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SYMBICORT 200/6 TURBOHALER

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

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Package leaflet: Information for the user

3. How to use Symbicort Turbohaler

Symbicort® Turbohaler® 200/6,
inhalation powder




budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.



PS08517

What is in this leaflet:
1. What Symbicort Turbohaler is and what it is used for
2. What you need to know before you use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Contents of the pack and other information
1. What Symbicort Turbohaler is and what it is used for
Symbicort Turbohaler is an inhaler that is used to treat asthma in adults and
adolescents aged 12 – 17 years. It is also used to treat the symptoms of
Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and
older. It contains two different medicines: budesonide and formoterol fumarate
dihydrate.
• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by
reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting beta2 adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your airways. This helps you to breathe more easily.
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. What you need to know before you use Symbicort Turbohaler
Do not use Symbicort Turbohaler:
• if you are allergic to budesonide, formoterol, or the other ingredient of this medicine
(listed in section 6), which is lactose (which contains small amounts of milk protein).
Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort Turbohaler 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.
Other medicines and Symbicort Turbohaler
Tell your doctor or pharmacist if you are using, have recently used or might use any
other medicines.
In particular, tell your doctor or pharmacist if you are using any of the following
medicines:
• Beta-blocker medicines (such as atenolol or propranolol for high blood
pressure), including eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to
treat high blood pressure.
• Steroid medicines that you take by mouth (such as prednisolone).
• 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.
• 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.
Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If you have been
told by your doctor that you have an intolerance to some sugars, talk to your
doctor before using this medicine. The amount of lactose in this medicine does not
normally cause problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins, which may cause an
allergic reaction.

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Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
It is important to use 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.
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 12 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.
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.
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 Symbicort Turbohaler upright with the red grip at the
bottom.
• Turn the red grip as far as it will go in one direction. Then turn
it as far as it will go in the other direction (it does not matter
which way you turn it first). You should hear a click sound.
• Do this again, turning the red grip in both directions.
• Your Symbicort Turbohaler is now ready for use.

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

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).

1. Unscrew the cover and lift it off. You may hear a rattling sound.
2. Hold your Symbicort Turbohaler upright with the red grip at the bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To load your
Symbicort Turbohaler with a dose, turn the red grip as far as it will go in one direction.
Then turn it as far as it will go in the other direction (it does not matter which way
you turn it first). You should hear a click sound. Your Turbohaler is now loaded and
ready to use. Only load your Symbicort Turbohaler when you need to use it.
4. Hold your Symbicort Turbohaler away from your mouth. Breathe out gently
(as far as is comfortable). Do not breathe out through your Symbicort 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 Symbicort Turbohaler from your mouth.
Then breathe out gently. The amount of medicine that is
inhaled is very small. This means you may not be able to taste
it after inhalation. If you have followed the instructions, you can still be confident
that you have inhaled the dose and the medicine is now in your lungs.
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
Symbicort Turbohaler and must not be taken off. Do not use your
Symbicort Turbohaler if it has been damaged or if the mouthpiece has come apart
from your Symbicort Turbohaler.
As with all inhalers, caregivers should ensure that children prescribed
Symbicort Turbohaler use correct inhalation technique, as described above.
Cleaning your Symbicort Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use
water or liquids.
When to start using a new inhaler
• The dose indicator tells you how many doses (inhalations)
are left in your Symbicort Turbohaler, starting with either
60 or 120 doses when it is full.
• The dose indicator is marked in intervals of 10 doses.
Therefore it does not show every dose.
• When you first see a red mark at the edge of the indicator
window, there are approximately 20 doses left. For the last
10 doses, the background of the dose indicator is red. When the ‘0’ on the red
background has reached the middle of the window, you must start using your
new Symbicort Turbohaler.
Note:
• The grip will still twist and ‘click’ even when your Symbicort Turbohaler is empty.
• The sound that you hear as you shake your Symbicort Turbohaler is produced
by a drying agent and not the medicine. Therefore, the sound does not tell you
how much medicine is left in your Symbicort Turbohaler.
• If you load your Symbicort Turbohaler more than once by mistake before taking
your dose, you will still only receive one dose. However, the dose indicator will
register all the loaded doses.
If you 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
If either of the following happen to you, stop using Symbicort Turbohaler and
talk to your doctor immediately:
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or
difficulty swallowing) or hives together with difficulty breathing (angioedema)
and/or sudden feeling of faintness. This may mean that you are having an allergic
reaction. This happens rarely, affecting less than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath immediately after using your inhaler.
If either of these symptoms occur, stop using your Symbicort Turbohaler
straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately
as you may need to have your treatment changed. This happens very rarely,
affecting less than 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Palpitations (awareness of your heart beating), trembling or shaking. If these
effects occur, they are usually mild and usually disappear as you continue to
use Symbicort Turbohaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your
mouth out with water after using your Symbicort Turbohaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
• Pneumonia (infection of the lung) in COPD patients.
Tell your doctor if you have any of the following while taking Symbicort Turbohaler,
they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus colour.
• Increased cough or increased breathing difficulties.
Uncommon (may affect up to 1 in 100 people)
• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing).
If the wheezing comes on suddenly after using Symbicort Turbohaler stop using
Symbicort Turbohaler and talk to your doctor immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
Very rare (may affect up to 1 in 10,000 people)
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.

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These effects are much less likely to happen with inhaled
corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme, Website: www.mhra.go.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 this medicine out of the sight and reach of children.
• Do not use this medicine 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
• Do not store above 30°C.
• Keep the container/cap tightly closed, in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Symbicort Turbohaler 200/6 contains
The active substances are budesonide and formoterol fumarate dihydrate.
Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms
of formoterol fumarate dihydrate, this corresponds to a metered dose of
200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Symbicort Turbohaler 200/6 looks like and contents of the pack
Symbicort Turbohaler 200/6 is an inhaler containing your medicine. The inhalation
powder is white in colour. Each inhaler contains either 60 or 120 doses and has
a white body 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.
Symbicort Turbohaler 200/6 is available in packs of 1, 2, 3, 10 or 18 inhaler(s)
containing 60 or 120 doses.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Symbicort Turbohaler 200/6 is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton LU1 3LU, UK.
Symbicort Turbohaler 200/6 is manufactured by AstraZeneca AB,
S-151 85 Södertälje, Sweden.
This medicinal product is authorised in the Member States of the EEA under
the following names:
Country
Trade name and strength
Austria
Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Belgium
Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Bulgaria
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Croatia
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Cyprus
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Czech Republic
Symbicort Turbuhaler 200 μg/6 μg/inhalation
Denmark
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation,
Estonia
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Finland
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
France
Symbicort Turbuhaler 200 μg/6 μg/inhalation
Germany
Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Greece
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Hungary
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Iceland
Symbicort Turbuhaler160 μg/4.5 μg/inhalation
Ireland
Symbicort Turbohaler 200 μg/6 μg/inhalation
Italy
Symbicort 160 μg/4.5 μg/inhalation
Latvia
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Lithuania
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Luxembourg
Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Malta
Symbicort Turbohaler 200 μg/6 μg/inhalation
Netherlands
Symbicort Turbuhaler 200 μg/6 μg/inhalation
Norway
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Poland
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Portugal
Symbicort Turbohaler160 μg/4.5 μg/inhalation
Romania
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Slovakia
Symbicort Turbuhaler 200 μg/6 μg/inhalation
Slovenia
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Spain
Symbicort Turbuhaler160 μg/4.5 μg/inhalation
Sweden
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
United Kingdom
Symbicort Turbohaler 200 μg/6 μg/inhalation

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name
Symbicort Turbohaler 200/6
Reference number
17901/0092
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in November 2016
© AstraZeneca 2016
Symbicort and Turbohaler are trade marks of the AstraZeneca group of companies.
RSP 16 0104

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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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