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SYMBICORT 100/6 TURBOHALER INHALATION POWDER

Active substance(s): BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE

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3.

PACKAGE LEAFLET: INFORMATION FOR THE USER



Symbicort® 100/6 Turbohaler® Inhalation Powder
(budesonide / formoterol fumarate)




Your medicine is available using the name Symbicort 100/6 Turbohaler but will be referred to as
Symbicort Turbohaler throughout this leaflet.
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.

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

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
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. It is not suitable for people with
severe asthma. It can be prescribed for asthma in two different ways.
a) Some people are prescribed two asthma inhalers: Symbicort Turbohaler and a
separate ‘reliever inhaler’.
• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from
happening.
• They use their ‘reliever inhaler’ when they get asthma symptoms, to make it easier to
breathe again.
b) Some people are prescribed Symbicort Turbohaler as their only asthma inhaler.
• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from
happening.
• They also use Symbicort Turbohaler when they need extra doses for relief of asthma
symptoms, to make it easier to breathe again. They do not need a separate inhaler for this.

2.

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.

HOW TO USE SYMBICORT TURBOHALER

Always use Symbicort Turbohaler exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
It is important to use Symbicort Turbohaler every day, even if you have no asthma
symptoms at the time.
Your doctor will want to regularly check your asthma symptoms.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the
number of tablets that you take, once you start to use Symbicort Turbohaler. If you have been
taking oral steroid tablets for a long time, your doctor may want you to have blood tests from
time to time. When reducing oral steroid tablets, you may feel generally unwell even though
your chest symptoms may be improving. You might experience symptoms such as a stuffy or
runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms
bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting
(being sick) occur, please contact your doctor immediately. You may need to take other
medication if you develop allergic or arthritic symptoms. You should speak to your doctor if you
are concerned as to whether you should continue to use Symbicort Turbohaler.
Your doctor may consider adding steroid tablets to your usual treatment during periods of stress
(for example, when you have a chest infection or before an operation).

Important information about your asthma symptoms

If you feel you are getting breathless or wheezy while using Symbicort Turbohaler, you should
continue to use Symbicort Turbohaler but go to see your doctor as soon as possible, as you may
need additional treatment.
Contact your doctor immediately if:
• Your breathing is getting worse or you often wake up at night with asthma.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
These signs could mean that your asthma is not being properly controlled and you may need
different or additional treatment immediately.

Asthma

Symbicort Turbohaler can be prescribed for asthma in two different ways. The amount of
Symbicort Turbohaler to use and when to use it depends on how it has been prescribed for you.
a) If you have been prescribed Symbicort Turbohaler and a separate reliever inhaler, read the
section called ‘a) Using Symbicort Turbohaler and a separate reliever inhaler’.
b) If you have been prescribed Symbicort Turbohaler as your only inhaler, read the section
called ‘b) Using Symbicort Turbohaler as your only asthma inhaler’.
a) Using Symbicort Turbohaler and a separate reliever inhaler
Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from
happening.

Adults (18 years and above)




The usual dose is 1 or 2 inhalations, twice a day.
Your doctor may increase this to 4 inhalations, twice a day.
If your symptoms are well controlled, your doctor may ask you to take your medicine once a
day.

Adolescents (12 to 17 years)



The usual dose is 1 or 2 inhalations, twice a day.
If your symptoms are well controlled, your doctor may ask you to take your medicine once a
day.

Children (6 to 11 years)


The usual dose is 2 inhalations, twice a day.

Symbicort Turbohaler is not recommended to be used in children who are younger than 6 years.
Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose
of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose
without talking to your doctor (or asthma nurse) first.
Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Symbicort

Turbohaler to treat asthma symptoms - use your reliever inhaler.

b) Using Symbicort Turbohaler as your only asthma inhaler
Only use Symbicort Turbohaler in this way if your doctor has told you to and if you are aged 18
or above.
Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from
happening. You can take:
• 1 inhalation in the morning and 1 inhalation in the evening
or
• 2 inhalations in the morning
or
• 2 inhalations in the evening.
Also use Symbicort Turbohaler as a ‘reliever inhaler’ to treat asthma symptoms when
they happen.
• If you get asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.
Always keep your Symbicort Turbohaler with you, so you can use it when you need it.
A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may
allow you to take up to 12 inhalations a day for a limited period.
If you regularly need to use 8 or more inhalations a day, make an appointment to see your
doctor or nurse.
They may need to change your treatment.
Do not use more than 12 inhalations in total in 24 hours.
If you are doing exercise and you get asthma symptoms, use Symbicort Turbohaler as
described here. However, do not use Symbicort Turbohaler just before exercise to stop asthma
symptoms from happening.

Preparing your new Symbicort Turbohaler

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

Page 1 of 2

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.

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.

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. Website: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.

5.






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





6.

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.

Symbicort Turbohaler contains two active ingredients, budesonide and
formoterol fumarate dihydrate.
Each inhaled dose (the dose leaving the mouthpiece) delivers 80 micrograms of budesonide and
4.5 micrograms of formoterol fumarate dihydrate. This corresponds to a dispensed dose of
100 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Symbicort Turbohaler also contains lactose monohydrate (which contains milk proteins).

What Symbicort Turbohaler looks like and contents of the pack

Symbicort Turbohaler is an inhaler containing your medicine. The inhalation powder is white in
colour. The Turbohaler has a white plastic body and white plastic cover with a red turning grip.
A Braille code '6' is embossed at the bottom of the turning grip for identification.
Symbicort Turbohaler is available in a pack of 1 containing 120 doses.

Manufacturer

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.

Manufactured by: AstraZeneca AB, Kvarnbergagatan 12, 151 85, Södertälje, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland,
NE42 6PX.

If you forget to use Symbicort Turbohaler


FURTHER INFORMATION

What Symbicort Turbohaler contains

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.



HOW TO STORE SYMBICORT TURBOHALER

Do not store above 30°C.
Keep the container tightly closed, in order to protect from moisture.
Keep out of the sight and reach of children.
Do not use the inhaler after the expiry date that is stated on the carton or on the label of
your inhaler after EXP. The expiry date refers to the last day of that month.
If your doctor tells you to stop using this medicine, please take it back to the pharmacist.
Only keep Symbicort Turbohaler if your doctor tells you to.
If your medicine appears to be discoloured or shows any other signs of deterioration, take it
back to your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. These measures will
help to protect the environment.

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.

PL No: 21828/0669

POM

Leaflet revision date: 11.01.16

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Symbicort® and Turbohaler® are registered trademarks of the AstraZeneca group of companies.

4.

To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302
365000 and ask for the Regulatory Department.

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.

Please be ready to give the following information:
Product name
Symbicort 100/6 Turbohaler Inhalation Powder
Reference number
21828/0669

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.

Page 2 of 2

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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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