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SYMBICORT 200/6 INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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PATIENT INFORMATION LEAFLET
®

SYMBICORT 200/6
TURBOHALER®

(budesonide and formoterol fumarate dihydrate)
The name of your medicine is Symbicort 200/6
Turbohaler but will be referred to as Symbicort
throughout this leaflet.
Read all of this leaflet carefully before you start
taking 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.
In this leaflet:
1. What Symbicort is and what it is used for
2. Before you use Symbicort
3. How to use Symbicort
4. Possible side effects
5. How to store Symbicort
6. Further information
1. WHAT SYMBICORT IS AND WHAT IT IS USED
FOR
Symbicort 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 can be prescribed for asthma in two different
ways.
a) Some people are prescribed two asthma inhalers:
Symbicort and a separate ‘reliever inhaler’.
• They use Symbicort 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 as their
only asthma inhaler.
• They use Symbicort every day. This helps to prevent
asthma symptoms from happening.
• They also use Symbicort 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 can also be used to treat the symptoms of
severe 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
Do not use Symbicort 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
Before you use Symbicort, 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 taking or
have recently taken 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
taking any of the following medicines:
• Beta-blocker medicines (such as atenolol or
propranolol for high blood pressure), including
eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as
quinidine).
• Medicines like digoxin, often used to treat heart
failure.
• Diuretics, also known as ‘water tablets’ (such as
furosemide). These are used to treat high blood
pressure.
• Steroid medicines that you take by mouth (such as
prednisolone).
• Xanthine medicines (such as theophylline or
aminophylline). These are often used to treat
asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline) and
the 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 levadopa).
• Medicines for thyroid problems (such as levothyroxine).
If any of the above applies to you, or if you are not sure,
talk to your doctor or pharmacist before using
Symbicort.
Also tell your doctor or pharmacist if you are going to
have a general anaesthetic for an operation or for dental
work.
Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant, talk
to your doctor before using Symbicort - do not use
Symbicort unless your doctor tells you to.
• If you get pregnant while using Symbicort, do not
stop using Symbicort but talk to your doctor
immediately.
• If you are breast-feeding, talk to your doctor before
using Symbicort.
Driving and using machines
Symbicort 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
Symbicort 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
• Always use Symbicort 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 every day, even if
you have no asthma or COPD symptoms at the time.
• If you are using Symbicort 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. 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.
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, you should continue to use Symbicort
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 can be prescribed for asthma in two different
ways. The amount of Symbicort to use and when to use
it depends on how it has been prescribed for you.
a) If you have been prescribed Symbicort and a
separate reliever inhaler, read the section called ‘a)
Using Symbicort and a separate reliever inhaler’.
b) If you have been prescribed Symbicort as your only
inhaler, read the section called ‘b) Using Symbicort
as your only asthma inhaler’.
a) Using Symbicort and a separate reliever inhaler
Use your Symbicort 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.

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 is available for children
aged from 6 to 11 years.
Symbicort 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 to treat asthma symptoms - use your
reliever inhaler.
b) Using Symbicort as your only asthma inhaler
Only use Symbicort in this way if your doctor has told
you to and if you are aged 18 or above.
Use your Symbicort 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 as a ‘reliever inhaler’ to treat
asthma symptoms when they happen.
• If you get asthma symptoms, take 1 inhalation and
wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.
Always keep your Symbicort 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 as described here. However,
do not use Symbicort just before exercise to stop
asthma symptoms from happening.
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
Before using your new Symbicort 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.

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

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.

If you forget to use Symbicort
• 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.

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 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 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.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Symbicort can cause side effects,
although not everybody gets them.
If either of the following happen to you, stop using
Symbicort 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 Symbicort
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.
• Thrush (a fungal infection) in the mouth. This is less
likely if you rinse your mouth out with water after
using your 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 stop using
Symbicort 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.
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.
5. HOW TO STORE SYMBICORT
• Keep out of the sight and reach of children.
• Do not use the inhaler after the expiry date that 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.
• Do not store this medicine above 30°C.
• When not in use, Symbicort should be stored with the
cover tightened.
• 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 contains
Symbicort contains two active ingredients, budesonide
and formoterol. Each inhalation contains 200
micrograms of budesonide and 6 micrograms
formoterol.
Symbicort also contains lactose monohydrate (which
contains milk proteins).
What Symbicort looks like and contents of the pack
Symbicort is a white powder in a white plastic inhalation
device with a red plastic base and braille on the bottom.
Each Symbicort contains 60 inhalations
Manufactured by AstraZeneca GmbH, 22876 Wedel,
Germany or AstraZeneca AB, Kvarnbergagatan 12, SE151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way,
Borehamwood, Herts. WD6 1EE.
Symbicort 200/Turbohaler

PL 20492/0301

POM
Symbicort and Turbohaler are registered trademarks of
the AstraZeneca Group.
Date of Preparation: 19th April 2013

PATIENT INFORMATION LEAFLET

SYMBICORT® 200/6 INHALATION
POWDER
(budesonide and formoterol fumarate dihydrate)
The name of your medicine is Symbicort 200/6
Inhalation Powder but will be referred to as Symbicort
throughout this leaflet.
Read all of this leaflet carefully before you start
taking 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.
In this leaflet:
1. What Symbicort is and what it is used for
2. Before you use Symbicort
3. How to use Symbicort
4. Possible side effects
5. How to store Symbicort
6. Further information
1. WHAT SYMBICORT IS AND WHAT IT IS USED
FOR
Symbicort 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 can be prescribed for asthma in two different
ways.
a) Some people are prescribed two asthma inhalers:
Symbicort and a separate ‘reliever inhaler’.
• They use Symbicort 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 as their
only asthma inhaler.
• They use Symbicort every day. This helps to prevent
asthma symptoms from happening.
• They also use Symbicort 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 can also be used to treat the symptoms of
severe 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
Do not use Symbicort 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
Before you use Symbicort, 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 taking or
have recently taken 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
taking any of the following medicines:
• Beta-blocker medicines (such as atenolol or
propranolol for high blood pressure), including
eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as
quinidine).
• Medicines like digoxin, often used to treat heart
failure.
• Diuretics, also known as ‘water tablets’ (such as
furosemide). These are used to treat high blood
pressure.
• Steroid medicines that you take by mouth (such as
prednisolone).
• Xanthine medicines (such as theophylline or
aminophylline). These are often used to treat
asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline) and
the 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 levadopa).
• Medicines for thyroid problems (such as levothyroxine).
If any of the above applies to you, or if you are not sure,
talk to your doctor or pharmacist before using
Symbicort.
Also tell your doctor or pharmacist if you are going to
have a general anaesthetic for an operation or for dental
work.
Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant, talk
to your doctor before using Symbicort - do not use
Symbicort unless your doctor tells you to.
• If you get pregnant while using Symbicort, do not
stop using Symbicort but talk to your doctor
immediately.
• If you are breast-feeding, talk to your doctor before
using Symbicort.
Driving and using machines
Symbicort 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
Symbicort 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
• Always use Symbicort 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 every day, even if
you have no asthma or COPD symptoms at the time.
• If you are using Symbicort 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. 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.
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, you should continue to use Symbicort
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.

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 is available for children
aged from 6 to 11 years.
Symbicort 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 to treat asthma symptoms - use your
reliever inhaler.
b) Using Symbicort as your only asthma inhaler
Only use Symbicort in this way if your doctor has told
you to and if you are aged 18 or above.
Use your Symbicort 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 as a ‘reliever inhaler’ to treat
asthma symptoms when they happen.
• If you get asthma symptoms, take 1 inhalation and
wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.
Always keep your Symbicort 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.

These signs could mean that your asthma or COPD is
not being properly controlled and you may need different
or additional treatment immediately.

If you are doing exercise and you get asthma
symptoms, use Symbicort as described here. However,
do not use Symbicort just before exercise to stop
asthma symptoms from happening.

Asthma
Symbicort can be prescribed for asthma in two different
ways. The amount of Symbicort to use and when to use
it depends on how it has been prescribed for you.

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.

a) If you have been prescribed Symbicort and a
separate reliever inhaler, read the section called ‘a)
Using Symbicort and a separate reliever inhaler’.
b) If you have been prescribed Symbicort as your only
inhaler, read the section called ‘b) Using Symbicort
as your only asthma inhaler’.

Your doctor may also prescribe other bronchodilator
drugs, for example anticholinergics (such as tiotropium
or ipratropium bromide) for your COPD disease.

a) Using Symbicort and a separate reliever inhaler
Use your Symbicort 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.

Preparing your new Symbicort
Before using your new Symbicort 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 device 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 device is now ready for use.

How to take an inhalation
Every time you need to take an inhalation, follow the
instructions below.

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

1. Unscrew the cover and lift it off. You may hear a
rattling sound.
2. Hold your device 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 device away from your mouth. Breathe out
gently (as far as is comfortable). Do not breathe out
through your device.
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 device 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.

If you forget to use Symbicort
• 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.

Do not try to remove or twist the mouthpiece. It is fixed
to your device and must not be taken off. Do not use
your device if it has been damaged or if the mouthpiece
has come apart from your device.
As with all inhalers, caregivers should ensure that
children prescribed Symbicort use correct inhalation
technique, as described above.
Cleaning your device
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 device
• The dose indicator tells you how
many doses (inhalations) are left
in your device, 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
device.
Note:
• The grip will still twist and ‘click’ even when your
device is empty.
• The sound that you hear as you shake your device is
produced by a drying agent and not the medicine.
Therefore the sound does not tell you how much
medicine is left in your device.
• If you load your device 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 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.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Symbicort can cause side effects,
although not everybody gets them.
If either of the following happen to you, stop using
Symbicort 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 Symbicort
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.
• Thrush (a fungal infection) in the mouth. This is less
likely if you rinse your mouth out with water after
using your 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 stop using
Symbicort 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.
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.
5. HOW TO STORE SYMBICORT
• Keep out of the sight and reach of children.
• Do not use the inhaler after the expiry date that 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.
• Do not store this medicine above 30°C.
• When not in use, Symbicort should be stored with the
cover tightened.
• 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 contains
Symbicort contains two active ingredients, budesonide
and formoterol. Each inhalation contains 200
micrograms of budesonide and 6 micrograms
formoterol.
Symbicort also contains lactose monohydrate (which
contains milk proteins).
What Symbicort looks like and contents of the pack
Symbicort is a white powder in a white plastic inhalation
device with a red plastic base and braille on the bottom.
Each Symbicort contains 60 inhalations
Manufactured by AstraZeneca GmbH, 22876 Wedel,
Germany or AstraZeneca AB, Kvarnbergagatan 12, SE151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way,
Borehamwood, Herts. WD6 1EE.
Symbicort 200/6 Inhalation Powder

PL 20492/0301

POM
Symbicort is registered trademarks of the AstraZeneca
Group.
Date of Preparation: 19th April 2013

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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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