Symbicort turbuhaler

Package leaflet: Information for the user

Symbicort Turbuhaler, (160 µg + 4.5 µg)/inhalation dose, inhalation powder
Budesonide + Formoterol fumarate dihydrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, including any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Symbicort Turbuhaler is a medicine delivered via an inhaler, used for the treatment of 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 active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called corticosteroids. It works by reducing and preventing inflammation and swelling in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta2-adrenergic agonists or bronchodilators. It works by relaxing the muscles in the airways, making breathing easier.

Asthma
Symbicort Turbuhaler may be prescribed for asthma treatment in two different ways.
a) Some patients are prescribed two inhaler medicines for asthma: Symbicort Turbuhaler and a separate rescue inhaler.

• Symbicort Turbuhaler is used daily. Regular use helps prevent asthma symptoms.
• A rescue inhaler is used when asthma symptoms occur, to help ease breathing.

b) Some patients are prescribed Symbicort Turbuhaler as the only inhaler medicine for asthma.

• Symbicort Turbuhaler is used daily to help prevent asthma symptoms.
• Symbicort Turbuhaler is also used as needed for additional doses to relieve asthma symptoms and make breathing easier, and, if agreed with your doctor, also to prevent asthma symptoms (for example, during physical exertion or exposure to allergens). These patients do not require a separate rescue inhaler.

Chronic obstructive pulmonary disease (COPD)
Symbicort Turbuhaler may also be used to treat symptoms of COPD in adults. COPD is a chronic lung disease affecting the airways, often caused by cigarette smoking.

2. Important information before using Symbicort Turbuhaler

When not to use Symbicort Turbuhaler:

• if the patient is allergic to budesonide, formoterol, or to any other component of this medicine (listed in section 6) – lactose (which contains small amounts of milk protein).

Warnings and precautions
Before starting treatment with Symbicort Turbuhaler, talk to your doctor or
pharmacist if the patient has:

• diabetes.
• lung infection.
• high blood pressure or a history of heart disease (including heart rhythm disorders, very fast heartbeat, narrowed arteries, or heart failure).
• thyroid or adrenal gland disorders.
• low potassium levels in the blood.
• severe liver function impairment. If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Symbicort Turbuhaler and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any
of the following medicines:

• beta-adrenergic receptor blocking agents (such as atenolol or propranolol, used to treat high blood pressure), including eye drops (such as timolol used in the treatment of glaucoma).
• medicines used for rapid or irregular heartbeat (such as quinidine).
• medicines such as digoxin, commonly used in the treatment of heart failure.
• diuretics (such as furosemide), used to treat high blood pressure.
• oral steroids (such as prednisolone).
• xanthine derivatives (e.g. theophylline or aminophylline). These are medicines commonly used in the treatment of asthma.
• other bronchodilators (such as salbutamol).
• tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• phenothiazine group medicines (such as chlorpromazine and prochlorperazine).
• medicines known as HIV protease inhibitors (e.g. ritonavir) used in the treatment of HIV infection.
• medicines used for infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• medicines used in Parkinson's disease (e.g. levodopa).
• medicines used for thyroid disorders (e.g. levothyroxine).

Patients taking any of the listed medicines or who have any doubts about using
other medicines should contact their doctor or pharmacist before using Symbicort Turbuhaler.
You should also inform your doctor or pharmacist if you are planning to undergo general
anaesthesia in connection with a surgical or dental procedure.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or planning to become pregnant, she should inform her doctor before using Symbicort Turbuhaler; Symbicort Turbuhaler should not be used without medical advice.
• If a patient being treated with Symbicort Turbuhaler becomes pregnant, she should not stop taking Symbicort Turbuhaler but should contact her doctor immediately.
• A breastfeeding patient should talk to her doctor before starting treatment with Symbicort Turbuhaler.

Driving and operating machinery
Symbicort Turbuhaler has no effect or has a negligible effect on the ability to drive
vehicles, use tools, or operate machinery.

Symbicort Turbuhaler contains lactose
Symbicort Turbuhaler contains lactose (a type of sugar). If the patient has been diagnosed with intolerance
to certain sugars, they should talk to their doctor before using this medicine. The amount of lactose
contained in one dose of this medicine usually does not cause symptoms in patients
with lactose intolerance.
Lactose, which is an excipient, contains small amounts of milk protein, which may cause
allergic reactions.

3. How to use Symbicort Turbuhaler

• This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
• It is important to use Symbicort Turbuhaler every day, even if you currently have no symptoms of asthma or COPD.
• If you are using Symbicort Turbuhaler for asthma treatment, your doctor will regularly monitor the severity of your asthma symptoms.

If you are currently taking steroid tablets for asthma or COPD, when starting Symbicort
Turbuhaler your doctor may reduce the number of oral steroid tablets you take. If you have been
taking oral steroids in tablet form for a prolonged period, your doctor may occasionally recommend
blood tests. After reducing the dose of oral steroids, you may feel unwell, and respiratory symptoms
may even worsen. Symptoms such as a stuffy nose, runny nose, weakness, muscle or joint pain,
and rash (skin eruption) may occur. If any of these symptoms concern you, or if you experience
symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately.
Additional medication may be required if you develop symptoms of allergy or joint inflammation.
If you have any doubts about continuing treatment with Symbicort Turbuhaler, you should consult
your doctor.
Your doctor may consider adding oral steroid tablets to your usual treatment during periods of
stress (e.g., chest infection or before surgery).

Important information regarding asthma or COPD symptoms
If you experience shortness of breath or wheezing while using Symbicort Turbuhaler, continue
using the medicine but contact your doctor as soon as possible, as additional treatment may be
necessary.
Contact your doctor immediately if:

• you have difficulty breathing or frequently wake up at night due to asthma attacks.
• you experience chest tightness in the morning upon waking, or chest tightness that lasts longer than usual.
• These symptoms may indicate inadequate control of asthma or COPD, and immediate initiation of alternative or additional treatment may be required.

Asthma
Symbicort Turbuhaler can be used to treat asthma in two different ways. The dose and frequency
of Symbicort Turbuhaler depend on the prescribed method of use.
a) If your doctor has prescribed Symbicort Turbuhaler and an additional separate reliever
inhaler, read the instructions below marked with the symbol “a) Using Symbicort Turbuhaler
and an additional reliever inhaler”.
b) If your doctor has prescribed Symbicort Turbuhaler as the only inhaled medicine, read the
instructions marked with the symbol “b) Using Symbicort Turbuhaler as the only inhaler in
asthma”.

a) Using Symbicort Turbuhaler and an additional reliever inhaler
Use Symbicort Turbuhaler every day. Using Symbicort Turbuhaler helps prevent asthma
symptoms.

Adults (aged 18 years and older)

• The usual dose is 1 or 2 inhalations twice daily.
• Your doctor may increase the dose to 4 inhalations twice daily.
• If symptoms are well controlled, your doctor may recommend taking the medicine once daily.

Adolescents (aged 12 to 17 years)

• The usual dose is 1 or 2 inhalations twice daily.
• If symptoms are well controlled, your doctor may recommend taking the medicine once daily. Symbicort Turbuhaler with a lower strength is available for children aged 6 to 11 years.

Symbicort Turbuhaler is not recommended for use in children under 6 years of age.
During treatment, your doctor will help you manage your asthma appropriately. Your doctor will
determine the lowest dose that controls your asthma symptoms effectively. Do not change the
dose or stop using Symbicort Turbuhaler without consulting your doctor.

If asthma symptoms occur, use the additional reliever inhaler. You should always carry your
additional reliever inhaler with you. Do not use Symbicort Turbuhaler to treat asthma symptoms –
the additional reliever inhaler is intended for this purpose.

b) Using Symbicort Turbuhaler as the only inhaler in asthma
Symbicort Turbuhaler should only be used this way if specifically prescribed by your doctor and
only in individuals aged 12 years and older.
Use Symbicort Turbuhaler every day. This helps prevent asthma symptoms. The medicine can
be taken as follows:

• 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 the dose to 2 inhalations twice daily.
You should also use Symbicort Turbuhaler as a “reliever inhaler” to treat asthma symptoms
and to prevent asthma symptoms (e.g., during physical exertion or 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 your Symbicort Turbuhaler with you and use it as needed.
A total daily dose exceeding 8 inhalations is usually not required. However, your doctor may
prescribe up to 12 inhalations per day for a limited period.
If you regularly require 8 or more inhalations per day, contact your doctor. A change in treatment
may be necessary.
Do not use more than 12 inhalations per day.
If asthma symptoms occur during physical exertion, use Symbicort Turbuhaler as described above.
It is important to discuss with your doctor the use of Symbicort Turbuhaler for preventing asthma
symptoms—how often you engage in physical activity or how frequently you are exposed to allergens,
as this may affect your prescribed treatment.

Chronic obstructive pulmonary disease (COPD)

• For use only in adults (aged 18 years and older).
• The usual dose is 2 inhalations twice daily.

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

Preparing the Symbicort Turbuhaler inhaler for first use
Before the first use of a new Symbicort Turbuhaler inhaler, prepare it as follows:

• Unscrew and remove the cap of the inhaler. You may hear a characteristic rattling sound while doing so.
• Hold the Symbicort Turbuhaler inhaler vertically with the red grip pointing downwards.
• Turn the red grip fully in one direction, then turn it fully in the opposite direction (the starting direction does not matter). You will hear a characteristic sound (click). It does not matter whether the click occurs after the first or second turn.
• Repeat this step by turning the red grip fully in both directions.
• The Symbicort Turbuhaler inhaler is now loaded and ready for use.

Using the inhaler
To inhale, always follow the instructions below:

1. Unscrew and remove the cap of the inhaler. You may hear a characteristic rattling sound.
2. Hold the Symbicort Turbuhaler inhaler vertically, with the red grip pointing downwards.

3. Do not hold the Symbicort Turbuhaler inhaler by the mouthpiece while loading. To load a dose of medicine, turn the red grip fully in one direction.

Then turn the grip fully in the opposite direction (the starting direction does not matter). You will hear a characteristic sound (click). It does not matter whether the click occurs after the first or second turn.
The Symbicort Turbuhaler inhaler is now loaded and ready for use. Load a dose of medicine only immediately before use.

4. Hold the Symbicort Turbuhaler inhaler away from your mouth. Breathe out gently (without force). Do not exhale through the mouthpiece of the Symbicort Turbuhaler inhaler.
5. Place the mouthpiece gently between your teeth. Close your lips around the mouthpiece and inhale as deeply and forcefully as possible through your mouth. Do not chew or bite the mouthpiece.

6. Remove the Symbicort Turbuhaler inhaler from your mouth. Breathe out calmly. The amount of medicine in a single inhalation dose is very small, so you may not taste the medicine after inhalation. However, if you follow the instructions correctly, you can be sure that the dose has been delivered and the medicine has reached your lungs.
7. If a second inhalation is prescribed, repeat steps 2 to 6.
8. After using the inhaler, replace the cap and close it tightly.

9. Rinse your mouth with water after taking the morning and/or evening dose. Do not swallow the water.

Do not remove or rotate the mouthpiece. It is attached to the Symbicort Turbuhaler inhaler and cannot be removed. Do not use the Symbicort Turbuhaler inhaler if it is damaged or if the mouthpiece is not properly attached.
As with all inhalers, caregivers should ensure that children prescribed Symbicort Turbuhaler use the correct inhalation technique as described above.

Cleaning the Symbicort Turbuhaler inhaler
Wipe the outer surface of the mouthpiece with a dry cloth once a week. Do not use water or other liquids.

When to start using a new inhaler

• The dose counter window shows how many doses (inhalations) remain in the Symbicort Turbuhaler inhaler; a full inhaler contains 30, 60, or 120 doses.

• The dose counter markings indicate every 10 inhalations (in inhalers containing 60 and 120 doses) and every 15 inhalations (in the inhaler containing 30 doses). Therefore, the dose counter does not change after each single dose.
• The appearance of a red mark at the edge of the dose counter window indicates that approximately 20 doses remain in the inhaler. The background of the dose counter window turns red during the last 10 doses. When the number 0 on a red background is centered in the dose counter window, it means you should start using a new Symbicort Turbuhaler inhaler.

Note:

• After the inhaler is empty, the grip will still turn and produce a characteristic sound (click).
• The sound heard when shaking the Symbicort Turbuhaler inhaler is produced by the moisture-absorbing agent, not the medicine. Therefore, you cannot assess the contents of the Symbicort Turbuhaler inhaler by the sound it makes when shaken.
• If more than one dose is accidentally loaded, you will still receive only one dose of medicine. However, all loaded doses will be counted in the dose counter.

Using more than the recommended dose of Symbicort Turbuhaler
It is important that you take only the doses described in this leaflet or prescribed by your doctor.
Do not increase the recommended dose without consulting your doctor.
The most common symptoms that may occur after taking more than the recommended dose of
Symbicort Turbuhaler are: tremors, headache, and rapid heartbeat.

Missed dose of Symbicort Turbuhaler

• If you miss 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 missed 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.
You must stop using Symbicort Turbuhaler and contact your doctor immediately if any of the following symptoms occur in the patient:

• swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing), or hives occurring together with breathing difficulties (angioedema) and/or sudden feeling of weakness (fainting). These may indicate an allergic reaction. This is rare, occurring in fewer than 1 in 1,000 people.
• Sudden increase in wheezing and breathlessness occurring immediately after inhaling the medicine. If any of these symptoms occur, stop using Symbicort Turbuhaler immediately and use a rescue inhaler. You must contact your doctor immediately,
  as treatment may need to be changed. These symptoms occur very rarely, in fewer than 1 in 10,000 people.

Other possible side effects:
Common (may occur in fewer than 1 in 10 people)

• Palpitations (awareness of heartbeat), tremor. If such symptoms occur, they are usually mild and tend to disappear during continued treatment with Symbicort Turbuhaler.
• Oral thrush (fungal infection in the mouth). The risk of developing oral thrush is reduced if the patient rinses their mouth with water after using Symbicort Turbuhaler.
• Mild irritation of the throat, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Tell your doctor if any of the following symptoms occur during treatment with
Symbicort Turbuhaler; these may be signs of a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Worsening cough or increased difficulty breathing.

Uncommon (may occur in fewer than 1 in 100 people)

• Anxiety, nervousness, or restlessness.
• Sleep disturbances.
• Dizziness.
• Nausea.
• Rapid heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

Rare (may occur in fewer than 1 in 1,000 people)

• Rash, itching.
• Bronchospasm (constriction of the airway muscles causing wheezing). If wheezing occurs immediately after taking the medicine, stop using Symbicort Turbuhaler and contact your doctor immediately.
• Low blood potassium levels.
• Irregular heartbeat.

Very rare (may occur in fewer than 1 in 10,000 people)

• Depression.
• Behavioural changes, particularly in children.
• Chest pain or tightness (symptoms of angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the body's production of steroid hormones, particularly if used long-term at high doses. These effects may include:

• changes in bone mineral density (bone thinning)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• slowed growth in children and adolescents
• effects on the adrenal glands (small glands located near the kidneys).

The likelihood of these effects is considerably lower with inhaled corticosteroids than with oral corticosteroid tablets.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Symbicort Turbuhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard package or on the inhaler label after EXP. The expiry date refers to the last day of the specified month.
• There are no special storage instructions for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Symbicort Turbuhaler contains
The active substances are budesonide and formoterol fumarate dihydrate. Each inhalation dose of Symbicort Turbuhaler contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).

What Symbicort Turbuhaler looks like and contents of the pack
Symbicort Turbuhaler is a medicine for use in an inhaler. The powder for inhalation is white in colour. Each inhaler contains 30, 60 or 120 doses of medicine. The inhaler has a white body and a red twist grip. On the grip there is a Braille code with the number 6, enabling identification and differentiation from other AstraZeneca inhalation medicines.

Symbicort Turbuhaler is available in packs containing 1 inhaler with 30 doses, or in packs containing 1, 2, 3, 10 or 18 inhalers each containing 60 or 120 doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Forskargatan 18
151 36 Södertälje
Sweden

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; Belgium: Symbicort Turbohaler 160 μg/4,5 μg/inhalatie; 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 160 μg/4.5 μg/inhalaci; Denmark: Symbicort Turbuhaler 160 μg/4,5 μg/inhalation; Estonia: Symbicort Turbuhaler, 160 μg/4,5 μg; Finland: Symbicort Turbuhaler 160 μg/4,5 μg/inhalation; France: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Germany: Symbicort Turbuhaler 160 μg/4,5 μg/inhalation; Greece: SYMBICORT TURBUHALER 160 μg/4,5 μg/inhalation; Hungary: Symbicort Turbuhaler 160 μg/4,5 μg/inhalacios; Iceland: Symbicort Turbuhaler 160 μg/4,5 μg/inhalation; Ireland: Symbicort Turbohaler 200 μg/6 μg/inhalation; Italy: SYMBICORT 160 μg/4,5 μg/inhalazione; Latvia: Symbicort Turbuhaler 160 μg/4,5 μg/inhalacija; Lithuania: Symbicort Turbuhaler 160 μg/4,5 μg/dose; Luxembourg: Symbicort Turbohaler 160 μg/4,5 μg/inhalation; Malta: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Netherlands: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Norway: Symbicort Turbuhaler 160 μg/4,5 μg/inhalasjon; Poland: Symbicort Turbuhaler (160 μg+4,5 μg)/dose; Portugal: Symbicort Turbohaler 160 μg/4,5 μg/inhalacao; Romania: Symbicort Turbuhaler 160 μg/4,5 μg/inhalat; Slovakia: Symbicort Turbuhaler 200 μg/6 μg/inhalacia; Slovenia: Symbicort Turbuhaler 160 μg/4,5 μg/inhaliranje; Spain: Symbicort Turbuhaler 160 μg/4,5 μg/inhalacion; Sweden: Symbicort Turbuhaler 160 μg/4,5 μg/inhalation; United Kingdom: Symbicort 200 μg/6 μg/inhalation Turbohaler.

For further information, please contact the representative of the Marketing Authorisation Holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warszawa
tel.: +48 22 245 73 00
fax: +48 22 485 30 07

Detailed and up-to-date information about this product is available by scanning with a smartphone the QR code indicated in the Patient Leaflet and on the outer packaging of the medicine. The same information is also available on the website: www.turbuhaler.pl