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SYMBICORT 100/6 MICROGRAM TURBOHALER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Symbicort® 100/6microgram Turbohaler®
(budesonide/formeterol fumarate dihydrate)
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.
The name of your medicine is Symbicort 100/6microgram Turbohaler but it
will be referred to as Symbicort Turbohaler throughout this leaflet.
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.

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.
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).

Your doctor has prescribed this medicine to treat asthma.
It is not suitable for people with severe asthma. It can be prescribed for
asthma in two different ways.

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.

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.

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.

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. 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 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 MAOI’s (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 and breast-feeding
• 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.

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 18 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 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 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 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 (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.
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.
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.
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. How to store Symbicort Turbohaler








KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take this medicine after the expiry date which is stated on the
carton label after ‘Exp’. The date refers to the last day of that month.
Do not store this medicine above 30°C.
Store with the cover tightly closed.
Do not use a damaged inhaler.
If your Turbohaler shows any signs if deterioration, seek the advice of
your pharmacist.
If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep Symbicort
Turbohaler if your doctor tells you to.

6. Further information
What Symbicort Turbohaler contains
Each metered actuation contains budesonide equivalent to 100micrograms
and formeterol fumarate dihydrate equivalent to 6micrograms.
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.
Manufactured by: AstraZeneca BV, Postbus 599, 2700 An Zoetermeer,
The Netherlands.
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 No: 18799/0676
Leaflet date: 21.11.2013
SYMBICORT and TURBOHALER are registered trademarks of the
AstraZeneca Group.

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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