicort Turbohaler is
available for children aged from 6 to 11
years.
Symbicort Turbohaler is not recommended
to be used in children who are younger
than 6 years.

6. Remove your Turbohaler from your
mouth. Then breathe out gently.
The amount of medicine that is inhaled
is very small. This means you may not
be able to taste it after inhalation. If
you have followed the instructions, you
can still be confident that you have
inhaled the dose and the medicine is
now in your lungs.

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
Symbicort Turbohaler 400/12 to treat
asthma symptoms - use your separate
‘reliever inhaler’.
Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18
years and above).
• The usual dose is 1 inhalation twice a
day.

7. If you are to take a second inhalation,
repeat steps 2 to 6.
8. Replace the cover tightly after use.

Your doctor may also prescribe other
bronchodilator
drugs,
for
example
anticholinergics (such as tiotropium or
ipratropium bromide) for your COPD
disease.
Preparing
your
new
Symbicort
Turbohaler
Before using your new Symbicort
Turbohaler for the first time, you need to
prepare it for use as follows:
• Unscrew the cover and lift it off. You
may hear a rattling sound.

9. Rinse your mouth with water after your
daily morning and/or evening doses,
and spit it out.
Do not try to remove or twist the
mouthpiece. It is fixed to your Turbohaler
and must not be taken off. Do not use your
Turbohaler if it has been damaged or if the
mouthpiece has come apart from your
Turbohaler.
As with all inhalers, caregivers should
ensure that children prescribed Symbicort
Turbohaler
use
correct
inhalation
technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a
week with a dry tissue. Do not use water or
liquids.

• Hold your Turbohaler upright with the
red grip at the bottom.
• Turn the red grip as far as it will go in
one direction. Then turn it as far as it
will go in the other direction (it does
not matter which way you turn it first).
You should hear a click sound.

When to start using a new Turbohaler
• The dose indicator tells you how many
doses (inhalations) are left in your
Turbohaler, starting with 60 doses
when it is full.
• The dose indicator is marked in
intervals of 10 doses. Therefore it
does not show every dose.
• When you first see a red mark at the
edge of the indicator window, there
are approximately 20 doses left. For
the last 10 doses, the background of
the dose indicator is red. When the ‘0’
on the red background has reached
the middle of the window, you must
start using your new Turbohaler.

• Do this again, turning the red grip in
both directions.
• Your Turbohaler is now ready for use.
How to take an inhalation
Every time you need to take an inhalation,
follow the instructions below.
1. Unscrew the cover and lift it off. You
may hear a rattling sound.
2. Hold your Turbohaler upright with
the red grip at the bottom.
3. Do not hold the mouthpiece when you
load your Turbohaler. To load your
Turbohaler with a dose, turn the red
grip as far as it will go in one direction.
Then turn it as far as it will go in the
other direction (it does not matter
which way you turn it first). You should
hear a click sound. Your Turbohaler is
now loaded and ready to use. Only
load your Turbohaler when you need
to use it.

Note:
• The grip will still twist and ‘click’ even
when your Turbohaler is empty.
• The sound that you hear as you shake
your Turbohaler is produced by a
drying agent and not the medicine.
Therefore the sound does not tell you
how much medicine is left in your
Turbohaler.
• If you load your Turbohaler more than
once by mistake before taking your
dose, you will still only receive one
dose. However, the dose indicator will
register all the loaded doses.

4. Hold your Turbohaler away from your
mouth. Breathe out gently (as far as is
comfortable). Do not breathe out
through your Turbohaler.

If you use more Symbicort Turbohaler
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.

5. Place the mouthpiece gently between
your teeth. Close your lips.
Breathe in as deeply and as hard as
you can through your mouth.
Do not chew or bite on the
mouthpiece.

The most common symptoms that may
occur if you use more Symbicort Turbohaler
than you should are trembling, headache or
a rapid heart beat.

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.

If you forget to use Symbicort
Turbohaler
• 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 medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Symbicort Turbohaler
can cause side effects, although not
everybody gets them.
If either of the following happen to you,
stop using Symbicort Turbohaler and
talk to your doctor immediately:
• Swelling of your face, particularly
around your mouth (tongue and/or
throat and/or difficulty swallowing) or
hives together with difficulty breathing
(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 Symbicort
Turbohaler 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.
Other possible side effects:
Common (affects less than 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 Symbicort Turbohaler.
• Thrush (a fungal infection) in the
mouth. This is less likely if you rinse
your mouth out with water after using
your Symbicort Turbohaler.
• Mild sore throat, coughing and a
hoarse voice.
• Headache.
Uncommon (affects less than 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 (affects less than 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 Symbicort
Turbohaler stop using Symbicort
Turbohaler and talk to your doctor
immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
Very rare (affects less than 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.

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T05805

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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