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• Symbicort mite Turbuhaler inhalation powder ENG PL

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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.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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.

• 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.

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’.

• They use Symbicort mite 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 mite Turbuhaler as their only asthma inhaler.

• They use Symbicort mite Turbuhaler every day. This helps to prevent asthma symptoms from happening.

• They also use Symbicort mite 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 mite Turbuhaler:

Warnings and precautions

Talk to your doctor or pharmacist before using Symbicort mite Turbuhaler 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.

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:

• 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.

• 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 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

• If you are pregnant, or planning to get pregnant, talk to your doctor before using Symbicort mite Turbuhaler - do not use Symbicort mite Turbuhaler unless your doctor tells you to.

• If you get pregnant while using Symbicort mite Turbuhaler, do not stop using Symbicort mite Turbuhaler but talk to your doctor immediately.

• If you are breast-feeding, talk to your doctor before using Symbicort mite Turbuhaler.

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.

• Always use this medicine 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 mite 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 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:

• 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 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.

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)

• 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)

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:

or

or

Also use Symbicort mite 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 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:

• 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.

• 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 mite Turbuhaler Inhaler is now ready for use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

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.

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

• The dose indicator tells you how many doses (inhalations) are left in your Symbicort mite 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 mite Turbuhaler Inhaler.

Note:

• The grip will still twist and ‘click’ even when your Symbicort mite Turbuhaler Inhaler is empty.

• The sound that you hear as you shake your Symbicort mite 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 mite Turbuhaler Inhaler.

• If you load your Symbicort mite 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 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 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.

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:

• 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 mite 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 (may affect up to1 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 mite Turbuhaler.

• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Symbicort mite Turbuhaler.

• Mild sore throat, coughing and a hoarse voice.

• Headache.

Uncommon (may affect up to 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 (may affect up to 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 mite Turbuhaler stop using Symbicort mite Turbuhaler and talk to your doctor immediately.

• Low levels of potassium in your blood.

• Uneven heart beat.

Very rare (may affect up to1 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.

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.

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

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine 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.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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>

QR code area