Skip to Content

SYMBICORT TURBOHALER 200/6 INHALATION POWDER

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

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Ref: 1657/131217/1/F



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.
• Pneumonia (infection of the lung) in COPD
patients.
Tell your doctor if you have any of the following
while taking Symbicort Turbohaler, they could be
symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus
colour.
• Increased cough or increased breathing
difficulties.
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 or
pharmacist. This includes any possible side effects
not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store. 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.
• Keep the container/cap tightly closed, in order
to protect from moisture.
• Do not use the inhaler 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.
• 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 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).
What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white 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.
• Each Turbohaler contains 120 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca AB, SE-151 85,
Sodertalje, Sweden and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 13/12/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of 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 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
Symbicort Turbohaler 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.
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.
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. 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.

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.

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.

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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice 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.
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.

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).

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.

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.

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.

Contact your doctor immediately if:

• Your breathing is getting worse or you often

Your doctor may increase this to 2 inhalations
twice a day.

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
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

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.

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.

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 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
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 Turbohaler is now loaded and
ready to use. Only load your Symbicort
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
Symbicort 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 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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.
Ref:1657/131217/1/B

Ref: 1657/131217/2/F



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.
• Pneumonia (infection of the lung) in COPD
patients.

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

5. How to store Symbicort Turbohaler






Tell your doctor if you have any of the following
while taking Symbicort Turbohaler, they could be
symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus
colour.
• Increased cough or increased breathing
difficulties.



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.

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 the inhaler 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.
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 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).
What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white 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.
• Each Turbohaler contains 120 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca UK Limited,
SK10 2NA, UK and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 13/12/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of 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 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
Symbicort Turbohaler 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.
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.
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. 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.

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.

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.

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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice 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.
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.

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).

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.

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.

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.

Contact your doctor immediately if:

• Your breathing is getting worse or you often

Your doctor may increase this to 2 inhalations
twice a day.

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
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

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.

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.

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 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
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 Turbohaler is now loaded and
ready to use. Only load your Symbicort
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
Symbicort 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 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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.
Ref:1657/131217/2/B

Ref: 1657/131217/3/F



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.
• Pneumonia (infection of the lung) in COPD
patients.
Tell your doctor if you have any of the following
while taking Symbicort Turbohaler, they could be
symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus
colour.
• Increased cough or increased breathing
difficulties.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store. 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.
Keep the container/cap tightly closed, in order
to protect from moisture.
Do not use the inhaler 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.
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

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.

What Symbicort Turbohaler contains
Each inhaled dose (the dose leaving the
mouthpiece) delivers 160 micrograms of
budesonide and 4.5 micrograms of formoterol
fumarate dihydrate. This corresponds to a
dispensed dose of 200 micrograms of
budesonide and 6 micrograms of formoterol
fumarate dihydrate.
• The other ingredient is lactose.
(which contains milk proteins).

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.

What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 200/6 is an inhaler with
white inhalation powder. The body of the inhaler
is white 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.
• Each Turbohaler contains 120 doses.

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.

Manufacturer and Licence Holder
Manufactured by AstraZeneca GmbH, D-22880,
Wedel, Germany and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.








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 you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1657 Symbicort Turbohaler
200/6, Inhalation powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 13/12/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

PATIENT INFORMATION LEAFLET

Symbicort ® Turbohaler ® 200/6, Inhalation powder
(budesonide / formoterol fumarate)
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.
Your medicine is called Symbicort Turbohaler
200/6, Inhalation powder and will be referred to as
Symbicort Turbohaler throughout the rest of 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 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
Symbicort Turbohaler 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.
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.
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. 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.

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.

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.

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.

Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 2 inhalations twice 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.
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.

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).

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.

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.

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.

Contact your doctor immediately if:

• Your breathing is getting worse or you often

Your doctor may increase this to 2 inhalations
twice a day.

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
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

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.

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.

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 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
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 Turbohaler is now loaded and
ready to use. Only load your Symbicort
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
Symbicort 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 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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.

Ref:1657/131217/3/B

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide