The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17901/0200.
Symbicort Turbohaler 400/12, Inhalation powder.
Symbicort® Turbohaler® 400/12, inhalation powder
budesonide/formoterol fumarate dihydrate
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
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.
For asthma, your doctor will prescribe two asthma inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’.
Do not use Symbicort Turbohaler 400/12 as a ‘reliever inhaler’.
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.
Talk to your doctor or pharmacist before using Symbicort Turbohaler if:
Contact your doctor if you experience blurred vision or other visual disturbances.
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:
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.
Symbicort Turbohaler has no or negligible effect on your ability to drive or to use tools or machines.
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 allergic reactions.
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).
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:
These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Use your Symbicort Turbohaler 400/12 every day. This helps to prevent asthma symptoms from happening.
Adults (18 years and above)
Adolescents (12 to 17 years)
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 400/12 to treat asthma symptoms - use your separate ‘reliever inhaler’.
Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.
Before using your new Symbicort Turbohaler for the first time, you need to prepare it for use as follows:
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. It does not matter whether the click comes on the first or the second twist. 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.
Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Tell your doctor if you have any of the following while taking Symbicort Turbohaler, they could be symptoms of a lung infection:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
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:
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: 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.
The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate, this corresponds to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).
Symbicort Turbohaler 400/12 is an inhaler containing your medicine. The inhalation powder is white in colour. Each inhaler contains 60 doses and has a white body 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.
Symbicort Turbohaler 400/12 is available in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 doses.
Not all pack sizes may be marketed.
The Marketing Authorisation for Symbicort Turbohaler 400/12 is held by
Symbicort Turbohaler 400/12 is manufactured by
Symbicort Turbohaler is authorised in the Member States of the EEA under the following names:
Country Trade name and strength
Austria Symbicort forte Turbohaler 320 μg/9 μg/inhalation
Belgium Symbicort forte Turbohaler 320 μg/9 μg/inhalation
Bulgaria Symbicort Turbuhaler 320 μg/9 μg/inhalation
Croatia Symbicort Turbuhaler 320 μg/9 μg/inhalation
Cyprus Symbicort Turbuhaler 320 μg/9 μg/inhalation
Czech Republic Symbicort Turbuhaler 320 μg/9 μg/inhalation
Denmark Symbicort forte Turbuhaler 320 μg/9 μg/inhalation,
Estonia Symbicort Turbuhaler, 320 μg/9 μg
Finland Symbicort Turbuhaler forte.320 μg/9 μg/inhalation
France Symbicort Turbuhaler 400 μg/12 μg/inhalation
Germany Symbicort Turbohaler 320 μg/9 μg/inhalation
Greece Symbicort Turbuhaler 320 μg/9 μg/inhalation
Hungary Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Iceland Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Ireland Symbicort Turbohaler 400 μg/12 μg/inhalation
Italy Symbicort 320 μg/9 μg/inhalation
Latvia Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Lithuania Symbicort Turbuhaler 320 μg/9 μg/inhalation
Luxembourg Symbicort forte Turbohaler 320 μg/9 μg/inhalation
Malta Symbicort Turbohaler 400 μg/12 μg/inhalation
Netherlands Symbicort Turbuhaler 400 μg/12 μg/inhalation
Norway Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Poland Symbicort Turbuhaler 320 μg/9 μg/inhalation
Portugal Symbicort Turbohaler 320 μg/9 μg/inhalation
Romania Symbicort Turbuhaler 320 μg/9 μg/inhalation
Slovakia Symbicort Turbuhaler forte 400 μg/12 μg/inhalation
Slovenia Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Spain Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
Sweden Symbicort forte Turbuhaler 320 μg/9 μg/inhalation
United Kingdom Symbicort Turbohaler 400 μg/12 μg/inhalation
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Product name Symbicort Turbohaler 400/12
Reference number 17901/0200
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This leaflet was last revised in October 2022.
© AstraZeneca 2022
Symbicort and Turbohaler are trade marks of the AstraZeneca group of companies.
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