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SYMBICORT TURBOHALER 400 MICROGRAMS-12 MICROGRAMS-INHALATION INHALATION POWDER

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

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Package leaflet: Information for the user

Symbicort® Turbohaler® 400/12,
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
PS03773
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.
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
For asthma, your doctor will prescribe two asthma inhalers:
Symbicort Turbohaler and a separate ‘reliever inhaler’.



Use Symbicort Turbohaler every day. This helps to prevent asthma
symptoms from happening.
Use your ‘reliever inhaler’ when you get asthma symptoms, to make it
easier to breathe again.

Do not use Symbicort Turbohaler 400/12 as a ‘reliever inhaler’.
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.

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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 allergic reactions.
3. How to use Symbicort Turbohaler




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
Use your Symbicort Turbohaler 400/12 every day. This helps to prevent
asthma symptoms from happening.
Adults (18 years and above)
• The usual dose is 1 inhalation, twice a day.
• Your doctor may increase this to 2 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take
your medicine once a day.
Adolescents (12 to 17 years)
• The usual dose is 1 inhalation, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take
your medicine once a day.
A lower strength of Symbicort Turbohaler is available for children aged from
6 to 11 years.
Symbicort Turbohaler is not recommended to be used in children who are
younger than 6 years.
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 400/12 to treat asthma symptoms use your separate ‘reliever inhaler’.
Chronic Obstructive Pulmonary Disease (COPD)
• Only to be used by adults (aged 18 years and above).
• The usual dose is 1 inhalation twice a day.
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.

These effects are much less likely to happen with
inhaled corticosteroids than with corticosteroid tablets.

8. Replace the cover tightly after use.

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 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.

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

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 400/12 contains
The active substances are budesonide and formoterol fumarate dihydrate.
Each inhaled dose contains 320 micrograms of budesonide and
9 micrograms of formoterol fumarate dihydrate, this corresponds to a metered
dose of 400 micrograms of budesonide and 12 micrograms of formoterol
fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Symbicort Turbohaler 400/12 looks like and contents of the pack
Symbicort Turbohaler 400/12 is an inhaler containing your medicine. The
inhalation powder is white in colour. Each inhaler contains 60 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 400/12 is available in packs of 1, 2, 3, 10 or
18 inhaler(s) containing 60 doses.

If you forget to use Symbicort Turbohaler
• If you forget to take a dose, take it as soon as you remember. However,
if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

Not all pack sizes may be marketed.

If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

Symbicort Turbohaler 400/12 is manufactured by AstraZeneca AB,
S-151 85 Södertälje, Sweden.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Symbicort Turbohaler 400/12 is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.

Symbicort Turbohaler is authorised in the Member States of the EEA
under the following names:
Like all medicines, this medicine can cause side effects, although not
Country
Trade name and strength
everybody gets them.
Austria
Symbicort forte Turbohaler 320 μg/9 μg/inhalation
If either of the following happens to you, stop using Symbicort Turbohaler
Belgium
Symbicort forte Turbohaler 320 μg/9 μg/inhalation
and talk to your doctor immediately:
Bulgaria
Symbicort Turbuhaler 320 μg/9 μg/inhalation
• Swelling of your face, particularly around your mouth (tongue and/or
Croatia
Symbicort Turbuhaler 320 μg/9 μg/inhalation
throat and/or difficulty to swallow) or hives together with difficulties to
Cyprus
Symbicort Turbuhaler 320 μg/9 μg/inhalation
breathe (angioedema) and/or sudden feeling of faintness. This may mean Czech Republic
Symbicort Turbuhaler 400 μg/12 μg/inhalation
that you are having an allergic reaction. This happens rarely, affecting
Denmark
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation,
less than 1 in 1,000 people.
Estonia
Symbicort Turbuhaler 320 μg/9 μg/inhalation
• Sudden acute wheezing or shortness of breath immediately after using
Finland
Symbicort Turbuhaler forte.320 μg/9 μg/inhalation
your inhaler. If either of these symptoms occur, stop using your
France
Symbicort Turbuhaler 400 μg/12 μg/inhalation
Symbicort Turbohaler straightaway and use your ‘reliever’ inhaler.
Germany
Symbicort Turbohaler 320 μg/9 μg/inhalation
Contact your doctor immediately as you may need to have your
Greece
Symbicort Turbuhaler 320 μg/9 μg/inhalation
treatment changed. This happens very rarely, affecting less than 1 in
Hungary
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
10,000 people.
Iceland
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Other possible side effects:
Ireland
Symbicort Turbohaler 400 μg/12 μg/inhalation
Common (may affect up to 1 in 10 people)
Italy
Symbicort 320 μg/9 μg/inhalation
• Palpitations (awareness of your heart beating), trembling or shaking.
Latvia
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
If these effects occur, they are usually mild and usually disappear as you
Lithuania
Symbicort Turbuhaler 320 μg/9 μg/inhalation
continue to use Symbicort Turbohaler.
Luxembourg
Symbicort forte Turbohaler 320 μg/9 μg/inhalation
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse
Malta
Symbicort Turbohaler 400 μg/12 μg/inhalation
your mouth out with water after using your Symbicort Turbohaler.
Netherlands
Symbicort Turbuhaler 400 μg/12 μg/inhalation
• Mild sore throat, coughing and a hoarse voice.
Norway
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
• Headache.
Poland
Symbicort Turbuhaler 320 μg/9 μg/inhalation
• Pneumonia (infection of the lung) in COPD patients.
Portugal
Symbicort Turbohaler 320 μg/9 μg/inhalation
Tell your doctor if you have any of the following while taking
Romania
Symbicort Turbuhaler 320 μg/9 μg/inhalation
Symbicort Turbohaler, they could be symptoms of a lung infection:
Slovakia
Symbicort Turbuhaler forte 400 μg/12 μg/inhalation
• Fever or chills.
Slovenia
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
• Increased mucus production, change in mucus colour.
Spain
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
• Increased cough or increased breathing difficulties.
Sweden
Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Uncommon (may affect up to 1 in 100 people)
United Kingdom
Symbicort Turbohaler 400 μg/12 μg/inhalation
• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
4. Possible side effects

Rare (may affect up to 1 in 1,000 people)
• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which
causes wheezing). If the wheezing comes on suddenly after using
Symbicort Turbohaler stop using Symbicort Turbohaler and talk to your
doctor immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
Very rare (may affect up to 1 in 10,000 people)
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.
Inhaled corticosteroids can affect the normal production of steroid hormones
in your body, particularly if you use high doses for a long time. The effects
include:
• changes in bone mineral density (thinning of the bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• a slowing of the rate of growth of children and adolescents
• an effect on the adrenal gland (a small gland next to the kidney).

522015-A06
21-09-16
PS03773
AZL030G
6724
Symbicort 400mcg/12mcg
Leaflet: Patient UK

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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 400/12
Reference number
17901/0200
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last updated in September 2016
© AstraZeneca 2016
Symbicort and Turbohaler are trade marks of the AstraZeneca group of
companies.
RSP 16 0017a

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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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