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SYMBICORT 100/6 MICROGRAM TURBOHALER

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® 100/6microgram Turbohaler®
(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.
The name of your medicine is Symbicort 100/6microgram Turbohaler
but it will be referred to as Symbicort Turbohaler or Turbohaler
throughout this leaflet.
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, adolescents and children aged 6 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.
This medicine is not suitable for people with severe asthma. It 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.

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 antidepressant 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.

3. How to use Symbicort Turbohaler


Always use this medicine 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 Turbohaler every day, even if you
have no asthma symptoms at the time.
 Your doctor will want to regularly check your asthma 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 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 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.
Children (6 to 11 years)
 The usual dose is 2 inhalations, twice a day.
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.
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.
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.
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 Symbicort
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 Symbicort Turbohaler is
now loaded and ready to use. Only load your 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
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
0
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 product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Symbicort Turbohaler can cause side effects,
although not everybody gets them.
If either of the following happen to you, stop using Symbicort
Turbohaler and talk to your doctor immediately:
 Swelling of your face, particularly around your mouth (tongue and/or
throat and/or difficulty swallowing) or hives together with difficulty
breathing (angioedema) and/or sudden feeling of faintness. This
may mean that you are having an allergic reaction. This happens
rarely, affecting less than 1 in 1,000 people.



Sudden acute wheezing or shortness of breath immediately after
using your inhaler. If either of these symptoms occur, stop using
your Symbicort Turbohaler straightaway and use your ‘reliever’
inhaler. Contact your doctor immediately as you may need to
have your treatment changed. This happens very rarely, affecting
less than 1 in 10,000 people.

Other possible side effects:
Common (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.
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.
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 any side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Symbicort Turbohaler








Keep out of the sight and reach of children.
Do not store above 30°C.
Store with the cover tightly closed.
Do not use the Turbohaler after the expiry date which is stated on
the carton and Turbohaler label after ‘Exp’. The expiry date refers to
the last day of that month.
If the Turbohaler becomes damaged, seek the advice of your
pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
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. Contents of the pack and other information
What Symbicort Turbohaler contains
The active ingredients in Symbicort Turbohaler are budesonide and
formoterol fumarate dihydrate.
Each inhaled dose contains 80 micrograms of budesonide and
4.5 micrograms of formoterol fumarate dihydrate, this corresponds to
a metered dose of 100 micrograms of budesonide and 6 micrograms of
formoterol fumarate dihydrate.
What Symbicort Turbohaler looks like and contents of the pack
The product is a multidose, breath actuated, powder inhaler with a
white plastic cover and red turning grip. On the turning grip a Braille
code is embossed.
Symbicort Turbohaler is available in pack containing 120 actuations.
Manufactured by: AstraZeneca AB, S-151 85, Sodertalje, Sweden.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Symbicort® 100/6microgram Turbohaler®; PL 18799/0676
Leaflet date: 18.05.2017
POM

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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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