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SYMBICORT 100/6 TURBOHALER INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE / BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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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 Symbicort
Turbohaler stop using Symbicort
Turbohaler and talk to your doctor
immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
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. 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.

Manufacturer and Product Licence
Holder:
Symbicort Turbohaler is manufactured by:

T06709

(budesonide/formoterol fumarate)

1. AstraZeneca AB, Forskargatan 18, SE151 85 Södertälje, Sweden.
2. AstraZeneca GmbH, Tinsdaler Weg 183,
D-22880 Wedel, Germany.
3. AstraZeneca UK Limited, Silk Road
Business Park, Macclesfield, SK10 2NA,
Great Britain.
It is procured from within the EU by the
Product Licence Holder: Swinghope Ltd,
Commerce Way, Edenbridge TN8 6ED, UK.
Repackaged by YMD Pharma Limited,
Commerce Way, Edenbridge TN8 6ED, UK.

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.
Read all of this leaflet carefully before
you start using 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.

POM
PL No: 10380/1623
Leaflet revision date: 29/03/2017
and
Turbohaler®
are
Symbicort®
trade marks of the AstraZeneca group of
companies, Sweden.

Blind or partially
sighted?
Is this leaflet hard to
see or read?
Call 02030969700 to
obtain the leaflet in a
format suitable for
you.

What is in this leaflet:
1. What Symbicort Turbohaler is and
what it is used for
2. What you need to know before you
use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Contents of the pack and other
information

1. What Symbicort Turbohaler is and
what it is used for
Symbicort Turbohaler is an inhaler that is
used to treat asthma in adults, adolescents
and children aged 6 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
adrenoceptor
‘long-acting
beta2
agonists’ or ‘bronchodilators’. It works
by relaxing the muscles in your
airways. This helps you to breathe
more easily.

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.

This medicine is not suitable for people with
severe asthma. It can be prescribed for
asthma in two different ways.
a)

b)

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 100 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 80 micrograms of
budesonide and 4.5 micrograms of
formoterol fumarate dihydrate.
The
other
monohydrate
proteins).

Symbicort® 100/6 Turbohaler®, Inhalation Powder

Some people are prescribed two
asthma inhalers:
Symbicort Turbohaler and a
separate ‘reliever inhaler’.
• They use Symbicort Turbohaler every
day. This helps to prevent asthma
symptoms from happening.
• They use their ‘reliever inhaler’ when
they get asthma symptoms, to make it
easier to breathe again.
Some people are prescribed
Symbicort Turbohaler as their only
asthma inhaler.
• They use Symbicort Turbohaler every
day. This helps to prevent asthma
symptoms from happening.
• They also use Symbicort Turbohaler
when they need extra doses for relief
of asthma symptoms, to make it easier
to breathe again. They do not need a
separate inhaler for this.

2. What you need to know before you
use Symbicort Turbohaler

ingredient
is
lactose
(which
contains
milk

Do not use Symbicort Turbohaler:
• if you are allergic to budesonide,
formoterol or the other ingredient of
this medicine (listed in section 6),
which is lactose (which contains small
amounts of milk protein).

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. A braille code '6' is
embossed on the red turning grip. The
inhalation powder is white in colour.

Warnings and precautions
Talk to your doctor or pharmacist before
using Symbicort Turbohaler if:
• You are diabetic.
• You have a lung infection.

Fold

Symbicort Turbohaler is available in packs
of 1 Turbohaler. Each inhaler contains 60
doses.

• 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.
Other
medicines
and
Symbicort
Turbohaler
Tell your doctor or pharmacist if you are
using, have recently used or might use any
other 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.
• 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.
Symbicort Turbohaler contains lactose
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 this medicine exactly as
your doctor has told you. You should
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 symptoms at the
time.
• Your doctor will want to regularly check
your asthma 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 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
is not being properly controlled and you
may need different or additional treatment
immediately.
Asthma
Symbicort Turbohaler can be prescribed for
asthma in two different ways. The amount
of Symbicort Turbohaler to use and when to
use it depends on how it has been
prescribed for you.
a) If you have been prescribed Symbicort
Turbohaler and a separate reliever inhaler,
read the section called ‘a) Using Symbicort
Turbohaler and a separate reliever inhaler’.
b) If you have been prescribed Symbicort
Turbohaler as your only inhaler, read the
section called ‘b) Using Symbicort
Turbohaler as your only asthma inhaler’.

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.

Symbicort Turbohaler is not recommended
to be used in children who are younger
than 6 years.
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.

2. Hold your Symbicort Turbohaler
upright with the red grip at the bottom.
3. Do not hold the mouthpiece when you
load your Symbicort Turbohaler. To
load your Symbicort 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 Symbicort Turbohaler is now
loaded and ready to use. Only load
your Turbohaler when you need to use
it.

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 to treat
asthma symptoms - use your reliever
inhaler.
b) Using Symbicort Turbohaler as your
only asthma inhaler
Only use Symbicort Turbohaler in this way
if your doctor has told you to and if you are
aged 12 or above.

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

Use your Symbicort Turbohaler 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.

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.

Also use Symbicort Turbohaler 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.

6. Remove your Symbicort 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.

Always keep your Symbicort Turbohaler
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.

7. If you are to take a second inhalation,
repeat steps 2 to 6.

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.

8. Replace the cover tightly after use.

Do not use more than 12 inhalations in total
in 24 hours.
If you are doing exercise and you get
asthma
symptoms,
use
Symbicort
Turbohaler as described here. However, do
not use Symbicort Turbohaler
just before exercise to stop asthma
symptoms from happening.

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 Symbicort
Turbohaler and must not be taken off.
Do not use your Symbicort Turbohaler if it
has been damaged or if the mouthpiece
has come apart from your Symbicort
Turbohaler.

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.

As with all inhalers, caregivers should
ensure that children prescribed Symbicort
Turbohaler
use
correct
inhalation
technique, as described above.
Cleaning your Symbicort Turbohaler
Wipe the outside of the mouthpiece once a
week with a dry tissue. Do not use water or
liquids.

Use your Symbicort Turbohaler every
day. This helps to prevent asthma
symptoms from happening.
• Hold your Symbicort 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 inhaler
• The dose indicator tells you how many
doses (inhalations) are left in your
Symbicort Turbohaler, starting with
either 60 or 120 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 Symbicort
Turbohaler.

Adolescents (12 to 17 years)
• The usual dose is 1 or 2 inhalations,
twice a day.
• If your symptoms are well controlled,
your doctor may ask you to take your
medicine once a day.
• Do this again, turning the red grip in
both directions.
• Your Symbicort Turbohaler is now
ready for use.
Fold

Children (6 to 11 years)
• The usual dose is 2 inhalations, twice
a day.

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

a) Using Symbicort Turbohaler and a
separate reliever inhaler

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.

Note:
• The grip will still twist and ‘click’ even
when your Symbicort Turbohaler is
empty.
• The sound that you hear as you shake
your
Symbicort 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 Symbicort Turbohaler.
• If you load your Symbicort 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.

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 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 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 (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 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 (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.
T06709

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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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