Active ingredient
- budesonide
- formoterol fumarate dihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 17901/0092.
Symbicort Turbohaler 200/6, inhalation powder
Package leaflet: Information for the user
Symbicort® Turbohaler® 200/6, inhalation powder
budesonide/formoterol fumarate dihydrate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
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
1. What Symbicort Turbohaler is and what it is used for
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.
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’.
b) Some people are prescribed Symbicort Turbohaler as their only asthma inhaler.
Chronic obstructive pulmonary disease (COPD)
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.
2. What you need to know before you use Symbicort Turbohaler
Do not use Symbicort Turbohaler:
Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort Turbohaler if:
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Symbicort Turbohaler
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.
Pregnancy, breast-feeding and fertility
Driving and using machines
Symbicort Turbohaler has no or negligible effect on your ability to drive or to use tools or machines.
Symbicort Turbohaler contains lactose
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
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:
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)
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 or stop 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 12 or above.
Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening. You can take:
or
or
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 and to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens).
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. It is important that you discuss with your doctor the use of Symbicort Turbohaler to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.
Chronic Obstructive Pulmonary Disease (COPD)
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:
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 Turbohaler upright with the red grip at the bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To load your Symbicort 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 Symbicort Turbohaler when you need to use it.
4. Hold your Symbicort Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Symbicort 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 Symbicort 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 Symbicort Turbohaler and must not be taken off. Do not use your Symbicort Turbohaler if it has been damaged or if the mouthpiece has come apart from your Symbicort Turbohaler.
As with all inhalers, caregivers should ensure that children prescribed Symbicort Turbohaler use correct inhalation technique, as described above.
Cleaning your Symbicort 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 inhaler
Note:
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 heartbeat.
If you forget to use Symbicort Turbohaler
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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:
Other possible side effects:
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.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 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.
5. How to store Symbicort Turbohaler
6. Contents of the pack and other information
What Symbicort Turbohaler 200/6 contains
The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate, this corresponds to a metered dose of 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 inhaler contains either 30, 60 or 120 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 200/6 is available in packs of 1 inhaler containing 30 doses or in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 or 120 doses.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Symbicort Turbohaler 200/6 is held by
Symbicort Turbohaler 200/6 is manufactured by
This medicinal product is authorised in the Member States of the EEA under the following names:
Country Trade name and strength
Austria Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Belgium Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Bulgaria Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Croatia Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Cyprus Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Czech Republic Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Denmark Symbicort Turbuhaler 160 μg/4.5 μg/inhalation,
Estonia Symbicort Turbuhaler, 160 μg/4.5 μg
Finland Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
France Symbicort Turbuhaler 200 μg/6 μg/inhalation
Germany Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Greece Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Hungary Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Iceland Symbicort Turbuhaler160 μg/4.5 μg/inhalation
Ireland Symbicort Turbohaler 200 μg/6 μg/inhalation
Italy Symbicort 160 μg/4.5 μg/inhalation
Latvia Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Lithuania Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Luxembourg Symbicort Turbohaler 160 μg/4.5 μg/inhalation
Malta Symbicort Turbohaler 200 μg/6 μg/inhalation
Netherlands Symbicort Turbuhaler 200 μg/6 μg/inhalation
Norway Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Poland Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Portugal Symbicort Turbohaler160 μg/4.5 μg/inhalation
Romania Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Slovakia Symbicort Turbuhaler 200 μg/6 μg/inhalation
Slovenia Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
Spain Symbicort Turbuhaler160 μg/4.5 μg/inhalation
Sweden Symbicort Turbuhaler 160 μg/4.5 μg/inhalation
United Kingdom Symbicort Turbohaler 200 μg/6 μg/inhalation
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Symbicort Turbohaler 200/6
Reference number 17901/0092
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in June 2020.
© AstraZeneca 2020
Symbicort and Turbohaler are trade marks of the AstraZeneca group of companies.
RSP 20 0009a
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
+44 (0)1582 838 000
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 838 003