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Symbicort Mite Turbuhaler

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Package leaflet : Information for the user


Symbicort mite Turbuhaler 80 micrograms/4.5 micrograms /inhalation, Inhalation Powder

Budesonide/Formoterol fumarate dihydrate


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


In this leaflet:

What Symbicort mite Turbuhaler is and what it is used for

What you need to know before you use Symbicort mite Turbuhaler

How to use Symbicort mite Turbuhaler

Possible side effects

How to store Symbicort mite Turbuhaler

Contents of the pack and other information


What Symbicort mite Turbuhaler is and what it is used for


Symbicort mite Turbuhaler is an inhaler that is used to treat asthma in adults, adolescents and children aged 6 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

This medicine 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 mite Turbuhaler and a separate ‘reliever inhaler’.


b) Some people are prescribed Symbicort mite Turbuhaler as their only asthma inhaler.


What you need to know before you use Symbicort mite Turbuhaler


Do not use Symbicort mite Turbuhaler:

if you are allergic to budesonide, formoterol or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein).


Warnings and precautions

Talk to your doctor or pharmacist before using Symbicort mite Turbuhaler if:


Other medicines and Symbicort mite Turbuhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking 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 mite 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


Driving and using machines

Symbicort mite Turbuhaler has no or negligible effect on your ability to drive or to use tools or machines.


Symbicort mite Turbuhaler contains lactose

Symbicort mite 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.


How to use Symbicort mite Turbuhaler



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 mite 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 mite 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 mite Turbuhaler, you should continue to use Symbicort mite Turbuhaler 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 is not being properly controlled and you may need different or additional treatment immediately.


Asthma

Symbicort mite Turbuhaler can be prescribed for asthma in two different ways. The amount of Symbicort mite Turbuhaler to use and when to use it depends on how it has been prescribed for you.

If you have been prescribed Symbicort mite Turbuhaler and a separate reliever inhaler, read the section called ‘a) Using Symbicort mite Turbuhaler and a separate reliever inhaler’.

If you have been prescribed Symbicort mite Turbuhaler as your only inhaler, read the section called ‘b) Using Symbicort mite Turbuhaler as your only asthma inhaler’.


a) Using Symbicort mite Turbuhaler and a separate reliever inhaler

Use your Symbicort mite Turbuhaler every day. This helps to prevent asthma symptoms from happening.


Adults (18 years and above)


Adolescents (12 to 17 years)


Children (6 to 11 years)

The usual dose is 2 inhalations, twice a day.


Symbicort mite 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 mite Turbuhaler to treat asthma symptoms - use your reliever inhaler.


b) Using Symbicort mite Turbuhaler as your only asthma inhaler

Only use Symbicort mite Turbuhaler in this way if your doctor has told you to and if you are aged 18 or above.


Use your Symbicort mite 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 mite Turbuhaler as a ‘reliever inhaler’ to treat asthma symptoms when they happen.


Always keep your Symbicort mite 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 mite Turbuhaler as described here. However, do not use Symbicort mite Turbuhaler just before exercise to stop asthma symptoms from happening.


Preparing your new Symbicort mite Turbuhaler Inhaler

Before using your new Symbicort mite Turbuhaler Inhaler 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.

Unscrew the cover and lift it off. You may hear a rattling sound.

Hold your Symbicort mite Turbuhaler Inhaler upright with the red grip at the bottom.





Do not hold the mouthpiece when you load your Symbicort mite Turbuhaler Inhaler. To load your Symbicort mite 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 mite Turbuhaler Inhaler is now loaded and ready to use. Only load your Symbicort mite Turbuhaler Inhaler when you need to use it.

Hold your Symbicort mite Turbuhaler Inhaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Symbicort mite Turbuhaler Inhaler.

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.





Remove your Symbicort mite 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.

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 Symbicort mite Turbuhaler Inhaler and must not be taken off. Do not use your Symbicort mite Turbuhaler Inhaler if it has been damaged or if the mouthpiece has come apart from your Symbicort mite Turbuhaler Inhaler.


As with all inhalers, caregivers should ensure that children prescribed Symbicort mite Turbuhaler use correct inhalation technique, as described above.


Cleaning your Symbicort mite 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





Note:


If you use more Symbicort mite 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 mite Turbuhaler than you should are trembling, headache or a rapid heart beat.


If you forget to use Symbicort mite Turbuhaler


If you have any further questions on the use of this product, 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 mite Turbuhaler and talk to your doctor immediately:


Other possible side effects:

Common (may affect up to1 in 10 people)


Uncommon (may affect up to 1 in 100 people)


Rare (may affect up to 1 in 1,000 people)


Very rare (may affect up to1 in 10,000 people)

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:

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [To be completed Nationally]. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Symicort mite Turbuhaler


6. Contents of the pack and other information


What Symbicort mite Turbuhaler contains

The active substances are budesonide and formoterol. Each inhaled dose contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

The other ingredient is lactose monohydrate (which contains milk proteins).


What Symbicort mite Turbuhaler looks like and contents of the pack

Symbicort mite Turbuhaler is an inhaler containing your medicine. The inhalation powder is white in colour. Each Inhaler contains either 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 mite Turbuhaler is available in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or120) doses.

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


[To be completed nationally]


This medicinal product is authorised in the Member States of the EEA under the following names:


Country

Trade name and strength

Austria

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Belgium

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Bulgaria

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Cyprus

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Czech Republic

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Denmark

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Estonia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Finland

Symbicort Turbuhaler mite 80 μg/4.5 μg/inhalation

France

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Germany

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Greece

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Hungary

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Iceland

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Ireland

Symbicort Turbohaler 100 μg/6 μg/inhalation

Italy

Symbicort mite 80 μg/4.5 μg/inhalation

Latvia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Lithuania

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Luxenbourg

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Malta

Symbicort Turbohaler 100 μg/6 μg/inhalation

Netherlands

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Norway

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Poland

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Portugal

Symbicort Turbohaler 80 μg/4.5 μg/inhalation

Romania

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Slovakia

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Slovenia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Spain

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Sweden

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

United Kingdom

Symbicort Turbohaler 100 μg/6 μg/inhalation


This leaflet was last revised in 2015-01-08


Detailed and updated information on this product is available by scanning the QR Code included in the PIL and outer carton with a smartphone. The same information is also available on the following URL: <[country specific URL to be included]> <and the <NCA> website, to be completed nationally>



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