SYMBICORT 160 MICROGRAMS/4.5 MICROGRAMS Inhalation powder

Зміст інструкції

1. Symbicort Turbohaler
   1. What is Symbicort Turbohaler and what is it used for
   2. What you need to know before using Symbicort Turbohaler
   3. How to use Symbicort Turbohaler
   4. Possible side effects
2. Symbicort Turbohaler 320 micrograms/9 micrograms/inhalation, powder for inhalation
   1. What is Symbicort Turbohaler and what is it used for
   2. What you need to know before using Symbicort Turbohaler
   3. How to use Symbicort Turbohaler
   4. Possible side effects
   5. How to store Symbicort Turbohaler
   6. Content of the pack and other information
3. Symbicort 160 micrograms/4.5 micrograms/actuation, pressurised suspension
   1. What is Symbicort and what is it used for
   2. What you need to know before using Symbicort
   3. How to use Symbicort
   4. Possible side effects
   5. How to store Symbicort
   6. Content of the pack and other information
4. Symbicort Turbohaler 320 micrograms/9 micrograms/inhalation, powder for inhalation
   1. What is Symbicort Turbohaler and what is it used for
   2. What you need to know before using Symbicort Turbohaler
   3. How to use Symbicort Turbohaler
   4. Possible side effects
   5. How to store Symbicort Turbohaler
   6. Content of the pack and other information
5. Symbicort 160 micrograms/4.5 micrograms/actuation, pressurised suspension
   1. What is Symbicort and what is it used for
   2. What you need to know before using Symbicort
   3. How to use Symbicort
   4. Possible side effects
   5. How to store Symbicort
   6. Content of the pack and other information
6. Symbicort 80 micrograms/2.25 micrograms/dose pressurised suspension for
   1. What is Symbicort and what is it used for?
   2. What you need to know before using Symbicort
   3. How to use Symbicort
   4. Possible side effects
   5. How to store Symbicort
   6. Contents of the pack and other information
7. Symbicort 80 micrograms/2.25 micrograms/inhalation, suspension for inhalation in

Symbicort Turbohaler

160 micrograms/4.5 micrograms/inhalation, powder for inhalation
Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Symbicort Turbohaler and what is it used for

Symbicort Turbohaler is a device consisting of an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and over. 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 β2-adrenoreceptor agonists” or “bronchodilators”. It works by relaxing the muscles of the airways making it easier to breathe.

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”.

• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from occurring.
• They use the “reliever inhaler” when they have asthma symptoms, to help them breathe more easily.

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

• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from occurring.
• They also use Symbicort Turbohaler when they need extra doses to relieve asthma symptoms to help them breathe more easily and, if agreed with their doctor, also to prevent asthma symptoms from occurring (for example, during exercise or when exposed to allergens). They do not need a separate inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)
Symbicort Turbohaler can also be used to treat the symptoms of severe COPD in adults.
COPD is a long-term disease of the lungs, often caused by smoking.

2. What you need to know before using Symbicort Turbohaler

Do not use Symbicort Turbohaler:
If you are allergic to budesonide, formoterol or any other ingredient of this medicine (listed in section 6), namely lactose (which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort Turbohaler if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or have ever had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: the use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.

Other medicines and Symbicort Turbohaler
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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (like ritonavir) used to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine). If you fall into any of the above categories, or if in doubt, consult your doctor or pharmacist before using Symbicort Turbohaler.

Tell your doctor or pharmacist also if you are going to have a general anaesthetic for surgery or dental treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning to become pregnant, ask your doctor for advice before taking Symbicort Turbohaler - do not take Symbicort Turbohaler unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort Turbohaler, do not stop using Symbicort Turbohaler but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before taking Symbicort Turbohaler.

Driving and using machines
Symbicort Turbohaler has no or negligible effect on the ability to drive and operate machines.

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before using this medicine. The amount of lactose contained in this medicine usually does not cause problems in people with lactose intolerance.
The excipient lactose contains small amounts of milk proteins that may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you do not have symptoms of asthma or COPD at the moment.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to check your symptoms periodically.

If you have taken steroids in tablet form for your asthma or COPD, your doctor may reduce the number of tablets you are taking, once you have started using Symbicort Turbohaler. If you have taken steroids in tablet form for a long period, your doctor may request to perform blood tests periodically. When reducing the amount of oral steroids you may experience a feeling of general malaise even though your respiratory symptoms may be improved. You may experience symptoms such as nasal congestion and rhinorrhea (runny nose), weakness or muscle or joint pain and skin rash (eczema). If any of these symptoms worry you or if symptoms such as headache, fatigue, nausea or vomiting occur, please contact your doctor immediately. You may need to take another medicine in case of allergic or arthritic symptoms. Ask your doctor if you have doubts about continuing or not with Symbicort Turbohaler therapy. Your doctor may consider adding steroids in tablet form to your usual treatment during periods of stress (for example when you have a respiratory infection or before surgery).

Important information about the symptoms of asthma or COPD
If you notice the onset of shortness of breath or wheezing while using Symbicort Turbohaler you should continue to use it but consult your doctor as soon as possible as you may need additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• If you start to feel tightness in your chest in the morning or if the chest tightness lasts longer than usual. These signs may mean that asthma or COPD is not properly controlled and that you may need immediate different or additional treatment.

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 your doctor's prescription.

• If you have been prescribed Symbicort Turbohaler and a reliever inhaler to use separately, read the paragraph “a) Using Symbicort Turbohaler and a separate reliever inhaler”.
• If you have been prescribed Symbicort Turbohaler as a single inhaler, read the paragraph “b) Using Symbicort Turbohaler as a single inhaler for asthma”.

a)Using Symbicort Turbohaler and a separate reliever inhaler
Use Symbicort Turbohaler every day.This helps to prevent asthma symptoms from occurring.

Adults (18 years of age and over)

• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may increase this dose to 4 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Adolescents (12-17 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 the medicine once a day. A lower dosage of Symbicort Turbohaler is available for children from 6 to 11 years of age.

The use of Symbicort Turbohaler is not recommended for children under 6 years of age.
The doctor (or nurse) will help you manage your asthma and adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not change or stop the dose without talking to your doctor (or nurse) first.

Use the separate “reliever inhaler” to treat asthma symptoms when they occur.
Always carry the “reliever inhaler” with you, to use when needed. Do not use Symbicort Turbohaler to treat asthma symptoms, but the reliever inhaler.

b) Using Symbicort Turbohaler as a single inhaler for asthma
Use Symbicort Turbohaler in this way only as directed by your doctor and if you are over 12 years of age.

Use Symbicort Turbohaler every day.This helps to prevent asthma symptoms from occurring. You can take:

• 1 inhalation in the morning and1 inhalation in the evening. or
• 2 inhalations in the morning or
• 2 inhalations in the evening. Your doctor may increase this dose to 2 inhalations, twice a day.

Also use Symbicort Turbohaler as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent the onset of asthma symptoms (for example, during exercise or when exposed to allergens).

• If asthma symptoms occur, 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 one time.

Always carry Symbicort Turbohaler with you, to use when needed.
Normally, a total daily dose of more than 8 inhalations is not necessary. However, your doctor may allow you to take up to 12 inhalations a day for a limited period.
If you need to use 8 or more inhalations regularly a day, consult your doctor or nurse as you may need to change your treatment.
Do not use more than 12 inhalations in total in 24 hours.
If asthma symptoms occur while exercising, use Symbicort Turbohaler as described in this leaflet. It is important to discuss with your doctor the use of Symbicort Turbohaler to prevent the onset of asthma symptoms; how often you exercise or how often you are exposed to allergens, this may affect the treatment that has been prescribed for you.

Chronic Obstructive Pulmonary Disease (COPD)

• Use is intended for adults only (18 years of age and over).
• The usual dose is 2 inhalations twice a day.

Your doctor may also prescribe other bronchodilator medicines, for example anticholinergics (such as tiotropium bromide or ipratropium bromide) for the treatment of COPD.

How to prepare Symbicort Turbohaler
Before using a newSymbicort Turbohaler for the first time, you need to prepare it for use as follows:

• Unscrew and remove the cap; you may hear a noise.
• Hold Symbicort Turbohaler upright with the red wheel facing downwards.
• Turn the red wheel in one direction to the end stop. Then turn it in the other direction to the end stop (it doesn't matter in which direction you start turning the wheel). You will hear a click during this operation.
• Repeat the operation, turning the red wheel in both directions.
• Symbicort Turbohaler is now ready for use.

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

• 1. Unscrew and remove the cap; you may hear a noise.
• 2. Hold Symbicort Turbohaler uprightwith the red wheel facing downwards
• 3. Do not touch the mouthpiece when loading Symbicort Turbohaler. To load Symbicort Turbohaler with a dose, turn the red wheel in one direction to the end stop.

Then turn it in the other direction to the end stop (it doesn't matter in which direction you start

turning the wheel). You will hear a click during this operation. Symbicort Turbohaler is now loaded and ready for use. Load Symbicort Turbohaler only when you need to use it.

• 4. Hold Symbicort Turbohaler away from your mouth. Breathe out gently (without forcing). Do not breathe out through Symbicort Turbohaler.
• 5. Place the mouthpiece gently between your teeth. Close your lips and inhale as deeply as possible through your mouth. Do not chew or bite the mouthpiece.

• 6. Take Symbicort Turbohaler away from your mouth. Breathe out gently.The amount of medicine inhaled is very small. This means that you may not taste it after inhalation. If you have followed the instructions, you can be sure you have inhaled the dose and the medicine is now in your lungs.

7. If you need to take a second inhalation, repeat steps 2 to 6.

• 8. After use, reposition the cap and screw it on.

• 9. Rinse your mouth with water after the morning and/or evening dose and spit out the water.

Do not try to remove or turn the mouthpiece. It is fixed to Symbicort Turbohaler and should not be removed. Do not use Symbicort Turbohaler if it is damaged or if the mouthpiece has come off Symbicort Turbohaler.
As with all inhalers, those who care for children should ensure that children who have been prescribed Symbicort Turbohaler use the correct inhalation technique, as described above.

How to clean Symbicort Turbohaler
Clean the outside of the mouthpiece once a week with a dry cloth. Do not use water or liquids.

When to start using a new inhaler

• The dose indicator shows how many doses (inhalations) remain in Symbicort Turbohaler, starting from 30, 60 or 120 doses when full.

• The dose indicator shows intervals of 10 doses (for 60 and 120 dose inhalers) and intervals of 15 doses (for the 30 dose inhaler). Therefore, the dose indicator does not show every dose.
• When a red mark first appears on the edge of the indicator window, it means that about 20 doses remain. 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 should start using a new Symbicort Turbohaler. Note:
• You will still be able to turn the red wheel and hear the “click” even when Symbicort Turbohaler is empty.
• The sound you hear when shaking Symbicort Turbohaler is made by a drying agent and not by the medicine. Therefore, this sound does not indicate how much medicine is left in Symbicort Turbohaler.
• If, by mistake, you load Symbicort Turbohaler more than once before taking the dose, you will still take only one dose. However, the indicator will still record all the doses loaded.

If you use more Symbicort Turbohaler than you should
If you use more Symbicort Turbohaler than you should, contact your doctor or pharmacist.
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that may occur if you use more Symbicort Turbohaler than you should are: tremor, headache or increased heart rate.

If you forget to use Symbicort Turbohaler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose. If you have any questions about using 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 any of the following happen, stop using Symbicort Turbohaler and contact
your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat) and/or difficulty swallowing or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Suddenly wheezing and becoming short of breath immediately after using the inhaler. If any of these symptoms occur, stop using Symbicort Turbohaler immediately and use your reliever inhaler. Contact your doctor immediately if you need to change your treatment. This happens rarely, affecting less than 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or shaking. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort Turbohaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort Turbohaler.
• Mild sore throat, cough and hoarseness.
• Headache.
• Pneumonia (lung infection), in patients with COPD (common side effect). Tell your doctor if you have any of the following symptoms while taking Symbicort Turbuhaler, they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus colour.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Skin bruising.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using Symbicort Turbohaler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or pressure (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones
in the body, particularly if you use high doses for a prolonged period. These 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).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney).

The occurrence of these effects is much less likely with inhaled corticosteroids than with
corticosteroids in tablets.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
The other excipient is lactose monohydrate (which contains milk proteins).

Description of Symbicort Turbohaler and contents of the pack
Symbicort Turbohaler consists of an inhaler that contains the medicine. The powder for inhalation
is white in colour. Each inhaler contains 30, 60 or 120 doses and has a white body and a red wheel.
The rotating dial contains Braille code number 6 for identification, to
differentiate from other AstraZeneca inhaler products.
Symbicort Turbohaler is available in packs containing 1 inhaler of 30 doses or in packs
containing 1, 2, 3, 10 or 18 inhalers containing 60 or 120 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris – Via Ludovico il Moro 6/C
Basiglio (MI) 20080

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden

or
AstraZeneca GmbH
Wedel (Germany)

or
AstraZeneca UK Limited
Macclesfield, Cheshire (England)

This medicine is authorised in the Member States of the European Economic Area with the
following names:
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 200 μg/6 μg/inhalation;

Denmark: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Estonia: Symbicort Turbuhaler
160 μg/4.5 μg/inhalation; 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 Turbuhaler
160 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 Turbohaler
160 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 Turbuhaler 160 μg/4.5 μg/inhalation; Sweden:
Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; United Kingdom: Symbicort Turbohaler
200 μg/6 μg/inhalation.

Detailed and up-to-date information on

this product is available by

scanning the QR Code included on the Package

Leaflet and the outer carton with a

smartphone. The same information is

also available at the following URL:
www.turbohaler.it
QR code Area

Symbicort Turbohaler 320 micrograms/9 micrograms/inhalation, powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Symbicort Turbohaler is and what it is used for
• 8. What you need to know before you use Symbicort Turbohaler
• 9. How to use Symbicort Turbohaler
• 10. Possible side effects
• 11. How to store Symbicort Turbohaler
• 12. Contents of the pack and other information

1. What is Symbicort Turbohaler and what is it used for

Symbicort Turbohaler is a device consisting of an inhaler used to treat asthma in adults and adolescents aged between 12 and 17 years. It is also used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years or over. 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 β - adrenoreceptor agonists” or “bronchodilators”. It works by relaxing the muscles of the airways making it easier to breathe.

Asthma

For asthma, your doctor will prescribe two inhalers: Symbicort Turbohaler and a separate “reliever inhaler”.

• Use Symbicort Turbohaler every day. This will help prevent asthma symptoms from appearing.
• Use the “reliever inhaler” when asthma symptoms occur, to help you breathe more easily. Do not use Symbicort Turbohaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)
Symbicort Turbohaler can also be used to treat the symptoms of severe COPD in adults.
COPD is a chronic disease of the airways in the lungs, often caused by cigarette smoking.

2. What you need to know before using Symbicort Turbohaler

Do not use Symbicort Turbohaler:

• If you are allergic to budesonide, formoterol or to any of the other ingredients of this medicine (listed in section 6), namely lactose (which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort Turbohaler if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or if you have ever had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Other medicines and Symbicort Turbohaler
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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used for the treatment of high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used for the treatment of asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (like ritonavir) used for the treatment of HIV infection.
• Medicines for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist before
using Symbicort Turbohaler.
Tell your doctor or pharmacist also if you are going to have a general anaesthetic for surgery or dental treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning a pregnancy, ask your doctor for advice before taking Symbicort Turbohaler - do not take Symbicort Turbohaler unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort Turbohaler, do not stop taking Symbicort Turbohaler but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before taking Symbicort Turbohaler.

Driving and using machines
Symbicort Turbohaler has no effect or negligible effect on the ability to drive or operate tools or machines.

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If your doctor has told you that you have
an intolerance to some sugars, consult your doctor before using this medicine. The amount of
lactose contained in this medicine usually does not cause problems in people with lactose intolerance.
The excipient lactose contains small amounts of milk proteins that may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you do not have symptoms of asthma or COPD at the moment.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to check your symptoms periodically.

If you have taken steroidsin tablet form for asthma or COPD, your doctor may reduce the number of
tablets you are taking, once you have started using Symbicort Turbohaler. If you have
taken steroids in tablet form for a long period, your doctor may request blood tests periodically. When you reduce the amount of oral steroids you may feel a
general feeling of unwellness despite your respiratory symptoms may be
improved. You may experience symptoms such as nasal congestion and rhinorrhea (runny nose), weakness
or muscle or joint pain and skin rash (eczema). If any of these
symptoms worry you or if you experience symptoms such as headache, fatigue, nausea or vomiting for
please contact your doctor immediately. You may need to take another medicine in
case of allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or
not the therapy with Symbicort Turbohaler.
Your doctor may consider adding steroids in tablet form to your usual treatment during
periods of stress (for example when you have a respiratory infection or before surgery).

Important information about the symptoms of asthma or COPD
If you notice the onset of shortness of breath or wheezing while using Symbicort Turbohaler, you should continue
to use it but consult your doctor as soon as possible as you may need
additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• If you start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual. These signs may mean that your asthma or COPD is not properly controlled and that you may need immediate different or additional treatment.

Asthma
Use Symbicort Turbohaler every day.This helps to prevent the onset of asthma symptoms.

Adults (18 years of age and over)

• The usual dose is 1 inhalation twice a day.
• The doctor may increase this dose to 2 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Adolescents (12-17 years)

• The usual dose is 1 inhalation twice a day.
• If your symptoms are well controlled, your doctor may ask you to take the medicine once a day.

A lower dosage of Symbicort Turbohaler is available for children aged 6 to 11 years.
The use of Symbicort Turbohaler is not recommended in children under 6 years of age.
The doctor (or nurse) will help you manage your asthma and adjust the dose of this medicine
to the lowest dose that controls your asthma. However, do not change the dose without talking to your
doctor (or nurse) first.
Use the “reliever inhaler” separately to treat asthma symptoms when they occur.
Always carry the “reliever inhaler” with you so you can use it when needed. Do not use
Symbicort Turbohaler to treat asthma symptoms, but the “reliever inhaler”.

Chronic Obstructive Pulmonary Disease (COPD)

• Use is intended only for adults (18 years of age and over).
• The usual dose is 1 inhalation twice a day. Your doctor may also prescribe you other bronchodilator medicines, for example anticholinergics (such as tiotropium bromide or ipratropium bromide) for the treatment of COPD.

How to prepare Symbicort Turbohaler
Before using a newSymbicort Turbohaler for the first time, you need to prepare it for use
as follows:

• Unscrew and remove the cap; you may hear a noise.
• Hold Symbicort Turbohaler in a vertical position with the red wheel facing down.
• Turn the red wheel in one direction to the end stop. Then turn it in the other direction to the end stop again (it doesn't matter in which direction you start turning the wheel). You will hear a click during this operation.
• Repeat the operation, turning the red wheel in both directions.
• Symbicort Turbohaler is now ready for use.

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

• 10. Unscrew and remove the cap; you may hear a noise.
• 11. Hold Symbicort Turbohaler in a vertical positionwith the red wheel facing down.
• 12. Do not touch the mouthpiece when loading Symbicort Turbohaler. To load the inhaler with a dose, turn the red wheel in one direction to the end stop.

Then turn it in the other direction to the end stop again (it doesn't matter in which direction you start
turning the wheel). You will hear a click during this operation. Your Symbicort Turbohaler is now
loaded and ready for use. Load Symbicort Turbohaler only when you need to use it.

• 13. Hold Symbicort Turbohaler away from your mouth. Exhale gently (without forcing). Do not exhale through Symbicort Turbohaler.
• 14. Place the mouthpiece gently between your teeth. Close your lips and inhale as deeply as possible through your mouth. Do not chew or bite the mouthpiece.
• 15. Move Symbicort Turbohaler away from your mouth. Exhale gently.The amount of medicine inhaled is very small. This means you may not taste it after inhalation. If you have followed the instructions, you can be sure you have inhaled the dose and the medicine is now in your lungs.
• 16. If you need to take a second inhalation, repeat steps 2 to 6.

• 17. After use, reposition the cap and screw it on.
• 18. Rinse your mouth with water after the morning and/or evening dose and spit out the water.

Do not try to remove or turn the mouthpiece. It is fixed to Symbicort Turbohaler and should not be
removed. Do not use Symbicort Turbohaler if it is damaged or if the mouthpiece has come off
Symbicort Turbohaler.
As with all inhalers, those who care for children should ensure that children who have been prescribed Symbicort Turbohaler use the correct inhalation technique, as described above.

How to clean Symbicort Turbohaler
Clean the outside of the mouthpiece once a week with a dry cloth. Do not use water or
liquids.

When to start using a new inhaler

• The dose indicator shows how many doses (inhalations) remain in Symbicort Turbohaler, starting from 60 doses when it is full.
• The dose indicator shows intervals of 10 doses. Therefore, it does not indicate every dose.
• When a red mark first appears on the edge of the indicator window, it means that about 20 doses remain. 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 need to start using a new Symbicort Turbohaler.

Note:

• You will still be able to turn the red wheel and hear the “click” even when Symbicort Turbohaler is empty.
• The sound you hear when shaking Symbicort Turbohaler is produced by a desiccant and not by the medicine. Therefore, this sound does not indicate how much medicine is left in Symbicort Turbohaler.
• If, by mistake, you load Symbicort Turbohaler more than once before taking the dose, you will still take only one dose. The dose indicator will, however, record all doses loaded.

If you use more Symbicort Turbohaler than you should
It is important that you take the dose as indicated on the label or as recommended by your doctor.
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that can occur if you use more Symbicort Turbohaler than you should
are: tremor, headache or increased heart rate.

If you forget to use Symbicort Turbohaler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose. If you have any further questions about 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 any of the following occur, stop using Symbicort Turbohaler and contact your
doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Suddenly wheezing and becoming short of breath immediately after using the inhaler. If any of these symptoms occur, stop using Symbicort Turbohaler immediately and use yourreliever inhaler. Contact your doctor immediately if you need tochange your treatment.This is very rare, affecting less than 1 in
• 10,000.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or shaking. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort Turbohaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort Turbohaler.
• Mild sore throat, cough and hoarseness.
• Headache.
• Pneumonia (lung infection), in patients with COPD. Tell your doctor if you have any of the following symptoms while taking Symbicort, they could be symptoms of a lung infection:
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using Symbicort Turbohaler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Alterations of taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid
hormones in the body, particularly if you use high doses for a
prolonged period. These effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataracts (clouding of the lens in the eye).
• Glaucoma (increased pressure in the eye).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney).

The occurrence of these effects is less likely with inhaled corticosteroids than with corticosteroids in tablets.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Symbicort Turbohaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or on the inhaler label after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Symbicort Turbohaler contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320
micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
The other excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Symbicort Turbohaler and contents of the pack
Symbicort Turbohaler consists of an inhaler that contains the medicine. The powder for inhalation
is white in colour. Each inhaler contains 60 doses and has a white body and a red wheel. The
rotating collar contains Braille code number 6 for identification, to differentiate it from other
AstraZeneca inhalation products.
Symbicort Turbohaler is available in packs containing 1, 2, 3, 10 or 18 inhalers
containing 60 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris – Via Ludovico il Moro 6/C
Basiglio (MI) 20080

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden

or
AstraZeneca GmbH
Wedel (Germany)

or
AstraZeneca UK Limited
Macclesfield, Cheshire (England)

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:

Detailed and up-to-date information on this

product is available by scanning

the outer carton with a smartphone. The same

information is also available at the following

URL:www.turbohaler.it
QR code Area

Symbicort 160 micrograms/4.5 micrograms/actuation, pressurised suspension

for inhalation
budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Symbicort is and what it is used for
• 2. What you need to know before you use Symbicort
• 3. How to use Symbicort
• 4. Possible side effects
• 5. How to store Symbicort
• 6. Contents of the pack and other information

1. What is Symbicort and what is it used for

Symbicort is an inhaler that is used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adult subjects aged 18 years or older. COPD is a long-term disease of the airways, which is often caused by cigarette smoking.
Symbicort 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 the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta-adrenergic receptor agonists” or “bronchodilators”. It works by relaxing the muscles of the airways, thus making breathing easier.

This medicine should not be used as a “rescue” inhaler.

2. What you need to know before using Symbicort

Do not use Symbicort:

• If you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or have had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For those who practice sports: the use of the drug without therapeutic need constitutes
doping and may still result in a positive doping test.

Children and adolescents
Symbicort is not recommended for children and adolescents under the age of 18 years.

Other medicines and Symbicort
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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also called ‘water tablets’ (such as furosemide), used to treat high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used to treat COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (like ritonavir) used to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist
before using Symbicort.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for
surgery or dental treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning a pregnancy, ask your doctor for advice before taking Symbicort - do not use Symbicort unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort, do not stop using Symbicort but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before using Symbicort.

Driving and using machines
Symbicort has no or negligible effect on the ability to drive and operate machines.

3. How to use Symbicort

• Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Symbicort every day, even if you do not have COPD symptoms at the moment.

The usual dose is 2 inhalations twice a day. Symbicort is not recommended in
children and adolescents under 18 years of age.
If you are taking steroids in tablet form for COPD, your doctor may reduce the number of
tablets you are taking, once you have started using Symbicort. If you are taking
steroids in tablet form for a long period, your doctor may request to perform blood tests periodically. When reducing the amount of oral steroids you may feel a
general feeling of unwellness even though your respiratory symptoms may improve. You may experience symptoms such as nasal congestion and rhinorrhea, weakness or muscle or joint pain and skin rash (eczema). If any of these
symptoms worry you or if you experience symptoms such as headache, fatigue, nausea
(feeling unwell) or vomiting (feeling sick), contact your
doctor immediately. You may need to take another medicine in case of allergic or
arthritic symptoms. Ask your doctor if you have doubts about continuing or stopping therapy with
Symbicort.
Your doctor may consider adding steroids in tablet form to the usual treatment
during periods of stress (for example when you have a respiratory infection or before
surgery).

Important information about COPD symptoms
If you notice the onset of shortness of breath or wheezing while using Symbicort, you should continue to
use it but consult your doctor as soon as possible as you may need
supplemental treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you often wake up at night due to shortness of breath.
• If you start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual. These signs may mean that your COPD is not properly controlled and that you may need immediate different or supplemental treatment.

Your doctor may also prescribe other bronchodilators, such as anticholinergics (such as
tiotropium or ipratropium bromide) for COPD.

Information about Symbicort

• Before you start using Symbicort, remove it from the aluminum blister. Throw away the blister and the desiccant found inside the blister. If the desiccant has leaked out of the package, do not use the inhaler.
• After you have removed the inhaler from the aluminum blister, you must use it within 3 months. Note the use by indicating the date (3 months from opening the blister) on the inhaler label, to remember when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will already be assembled when you receive it for the first time. Do not disassemble it. If the canister comes loose, reinsert it into the inhaler and continue to use the inhaler.

Preparing Symbicort
You must prepare the inhaler for use in the following cases:

• If you are using a new Symbicort for the first time.
• If you have not used it for more than 7 days.
• If it has fallen to the ground.

To prepare the inhaler for use, follow the instructions below:

• 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. The tab on the mouthpiece cap will remain attached to the inhaler.
• 3. Hold the inhaler in an upright position. Then press the dose indicator (at the top of the inhaler) to release a spray into the air. You can use one or both hands, as shown in the images.

• 4. Lift your finger(s) from the indicator.
• 5. Wait 10 seconds, shake the inhaler well and then repeat steps 3 and 4.
• 6. Now the inhaler is ready for use.

How to take an inhalation
Each time you need to take an inhalation, follow the instructions below:

• 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. Check that the mouthpiece is not blocked.

• 3. Hold the inhaler in an upright position (using one or both hands). Exhale slowly.
• 4. Position the mouthpiece gently between your teeth. Close your lips.
• 5. Start to inhale slowly and deeply with your mouth. Press firmly on the dose indicator (at the top of the inhaler) to release a spray. Continue to inhale for a few seconds after pressing the indicator. Inhaling at the same time as the inhaler is activated ensures that the medicine reaches your lungs.
• 6. Hold your breath for 10 seconds or until comfortable.
• 7. Before exhaling, remove your finger from the indicator and remove the mouthpiece from your mouth. Hold the inhaler in an upright position.
• 8. Then exhale slowly. To take another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3 to 7.
• 9. Replace the mouthpiece cap.
• 10. Rinse your mouth with water after the morning and evening dose and spit it out.

Using a spacer device
Your doctor, nurse or pharmacist may suggest using a spacer device (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the

How to clean Symbicort

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or other liquids and do not remove the canister from the inhaler.

How do I know when to replace Symbicort?

• The dose indicator, located at the top of the inhaler, tells you the number of sprays (deliveries) remaining in Symbicort. It indicates 120 sprays when full.
• With each inhalation or release of a spray into the air, the arrow moves down towards zero (‘0’).
• When the arrow first enters the yellow area, it means that about 20 sprays remain.

• When the arrow reaches ‘0’, you must stop using Symbicort. It may appear that the inhaler is not empty and still works. However, if you continue to use it, the device will not deliver the correct amount of medicine.

If you use more Symbicort than you should
If you use more Symbicort than you should, contact your doctor or pharmacist. The following symptoms may occur: tremor, headache or rapid heartbeat.

If you forget to use Symbicort

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose.

If you stop using Symbicort
You should consult your doctor or pharmacist before stopping treatment with Symbicort.
If you stop treatment with Symbicort, the signs and symptoms of COPD may worsen.
If you have any questions about using 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 any of the following occur, stop using Symbicort immediately and contact your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat) and/or difficulty swallowing, redness of the skin or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate that you are having an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Sudden onset of wheezing or shortness of breath immediately after using the inhaler. If any of these symptoms occur, stop using Symbicort immediately and use your reliever inhaler. Contact your doctor immediately, as you may need to change your treatment. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or shaking. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort.
• Mild sore throat, cough and hoarseness.
• Headache.
• Pneumonia (lung infection), in patients with COPD. Tell your doctor if you have any of the following symptoms while taking Symbicort, as they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Not common (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort, stop using Symbicort and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behavior, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Alterations of taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, particularly if you use high doses for a prolonged period. These 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).
• Reduced growth rate in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney).

The occurrence of these effects is much less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Symbicort

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label, the carton or the aluminium pouch after Exp. The expiry date refers to the last day of that month.
• As with many other inhaled medicines contained in a pressurised canister, the effect of this medicine may be reduced when the canister is cold. For best results, this medicine should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• After you have taken the inhaler out of the aluminium pouch, you must use it within 3 months. Note the use by indicating the date (3 months from opening the pouch) on the inhaler label to remind yourself when to stop using the inhaler.
• After each use of the inhaler, always firmly replace the mouthpiece cover and snap it into place.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Warning:The canister contains a pressurised liquid. Do not expose to temperatures
above 50°C. Do not puncture the canister. Do not break, puncture or burn the canister,
even when it appears empty.

6. Content of the pack and other information

What Symbicort contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each spray (actuation)
contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
The other ingredients are apaflurane (HFA 227), povidone and macrogol. This inhaler does
not contain CFCs.

Description of Symbicort’s appearance and content of the pack
Symbicort consists of an inhaler that contains the medicine. The pressurized canister, equipped with a dose indicator, contains a white-colored inhalation suspension of
color white. The canister is inserted into a red plastic actuator which includes a
white plastic mouthpiece and an integrated grey plastic protective cap. Each
inhaler contains 120 sprays (actuations) after it has been prepared for use. Each
inhaler is individually packaged in an aluminium blister containing a
desiccant.
Symbicort, 160 micrograms/4.5 micrograms/actuation, pressurized suspension for
inhalation (Budesonide/Formoterol fumarate dihydrate) is commercially available in
packs of one inhaler.

Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080

Manufacturer
AstraZeneca Dunkerque Production
224 avenue de la Dordogne
59640 DUNKERQUE
France

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:

Symbicort Turbohaler 320 micrograms/9 micrograms/inhalation, powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 13. What Symbicort Turbohaler is and what it is used for
• 14. What you need to know before you use Symbicort Turbohaler
• 15. How to use Symbicort Turbohaler
• 16. Possible side effects
• 17. How to store Symbicort Turbohaler
• 18. Contents of the pack and other information

1. What is Symbicort Turbohaler and what is it used for

Symbicort Turbohaler is comprised of an inhaler used to treat asthma in adults and adolescents aged between 12 and 17 years. It is also used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years or over. 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 β - adrenoreceptor agonists” or “bronchodilators”. It works by relaxing the muscles of your airways making it easier to breathe.

Asthma

For asthma, your doctor will prescribe two inhalers: Symbicort Turbohaler and a separate “reliever inhaler”.

• Use Symbicort Turbohaler every day. This will help to prevent asthma symptoms from appearing.
• Use the “reliever inhaler” when asthma symptoms occur, to help you breathe more easily. Do not use Symbicort Turbohaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)
Symbicort Turbohaler can also be used to treat the symptoms of severe COPD in adults.
COPD is a chronic disease of the airways in the lungs, often caused by cigarette smoking.

2. What you need to know before using Symbicort Turbohaler

Do not use Symbicort Turbohaler:

• If you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6), namely lactose (which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort Turbohaler if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or if you have ever had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For those who participate in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Other medicines and Symbicort Turbohaler
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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used for the treatment of high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used for the treatment of asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (like ritonavir) used for the treatment of HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if in doubt, consult your doctor or pharmacist before
using Symbicort Turbohaler.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for surgery or dental
treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning to become pregnant, ask your doctor for advice before taking Symbicort Turbohaler - do not take Symbicort Turbohaler unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort Turbohaler, do not stop taking Symbicort Turbohaler but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before taking Symbicort Turbohaler.

Driving and using machines
Symbicort Turbohaler has no or negligible effect on the ability to drive or operate tools or machines.

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If your doctor has told you that you have
an intolerance to some sugars, consult your doctor before using this medicine. The amount of
lactose contained in this medicine usually does not cause problems in people intolerant to
lactose.
The excipient lactose contains small amounts of milk proteins that can cause allergic
reactions.

3. How to use Symbicort Turbohaler

• Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you do not have symptoms of asthma or COPD at the moment.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to periodically check your symptoms.

If you have taken steroidsin tablet form for asthma or COPD, your doctor may reduce the number of
tablets you are taking, once you have started using Symbicort Turbohaler. If you have
taken steroids in tablet form for a long period, your doctor may request periodic blood tests. When you reduce the amount of oral steroids, you may feel a
general feeling of malaise despite your respiratory symptoms may be
improved. You may experience symptoms such as nasal congestion and rhinorrhea (runny nose), weakness
or muscle or joint pain and skin rash (eczema). If any of these
symptoms worry you or if symptoms such as headache, fatigue, nausea or vomiting occur for
please contact your doctor immediately. You may need to take another medicine in
case of allergic or arthritic symptoms. Ask your doctor if you have doubts about continuing or
whether to continue therapy with Symbicort Turbohaler.
Your doctor may consider adding steroids in tablet form to your usual treatment during
periods of stress (for example when you have a respiratory infection or before surgery).

Important information about the symptoms of asthma or COPD
If you notice the onset of shortness of breath or wheezing while using Symbicort Turbohaler, you should continue
to use it but consult your doctor as soon as possible as you may need
additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• If you start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual. These signs may mean that asthma or COPD is not properly controlled and that you may need immediate different or additional treatment.

Asthma
Use Symbicort Turbohaler every day.This helps prevent the onset of asthma symptoms.

Adults (18 years of age and over)

• The usual dose is 1 inhalation twice a day.
• The doctor may increase this dose to 2 inhalations, twice a day.
• If symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Adolescents (12-17 years)

• The usual dose is 1 inhalation twice a day.
• If symptoms are well controlled, your doctor may ask you to take the medicine once a day.

A lower dosage of Symbicort Turbohaler is available for children aged 6 to 11 years.
The use of Symbicort Turbohaler is not recommended in children under 6 years of age.
The doctor (or nurse) will help you manage asthma and adjust the dose of this medicine
to the lowest dose that controls asthma. However, do not change the dose without first talking to
your doctor (or nurse).
Use the "reliever inhaler" separately to treat asthma symptoms when they occur.
Always carry the "reliever inhaler" with you so you can use it when needed. Do not use
Symbicort Turbohaler to treat asthma symptoms, but the "reliever inhaler".

Chronic Obstructive Pulmonary Disease (COPD)

• Use is intended exclusively for adults (18 years of age and over).
• The usual dose is 1 inhalation twice a day. Your doctor may also prescribe you other bronchodilator medications, such as anticholinergics (such as tiotropium bromide or ipratropium bromide) for the treatment of COPD.

How to prepare Symbicort Turbohaler
Before using a newSymbicort Turbohaler for the first time, you must prepare it for use
as follows:

• Unscrew and remove the cap; you may hear a noise.
• Hold Symbicort Turbohaler in a vertical position with the red wheel facing down.
• Turn the red wheel in one direction to the end stop. Then turn it in the other direction again to the end stop (it doesn't matter in which direction you start turning the wheel). You will hear a click during this operation.
• Repeat the operation, turning the red wheel in both directions.
• Symbicort Turbohaler is now ready for use.

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

• 19. Unscrew and remove the cap; you may hear a noise.
• 20. Hold Symbicort Turbohaler in a vertical positionwith the red wheel facing down.
• 21. Do not touch the mouthpiece when loading Symbicort Turbohaler. To load the inhaler with a dose, turn the red wheel in one direction to the end stop.

Then turn it in the other direction again to the end stop (it doesn't matter in which direction you start
to turn the wheel). You will hear a click during this operation. Your Symbicort Turbohaler is now
loaded and ready for use. Load Symbicort Turbohaler only when you need to use it.

• 22. Hold Symbicort Turbohaler away from your mouth. Exhale gently (without forcing). Do not exhale through Symbicort Turbohaler.
• 23. Position the mouthpiece gently between your teeth. Close your lips and inhale as deeply as possible through your mouth. Do not chew or bite the mouthpiece.
• 24. Remove Symbicort Turbohaler from your mouth. Exhale gently.The amount of medicine inhaled is very small. This means that you may not feel the taste after inhalation. If you have followed the instructions, you can be sure you have inhaled the dose and the medicine is now in your lungs.
• 25. If you need to take a second inhalation, repeat operations 2 to 6.

• 26. After use, reposition the cap and screw it on.
• 27. Rinse your mouth with water after the morning and/or evening dose and spit out the water.

Do not try to remove or turn the mouthpiece. It is fixed to Symbicort Turbohaler and should not be
removed. Do not use Symbicort Turbohaler if it is damaged or if the mouthpiece has come off
from Symbicort Turbohaler.
As with all inhalers, those who care for children should ensure that children who have been prescribed Symbicort Turbohaler use the correct inhalation technique, as described above.

How to clean Symbicort Turbohaler
Clean the outside of the mouthpiece once a week with a dry cloth. Do not use water or
liquids.

When to start using a new inhaler

• The dose indicator shows how many doses (inhalations) remain in Symbicort Turbohaler, starting from 60 doses when it is full.
• The dose indicator shows intervals of 10 doses. Therefore, it does not indicate every dose.
• When a red mark first appears on the edge of the indicator window, it means that about 20 doses remain. 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 need to start using a new Symbicort Turbohaler.

Note:

• You will still be able to rotate the red wheel and hear the "click" even when Symbicort Turbohaler is empty.
• The sound you hear when shaking Symbicort Turbohaler is produced by a drying agent and not by the medicine. Therefore, this sound does not indicate how much medicine is left in Symbicort Turbohaler.
• If, by mistake, you load Symbicort Turbohaler more than once before taking the dose, you will still take only one dose. The dose indicator will still record all loaded doses.

If you use more Symbicort Turbohaler than you should
It is important that you take the dose as indicated on the label or as recommended by your doctor.
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that may occur if you use more Symbicort Turbohaler than you should
are: tremor, headache or increased heart rate.

If you forget to use Symbicort Turbohaler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop using Symbicort Turbohaler and contact your
doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Suddenly wheezing and becoming short of breath immediately after using the inhaler. If any of these symptoms occur, stop using Symbicort Turbohaler immediately and use yourreliever inhaler. Contact your doctor immediately if you need tochange your treatment.This is very rare, affecting less than 1 in
• 10,000.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or nervousness. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort Turbohaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort Turbohaler.
• Mild sore throat, cough and hoarseness.
• Headache.
• Pneumonia (lung infection), in patients with COPD. Tell your doctor if you have any of the following symptoms while taking Symbicort, they could be symptoms of a lung infection:
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using Symbicort Turbohaler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or pressure (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid
hormones in the body, particularly if you use high doses for a prolonged
period. These 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).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney).

The occurrence of these effects is less likely with inhaled corticosteroids than with
corticosteroids in tablets.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Symbicort Turbohaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or on the inhaler label after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Symbicort Turbohaler contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320
micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
The other excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Symbicort Turbohaler and content of the pack
Symbicort Turbohaler consists of an inhaler that contains the medicine. The powder for inhalation
is white in colour. Each inhaler contains 60 doses and has a white body and a red wheel. The
rotating collar contains Braille code number 6 for identification, to differentiate it from other
AstraZeneca inhaler products.
Symbicort Turbohaler is available in packs containing 1, 2, 3, 10 or 18 inhalers
containing 60 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris – Via Ludovico il Moro 6/C
Basiglio (MI) 20080

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden

or
AstraZeneca GmbH
Wedel (Germany)

or
AstraZeneca UK Limited
Macclesfield, Cheshire (England)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Detailed and updated information on this

product is available by scanning

the outer packaging with a smartphone. The same

information is also available at the following

URL:www.turbohaler.it
QR code Area

Symbicort 160 micrograms/4.5 micrograms/actuation, pressurised suspension

for inhalation
budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Symbicort is and what it is used for
• 8. What you need to know before you use Symbicort
• 9. How to use Symbicort
• 10. Possible side effects
• 11. How to store Symbicort
• 12. Contents of the pack and other information

2. What is Symbicort and what is it used for

Symbicort is an inhaler used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adult subjects aged 18 years or older. COPD is a long-term disease of the airways, often caused by cigarette smoking. Symbicort 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 the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting β adrenoceptor agonists” or “bronchodilators”. It works by relaxing the muscles of the airways, making it easier to breathe.

This medicine should not be used as a “rescue” inhaler.

4. What you need to know before using Symbicort

Do not use Symbicort:

• If you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or have had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: the use of the drug without therapeutic necessity constitutes
doping and may still result in a positive doping test.

Children and adolescents
Symbicort is not recommended for children and adolescents under the age of 18 years.

Other medicines and Symbicort
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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also called ‘water tablets’ (such as furosemide), used to treat high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used to treat COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (like ritonavir) used to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist
before using Symbicort.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for
surgery or dental treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning to become pregnant, ask your doctor for advice before taking Symbicort - do not use Symbicort unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort, do not stop using Symbicort but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before using Symbicort.

Driving and using machines
Symbicort has no or negligible effect on the ability to drive or operate tools or machinery.

5. How to use Symbicort

• Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Symbicort every day, even if you do not have symptoms of COPD at the moment.

The usual dose is 2 inhalations twice a day. Symbicort is not recommended in
children and adolescents under the age of 18 years.
If you are taking steroids in tablet form for COPD, your doctor may reduce the number of
tablets you are taking, once you have started using Symbicort. If you are taking
steroids in tablet form for a long period, your doctor may request to perform blood
tests periodically. When reducing the amount of oral steroids you may experience a
feeling of general malaise even though your respiratory symptoms may improve. You may experience symptoms such as nasal congestion and rhinorrhea, weakness or muscle or joint pain and rash (eczema). If any of these
symptoms worry you or if you experience symptoms such as headache, fatigue, nausea
(feeling sick) or vomiting (feeling unwell), contact your
doctor immediately. You may need to take another medicine in case of allergic or
arthritic symptoms. Ask your doctor if you have doubts about continuing or stopping therapy with
Symbicort.
Your doctor may consider adding steroids in tablet form to the usual treatment
during periods of stress (for example when you have a respiratory infection or before
surgery).

Important information about COPD symptoms
If you notice the onset of shortness of breath or wheezing while using Symbicort, you should continue to
use it but consult your doctor as soon as possible as you may need
supplemental treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to shortness of breath.
• If you start to feel tightness in the chest in the morning or if the chest tightness lasts longer than usual. These signs may mean that COPD is not properly controlled and that you may need immediate different or additional treatment.

The doctor may also prescribe other bronchodilators, for example anticholinergics (such as
tiotropium or ipratropium bromide) for COPD.

Information about Symbicort

• Before starting to use Symbicort, remove it from the aluminum blister. Throw away the blister and the desiccant found inside the blister. If the desiccant has leaked out of the package, do not use the inhaler.
• After removing the inhaler from the aluminum blister, you must use it within 3 months. Note the use by indicating the date (3 months from opening the blister) on the inhaler label, to remember when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will already be assembled when you receive it for the first time. Do not disassemble it. If the canister loosens, reinsert it into the inhaler and continue to use the inhaler.

Preparing Symbicort
You must prepare the inhaler for use in the following cases:

• If you are using a new Symbicort for the first time.
• If you have not used it for more than 7 days.
• If it has fallen to the ground.

To prepare the inhaler for use, follow the instructions below:

• 7. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 8. Remove the mouthpiece cap by pressing lightly on the protrusions located on the side. The tab on the mouthpiece cap will remain attached to the inhaler.
• 9. Hold the inhaler in an upright position. Then press the dose indicator (at the top of the inhaler) to release a spray into the air. You can use one or both hands, as shown in the images.

• 10. Lift your finger from the indicator.
• 11. Wait 10 seconds, shake the inhaler well and then repeat steps 3 and 4.
• 12. Now the inhaler is ready for use.

How to take an inhalation
Each time you need to take an inhalation, follow the instructions below:

• 11. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 12. Remove the mouthpiece cap by pressing lightly on the protrusions located on the side. Check that the mouthpiece is not blocked.

• 13. Hold the inhaler in an upright position (using one or both hands). Exhale slowly.
• 14. Position the mouthpiece gently between your teeth. Close your lips.
• 15. Start to inhale slowly and deeply with your mouth. Press firmly on the dose indicator (at the top of the inhaler) to release a spray. Continue to inhale for a few seconds after pressing the indicator. Inhaling at the same time as the inhaler is activated ensures that the medicine reaches the lungs.
• 16. Hold your breath for 10 seconds or until comfortable.
• 17. Before exhaling, remove your finger from the indicator and remove the mouthpiece from your mouth. Hold the inhaler in an upright position.
• 18. Then exhale slowly. To take another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3 to 7.
• 19. Replace the mouthpiece cap.
• 20. Rinse your mouth with water after the morning and evening dose and spit it out.

Using a spacer device
Your doctor, nurse or pharmacist may suggest using a spacer device (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the

How to clean Symbicort

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or other liquids and do not remove the canister from the inhaler.

How do I know when to replace Symbicort?

• The dose indicator, located at the top of the inhaler, tells you the number of sprays (deliveries) remaining in Symbicort. It indicates 120 sprays when full.
• With each inhalation or release of a spray into the air, the arrow moves down towards zero (‘0’).
• When the arrow first enters the yellow area, it means that about 20 sprays remain.

• When the arrow reaches ‘0’, you must stop using Symbicort. It may appear that the inhaler is not empty and still works. However, if you continue to use it, the device will not deliver the correct amount of medication.

If you use more Symbicort than you should
If you use more Symbicort than you should, contact your doctor or pharmacist. The following symptoms may occur: tremor, headache or a racing heartbeat.

If you forget to use Symbicort

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose.

If you stop treatment with Symbicort
You should consult your doctor or pharmacist before stopping treatment with Symbicort.
If you stop treatment with Symbicort, the signs and symptoms of COPD may worsen.
If you have any questions about using 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 any of the following occur, stop using Symbicort immediately and contact your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat) and/or difficulty swallowing, redness of the skin or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate that you are having an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Sudden onset of wheezing or shortness of breath immediately after using the inhaler. If any of these symptoms occur, stop using Symbicort immediately and use your reliever inhaler. Contact your doctor immediately, as you may need to change your treatment. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or restlessness. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort.
• Mild sore throat, cough and hoarseness.
• Headache.
• Pneumonia (lung infection), in patients with COPD. Tell your doctor if you have any of the following symptoms while taking Symbicort, as they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort, stop using Symbicort and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Alterations in taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, particularly if you use high doses for a prolonged period. These 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).
• Reduced growth rate in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney).

The occurrence of these effects is much less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Symbicort

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label, the carton or the aluminium pouch after Exp. The expiry date refers to the last day of that month.
• As with many other inhaled medicines contained in a pressurised canister, the effect of this medicine may be reduced when the canister is cold. For best results, this medicine should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• After you have taken the inhaler out of the aluminium pouch, you must use it within 3 months. Note the date of use (3 months from opening the pouch) on the inhaler label to remind you when to stop using the inhaler.
• After each use of the inhaler, always firmly replace the mouthpiece cover and snap it into place.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Warning:The canister contains a pressurised liquid. Do not expose to temperatures
above 50°C. Do not puncture the canister. Do not break, puncture or burn the canister,
even when it appears empty.

6. Content of the pack and other information

What Symbicort contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each spray (actuation)
contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
The other ingredients are apaflurane (HFA 227), povidone and macrogol. This inhaler does
not contain CFCs.

Description of Symbicort and contents of the pack
Symbicort consists of an inhaler that contains the medicine. The pressurized canister, equipped with a dose indicator, contains a white-colored inhalation suspension of
color. The canister is inserted into a red plastic actuator which includes a
white plastic mouthpiece and an integrated grey plastic protective cap. Each
inhaler contains 120 sprays (actuations) after it has been prepared for use. Each
inhaler is individually packaged in an aluminum pouch containing a
desiccant.
Symbicort, 160 micrograms/4.5 micrograms/actuation, pressurized suspension for
inhalation (Budesonide/Formoterol fumarate dihydrate) is commercially available in
packs of one inhaler.

Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080

Manufacturer
AstraZeneca Dunkerque Production
224 avenue de la Dordogne
59640 DUNKERQUE
France

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:

Symbicort 80 micrograms/2.25 micrograms/dose pressurised suspension for

inhalation,
budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 13. What Symbicort is and what it is used for
• 14. What you need to know before you use Symbicort
• 15. How to use Symbicort
• 16. Possible side effects
• 17. How to store Symbicort
• 18. Contents of the pack and other information

3. What is Symbicort and what is it used for?

What is Symbicort
Symbicort is an inhaler used to treat asthma in adults and adolescents aged
between 12 and 17 years. Symbicort contains two different medicines: budesonide and
formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called “corticosteroids”.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta-adrenergic receptor agonists” or “bronchodilators”.

What is Symbicort used to treat
Symbicort is used to treat asthma and may be prescribed as monotherapy or with a
separate reliever inhaler:
Some people are prescribed two inhalers for asthma: the Symbicort inhaler and a
separate “reliever inhaler”

• These people use Symbicort every day. This helps prevent asthma symptoms from occurring.
• They use their “reliever inhaler” when they experience asthma symptoms, to help them breathe more easily.

Some people are prescribed Symbicort as their only inhaler for asthma

• These people use Symbicort every day. This helps prevent asthma symptoms from occurring.
• They also use Symbicort when they need extra doses to relieve asthma symptoms to help them breathe more easily and, if agreed with their doctor, to prevent asthma symptoms from occurring (for example, during

exercise or when exposed to allergens). These people do not need
a separate inhaler for this purpose.

How Symbicort works

• Budesonide works by reducing and preventing swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate works by relaxing the muscles in the airways - making it easier to breathe.

6. What you need to know before using Symbicort

Do not use Symbicort:

• If you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Symbicort if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or have had heart problems in the past (e.g. irregular heartbeat, 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 serious liver problems. Contact your doctor if you experience blurred vision or other visual disturbances while using Symbicort.

For athletes: the use of the drug without therapeutic need constitutes
doping and may still result in a positive doping test.

Children
Do not use this medicine in children under 12 years of age.

Other medicines and Symbicort
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-blockers for high blood pressure (such as atenolol or propranolol).
• Eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also called ‘water tablets’ (such as furosemide), used to treat high blood pressure.
• Steroids taken by mouth (such as prednisolone).
• Xanthines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Antidepressants (such as amitriptyline) and nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines for the treatment of HIV infection (such as ritonavir).
• Medicines for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist
before using Symbicort.
Also inform your doctor or pharmacist if you are to have a general anaesthetic for a
surgical or dental procedure.

Pregnancy and breastfeeding

• If you are pregnant, or planning to become pregnant, ask your doctor for advice before taking Symbicort - do not use Symbicort unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort, do not stop using Symbicort but consult your doctor immediately.
• If you are breastfeeding, tell your doctor before taking Symbicort.

Driving and using machines
Symbicort has no or negligible effect on the ability to drive or operate tools or machinery.

7. How to use Symbicort

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

• It is important to use Symbicort every day, even if you do not have asthma symptoms at the moment.
• Your doctor will want to regularly check your asthma symptoms.
• Your doctor may consider adding steroids in tablets to your usual treatment during periods of stress (for example when you have a respiratory infection or before surgery).

Symbicort can be prescribed for asthma as monotherapy or with a separate rescue inhaler
. You need to take two puffs (actuations) of Symbicort to obtain a full dose
. The amount of Symbicort to use and when to use it depends on what has been
prescribed to you.
a) If you have been prescribed Symbicort and a separate rescue inhaler, read the section
“a) Using Symbicort and a separate rescue inhaler”.
b) If you have been prescribed Symbicort as a single inhaler, read the section “b) Using
Symbicort as a single inhaler for asthma”.

a)Using Symbicort and a “rescue inhaler” separately
Use Symbicort every day. This helps to prevent asthma symptoms from appearing.
Adults (18 years and over)

• The usual dose is 2 - 4 puffs, twice a day.
• Your doctor may increase the dose to 8 puffs, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Adolescents (12 to 17 years)

• The usual dose is 2 - 4 puffs, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take the medicine once a day.

The doctor (or asthma nurse) will help you manage your asthma. They will adjust the
dose of the medicine to the lowest dose that can control your asthma. However, do not
change or stop the dose without first consulting your doctor (or asthma nurse).
Use the separate “rescue inhaler” to treat asthma symptoms when they occur.

• Always keep the “rescue inhaler” with you to use when you need it.
• Do not use Symbicort to treat asthma symptoms - use your rescue inhaler.

b)Using Symbicort as a single inhaler for asthma
Use Symbicort in this way only as directed by your doctor and if you are 12 years of age or older.
Use Symbicort every day. This helps to prevent asthma symptoms from appearing. You can
take:

• 2 puffs in the morning and 2 puffs in the evening
• 4 puffs in the morning
• 4 puffs in the evening

Your doctor may increase the dose to 4 puffs, twice a day.
Use Symbicort also as a “rescue inhaler” to treat asthma symptoms when
they occur and to prevent the onset of asthma symptoms (for example, during exercise
or exposure to allergens).

• If asthma symptoms occur, take 2 puffs and wait a few minutes.
• If you do not feel better, take another 2 puffs.
• Do not take more than 12 puffs at one time.

Always keep your Symbicort inhaler with you to use when you need it.
A total daily dose of more than 16 puffs is usually not necessary. However,
your doctor may allow you to take a maximum of 24 puffs a day for a limited
period of time.
If you regularly need to use 16 or more puffs a day, make an appointment
to consult your doctor or nurse. You may need to change your
treatment.
Do not use more than 24 puffs in 24 hours.
If asthma symptoms occur while you are exercising, use Symbicort as
described here. It is important to discuss with your doctor the use of Symbicort to prevent
the onset of asthma symptoms; how often you exercise or how often you are
exposed to allergens may affect the treatment that has been prescribed for you.

Symbicort and oral steroids
If you are taking oral steroids for asthma, your doctor may reduce the number of
tablets you are taking once you have started using Symbicort. If you have been taking
oral steroids for a long period, your doctor may request periodic blood tests. When you reduce the amount of oral steroids you may feel
a general feeling of unwellness even though your respiratory symptoms may be
improved. The signs may include:

• nasal congestion and runny nose
• weakness
• joint or muscle pain
• skin rash (eczema).

Contact your doctor immediately if you have signs such as:

• headache
• fatigue
• feeling sick (nausea)
• unwell (vomiting).

If you experience any of the above signs, contact your doctor immediately. You may
need to take another medicine. Ask your doctor if you have any doubts about
continuing or not with Symbicort therapy.

Use in children
Other forms of this medicine are suitable for children; ask your doctor or
pharmacist.

Important information about asthma symptoms
If you notice the onset of shortness of breath or wheezing while using Symbicort, you should continue to
use it but consult your doctor as soon as possible as you may need
additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• You start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual.
• These signs may mean that your asthma is not properly controlled and that you may need different or additional treatment immediately.

Information about Symbicort

• Before starting to use Symbicort, remove it from the aluminum foil. Throw away the foil and the desiccant inside the foil. If the desiccant has leaked out of the package, do not use the inhaler.
• After you have removed the inhaler from the aluminum foil, you must use it within 3 months. Note the date of use (3 months from opening the foil) on the inhaler label to remember when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will already be assembled when you receive it for the first time. If the canister loosens, reinsert it into the inhaler and continue using the inhaler.

Preparing Symbicort
You must prepare the inhaler for use in the following cases:

• If you are using a new Symbicort for the first time.

• If you have not used it for more than 7 days.
• If it has fallen to the ground.

To prepare the inhaler for use, follow the instructions below:

• 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. The tab on the mouthpiece cap will remain attached to the inhaler.
• 3. Hold the inhaler in an upright position. Then press the dose indicator (at the top of the inhaler) to release a spray into the air. You can use one or both hands, as shown in the images.
• 4. Lift your finger from the indicator.
• 5. Wait 10 seconds, shake well and then repeat steps 3 and 4.
• 6. Now the inhaler is ready for use.

How to take an inhalation
Each time you need to take an inhalation, follow the instructions below:

• 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• 2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. Check that the mouthpiece is not blocked.
• 3. Hold the inhaler in an upright position (using one or both hands). Exhale slowly.
• 4. Position the mouthpiece gently between your teeth. Close your lips.
• 5. Start to inhale slowly and deeply with your mouth. Press the dose indicator (at the top of the inhaler) firmly to release a spray. Continue to inhale for a few seconds after pressing the indicator. Inhaling at the same time as actuating the inhaler ensures that the medicine reaches your lungs.
• 6. Hold your breath for 10 seconds or until comfortable.
• 7. Before exhaling, remove your finger from the indicator and remove the mouthpiece from your mouth. Hold the inhaler in an upright position.
• 8. Then exhale slowly. To take another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3 to 7.
• 9. Replace the mouthpiece cap.
• 10. Rinse your mouth with water after the morning and evening dose and spit it out.

Using a spacer device
Your doctor, nurse or pharmacist may suggest using a spacer device (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the

How to clean Symbicort

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or other liquids
• Do not remove the canister from the inhaler.

How do I know when to replace Symbicort

• The dose indicator, located at the top of the inhaler, tells you the number of puffs (actuations) remaining in Symbicort. It indicates 60 or 120 puffs when full.

• With each inhalation or release of a spray into the air, the arrow moves down towards zero (“0”).
• When the arrow first enters the yellow zone, it means there are about 20 puffs left.

• When the arrow reaches “0”, you must stop using Symbicort. It may appear that the inhaler is not empty and still works. However, if you continue to use it, the device will not deliver the correct amount of medicine.

If you use more Symbicort than you should
It is important that you take the dose shown on the pharmacist’s label or as recommended
by your doctor. Do not take more than the prescribed dose without seeking medical advice.
If you use more Symbicort than you should, contact your doctor or pharmacist for advice.
The following effects may occur: tremor, headache or a fast heartbeat.

If you forget to use Symbicort

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose
• Do nottake a double dose to make up for a missed dose.

If you stop using Symbicort
You should consult your doctor or pharmacist before stopping treatment with Symbicort.
If you stop treatment with Symbicort, the signs and symptoms of asthma may worsen.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If any of the following occur, stop using Symbicort and contact your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat) and/or difficulty swallowing, redness of the skin or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate that you are having an allergic reaction. This effect is rare and affects less than 1 in 1,000 people.
• Sudden onset of wheezing or shortness of breath immediately after using the Symbicort inhaler. If any of these symptoms occur, stop using Symbicort immediately and use your reliever inhaler. Contact your doctor immediately, as you may need to change your treatment. This is very rare, affecting less than 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heartbeat), tremor or restlessness. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort.
• Candida (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Symbicort morning and evening.
• Mild sore throat, cough and hoarseness.
• Headache.

Not common (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort, stop using Symbicort and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, particularly if you use high doses for a prolonged period. These 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).
• Reduced growth rate in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney). The occurrence of these effects is much less likely with inhaled corticosteroids than with corticosteroids in tablet form.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symbicort

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the canister label, the carton or the aluminium pouch after “Exp.”. The expiry date refers to the last day of that month.
• After you have removed the inhaler from the aluminium pouch, you must use it within 3 months. Note the date of use (3 months from opening the pouch) on the inhaler label, to remind you when to stop using the inhaler.
• As with many other inhaled medicines contained in a pressurised canister, the effect of this medicine may be reduced when the canister is cold. For best results, this medicine should be at room temperature before use.
• Do not refrigerate or freeze. Protect from frost and direct sunlight.
• After using the inhaler, always firmly replace the mouthpiece cover and snap it into place.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Warning: The canister contains a pressurised liquid. Do not expose to temperatures
above 50 °C. Do not puncture the canister. Do not break, puncture or burn the canister,
even when it appears empty.

6. Contents of the pack and other information

What Symbicort contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each spray contains
80 micrograms of budesonide and 2.25 micrograms of formoterol fumarate dihydrate.
The other ingredients are apaflurane (HFA 227), povidone and macrogol. This inhaler does not
contain CFCs.

Description of Symbicort and contents of the pack
Symbicort consists of an inhaler containing the medicine. The medicine, a
white inhalation suspension, is contained in a pressurised canister, equipped with a dose
indicator. The canister is inserted into a red plastic actuator which includes a white plastic
mouthpiece and an integrated grey plastic protective cap. Each inhaler contains 60 or 120 sprays
after it has been prepared for use. Each inhaler is individually packaged in an aluminium
sachet containing a desiccant.
Symbicort 80 micrograms/2.25 micrograms/dose pressurised inhalation suspension (Budesonide/Formoterol fumarate dihydrate) is commercially available in
packs of one inhaler.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080
Production:
AstraZeneca Dunkerque Production (AZDP)
224 Avenue de la Dordogne
Dunkerque, 59640
France

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Austria: Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation Druckgasinhalation,
Suspension; Belgium: Symbicort 80 microgram/2,25 microgram/inhalatie, aerosol, suspensie;

Symbicort 80 micrograms/2.25 micrograms/inhalation, suspension for inhalation in

pressurized container; Symbicort 80 Micrograms/2.25 Micrograms/Inhalation,
Pressurized inhalation, Suspension; Bulgaria: Symbicort 80 micrograms/2.25
micrograms/spray Suspension under pressure for inhalation; Croatia: Symbicort 80
micrograms/2.25 micrograms per actuation, pressurized inhaler, suspension; Cyprus: Symbicort 80
micrograms/2.25 micrograms/spray; Czech Republic: Symbicort 80
micrograms/2.25 micrograms/inhalation, suspension in pMDI; Denmark: Symbicort 80
micrograms/2.25 micrograms/inhalation; Estonia: Symbicort; Finland: Symbicort 80
micrograms/2.25 micrograms/inhalation; France: Symbicort 100/3 micrograms per inhalation,
suspension for inhalation in pressurized container; Greece: Symbicort 80 micrograms/2.25
micrograms/spray; Hungary: Symbicort 2.25 micrograms/80 micrograms/ dose
pressurized inhalation suspension; Iceland: Symbicort 80 micrograms/2.25 micrograms/
inhalation; Italy: Symbicort; Latvia: Symbicort 80 micrograms/2.25 micrograms/
inhalation, spray, aerosol for inhalation under pressure; Lithuania: Symbicort 80
micrograms/2.25 micrograms/spray pressurized inhalation suspension; Luxembourg:
Symbicort 80 micrograms/2.25 micrograms/inhalation, suspension for inhalation in
pressurized container; Malta: Symbicort 100 micrograms/3 micrograms/inhalation; Netherlands:
Symbicort aerosol 100/3, 100 micrograms/3 micrograms per dose, aerosol, suspension;

Norway: Symbicort 80 micrograms/2.25 micrograms/ inhalation; Poland: Symbicort;

Portugal: Symbicort 80 micrograms/2.25 micrograms/inhalation Pressurized suspension
for inhalation; Slovakia: Symbicort 80 micrograms/2.25 micrograms/inhalation dose,
inhalation suspension in a pressurized container; Slovenia: Symbicort 80 micrograms/2.25
micrograms per inhalation, inhalation suspension under pressure; Spain: Symbicort 80
micrograms/2.25 micrograms/inhalation suspension for inhalation in pressurized container;

Sweden: Symbicort 80 micrograms/2.25 micrograms/inhalation; United Kingdom: Symbicort 100
micrograms/3 micrograms actuation pressurised inhalation, suspension