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SYMBICORT 200/6 MICROGRAM TURBOHALER

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Symbicort® 200/6 Microgram Turbohaler®
budesonide/formoterol fumarate
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
The name of your medicine is Symbicort 200/6 Microgram Turbohaler but it will be referred
to as Symbicort Turbohaler throughout most of the remainder of this leaflet.
In this leaflet:
1. What Symbicort Turbohaler is and what it is used for
2. Before you use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Further information

1. What Symbicort Turbohaler is and what it is used for
Symbicort Turbohaler is an inhaler. It contains two different medicines: budesonide and
formoterol fumarate dihydrate.
• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing
and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta2
adrenoreceptor 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 anti-depressant 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.
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
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. 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.

4. Possible side effects
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.

7.
8.
9.

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.
If you are to take a second inhalation, repeat steps 2 to 6.
Replace the cover tightly after use.
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.
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 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.

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.

5. How to store Symbicort Turbohaler
• KEEP SYMBICORT TURBOHALER IN A SAFE PLACE, OUT OF THE SIGHT AND
REACH OF CHILDREN.
• Do not use Symbicort Turbohaler after the expiry date printed on the carton or the side of
the inhaler.
• Do not store this medicine above 30°C.
• Store with the cover tightly closed.
• If your Turbohaler shows any signs if deterioration, seek the advice of your pharmacist.
• If your doctor tells you to stop taking this medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep Symbicort Turbohaler if your doctor tells you to.

6. Further information
What Symbicort Turbohaler 200/6 contains
Each Symbicort Turbohaler contains 120 actuations. Symbicort Turbohaler contains two
active ingredients, budesonide and eformoterol (eformoterol fumarate dihydrate).
Each actuation contains 200 micrograms of budesonide and 6 micrograms of eformoterol
fumarate dihydrate.
The active ingredient eformoterol is also known as formoterol.
Symbicort Turbohaler also contains lactose monohydrate.
What Symbicort Turbohaler 200/6 looks like and contents of the pack
Symbicort Turbohaler is a multi-dose, dry powder inhaler. It works when you inhale
(breathe in) through the mouthpiece
Each Symbicort Turbohaler contains 120 inhalations.
Manufactured by: AstraZeneca AB, S-151 36 Södertälje, Sweden.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
SYMBICORT® 200/6 MICROGRAM TURBOHALER® - PL No: 18799/0238

POM
SYMBICORT and TURBOHALER are registered trademarks of the AstraZeneca Group.
Leaflet date: 19.11.2012

Expand Transcript

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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