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SYMBICORT TURBOHALER 200/6 INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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Transcript
Ref: 1657/080616/1/F

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.





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
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 the inhaler after the expiry date
which is stated on the carton or on the label of
your inhaler after EXP. 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 no
longer required. These measures will help to
protect the environment.



6. Further information
What Symbicort Turbohaler contains
• Each inhaled dose (the dose leaving the
mouthpiece) delivers 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).
What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white with a red turning grip. The turning grip
contains a Braille code with the number 6 for
identification, to differ from other AstraZeneca
inhaled products.
• Each Turbohaler contains 120 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca AB, SE-151 85,
Sodertalje, Sweden and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 08/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of this
leaflet.
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
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 ‘long-acting beta2
adrenoceptor agonists’ or ‘bronchodilators’. It
works by relaxing the muscles in your airways.
This helps you to breathe more easily.
Your doctor has prescribed this medicine to treat
asthma or chronic obstructive pulmonary disease
(COPD).
Asthma
Symbicort Turbohaler can be prescribed for
asthma in two different ways.
a) 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.
b) 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.
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.

2. Before you use Symbicort Turbohaler
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).
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).
• 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 anti-depressant nefazodone.
• Mono-Amine Oxidase Inhibitors, also known as
MAOIs (such as phenelzine).
• Phenothiazine medicines (such as
chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease 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.
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
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’.
a) Using Symbicort Turbohaler and a separate
reliever inhaler Use your Symbicort
Turbohaler 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.

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.
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 Symbicort Turbohaler as described
here. However, do not use Symbicort Turbohaler
just before exercise to stop asthma symptoms
from happening.



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.
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.
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 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 18 or
above.
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.
Your doctor may increase this to 2 inhalations
twice a day.
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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice a day.
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.
• 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.
• 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.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
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.

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.
7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly after
use.
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.
When to start using a new Turbohaler
• The dose indicator tells you
how many doses (inhalations)
are left in your 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 Turbohaler.
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.
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.
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.
Ref:1657/080616/1/B

Ref: 1657/080616/2/F

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.





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
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 the inhaler after the expiry date
which is stated on the carton or on the label of
your inhaler after EXP. 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 no
longer required. These measures will help to
protect the environment.



6. Further information
What Symbicort Turbohaler contains
• Each inhaled dose (the dose leaving the
mouthpiece) delivers 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).
What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white with a red turning grip. The turning grip
contains a Braille code with the number 6 for
identification, to differ from other AstraZeneca
inhaled products.
• Each Turbohaler contains 120 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca UK Limited,
SK10 2NA, UK and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 08/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of this
leaflet.
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
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 ‘long-acting beta2
adrenoceptor agonists’ or ‘bronchodilators’. It
works by relaxing the muscles in your airways.
This helps you to breathe more easily.
Your doctor has prescribed this medicine to treat
asthma or chronic obstructive pulmonary disease
(COPD).
Asthma
Symbicort Turbohaler can be prescribed for
asthma in two different ways.
a) 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.
b) 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.
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.

2. Before you use Symbicort Turbohaler
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).
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).
• 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 anti-depressant nefazodone.
• Mono-Amine Oxidase Inhibitors, also known as
MAOIs (such as phenelzine).
• Phenothiazine medicines (such as
chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease 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.
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
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’.
a) Using Symbicort Turbohaler and a separate
reliever inhaler Use your Symbicort
Turbohaler 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.

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.
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 Symbicort Turbohaler as described
here. However, do not use Symbicort Turbohaler
just before exercise to stop asthma symptoms
from happening.



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.
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.
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 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 18 or
above.
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.
Your doctor may increase this to 2 inhalations
twice a day.
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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice a day.
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.
• 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.
• 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.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
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.

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.
7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly after
use.
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.
When to start using a new Turbohaler
• The dose indicator tells you
how many doses (inhalations)
are left in your 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 Turbohaler.
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.
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.
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.
Ref:1657/080616/2/B

Ref: 1657/080616/3/F

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.





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
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 the inhaler after the expiry date
which is stated on the carton or on the label of
your inhaler after EXP. 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 no
longer required. These measures will help to
protect the environment.



6. Further information
What Symbicort Turbohaler contains
• Each inhaled dose (the dose leaving the
mouthpiece) delivers 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).
What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white with a red turning grip. The turning grip
contains a Braille code with the number 6 for
identification, to differ from other AstraZeneca
inhaled products.
• Each Turbohaler contains 120 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca GmbH, D-22880,
Wedel, Germany and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 08/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of this
leaflet.
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
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 ‘long-acting beta2
adrenoceptor agonists’ or ‘bronchodilators’. It
works by relaxing the muscles in your airways.
This helps you to breathe more easily.
Your doctor has prescribed this medicine to treat
asthma or chronic obstructive pulmonary disease
(COPD).
Asthma
Symbicort Turbohaler can be prescribed for
asthma in two different ways.
a) 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.
b) 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.
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.

2. Before you use Symbicort Turbohaler
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).
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).
• 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 anti-depressant nefazodone.
• Mono-Amine Oxidase Inhibitors, also known as
MAOIs (such as phenelzine).
• Phenothiazine medicines (such as
chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease 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.
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
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’.
a) Using Symbicort Turbohaler and a separate
reliever inhaler Use your Symbicort
Turbohaler 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.

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.
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 Symbicort Turbohaler as described
here. However, do not use Symbicort Turbohaler
just before exercise to stop asthma symptoms
from happening.



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.
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.
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 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 18 or
above.
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.
Your doctor may increase this to 2 inhalations
twice a day.
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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice a day.
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.
• 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.
• 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.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
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.

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.
7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly after
use.
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.
When to start using a new Turbohaler
• The dose indicator tells you
how many doses (inhalations)
are left in your 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 Turbohaler.
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.
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.
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.
Ref:1657/080616/3/B

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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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