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SYMBICORT TURBOHALER 400/12 INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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Assessed against UK PIL
dated October 2015
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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Symbicort Turbohaler 400/12, 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 known as Symbicort® Turbohaler® 400/12,
inhalation powder but will be referred to as Symbicort Turbohaler
throughout the following 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
For asthma, your doctor will prescribe two asthma inhalers:
Symbicort Turbohaler and a separate ‘reliever inhaler’.



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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. 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 antidepressant 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
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.
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 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.
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
P

1.
2.

e effects

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, 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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine
5. H

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 after the expiry date printed on the carton or device
label.
If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek The advice of your pharmacist
who will tell you what to do.
F

6. Further Information
What Symbicort Turbohaler contains
 Each inhaled Dose (the dose leaving the mouthpiece) delivers
320 micrograms of budesonide and 9 micrograms of formoterol
fumarate dihydrate. This corresponds to dispensed dose of 400
microgram of budesonide and 12 micrograms of formoterol
fumarate dihydrate.
 Symbicort Turbohaler also contains lactose monohydrate
(which contains milk proteins).
What Symbicort Turbohaler looks like and contents of the pack
Symbicort Turbohaler is a white, plastic, inspiratory-flow driven,
multidose powder inhaler containing white rounded granules with a
red turning grip embossed with a braille code.
Each Symbicort Turbohaler contains 60 actuations.
Manufactured by: AstraZeneca AB, Kvarnbergagatan 12, 151 85
Sodertalje, Sweden.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL, UK

Symbicort® Turbohaler® 400/12,
inhalation powder
PL: 39352/0318

POM

Like all medicines, Symbicort Turbohaler can cause side effects,
although not everybody gets them.

Symbicort® and Turbohaler® are registered trademarks of the
AstraZeneca group of companies.

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.

Leaflet date: 27.11.2015

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.

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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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