Symbicort Mite

Patient Information Leaflet: Information for the User

SymbicortMite Turbohaler 80 micrograms/4.5 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

SymbicortMite Turbohaler is an inhaler used to treat asthma in adults, adolescents, and children aged over 6 years. 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 beta-adrenoceptor agonists" or "bronchodilators". It works by relaxing the muscles in the airways, making breathing easier.

This medicine is not suitable for people with severe asthma. It may be prescribed for asthma in two different ways.
a) Some people are prescribed two asthma inhalers: SymbicortMite Turbohaler and a separate
"reliever inhaler".

• They use SymbicortMite Turbohaler every day to help prevent asthma symptoms from occurring.
• They use the "reliever inhaler" when asthma symptoms occur, to help relieve breathing difficulties.

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

• They use SymbicortMite Turbohaler every day to help prevent asthma symptoms from occurring.
• They also use SymbicortMite Turbohaler when they need extra doses to relieve asthma symptoms, to help relieve breathing difficulties. They do not need a separate inhaler for this purpose.

2. What you need to know before using SymbicortMite Turbohaler

Do not use SymbicortMite 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 SymbicortMite Turbohaler if:

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (including 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.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and SymbicortMite Turbohaler
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 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 in doubt, consult your doctor or pharmacist before using SymbicortMite 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 SymbicortMite Turbohaler – do not take SymbicortMite Turbohaler unless advised by your doctor.
• If you become pregnant while being treated with SymbicortMite Turbohaler, do not stop using SymbicortMite Turbohaler but consult your doctor immediately.
• If you are breastfeeding, inform your doctor before taking SymbicortMite Turbohaler.

Driving and using machines
SymbicortMite Turbohaler has no effect or a negligible effect on the ability to drive or operate tools or machinery.
SymbicortMite Turbohaler contains lactose
SymbicortMite 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 is generally not expected to 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 SymbicortMite Turbohaler

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

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of
tablets you are taking once you have started using SymbicortMite Turbohaler. If you have taken steroid
tablets for a long period, your doctor may require you to have periodic blood tests. As you reduce the
amount of oral steroids, you may feel generally unwell even though your respiratory symptoms may
improve. You might experience symptoms such as nasal congestion and rhinorrhea (runny nose),
muscle or joint weakness or pain, or 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 if you have allergic or arthritic symptoms.
Ask your doctor if you have any doubts about continuing treatment with SymbicortMite
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 symptoms
If you notice the onset of breathlessness or wheezing while using SymbicortMite Turbohaler, 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 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 is not adequately controlled and that immediate different or additional treatment may be required.

Asthma
SymbicortMite Turbohaler may be prescribed for asthma in two different ways. The amount of
SymbicortMite Turbohaler to use and when to use it depends on your doctor’s prescription.
a) If you have been prescribed SymbicortMite Turbohaler and a separate reliever inhaler, read section
“a) Use of SymbicortMite Turbohaler and a separate reliever inhaler”.
b) If you have been prescribed SymbicortMite Turbohaler as the only inhaler, read section “b) Use of
SymbicortMite Turbohaler as the only inhaler for asthma”.

a) Use of SymbicortMite Turbohaler and a separate reliever inhaler
Use SymbicortMite 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)

• 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.

Children (6–11 years)

• The usual dose is 2 inhalations twice daily.

The use of SymbicortMite 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 the 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
SymbicortMite Turbohaler to treat asthma symptoms—use the reliever inhaler instead.

b) Use of SymbicortMite Turbohaler as the only inhaler for asthma
Use SymbicortMite Turbohaler in this way only on your doctor’s advice and if you are over 12 years of
age.
Use SymbicortMite 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.

Also use SymbicortMite Turbohaler as a “reliever inhaler” to treat asthma symptoms when they
occur.

• 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 SymbicortMite Turbohaler with you to 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 SymbicortMite Turbohaler as described in this
leaflet. However, do not use SymbicortMite Turbohaler immediately before exercise to prevent the
onset of symptoms.

How to prepare SymbicortMite Turbohaler
Before using a new SymbicortMite Turbohaler for the first time, it must be prepared for use as
follows:

• Unscrew and remove the cap; you may hear a sound.
• Hold SymbicortMite Turbohaler vertically 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). During this process, you will hear a click. It does not matter whether the click occurs on the first or second turn.
• Repeat this process, turning the red wheel in both directions.
• SymbicortMite Turbohaler is now primed and 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 SymbicortMite Turbohaler vertically with the red wheel facing downwards.

3. Do not touch the mouthpiece when priming SymbicortMite Turbohaler. To load a dose into the inhaler, 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). During this process, you will hear a click. It does not matter whether the click occurs on the first or second turn. SymbicortMite Turbohaler is now loaded and ready for use.
Only prime SymbicortMite Turbohaler when you are about to use it.

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

6. Remove SymbicortMite 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 you have inhaled the dose, and the medicine is now in your lungs.
7. If you need to take a second inhalation, repeat steps 2 to 6.
8. After use, 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 SymbicortMite Turbohaler and must not be removed. Do not use the inhaler if it is damaged or if the mouthpiece has become detached from SymbicortMite Turbohaler.
As with all inhalers, caregivers responsible for children must ensure that children prescribed
SymbicortMite Turbohaler use the correct inhalation technique as described above.

How to clean SymbicortMite 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 SymbicortMite Turbohaler, starting from 60 or 120 doses when full.

• The dose indicator shows intervals of 10 doses. Therefore, it does not indicate 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 SymbicortMite Turbohaler.

Note:

• You will still be able to turn the red wheel and hear a "click" even when SymbicortMite Turbohaler is empty.
• The sound heard when shaking SymbicortMite Turbohaler is produced by a desiccant and not by the medicine. Therefore, this sound does not indicate how much medicine remains in the SymbicortMite Turbohaler.
• If, by mistake, you prime SymbicortMite Turbohaler more than once before taking a dose, you will still only inhale one dose. However, the dose indicator will count all primed doses.

If you use more SymbicortMite 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 SymbicortMite Turbohaler than you
should are: tremor, headache, or rapid heartbeat.

If you forget to use SymbicortMite 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop using SymbicortMite 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, which 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 your inhaler. If you experience any of these symptoms, stop using SymbicortMite Turbohaler immediately and use your “as-needed” 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 use of SymbicortMite Turbohaler.
• Oral thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using SymbicortMite Turbohaler.
• Mild sore throat, cough, and hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervousness, or agitation.
• 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 airway muscles, causing wheezing). If you experience wheezing immediately after using SymbicortMite Turbohaler, stop using SymbicortMite Turbohaler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

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

• Depression.
• Behavioural changes, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as 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 eye's lens).
• 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SymbicortMite 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 inhaler label 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 SymbicortMite Turbohaler contains
The active substances are budesonide and formoterol. Each inhaled dose contains 80 micrograms of
budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
The excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of SymbicortMite Turbohaler and package contents
SymbicortMite Turbohaler consists of an inhaler containing the medicinal product. The inhalation powder is white in colour. Each inhaler contains 60 or 120 doses and has a white body and a red wheel. The rotating ring bears the Braille code with the number 6 for identification, to differentiate it from other AstraZeneca inhaler products.
SymbicortMite Turbohaler is available in packages containing 1, 2, 3, 10 or 18 inhalers, each containing 60 (or 120) doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AstraZeneca S.p.A.
Viale Decumano 39, 20157 Milan, Italy

Manufacturer
AstraZeneca AB
SE-151 85 Södertälje, Sweden

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

Up-to-date and detailed information on this product is available by scanning the QR Code included on the Patient Information Leaflet and the outer carton using a smartphone. The same information is also available at the following URL: www.turbohaler.it and the AIFA website