Symbicort

Package leaflet: Information for the user

Symbicort Turbohaler

160 micrograms/4.5 micrograms/inhalation, powder for inhalation
Budesonide/formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using this medicine because 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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Contents of the pack and other information

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

Symbicort Turbohaler is an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called "corticosteroids". It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting β-adrenoceptor agonists" or "bronchodilators". It works by relaxing the muscles in the airways, making breathing easier.

Asthma
Symbicort Turbohaler may be prescribed for asthma in two different ways.
a) Some people are prescribed two inhalers for asthma: Symbicort Turbohaler and a separate
"reliever inhaler".

• They use Symbicort Turbohaler every day. This helps 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 prevent asthma symptoms from occurring.
• They also use Symbicort Turbohaler when they need extra doses to relieve asthma symptoms and help them breathe more easily, and, if agreed with their doctor, to prevent asthma symptoms (for example, during physical 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 symptoms of severe COPD in adults.
COPD is a chronic lung airway disease, 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), i.e. lactose (which contains small amounts of milk proteins).

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

• You have diabetes.
• 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, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Symbicort Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
In particular, inform 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 rapid 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.
• Oral steroids (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” (such as 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 Turbohaler.

Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding and fertility

• If you are pregnant, or planning to become pregnant, consult your doctor before taking Symbicort Turbohaler – do not take Symbicort Turbohaler unless advised by your doctor.
• If you become pregnant while being treated with Symbicort Turbohaler, do not stop using Symbicort Turbohaler but consult your doctor immediately.
• If you are breastfeeding, inform your doctor before taking Symbicort Turbohaler.

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

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain 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 which may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you currently have no asthma or COPD symptoms.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to check your symptoms periodically.

If you have been taking steroid tablets for your asthma or COPD, your doctor may gradually reduce the number of tablets you are taking once you have started using Symbicort Turbohaler. If you have taken steroid tablets for a long time, your doctor may require you to have periodic blood tests. As you reduce the amount of oral steroids, you may feel generally unwell despite improvement in your respiratory symptoms. You might 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 concern you, or if you experience symptoms such as headache, fatigue, nausea, or vomiting, please contact your doctor immediately. You may need to take another medicine to treat allergic or arthritic symptoms. Ask your doctor if you are unsure whether to continue treatment with Symbicort Turbohaler. Your doctor may consider adding oral steroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before surgery).

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

• Your breathing worsens or you wake up frequently at night due to asthma.
• You start experiencing chest tightness in the morning or if chest tightness lasts longer than usual. These signs may indicate that your asthma or COPD is not adequately controlled and that you may need different or additional treatment immediately.

Asthma
Symbicort Turbohaler may 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 separate reliever inhaler, read section “a) Use of Symbicort Turbohaler and a separate reliever inhaler”.
• If you have been prescribed Symbicort Turbohaler as the only inhaler, read section “b) Use of Symbicort Turbohaler as the only inhaler for asthma”.

a) Use of Symbicort Turbohaler and a separate reliever inhaler
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 or 2 inhalations twice daily.
• Your doctor may increase this dose to 4 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.

Adolescents (12–17 years of age)

• The usual dose is 1 or 2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily. A lower dose formulation of Symbicort Turbohaler is available for children aged 6 to 11 years.

Use of Symbicort Turbohaler is not recommended in children under 6 years of age.
Your doctor (or nurse) will help 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 first discussing it with your doctor (or nurse).
Use the separate “reliever inhaler” to treat asthma symptoms when they occur.
Always carry your “reliever inhaler” with you for use when needed. Do not use Symbicort Turbohaler to treat asthma symptoms—use the reliever inhaler instead.

b) Use of Symbicort Turbohaler as the only inhaler for asthma
Use Symbicort Turbohaler in this way only if instructed by your doctor and if you are over 12 years of age.
Use Symbicort Turbohaler every day. This helps prevent the onset of asthma symptoms. You may take:

• 1 inhalation in the morning and 1 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 daily.

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 physical exercise or upon exposure 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 for use when needed.
Normally, a total daily dose exceeding 8 inhalations is not required. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.
If you regularly need to use 8 or more inhalations per day, consult your doctor or nurse, as your treatment may need to be adjusted.
Do not use more than 12 inhalations in total within 24 hours.
If asthma symptoms occur during physical exercise, use Symbicort Turbohaler as described in this leaflet. It is important to discuss with your doctor the use of Symbicort Turbohaler for preventing asthma symptoms—how often you exercise or how often you are exposed to allergens may influence your prescribed treatment.

Chronic obstructive pulmonary disease (COPD)

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

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

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

• Unscrew and remove the cap; you may hear a sound.
• Hold Symbicort Turbohaler upright with the red wheel facing downwards.
• Turn the red wheel fully in one direction, then fully in the opposite direction (it does not matter which direction you start in). You will hear a click during this process.
• Repeat this process, 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 sound.
2. Hold Symbicort Turbohaler upright with the red wheel facing downwards.

3. Do not touch the mouthpiece when loading Symbicort Turbohaler. To load a dose, turn the red wheel fully in one direction, then fully in the opposite direction (it does not matter which direction you start in). You will hear a click. Symbicort Turbohaler is now loaded and ready for use. Only load Symbicort Turbohaler when you are about to use it.

4. Hold Symbicort Turbohaler away from your mouth. Breathe out gently (without forcing). Do not breathe out through Symbicort Turbohaler.

5. Gently place the mouthpiece between your teeth. Close your lips and inhale as deeply as possible through your mouth. Do not chew or bite the mouthpiece.

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

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

8. After use, replace the cap and screw it back on.

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

Do not attempt to remove or rotate the mouthpiece. It is fixed to Symbicort Turbohaler and must not be removed. Do not use Symbicort Turbohaler if it is damaged or if the mouthpiece has detached from the device.
As with all inhalers, caregivers of children must ensure that children 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 single dose.
• When a red mark first appears at the edge of the indicator window, approximately 20 doses remain. For the last 10 doses, the background of the dose indicator turns red. When the '0' on the red background reaches 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 heard when shaking Symbicort Turbohaler comes from a drying agent and not from the medicine. Therefore, this sound does not indicate how much medicine remains in Symbicort Turbohaler.
• If, by mistake, you load Symbicort Turbohaler more than once before taking a dose, you will still only inhale one dose. However, the dose indicator will count all loaded doses.

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 doctor.
The most common symptoms that may occur if you use too much Symbicort Turbohaler are: tremor, headache, or rapid heartbeat.

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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose. 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 Turbohaler and contact your doctor
immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by breathing difficulties (angioedema) and/or sudden fainting. This could indicate an allergic reaction. This side effect is rare, affecting fewer than 1 in 1,000 people.
• Sudden wheezing and shortness of breath immediately after using the inhaler. If you experience any of these symptoms, stop using Symbicort Turbohaler immediately and use your "reliever" inhaler. Contact your doctor immediately if you need to change your treatment. This occurs rarely, affecting fewer than 1 in 10,000 people.

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

• Palpitations (awareness of heartbeat), tremor, or restlessness. If these effects occur, they are usually mild and tend to disappear with continued use of Symbicort Turbohaler.
• Oral 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). Inform your doctor if you experience any of the following symptoms while taking Symbicort Turbuhaler, as they could indicate a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using it 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if high doses are used over 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 oral corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 the appearance of Symbicort Turbohaler and contents of the pack
Symbicort Turbohaler consists of an inhaler containing the medicinal product. The inhalation powder
is white in colour. Each inhaler contains 30, 60 or 120 doses and has a white body with a red wheel.
The rotating ring bears the Braille code number 6 for identification, to distinguish it from other AstraZeneca inhaler products.
Symbicort Turbohaler is available in packs containing 1 inhaler with 30 doses or in packs containing 1, 2, 3, 10 or 18 inhalers with 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
Italy
Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden
or
AstraZeneca GmbH
Wedel (Germany)
or
AstraZeneca UK Limited
Macclesfield, Cheshire (United Kingdom)
This medicinal product is authorised in the Member States of the European Economic Area under 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 in the Package Leaflet
and on the outer carton with a smartphone. QR code area
The same information is also available at
the following URL:
www.turbohaler.it

Package leaflet: Information for the user

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

Budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using 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 Symbicort Turbohaler is and what it is used for

Symbicort Turbohaler is an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called "corticosteroids". It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting β₂-adrenergic agonists” or “bronchodilators”. It works by relaxing the muscles in the airways, making breathing easier.

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 occurring.
• 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 symptoms of severe COPD in adults. COPD is a chronic lung disease, 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), i.e. lactose (which contains small amounts of milk proteins).

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

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat, very fast pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low potassium levels in the blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: using this medicine without a medical need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Symbicort Turbohaler
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol for hypertension), including eye drops (such as timolol for glaucoma).
• Medicines for rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used to treat hypertension.
• Oral steroids (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” (such as 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 Turbohaler.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

Pregnancy, breast-feeding and fertility

• If you are pregnant or planning a pregnancy, consult your doctor before taking Symbicort Turbohaler – do not take Symbicort Turbohaler unless instructed by your doctor.
• If you become pregnant while being treated with Symbicort Turbohaler, do not stop using Symbicort Turbohaler but contact your doctor immediately.
• If you are breast-feeding, inform your doctor before taking Symbicort Turbohaler.

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

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain 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 which may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you currently have no symptoms of asthma or COPD.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to review your symptoms periodically.

If you have taken oral steroids 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 oral steroids for a long period, your doctor may require you to have periodic blood tests. When reducing the dose of oral steroids, you may feel generally unwell despite improvement in your respiratory symptoms. You might experience symptoms such as nasal congestion and rhinorrhea (runny nose), muscle weakness or joint pain, or skin rash (eczema). If any of these symptoms concern you, or if you develop headache, fatigue, nausea, or vomiting, contact your doctor immediately. You may need to take another medicine if you have allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or discontinuing treatment with Symbicort Turbohaler. Your doctor may consider adding oral steroids to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

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

• Your breathing worsens or you wake up frequently at night due to asthma.
• You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual. These signs may indicate that your asthma or COPD is not adequately controlled and that you may need different or additional treatment immediately.

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 daily.
• Your doctor may increase this dose to 2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.

Adolescents (12–17 years of age)

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

A lower strength 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.
Your doctor (or nurse) will help 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 first discussing it with your doctor (or nurse).
Use a separate "reliever inhaler" to treat asthma symptoms when they occur.
Always carry your "reliever inhaler" with you so you can use it when needed. Do not use Symbicort Turbohaler to treat asthma symptoms—use the "reliever inhaler" instead.

Chronic obstructive pulmonary disease (COPD)

• This medicine is intended for use in adults only (18 years of age and over).
• The usual dose is 1 inhalation twice daily. Your doctor may also prescribe other bronchodilator medicines, such as anticholinergics (e.g. tiotropium bromide or ipratropium bromide), for the treatment of COPD.

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

• Unscrew and remove the cap; you may hear a sound.
• Hold Symbicort Turbohaler upright with the red wheel facing downwards.
• Turn the red wheel fully in one direction, then turn it fully in the opposite direction (it does not matter which direction you start with). You will hear a click during this process.
• Repeat this step, 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 sound.
11. Hold Symbicort Turbohaler upright with the red wheel facing downwards.

12. Do not touch the mouthpiece when loading Symbicort Turbohaler. To load a dose, turn the red wheel fully in one direction.

Then turn it fully in the opposite direction (it does not matter which direction you start with). You will hear a click during this process. Your Symbicort Turbohaler is now loaded and ready for use. Only load Symbicort Turbohaler when you are ready to use it.

13. Hold Symbicort Turbohaler away from your mouth. Breathe out gently (do not force the breath). Do not breathe out 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. Remove Symbicort Turbohaler from your mouth. Breathe out gently. The amount of medicine inhaled is very small. This means you may not taste it after inhalation. If you have followed the instructions correctly, you can be sure that you have inhaled the dose and that the medicine is now in your lungs.
16. If you need to take a second inhalation, repeat steps 2 to 6.
17. After use, replace and screw on the cap.

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

Do not attempt to remove or rotate the mouthpiece. It is fixed to Symbicort Turbohaler and must not be removed. Do not use Symbicort Turbohaler if it is damaged or if the mouthpiece has become detached from the device.
As with all inhalers, caregivers of children must ensure that children 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 full.

• The dose indicator displays intervals of 10 doses. Therefore, it does not show each individual dose.
• When a red mark first appears at the edge of the indicator window, approximately 20 doses remain. For the last 10 doses, the background of the dose indicator turns red. When the '0' on the red background reaches 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 a "click" even when Symbicort Turbohaler is empty.
• The sound heard when shaking Symbicort Turbohaler is produced by a desiccant and not by the medicine. Therefore, this sound does not indicate how much medicine remains in the device.
• If, by mistake, you load Symbicort Turbohaler more than once before taking a dose, you will still only receive one dose. However, the dose indicator will count all the doses that were 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 advised by your doctor. Do not exceed the prescribed dose without consulting your doctor.
The most common symptoms that may occur if you use more Symbicort Turbohaler than you should are: tremor, headache, or rapid heartbeat.

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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose. If you have any further questions 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 you experience any of the following, stop using Symbicort Turbohaler and contact your
doctor immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by breathing difficulties (angioedema) and/or sudden fainting sensation. This could indicate an allergic reaction. This side effect is rare and affects fewer than 1 in 1,000 people.
• Sudden wheezing and shortness of breath immediately after using the inhaler. If you experience any of these symptoms, stop using Symbicort Turbohaler immediately and use your "rescue" inhaler. Contact your doctor immediately if you need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 people.

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

• Palpitations (awareness of heartbeat), tremor, or restlessness. If these effects occur, they are usually mild and disappear with continued treatment with Symbicort Turbohaler.
• Oral 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. Inform your doctor if you experience any of the following symptoms while taking Symbicort, as they could indicate a lung infection:
• Fever or chills.
• Increased mucus production or changes in mucus color.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous, or agitated.
• Sleep disturbances.
• Dizziness.
• Nausea (feeling unwell).
• Fast heartbeat.
• Skin bruising.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (constriction of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using it 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as an unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body,
particularly if high doses are used for prolonged periods. 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.
• Effects on the adrenal gland (a small gland near the kidney).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroid tablets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton or label of the inhaler after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Symbicort Turbohaler contains
The active substances 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 containing the medicine. The inhaled powder is white in colour. Each inhaler contains 60 doses and has a white body with a red wheel. The rotating ring features the Braille code number 6 for identification, to distinguish it from other AstraZeneca inhaler products.
Symbicort Turbohaler is available in packs containing 1, 2, 3, 10 or 18 inhalers, each 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
Italy

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden
or
AstraZeneca GmbH
Wedel (Germany)
or
AstraZeneca UK Limited
Macclesfield, Cheshire (United Kingdom)

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

Detailed and up-to-date information on this
product is available by scanning the QR Code
included in the Package Leaflet and on the
outer carton using a smartphone. The same
QR code area
information is also available at the following
URL: www.turbohaler.it

Patient Information Leaflet: Information for the User

Symbicort 160 micrograms/4.5 micrograms/dose, pressurized suspension

for inhalation
budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 Symbicort is and what it is used for

Symbicort is an inhaler used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adult patients aged 18 years and 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 beta-2 adrenergic agonists” or “bronchodilators”. It works by relaxing the muscles in the airways, thereby 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 have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat, very fast pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

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

Other medicines and Symbicort
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform 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 rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as 'water tablets' (such as furosemide), used to treat high blood pressure.
• Oral steroids (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” (such as 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 in doubt, consult your doctor or pharmacist before using Symbicort.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before taking Symbicort – do not use Symbicort unless advised by your doctor.
• If you become pregnant while being treated with Symbicort, do not stop using Symbicort but consult your doctor immediately.
• If you are breastfeeding, inform your doctor before using Symbicort.

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

3. How to use Symbicort

• Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Symbicort every day, even if you currently have no symptoms of COPD.

The usual dose is 2 inhalations twice daily. Symbicort is not recommended in children and adolescents under 18 years of age.
If you are taking steroid tablets for COPD, your doctor may reduce the number of tablets you are taking once you have started using Symbicort. If you have been taking steroid tablets for a long time, your doctor may require you to have periodic blood tests. When reducing the amount of oral steroids, you may feel generally unwell despite improvement in your respiratory symptoms. 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 concern you, or if you develop symptoms such as headache, fatigue, nausea (feeling unwell), or vomiting (being unwell), contact your doctor immediately. You may need to take another medicine for allergic or arthritic symptoms. Ask your doctor if you are unsure whether to continue Symbicort treatment.
Your doctor may consider adding oral steroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

Important information about COPD symptoms
If you notice the onset of breathlessness or wheezing while using Symbicort, you must continue using it but consult your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:

• Your breathing worsens or you wake up frequently at night due to breathlessness.
• You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual. These signs may indicate that your COPD is not adequately controlled and that different or additional treatment may be urgently required.

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

Information about Symbicort

• Before starting to use Symbicort, remove it from the aluminium foil pouch. Discard the pouch and the desiccant contained inside the pouch. Do not use the inhaler if the desiccant has leaked out of the packaging.
• After removing the inhaler from the aluminium foil pouch, it must be used within 3 months. Record the date (3 months from opening the pouch) on the label of the inhaler to remind yourself when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will be pre-assembled when you first receive it. Do not disassemble it. If the canister becomes loose, reinsert it into the inhaler and continue using the inhaler.

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

• When using a new Symbicort inhaler for the first time.
• If you have not used it for more than 7 days.
• If it has been dropped on the floor. 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 gently pressing the side protrusions. The tab on the mouthpiece cap will remain attached to the inhaler.
  3. Hold the inhaler upright (using one or both hands). Then press the dose indicator (on the top of the inhaler) to release one spray into the air. You may use one or both hands, as shown in the images.

4. Lift your finger(s) off the dose indicator.
5. Wait 10 seconds, shake the inhaler well again, then repeat steps 3 and 4.
6. The inhaler is now 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 gently pressing the side protrusions. Check that the mouthpiece is not blocked.

3. Hold the inhaler upright (using one or both hands). Breathe out slowly.
4. Gently place the mouthpiece between your teeth. Close your lips around it.
5. Begin to inhale slowly and deeply through your mouth. At the same time, press firmly on the dose indicator (on the top of the inhaler) to release one spray. Continue inhaling for a few seconds after pressing the dose indicator. Inhaling at the same time as activating the inhaler ensures that the medicine reaches your lungs.
6. Hold your breath for 10 seconds or as long as comfortable.
7. Before exhaling, remove your finger from the dose indicator and remove the mouthpiece from your mouth. Keep the inhaler upright.
8. Then breathe out slowly. To take a second 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 doses and spit the water out.

Use of a spacer device
Your doctor, nurse, or pharmacist may recommend using a spacer device (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the instructions provided in the leaflet accompanying the spacer device.

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 on the top of the inhaler, shows the number of sprays (doses) remaining in Symbicort. It indicates 120 sprays when full.

• With each inhalation or spray released into the air, the arrow moves downward toward zero ('0').
• When the arrow first enters the yellow zone, approximately 20 sprays remain.

• When the arrow reaches '0', you must stop using Symbicort. The inhaler may still appear to work and release a spray, but 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 prescribed, 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Symbicort
You must consult your doctor or pharmacist before stopping treatment with Symbicort.
If you stop using Symbicort, signs and symptoms of COPD may worsen.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop using Symbicort immediately and contact your
doctor without delay:

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

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

• Palpitations (awareness of heartbeat), tremor or restlessness. If these effects occur, they are usually mild and tend to disappear with continued treatment with Symbicort.
• Oral candidiasis (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. Inform your doctor if you experience any of the following symptoms while taking Symbicort, as they may indicate a lung infection:
  • Fever or chills.
  • Increased mucus production, changes in mucus colour.
  • Worsening cough or increased breathlessness.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (narrowing 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.
• Behavioural changes, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body,
particularly if high doses are used for prolonged periods. 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).

These effects are much less likely to occur with inhaled corticosteroids than with oral
corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor,
pharmacist or nurse. You can also report side effects directly via the national reporting system
at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Symbicort

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

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

6. Package contents and other information

What Symbicort contains
The active substances are budesonide and formoterol fumarate dihydrate. Each spray (dose)
contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
The other ingredients are norflurane (HFA 227), povidone and macrogol. This inhaler does not
contain CFCs.
Description of the appearance of Symbicort and contents of the pack
Symbicort consists of an inhaler containing the medicinal product. The pressurised canister,
equipped with a dose indicator, contains a white inhalation suspension. The canister is inserted
into a red plastic actuator which includes a white plastic mouthpiece and an integrated grey
protective cap. Each inhaler contains 120 sprays (doses) after it has been prepared for use. Each
inhaler is individually packed in an aluminium foil pouch containing a desiccant.
Symbicort, 160 micrograms/4.5 micrograms/dose, pressurised inhalation suspension
(Budesonide/Formoterol fumarate dihydrate) is available in packs containing one inhaler.
Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080
Italy
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 names:

Patient Information Leaflet: Information for the user

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

Budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 Symbicort Turbohaler is and what it is used for

Symbicort Turbohaler is an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called “corticosteroids”. It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting β₂-adrenoceptor agonists” or “bronchodilators”. It works by relaxing the muscles in the airways, making it easier to breathe.

Asthma
Your doctor will prescribe two inhalers: Symbicort Turbohaler and a separate “reliever inhaler” to be used as needed.

• Use Symbicort Turbohaler every day. This will help prevent asthma symptoms from occurring.
• 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 may also be used to treat symptoms of severe COPD in adults.
COPD is a chronic lung airway disease, 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), i.e. lactose (which contains small amounts of milk proteins).

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

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat, very fast pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low potassium levels in the blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Symbicort Turbohaler
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol for hypertension), including eye drops (such as timolol for glaucoma).
• Medicines for rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used to treat hypertension.
• Oral steroids (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptiline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as 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 any of the above apply to you, or if you are in any doubt, consult your doctor or pharmacist before using Symbicort Turbohaler.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

Pregnancy, breast-feeding and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before taking Symbicort Turbohaler – do not take Symbicort Turbohaler unless advised by your doctor.
• If you become pregnant while being treated with Symbicort Turbohaler, do not stop using Symbicort Turbohaler but consult your doctor immediately.
• If you are breast-feeding, inform your doctor before taking Symbicort Turbohaler.

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

Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain 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 which may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
• It is important to use Symbicort Turbohaler every day, even if you currently have no asthma or COPD symptoms.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to check your symptoms periodically.

If you have been taking steroid tablets 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 steroid tablets for a long period, your doctor may require you to have periodic blood tests. When reducing the amount of oral steroids, you may feel generally unwell even though your respiratory symptoms may have improved. You might experience symptoms such as nasal congestion and rhinorrhea (runny nose), muscle weakness or joint pain, and skin rash (eczema). If any of these symptoms concern you, or if you develop symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. You may need to take another medicine if you have allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or discontinuing treatment with Symbicort Turbohaler.
Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

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

• Your breathing worsens or you wake up frequently at night due to asthma.
• You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual. These signs may indicate that your asthma or COPD is not adequately controlled and that you may need different or additional treatment immediately.

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 daily.
• Your doctor may increase this dose to 2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.

Adolescents (12–17 years of age)

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

A lower strength Symbicort Turbohaler is available for children aged 6 to 11 years.
Use of Symbicort Turbohaler is not recommended in children under 6 years of age.
Your doctor (or nurse) will help 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 first discussing it with your doctor (or nurse).
Use a separate "reliever inhaler" to treat asthma symptoms when they occur.
Always carry your "reliever inhaler" with you so you can use it when needed. Do not use Symbicort Turbohaler to treat asthma symptoms—use your "reliever inhaler" instead.

Chronic obstructive pulmonary disease (COPD)

• This medicine is intended for use in adults only (18 years of age and over).
• The usual dose is 1 inhalation twice daily. Your doctor may also prescribe other bronchodilator medicines, such as anticholinergics (e.g., tiotropium bromide or ipratropium bromide), for the treatment of COPD.

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

• Unscrew and remove the cap; you may hear a sound.
• Hold the Symbicort Turbohaler upright with the red wheel facing downwards.
• Turn the red wheel fully in one direction, then turn it fully in the opposite direction (it does not matter which direction you start in). You will hear a click during this process.
• Repeat this step, turning the red wheel in both directions.
• The 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 sound.
20. Hold the Symbicort Turbohaler upright with the red wheel facing downwards.

21. Do not touch the mouthpiece when loading the Symbicort Turbohaler. To load a dose, turn the red wheel fully in one direction, then fully in the opposite direction (it does not matter which direction you start in). You will hear a click. Your Symbicort Turbohaler is now loaded and ready for use. Only load the Symbicort Turbohaler when you are ready to use it.

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

24. Remove the Symbicort Turbohaler from your mouth. Breathe out gently. The amount of medicine inhaled is very small, which means you may not taste it after inhalation. If you have followed the instructions correctly, you can be sure that you have inhaled the dose and that the medicine is now in your lungs.
25. If you need to take a second inhalation, repeat steps 2 to 6.
26. After use, replace the cap and screw it back on securely.

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

Do not attempt to remove or rotate the mouthpiece. It is fixed to the Symbicort Turbohaler and must not be removed. Do not use the Symbicort Turbohaler if it is damaged or if the mouthpiece has become detached.
As with all inhalers, caregivers of children must ensure that children 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 the Symbicort Turbohaler, starting from 60 doses when full.

• The dose indicator displays doses in increments of 10. Therefore, it does not show every single dose.
• When the red mark first appears at the edge of the indicator window, approximately 20 doses remain. For the last 10 doses, the background of the dose indicator turns red. When the '0' on the red background reaches the middle of the window, you should start using a new Symbicort Turbohaler.

Note:

• You may still be able to turn the red wheel and hear a "click" even when the Symbicort Turbohaler is empty.
• The sound heard when shaking the Symbicort Turbohaler is caused by a drying agent, not the medicine. Therefore, this sound does not indicate how much medicine remains in the device.
• If you accidentally load the Symbicort Turbohaler more than once before inhaling, you will still only inhale one dose. However, the dose counter will record all the doses that were 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 advised by your doctor. Do not exceed the prescribed dose without consulting your doctor.
The most common symptoms that may occur if you use more Symbicort Turbohaler than prescribed are: tremor, headache, or rapid heartbeat.

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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop using Symbicort Turbohaler and contact your
doctor immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden fainting sensation. This could indicate an allergic reaction. This side effect is rare and affects fewer than 1 in 1,000 people.
• Sudden wheezing and shortness of breath immediately after using the inhaler. If you experience any of these symptoms, stop using Symbicort Turbohaler immediately and use your “as-needed” inhaler instead. Contact your doctor immediately if you need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 people.

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

• Palpitations (awareness of heartbeat), tremor, or restlessness. If these effects occur, they are usually mild and tend to disappear with continued use of Symbicort Turbohaler.
• Oral 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. Inform your doctor if you experience any of the following symptoms while taking Symbicort, as they could indicate a lung infection:
  • Fever or chills.
  • Increased mucus production or change in mucus color.
  • Worsening cough or increased breathing difficulty.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous, or agitated.
• Sleep disturbances.
• Dizziness.
• Nausea (feeling unwell).
• Fast heartbeat.
• Skin bruising.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Symbicort Turbohaler, stop using it 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as an unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body,
particularly if high doses are used for prolonged periods. These effects may 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).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton or on the label of the inhaler after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• 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.

6. Package contents and other information

What Symbicort Turbohaler contains
The active substances 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 pack contents
Symbicort Turbohaler consists of an inhaler containing the medicinal product. The inhaled powder
is white in colour. Each inhaler contains 60 doses and has a white body and a red rotating wheel. The rotating ring bears the Braille code number 6 for identification, to distinguish it from other AstraZeneca inhaler products.
Symbicort Turbohaler is available in packs containing 1, 2, 3, 10 or 18 inhalers
each 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
Italy

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje
Sweden
or
AstraZeneca GmbH
Wedel (Germany)
or
AstraZeneca UK Limited
Macclesfield, Cheshire (United Kingdom)

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

Detailed and up-to-date information about this
product is available by scanning the QR Code
included in the Package Leaflet and on the
outer carton using a smartphone. The same
Area QR code
information is also available at the following
URL: www.turbohaler.it

Package leaflet: Information for the user

Symbicort 160 micrograms/4.5 micrograms/dose, pressurized suspension

for inhalation
budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 Symbicort is and what it is used for

Symbicort is an inhaler used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adult patients aged 18 years and 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 beta-2 adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, thereby making breathing easier.

This medicine must 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 have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat, very fast pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For those engaged in sports: using this medicine without a medical need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
Symbicort is not recommended for children and adolescents under 18 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, inform 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 rapid 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.
• Oral steroids (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” (such as 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 inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.
Pregnancy, breastfeeding, and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before taking Symbicort – do not use Symbicort unless advised by your doctor.
• If you become pregnant while being treated with Symbicort, do not stop using Symbicort but contact your doctor immediately.
• If you are breastfeeding, inform your doctor before using Symbicort.

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

5. How to use Symbicort

• Always use this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
• It is important to use Symbicort every day, even if you do not currently have COPD symptoms.

The usual dose is 2 inhalations twice daily. Symbicort is not recommended for children and adolescents under 18 years of age.
If you are taking oral steroid tablets for COPD, 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 time, your doctor may require you to have periodic blood tests. As you reduce the amount of oral steroids, you may feel generally unwell despite improvement in your breathing symptoms. You might experience symptoms such as nasal congestion and rhinorrhea, weakness, muscle or joint pain, or skin rash (eczema). If any of these symptoms concern you, or if you develop symptoms such as headache, fatigue, nausea (feeling unwell), or vomiting (being unwell), contact your doctor immediately. You may need to take another medicine for allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or discontinuing treatment with Symbicort.
Your doctor may consider adding oral steroids to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

Important information about COPD symptoms
If you notice the onset of breathlessness or wheezing while using Symbicort, continue using it but consult your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:

• Your breathing worsens or you wake up frequently at night due to breathlessness.
• You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual. These signs may mean that your COPD is not adequately controlled and that you may need different or additional treatment immediately.

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

Information about Symbicort

• Before starting to use Symbicort, remove it from the aluminium foil pouch. Discard the pouch and the desiccant contained within it. If the desiccant has leaked out of the packaging, do not use the inhaler.
• After removing the inhaler from the aluminium foil pouch, you must use it within 3 months. Note this on the inhaler label (3 months from opening the pouch) to remind yourself when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will already be assembled when you first receive it. Do not disassemble it. If the canister becomes loose, reinsert it into the inhaler and continue using the inhaler.

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

• When using a new Symbicort inhaler for the first time.
• If you have not used it for more than 7 days.
• If it has been dropped. 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 gently pressing the protrusions on the sides. The tab on the mouthpiece cap will remain attached to the inhaler. 9. Hold the inhaler upright. Then press the dose indicator (on the top of the inhaler) to release one spray into the air. You may use one or both hands, as shown in the images.

10. Lift your finger(s) off the dose indicator.
11. Wait 10 seconds, shake the inhaler well, and then repeat steps 3 and 4.
12. The inhaler is now 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 gently pressing the protrusions on the sides. Check that the mouthpiece is not blocked.

13. Hold the inhaler upright (using one or both hands). Breathe out slowly.
14. Gently place the mouthpiece between your teeth. Close your lips around it.
15. Begin to inhale slowly and deeply through your mouth. At the same time, press firmly on the dose indicator (on the top of the inhaler) to release one spray. Continue inhaling for a few seconds after pressing the dose indicator. Inhaling at the same time as activating the inhaler ensures that the medicine reaches your lungs.
16. Hold your breath for 10 seconds or as long as comfortable.
17. Before exhaling, remove your finger from the dose indicator and take the mouthpiece out of your mouth. Keep the inhaler upright.
18. Then breathe out slowly. To take a second 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 doses and spit it out.

Using a spacer device
Your doctor, nurse, or pharmacist may recommend using a spacer device (e.g., AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the instructions provided in the leaflet accompanying the spacer device.

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 any other liquids, and do not remove the canister from the inhaler.

How do I know when to replace Symbicort?

• The dose indicator, located on the top of the inhaler, shows the number of sprays (actuations) remaining in Symbicort. It indicates 120 sprays when full.

• With each inhalation or spray released into the air, the arrow moves downward toward zero ('0').
• When the arrow first enters the yellow zone, approximately 20 sprays remain.

• When the arrow reaches '0', you must stop using Symbicort. The inhaler may still appear full and seem to work, but if you continue using 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 prescribed, 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you stop using Symbicort
You must consult your doctor or pharmacist before stopping treatment with Symbicort. If you discontinue treatment with Symbicort, your COPD signs and symptoms may worsen.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following, stop using Symbicort immediately and contact your
doctor straight away:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing), skin redness or hives accompanied by breathing difficulties (angioedema) and/or sudden fainting. These may indicate you are having an allergic reaction. This side effect is rare and affects fewer than 1 in 1,000 people.
• Sudden wheezing or shortness of breath immediately after using the inhaler. If you experience any of these symptoms, stop using Symbicort immediately and use your "reliever" inhaler instead. Contact your doctor straight away, as you may need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 people.

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

• Palpitations (awareness of heartbeat), tremor or restlessness. If these effects occur, they are usually mild and tend to disappear with continued use of Symbicort.
• Oral candidiasis (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. Inform your doctor if you experience any of the following symptoms while taking Symbicort, as they may be signs of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus colour.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (narrowing 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as an unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body,
particularly if high doses are used for prolonged periods. 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 velocity in children and adolescents.
• Effects 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
corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor,
pharmacist or nurse. You can also report side effects directly via 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 stated on the label, the carton, or the aluminium foil wrapper after Exp. The expiry date refers to the last day of that month.
• As with many other pressurised inhalers, the effect of this medicine may be reduced when the canister is cold. For best results, the medicine should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• After removing the inhaler from the aluminium foil wrapper, it must be used within 3 months. Record the date of first use (3 months from opening the wrapper) on the inhaler label to remind yourself when to stop using the inhaler.
• After each use of the inhaler, always firmly replace the mouthpiece cap and snap it into place.
• Do not dispose of any medicine 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 pierce the canister. Do not break, pierce, or burn the canister, even when it appears to be empty.

6. Package contents and other information

What Symbicort contains
The active substances are budesonide and formoterol fumarate dihydrate. Each spray (dose)
contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
The other ingredients are norflurane (HFA 227), povidone and macrogol. This inhaler does
not contain CFCs.
Description of the appearance of Symbicort and contents of the pack
Symbicort consists of an inhaler containing the medicine. The pressurised canister, equipped with a dose indicator, contains a white inhalation suspension. 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 (doses) after it has been prepared for use. Each inhaler is individually packed in an aluminium foil pouch containing a desiccant.
Symbicort, 160 micrograms/4.5 micrograms/dose, pressurised inhalation suspension (Budesonide/Formoterol fumarate dihydrate) is available in packs containing one inhaler.
Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080
Italy
Manufacturer
AstraZeneca Dunkerque Production
224 avenue de la Dordogne
59640 DUNKERQUE
France
This medicinal product is authorised in the European Economic Area Member States
under the following names:

Package leaflet: Information for the user

Symbicort 80 micrograms/2.25 micrograms/dose pressurized suspension for

inhalation,
budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 using 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 Symbicort is and what it is used for

What Symbicort is
Symbicort is an inhaler used to treat asthma in adults and adolescents aged 12 to 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 beta2-adrenergic agonists" or "bronchodilators".

What Symbicort is used to treat
Symbicort is used to treat asthma and may be prescribed either as monotherapy or together 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 the onset of asthma symptoms.
• They use their "reliever inhaler" when they experience asthma symptoms, to help them breathe more easily.

Some people are prescribed Symbicort as their only asthma inhaler.

• These people use Symbicort every day. This helps prevent the onset of asthma symptoms.
• They also use Symbicort when they need extra doses to relieve asthma symptoms and, if agreed with their doctor, to prevent the onset of asthma symptoms (for example, during
  physical exercise or exposure to allergens). These people do not require
  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, thus making breathing easier.

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 have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat, very rapid pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances while using Symbicort.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-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, inform 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 rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as 'water tablets' (such as furosemide), used to treat high blood pressure.
• Oral steroids (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 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 inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.
Pregnancy and breastfeeding

• If you are pregnant or planning a pregnancy, ask your doctor for advice before taking Symbicort – do not use Symbicort unless instructed by your doctor.
• If you become pregnant while being treated with Symbicort, do not stop using Symbicort but consult your doctor immediately.
• If you are breastfeeding, inform your doctor before taking Symbicort.

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

7. How to use Symbicort

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• It is important to use Symbicort every day, even if you currently have no asthma symptoms.
• Your doctor will want to regularly monitor your asthma symptoms.
• Your doctor may consider adding oral steroid tablets to your usual treatment during periods of stress (e.g., when you have a respiratory infection or before surgery).

Symbicort may be prescribed for asthma either as monotherapy or together with a separate reliever inhaler. You need to take two puffs (actuations) of Symbicort to receive a full dose. The amount of Symbicort to use and when to use it depends on what has been prescribed for you.
a) If you have been prescribed Symbicort and a separate reliever inhaler, read section
“a) Use of Symbicort and a separate reliever inhaler”.
b) If you have been prescribed Symbicort as your only inhaler, read section “b) Use of Symbicort as the sole inhaler for asthma”.

a) Use of Symbicort and a separate “reliever inhaler”
Use Symbicort every day. This helps prevent asthma symptoms from occurring.
Adults (18 years and over)

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

Adolescents (12 to 17 years)

• The usual dose is 2–4 puffs twice daily.
• If your symptoms are well controlled, your doctor may advise you to take the medicine once daily.

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

• Always carry your “reliever inhaler” with you to use when needed.
• Do not use Symbicort to treat asthma symptoms—use your reliever inhaler instead.

b) Use of Symbicort as the sole inhaler for asthma
Use Symbicort in this way only if instructed by your doctor and if you are aged 12 years or older.
Use Symbicort every day. This helps prevent asthma symptoms from occurring. You may 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 your dose to 4 puffs twice daily.
Use Symbicort also as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent the onset of asthma symptoms (e.g., during physical 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 carry your Symbicort inhaler with you for use when needed.
A total daily dose of more than 16 puffs is normally not required. However, your doctor may allow you to take up to 24 puffs per day for a limited period.
If you regularly need to use 16 or more puffs per day, make an appointment to consult your doctor or nurse. Your treatment may need to be adjusted.
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 asthma symptoms; how often you exercise or are exposed to allergens may affect your prescribed treatment.

Symbicort and oral steroids
If you are taking oral steroid tablets for asthma, your doctor may reduce the number of tablets you take once you have started using Symbicort. If you have been taking oral steroids for a long time, your doctor may ask you to have periodic blood tests. When reducing the amount of oral steroids, you may feel generally unwell even though your breathing symptoms may improve. Symptoms may include:

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

Contact your doctor immediately if you experience any of the following:

• headache
• fatigue
• feeling unwell (nausea)
• malaise (vomiting)

If you experience any of the above symptoms, contact your doctor immediately. You may need to take another medicine. Ask your doctor if you have any doubts about continuing or stopping treatment with Symbicort.

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

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

• Your breathing worsens or you wake up frequently at night due to asthma.
• You start experiencing chest tightness in the morning or if chest tightness lasts longer than usual.
• These signs may mean that your asthma is not adequately controlled and you may need immediate different or additional treatment.

Information about Symbicort

• Before starting to use Symbicort, remove it from the aluminium foil pouch. Discard the pouch and the desiccant inside. If the desiccant has escaped from the packaging, do not use the inhaler.

• After removing the inhaler from the aluminium foil pouch, you must use it within 3 months. Mark the date (3 months from opening the pouch) on the inhaler label to remind yourself when to stop using the inhaler.
• The components of the inhaler are shown in the image. The inhaler will be pre-assembled when you first receive it. If the canister becomes loose, reinsert it into the inhaler and continue using the inhaler.

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

• When using a new Symbicort inhaler for the first time.
• If you have not used it for more than 7 days.
• If it has been dropped.

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 gently pressing the side protrusions. The tab on the mouthpiece cap will remain attached to the inhaler.
3. Hold the inhaler upright. Then press the dose indicator

(located at the top of the inhaler) to release one puff into the air. You may use one or both hands, as shown in the images.

4. Lift your finger off the dose indicator.
5. Wait 10 seconds, shake well, and then repeat steps 3 and 4.
6. The inhaler is now 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 gently pressing the side protrusions. Check that the mouthpiece is not blocked.
3. Hold the inhaler upright (using one or both hands). Breathe out slowly.

4. Place the mouthpiece gently between your teeth. Close your lips around it.
5. Start to inhale slowly and deeply through your mouth. At the same time, press firmly on the dose indicator (at the top of the inhaler) to release one puff. Continue inhaling for a few seconds after pressing the dose indicator. Inhaling at the same time as actuating the inhaler ensures the medicine reaches your lungs.
6. Hold your breath for 10 seconds or as long as comfortable.
7. Before exhaling, remove your finger from the dose indicator and take the mouthpiece out of your mouth. Keep the inhaler upright.
8. Then breathe out slowly. To take a second 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 doses and spit it out.

Use of a spacer device
Your doctor, nurse, or pharmacist may recommend using a spacer device (e.g., AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the instructions provided in the leaflet supplied with the spacer device.

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 to know when to replace Symbicort

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

• With each inhalation or puff released into the air, the arrow moves downward toward zero (“0”).
• When the arrow first enters the yellow zone, approximately 20 puffs remain.

• When the arrow reaches “0”, you must stop using Symbicort. The inhaler may appear not empty and may still seem to work. 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 advised 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.
Possible effects include: 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Symbicort
You must consult your doctor or pharmacist before stopping treatment with Symbicort.
If you stop treatment with Symbicort, your asthma symptoms may worsen.
If you have any doubts about using this medicine, consult 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 and contact your doctor
immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing), skin redness or hives accompanied by breathing difficulties (angioedema) and/or sudden fainting sensation. This could indicate you are experiencing an allergic reaction. This side effect is rare and affects fewer than 1 in 1,000 people.
• Sudden onset of wheezing or shortness of breath immediately after using the Symbicort inhaler. If you experience any of these symptoms, stop using Symbicort immediately and use your “as-needed” inhaler instead. Contact your doctor immediately, as you may need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 people.

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

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

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervousness or agitation.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling unwell).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If wheezing occurs 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if high doses are used for prolonged periods. 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 velocity in children and adolescents.
• Effects on the adrenal gland (a small gland near the kidney). The occurrence of these effects is much less likely with inhaled corticosteroids than with corticosteroid tablets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the canister label, on the carton, or on the aluminium foil after "Exp.". The expiry date refers to the last day of that month.
• After removing the inhaler from the aluminium foil pouch, it must be used within 3 months. Record the date of first use (3 months from opening the pouch) on the label of the inhaler to remind yourself when to stop using the inhaler.
• As with many other pressurised inhalation medicines, the effect of this medicine may be reduced when the canister is cold. For best results, the 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 cap and snap it back into place.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

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

6. Package contents and other information

What Symbicort contains
The active substances 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 the appearance of Symbicort and contents of the pack
Symbicort consists of an inhaler containing the medicinal product. The medicinal product, a
white-coloured 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 foil pouch containing a desiccant.

Symbicort 80 microgram/2.25 microgram/dose pressurised inhalation suspension (Budesonide/Formoterol fumarate dihydrate) is available in packs containing 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
Italy

Manufacturer
AstraZeneca Dunkerque Production (AZDP)
224 Avenue de la Dordogne
Dunkerque, 59640
France

This medicinal product is authorised in the European Economic Area (EEA) Member States
under the following names:
Austria: Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation Druckgasinhalation, Suspension;
Belgium: Symbicort 80 microgram/2,25 microgram/inhalatie, aërosol, suspensie; Symbicort 80 microgrammes/2,25 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé; Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation, Druckgasinhalation, Suspension;
Bulgaria: Симбикорт 80 микрограма/2,25 микрограма/впръскване Суспензия под налягане за инхалация;
Croatia: Symbicort 80 mikrograma/2,25 mikrograma po potisku, stlačeni inhalat, suspenzija;
Cyprus: Symbicort 80 μικρογραμμάρια/2,25 μικρογραμμάρια/ψεκασμό;
Czech Republic: Symbicort 80 micrograms/2,25 micrograms/inhalation, suspension in pMDI;
Denmark: Symbicort 80 mikrogram/2.25 mikrogram/inhalation;
Estonia: Symbicort;
Finland: Symbicort 80 mikrog/2.25 mikrog/inhalaatio;
France: Symbicort 100/3 microgrammes par inhalation, suspension pour inhalation en flacon préssurisé;
Greece: Symbicort 80 μικρογραμμάρια/2,25 μικρογραμμάρια/ψεκασμό;
Hungary: Symbicort 2,25 mikrogramm/80 mikrogramm/adag túlnyomásos inhalációs szuszpenzió;
Iceland: Symbicort 80 míkrógrömm/2,25 míkrógrömm/inhalation;
Italy: Symbicort;
Latvia: Symbicort 80 mikrogrami/2.25 mikrogrami/inhalācijā, izsmidzinājumā, aerosols inhalācijām zem spiediena;
Lithuania: Symbicort 80 mikrogramo/2,25 mikrogramo/išpurškime suslėgtoji įkvepiamoji suspensija;
Luxembourg: Symbicort 80 microgrammes/2,25 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé;
Malta: Symbicort 100 micrograms/3 micrograms/inhalation;
Netherlands: Symbicort aërosol 100/3, 100 microgram/3 microgram per dosis, aërosol, suspensie;
Norway: Symbicort 80 mikrogram/2.25 mikrogram/inhalasjon;
Poland: Symbicort;
Portugal: Symbicort 80 microgramas/2,25 microgramas/inalação Suspensão pressurizada para inalação;
Slovakia: Symbicort 80 mikrogramov/2,25 mikrogramov/inhalačná dávka, inhalačná suspenzia v tlakovom obale;
Slovenia: Symbicort 80 mikrogramov/2,25 mikrograma na vdih, inhalacijska suspenzija pod tlakom;
Spain: Symbicort 80 microgramos/2,25 microgramos/inhalación suspensión para inhalación en envase a presión;
Sweden: Symbicort 80 mikrogram/2.25 mikrogram/inhalation;
United Kingdom: Symbicort 100 micrograms/3 micrograms actuation pressurised inhalation, suspension