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SYMBICORT 200/6 TURBOHALER

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

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Variation No: 0006. Reason. To update manufacturer sites on licence to 1. AstraZeneca AB, SE-15185, Sodertalje, Sweden. 2. AstraZeneca GmbH, Tinsdaler Weg 183, D-22880 Wedel, Germany. 3. AstraZeneca UK
Limited., Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK. Variation No: 0009. Reason: Add/amend: To correct the spelling of 'Cheshire' on labels and leaflet.

Patient Information Leaflet
Assessed against UK PIL dated December 2012

Symbicort®

200/6

Turbohaler®

(budesonide, formoterol fumarate dihydrate)
Read all of this leaflet carefully before you start taking this
medicine
Your medicine is called Symbicort® 200/6 Turbohaler® but will
be referred to as Symbicort Turbohaler throughout this leaflet.




In
1.
2.
3.
4.
5.
6.

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.
this leaflet:
What Symbicort Turbohaler is and what it is used for
Before you use Symbicort Turbohaler
How to use Symbicort Turbohaler
Possible side effects
How to store Symbicort Turbohaler
Further information

1. What Symbicort Turbohaler is and what it is used for
Symbicort Turbohaler is an inhaler. It contains two different
medicines: budesonide and formoterol fumarate dihydrate.
• Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and preventing swelling
and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines
called ‘long-acting beta2 adrenoceptor agonists’ or
‘bronchodilators’. It works by relaxing the muscles in your
airways. This helps you to breathe more easily.
Your doctor has prescribed this medicine to treat asthma or
chronic obstructive pulmonary disease (COPD).
Asthma
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
severe COPD in adults. COPD is a long-term disease of the
airways in the lungs, which is often caused by cigarette smoking.

2.

Before you use Symbicort Turbohaler

Do not use Symbicort Turbohaler if:
• You are allergic (hypersensitive) to budesonide, formoterol, or
the other ingredient, which is lactose (which contains small
amounts of milk proteins).
Take special care with Symbicort Turbohaler
Before you use Symbicort Turbohaler, tell your doctor or
pharmacist if:
• You are diabetic.
• You have a lung infection.
• You have high blood pressure or you have ever had a heart
problem (including an uneven heart beat, a very fast pulse,
narrowing of the arteries or heart failure).
• You have problems with your thyroid or adrenal glands.
• You have low levels of potassium in your blood.
• You have severe liver problems.
Taking other medicines
Please tell your doctor or pharmacist if you are 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 antidepressant nefazodone.
• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as
phenelzine).
• Phenothiazine medicines (such as chlorpromazine and
prochlorperazine).
• Medicines called ‘HIV-protease inhibitors’ (such as ritonavir) to
treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole,
voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as leva-dopa).
• Medicines for thyroid problems (such as levo-thyroxine).
If any of the above applies to you, or if you are not sure, talk to
your doctor or pharmacist before using Symbicort Turbohaler.
Also tell your doctor or pharmacist if you are going to have a
general anaesthetic for an operation or for dental work.
Pregnancy 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.

By Bushra Hussain at 3:03 pm, Sep 21, 2015

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 or COPD symptoms at the time.
If you are using Symbicort Turbohaler for asthma, your doctor will
want to regularly check your symptoms.

If you have been taking steroid tablets for your asthma or COPD,
your doctor may reduce the number of tablets that you take, once
you start to use Symbicort Turbohaler. If you have been taking oral
steroid tablets for a long time, your doctor may want you to have
blood tests from time to time. When reducing oral steroid tablets, you
may feel generally unwell even though your chest symptoms may be
improving. You might experience symptoms such as a stuffy or runny
nose, weakness or joint or muscle pain and rash (eczema). If any of
these symptoms bother you, or if symptoms such as headache,
tiredness, nausea (feeling sick) or vomiting (being sick) occur, please
contact your doctor immediately. You may need to take other
medication if you develop allergic or arthritic symptoms. You should
speak to your doctor if you are concerned as to whether you should
continue to use Symbicort Turbohaler.
Your doctor may consider adding steroid tablets to your usual
treatment during periods of stress (for example, when you have a
chest infection or before an operation).
Important information about your asthma or COPD symptoms
If you feel you are getting breathless or wheezy while using
Symbicort Turbohaler, you should continue to use Symbicort
Turbohaler but go to see your doctor as soon as possible, as you
may need additional treatment.
Contact your doctor immediately if:
• Your breathing is getting worse or you often wake up at night
with asthma.
• Your chest starts to feel tight in the morning or your chest
tightness lasts longer than usual.
These signs could mean that your asthma or COPD is not being
properly controlled and you may need different or additional
treatment immediately.
Asthma
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.
A lower strength of Symbicort Turbohaler is available for children
aged from 6 to 11 years.
Symbicort Turbohaler is not recommended to be used in children
who are younger than 6 years.
Your doctor (or asthma nurse) will help you to manage your
asthma. They will adjust the dose of this medicine to the lowest
dose that controls your asthma. However, do not adjust the dose
without talking to your doctor (or asthma nurse) first.
Use your separate ‘reliever inhaler’ to treat asthma
symptoms when they happen. Always keep your ‘reliever
inhaler’ with you to use when you need it. Do not use Symbicort
Turbohaler 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.
Your doctor may increase this to 2 inhalations twice a day.
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.
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.
Your doctor may also prescribe other bronchodilator drugs, for
example anticholinergics (such as tiotropium or ipratropium bromide)
for your COPD disease.
Preparing your new Symbicort Turbohaler
Before using your new Symbicort Turbohaler for the first time, you
need to prepare it for use as follows:







Unscrew the cover and lift it off. You
may hear a rattling sound.
Hold your Turbohaler upright with the
red grip at the bottom.
Turn the red grip as far as it will go in
one direction. Then turn it as far as it
will go in the other direction (it does
not matter which way you turn it first).
You should hear a click sound.
Do this again, turning the red grip in
both directions.
Your Turbohaler is now ready for use.

How to take an inhalation
Every time you need to take an inhalation, follow the instructions
below.
1. Unscrew the cover and lift it off. You may hear a rattling sound.
2. Hold your Turbohaler upright with the red grip at the bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To
load your Turbohaler with a dose, turn the red grip as far as it will
go in one direction. Then turn it as far as it will go in the other
direction (it does not matter which way you turn it first). You
should hear a click sound. Your Turbohaler is now loaded and
ready to use. Only load your Turbohaler when you need to use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently
(as far as is comfortable). Do not breathe out through your
Turbohaler.
5. Place the mouthpiece gently
between your teeth. Close your
lips. Breathe in as deeply and
as hard as you can through
your mouth. Do not chew or bite
on the mouthpiece.

6. Remove your Turbohaler from your mouth. Then breathe out
gently. The amount of medicine that is inhaled is very small. This
means you may not be able to taste it after inhalation. If you have
followed the instructions, you can still be confident that you have
inhaled the dose and the medicine is now in your lungs.
7. If you are to take a second
inhalation, repeat steps 2 to 6.
8. Replace the cover tightly after
use.
9. Rinse your mouth with water after
your daily morning and/or evening
doses, and spit it out.
Do not try to remove or twist the mouthpiece. It is fixed to your
Turbohaler and must not be taken off. Do not use your Turbohaler if
it has been damaged or if the mouthpiece has come apart from your
Turbohaler.
As with all inhalers, caregivers should ensure that children
prescribed Symbicort Turbohaler use correct inhalation technique, as
described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once
a week with a dry tissue. Do not use
water or liquids.
When to start using a new Turbohaler
• The dose indicator tells you how
many doses (inhalations) are left in
your Turbohaler, starting with 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 store above 30°C.
Protect from moisture
When not in use, Symbicort Turbohaler should be stored with the
cover tightened.
Do not use Symbicort Turbohaler after the expiry date printed on
the carton or on the label of your Turbohaler. 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 that are no longer required. This will help to protect
the environment.

6. Further information
What Symbicort Turbohaler 200/6 contains
The active substances are budesonide and formoterol.
Each inhaled dose contains 200 micrograms of budesonide and
6 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk
proteins).
What Symbicort Turbohaler 200/6 looks like and contents of
the pack
Symbicort Turbohaler 200/6 is an inhaler containing your medicine.
The inhalation powder is white in colour. Each Turbohaler contains
60 doses and has a white body with a red turning grip.
Symbicort Turbohaler is available in packs of 1 and 2 inhalers.
Manufacturers:
AstraZeneca AB, SE-15185, Sodertalje, Sweden
or
AstraZeneca GmbH, Tinsdaler Weg 183, D-22880 Wedel, Germany
or
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
Procured from within the EU by the Product Licence Holder: Ecosse
Pharmaceuticals Limited, 3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD
POM
PL 19065/0302
E0302/5
This leaflet was revised 26/08/2015
Symbicort® and Turbohaler® are trademarks of the AstraZeneca group of
companies

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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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