Symbicort Turbuhaler 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 Turbuhaler and a separate ‘reliever inhaler’:
• They use Symbicort Turbuhaler 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 Turbuhaler as their only asthma inhaler:
• They use Symbicort Turbuhaler every day. This helps to prevent asthma symptoms from happening.

• They also use Symbicort Turbuhaler 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.

Do not use Symbicort Turbuhaler if:
• You are allergic (hypersensitive) to budesonide, formoterol, or the other ingredient, which is lactose (which contains small amounts of milk protein).
Take special care with Symbicort Turbuhaler:
Before you use Symbicort Turbuhaler, 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 Turbuhaler.
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 Turbuhaler - do not use Symbicort Turbuhaler unless your doctor tells you to.
• If you get pregnant while using Symbicort Turbuhaler, do not stop using Symbicort Turbuhaler but talk to your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Symbicort Turbuhaler.
Driving and using machines:
Symbicort Turbuhaler 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 Turbuhaler:
Symbicort Turbuhaler 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 allergic reaction.

• Always use Symbicort Turbuhaler 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 Turbuhaler 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 Turbuhaler. 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 Turbuhaler.
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 Turbuhaler, you should continue to use Symbicort Turbuhaler 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 Turbuhaler can be prescribed for asthma in two different ways. The amount of Symbicort Turbuhaler to use and when to use it depends on how it has been prescribed for you.
a) If you have been prescribed Symbicort Turbuhaler and a separate reliever inhaler, read the section called ‘a) Using Symbicort Turbuhaler and a separate reliever inhaler’.
b) If you have been prescribed Symbicort Turbuhaler as your only inhaler, read the section called ‘b) Using Symbicort Turbuhaler as your only asthma inhaler’.
a) Using Symbicort Turbuhaler and a separate reliever inhaler:
Use your Symbicort Turbuhaler 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 Turbuhaler 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 Turbuhaler to treat asthma symptoms - use your reliever inhaler.
b) Using Symbicort Turbuhaler as your only asthma inhaler:
Only use Symbicort Turbuhaler in this way if your doctor has told you to and if you are aged 18 or above.
Use your Symbicort Turbuhaler 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 Turbuhaler 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 Turbuhaler Inhaler 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 Turbuhaler as
described here. However, do not use Symbicort Turbuhaler just before exercise to stop
asthma symptoms from happening.
Preparing your new Symbicort Turbuhaler Inhaler:
Before using your new Symbicort Turbuhaler Inhaler 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 Turbuhaler Inhaler 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 Turbuhaler Inhaler 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 Turbuhaler Inhaler upright with the red grip at the bottom.

3. Do not hold the mouthpiece when you load your Symbicort Turbuhaler Inhaler. To
load your Symbicort Turbuhaler Inhaler with a dose, turn the red grip as far as it will
go in one direction.

Then turn it as far as it will go in the other direction (it does not matter which way you
turn it first). You should hear a click sound. Your Symbicort Turbuhaler Inhaler is now
loaded and ready to use. Only load your Symbicort Turbuhaler Inhaler when you
need to use it.
4. Hold your Symbicort Turbuhaler Inhaler away from your mouth. Breathe out gently
(as far as is comfortable). Do not breathe out through your Symbicort Turbuhaler
Inhaler.
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 Turbuhaler Inhaler 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
Turbuhaler Inhaler and must not be taken off. Do not use your Symbicort Turbuhaler
Inhaler if it has been damaged or if the mouthpiece has come apart from your
Symbicort Turbuhaler Inhaler.
As with all inhalers, caregivers should ensure that children prescribed Symbicort
Turbuhaler use correct inhalation technique, as described above.

Cleaning your Symbicort Turbuhaler Inhaler:
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
Turbuhaler Inhaler, 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 Turbuhaler Inhaler.
Note:
• The grip will still twist and ‘click’ even when your Symbicort Turbuhaler Inhaler is
empty.
• The sound that you hear as you shake your Symbicort Turbuhaler Inhaler 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 Turbuhaler Inhaler.
• If you load your Symbicort Turbuhaler Inhaler 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 Turbuhaler 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 after if you use more Symbicort Turbuhaler
than you should are trembling, headache or a rapid heart beat.

If you forget to use Symbicort Turbuhaler:
• 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 Turbuhaler can cause side effects, although not everybody gets them.
If either of the following happen to you, stop using Symbicort Turbuhaler and talk to your doctor immediately:
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breath (angoioedema) and or sudden feeling if 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 Turbuhaler Inhaler 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 Turbuhaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Symbicort Turbuhaler.
• 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 Turbuhaler stop using Symbicort Turbuhaler 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 gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use the inhaler after the expiry date that is stated on the carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Keep the container/cap tightly closed, in order to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.