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SYMBICORT TURBOHALER 100/6 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®
100/6, inhalation powder
(budesonide, formoterol fumarate)
This medicine is called Symbicort Turbohaler 100/6, inhalation powder but
will be referred to as Symbicort Turbohaler throughout this leaflet.

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
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.
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 ‘longacting 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 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.

• 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.

• 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.

• Hold your Symbicort Turbohaler upright with the red grip
at the bottom.

Other possible side effects:

• 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.

• 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.

Common (may affect up to 1 in 10 people)

• Do this again, turning the red grip in both directions.
• Your Symbicort Turbohaler is now ready for use.

Uncommon (may affect up to 1 in 100 people)
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

• 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.

morning and/or evening doses, and spit it out.

Reporting of side effects

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.

If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

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.

5. How to store Symbicort Turbohaler
• Keep out of the sight and reach of children
• Do not use the inhaler after the expiry date that 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.
• 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
Each inhaled dose (the dose leaving the mouthpiece) delivers
80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate
dihydrate. This corresponds to a dispensed dose of 100 micrograms of
budesonide and 6 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).

What Symbicort Turbohaler looks like and contents of the pack

• 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.

Symbicort Turbohaler is an inhaler containing your medicine. The inhalation
powder is white in colour.
Each Turbohaler contains 120 doses and has a white body with a red turning
grip. The turning grip contains a Braille code with the number 6.

• 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.

Symbicort Turbohaler is available in pack of 1 Turbohaler containing 120
doses.

If you use more Symbicort Turbohaler than you should

Manufacturer

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.

This product is manufactured by AstraZeneca AB, Kvarnbergagatan 12,
151 85 Södertälje, Sweden. Procured from within the EU and repackaged by
Mediwin Limited, Product Licence Holder: Mediport Limited 13 Martello
Enterprise Centre, Courtwick Lane, Littlehampton, BN17 7PA, United Kingdom.

The most common symptoms that may occur if you use more Symbicort
Turbohaler than you should are trembling, headache or a rapid heart beat.

POM PL No: 18980/0869

If you forget to use Symbicort Turbohaler

Symbicort® and Turbohaler® are trade marks of the AstraZeneca AB.

• 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.

Date of leaflet preparation: 10/03/2017

• 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, this medicine can cause side effects, although not
everybody gets them.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0330 684 1100 to obtain the leaflet
in a format suitable for you.

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.

PIL-0869-S0003

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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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