Symbicort turbuhaler

Symbicort Turbuhaler, (320 µg + 9 µg)/dose, powder for inhalation
Budesonide + Formoterol fumarate dihydrate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Symbicort Turbuhaler is and what it is used for
2. Important information 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
For asthma, your doctor will prescribe two inhaled medicines: Symbicort Turbuhaler
and another medicine for immediate use.

• Symbicort Turbuhaler is taken daily. Regular use helps prevent asthma symptoms.
• The reliever inhaler should be used when asthma symptoms occur to help ease breathing.

Symbicort Turbuhaler must not be used as a rescue medicine during asthma attacks.
Chronic obstructive pulmonary disease (COPD)
Symbicort Turbuhaler can also be used to treat COPD symptoms 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 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.
• a lung infection.
• high blood pressure or has ever had heart problems (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 dysfunction. If the patient experiences blurred vision or other vision disturbances, contact a 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 any of the following medicines are being used:

• beta-adrenergic blocking agents (such as atenolol or propranolol, used to treat high blood pressure), including eye drops (such as timolol used in glaucoma treatment).
• 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 to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• medicines used in Parkinson's disease (e.g. levodopa).
• medicines used in thyroid disorders (e.g. levothyroxine).

A patient taking any of the listed medicines or who has any doubts about using other medicines should contact a doctor or pharmacist before using Symbicort Turbuhaler.
You should also inform your doctor or pharmacist if general anaesthesia is planned due to a surgical or dental procedure.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or planning pregnancy, 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 the medicine but should contact her doctor immediately.
• A breastfeeding patient should speak with 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, 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, talk to a doctor before using this medicine. The amount of lactose present in one dose of this medicine usually does not cause symptoms in patients with lactose intolerance.
Lactose, as an excipient, contains small amounts of milk proteins, 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 daily, even if you currently have no asthma or COPD symptoms.
• If Symbicort Turbuhaler is used for asthma treatment, your doctor will regularly monitor the severity of your asthma symptoms.

If you are taking oral steroid tablets for asthma or COPD, when starting Symbicort
Turbuhaler, your doctor may gradually reduce the number of oral steroid tablets you take. If you
have been taking oral steroids for a prolonged period, your doctor may occasionally recommend
blood tests. After reducing the dose of oral steroids, you may feel worse, and respiratory
symptoms may even worsen. Symptoms such as nasal congestion, runny nose, fatigue, 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, tiredness, nausea, or vomiting, contact your doctor
immediately. Additional medications may be required if allergic reactions or joint inflammation occur. If you have
any doubts about continuing Symbicort Turbuhaler, 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 experience difficulty breathing or frequently wake up at night due to asthma attacks.
• you have a feeling of 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 different or additional treatment may be required.

Asthma
Use Symbicort Turbuhaler daily. Using Symbicort Turbuhaler helps prevent asthma symptoms.
Adults (aged 18 years and older)

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

For children aged 6 to 11 years, a lower-strength Symbicort Turbuhaler is available.
Symbicort Turbuhaler is not recommended for use in children under 6 years of age.
During treatment, your doctor will assist you in properly managing your asthma. Your doctor will determine the lowest dose that effectively controls asthma symptoms. Do not change the dose of Symbicort Turbuhaler without consulting your doctor.
If asthma symptoms occur, use an additional reliever inhaler. You should always carry an additional reliever inhaler. Do not use Symbicort Turbuhaler to treat asthma symptoms—this is what the additional reliever inhaler is for.

Chronic obstructive pulmonary disease (COPD)

• For use in adults only (aged 18 years and older).
• The usual dose is 1 inhalation twice daily.

Your doctor may also prescribe other bronchodilator medications for COPD, such as anticholinergics (e.g., tiotropium bromide and 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 inhaler cap. You may hear a characteristic rattling sound while unscrewing.
• Hold the Symbicort Turbuhaler inhaler vertically, with the red grip facing downwards.
• Turn the red grip fully in one direction, then fully in the opposite direction (the starting direction does not matter). You will hear a characteristic click sound. It does not matter whether the click occurs during the first or second turn.
• Repeat the above step, turning the red grip fully in both directions.
• The Symbicort Turbuhaler inhaler is now loaded and ready for use.

Using the inhaler
To perform inhalation, always follow the instructions below:

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

3. Do not hold the Symbicort Turbuhaler inhaler by the mouthpiece when loading the dose. 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 click sound. It does not matter whether the click occurs during the first or second turn.
The Symbicort Turbuhaler inhaler is now loaded and ready for use. Only load a dose 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 inhaler 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 slowly. 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 twist the mouthpiece. It is attached to the Symbicort Turbuhaler inhaler and must not be removed. Do not use a Symbicort Turbuhaler inhaler that 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 weekly with a dry cloth. 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 60 doses.

• The dose counter is marked in increments of 10 inhalations, so the counter does not change after each single dose.
• When a red mark appears at the edge of the dose counter window, approximately 20 doses of medicine remain. During the last 10 doses, the background of the dose counter window turns red. When the number 0 on a red background is in the center of the 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 click sound.
• 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 made when shaking it.
• 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.

Taking more than the recommended dose of Symbicort Turbuhaler
It is important to 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.

If you forget to use 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should stop using Symbicort Turbuhaler and contact your doctor immediately if the patient experiences any of the following symptoms:

• 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 occurs rarely, in less than 1 in 1,000 patients.
• Sudden worsening of 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. Contact your doctor immediately, as a change in treatment may be necessary. These symptoms occur very rarely, in less than 1 in 10,000 patients.

Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients)

• Palpitations (awareness of heartbeat), tremor. If such symptoms occur, they are usually mild and tend to disappear during continued use of Symbicort Turbuhaler.
• Oral candidiasis (fungal infection in the mouth). The risk of oral candidiasis is reduced if the patient rinses the mouth with water after using Symbicort Turbuhaler.
• Mild throat irritation, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD. Inform 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 production of mucus, change in mucus color.
• Worsening cough or increased difficulty breathing.

Uncommon (may occur in up to 1 in 100 patients)

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

Rare (may occur in up to 1 in 1,000 patients)

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

Very rare (may occur in up to 1 in 10,000 patients)

• Depression.
• Behavioral changes, particularly in children.
• Pain or feeling of pressure in the chest (symptoms of angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled glucocorticosteroids may affect the body's production of steroid hormones, particularly when used long-term at high doses. Symptoms include:

• Changes in bone mineral density (osteoporosis)
• 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 symptoms is considerably lower with inhaled glucocorticosteroids than with oral glucocorticosteroid tablets.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 box or on the label of the inhaler following EXP. The expiry date refers to the last day of the stated month.
• There are no special requirements for storage.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 dose of
Symbicort Turbuhaler contains 320 micrograms of budesonide and 9 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 in an inhaler. The inhalation powder is white. Each inhaler
contains 60 doses of medicine. The inhaler has a white body and a red rotating cap. The cap has a
Braille code with the number 6, enabling identification and allowing differentiation from other
AstraZeneca inhalation medicines.
Symbicort Turbuhaler 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
AstraZeneca AB
151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Forskargatan 18
151 36 Södertälje
Sweden

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

For more detailed information, please contact the representative of the marketing authorisation holder:
AstraZeneca Pharma Poland Sp. z o.o.
Postępu 14
02-676 Warsaw
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 Information Leaflet QR code area
and on the outer packaging of the medicine. The same
information is also available on the website:
www.turbuhaler.pl