SYMBICORT 80 mcg + 4.5 mcg Powder

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Symbicort Turbuhaler, (80 µg + 4.5 µg)/inhalation dose, inhalation powder
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Symbicort Turbuhaler and what is it used for
   1. Turbuhaler
4. Important information before using Symbicort Turbuhaler
   1. When not to use Symbicort Turbuhaler:
   2. Warnings and precautions
   3. Symbicort Turbuhaler and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Symbicort Turbuhaler contains lactose
5. How to use Symbicort Turbuhaler
   1. Important information about asthma symptoms
   2. The patient should contact their doctor immediately if:
   3. Asthma
   4. Adults (18 years and older)
   5. Adolescents (12-17 years old)
   6. Children (6-11 years old)
   7. In case of asthma symptoms, use a separate emergency inhaler
   8. The patient should also use Symbicort Turbuhaler as an "emergency inhaler" to treat
   9. Preparing the Symbicort Turbuhaler inhaler for first use
   10. Using the inhaler
   11. Cleaning the Symbicort Turbuhaler inhaler
   12. When to start using a new inhaler
   13. Using a higher dose of Symbicort Turbuhaler than recommended
   14. Missing a dose of Symbicort Turbuhaler
6. Possible side effects
   1. The patient should stop using Symbicort Turbuhaler and contact their doctor immediately if they experience the following symptoms:
   2. If any of these symptoms occur, the patient should stop using Symbicort Turbuhaler and use their emergency inhaler.
   3. The patient should contact their doctor immediately, as a change in treatment may be necessary.
   4. Other possible side effects:
   5. Common (may occur in up to 1 in 10 patients)
   6. Uncommon (may occur in up to 1 in 100 patients)
   7. Rare (may occur in up to 1 in 1000 patients)
   8. Very rare (may occur in up to 1 in 10,000 patients)
   9. Reporting side effects
7. How to store Symbicort Turbuhaler
8. Contents of the pack and other information
   1. What Symbicort Turbuhaler contains
   2. What Symbicort Turbuhaler looks like and contents of the pack
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Patient Information Leaflet: User Information

Symbicort Turbuhaler, (80 µg + 4.5 µg)/inhalation dose, inhalation powder

Budesonide + Formoterol fumarate dihydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Symbicort Turbuhaler is an inhaler medicine used to treat asthma in adults, adolescents, and children aged 6 and over. It contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called corticosteroids. The medicine works by reducing and preventing swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta2-adrenergic receptor agonists or bronchodilators. Its action is to relax the muscles in the airways, making it easier to breathe.

This is not a suitable medicine for treating severe asthma. Treatment can be carried out in two ways.
a) Some patients are prescribed two inhalers for asthma: Symbicort Turbuhaler and a separate inhaler for emergency use.

Turbuhaler

• Symbicort Turbuhaler is used daily. Its use helps prevent the occurrence of asthma symptoms.
• The emergency inhaler is used when asthma symptoms occur to facilitate breathing.

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

• Symbicort Turbuhaler is used daily. Its use helps prevent the occurrence of asthma symptoms.
• Symbicort Turbuhaler is also used when additional doses are needed to relieve asthma symptoms and facilitate breathing. These patients do not require a separate emergency inhaler.

2. Important information before using Symbicort Turbuhaler

When not to use Symbicort Turbuhaler:

Warnings and precautions

Before starting to use Symbicort Turbuhaler, the patient should talk to their doctor or pharmacist if they have:

• diabetes.
• lung infection.
• high blood pressure or if they have ever had heart problems (including irregular heart rhythm, very fast heart rate, narrowing of the arteries, or heart failure).
• thyroid or adrenal gland problems.
• low potassium levels in the blood.
• severe liver problems. If the patient experiences blurred vision or other vision problems, they should contact their doctor.

Symbicort Turbuhaler and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Particularly, the doctor or pharmacist should be informed about the use of any of the following medicines:

• beta-blocker medicines (such as atenolol or propranolol, used to treat high blood pressure), also in the form of eye drops (such as timolol used to treat glaucoma).
• medicines used in the case of accelerated or irregular heart rhythm (such as quinidine).
• medicines, such as digoxin, often used to treat heart failure.
• diuretic medicines (such as furosemide), used to treat high blood pressure.
• oral steroids (such as prednisolone).
• xanthine derivatives (e.g., theophylline or aminophylline). These are medicines 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).
• HIV protease inhibitors (e.g., ritonavir) used to treat HIV infection.
• medicines used in infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• medicines used in Parkinson's disease (e.g., levodopa).
• medicines used in thyroid diseases (e.g., levothyroxine).

A person taking any of the listed medicines or having doubts about taking other medicines should contact their doctor or pharmacist before using Symbicort Turbuhaler.
The doctor or pharmacist should also be informed about the planned general anesthesia in connection with a surgical or dental procedure.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or plans to become pregnant, they should tell their doctor before using Symbicort Turbuhaler; they should not use Symbicort Turbuhaler without their doctor's recommendation.
• If the patient becomes pregnant while taking Symbicort Turbuhaler, they should not stop taking Symbicort Turbuhaler but should contact their doctor immediately.
• A breastfeeding patient should talk to their doctor before starting to use Symbicort Turbuhaler.

Driving and using machines

Symbicort Turbuhaler has no or negligible influence on the ability to drive and use machines.

Symbicort Turbuhaler contains lactose

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

3. How to use Symbicort Turbuhaler

• This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
• It is essential to use Symbicort Turbuhaler daily, even if the patient does not experience asthma symptoms at the time.
• The doctor will regularly monitor the severity of asthma symptoms.

If the patient is taking oral steroids for asthma or COPD, when introducing Symbicort Turbuhaler, the doctor may reduce the number of oral steroid tablets taken. If the patient has been taking oral steroids in tablet form for a long time, the doctor may occasionally recommend blood tests. After reducing the dose of oral steroids, the patient may feel worse, and asthma symptoms may worsen. Symptoms such as a stuffy nose, runny nose, weakness, or muscle or joint pain and rash (hives) may occur. If any of these symptoms concern the patient or if symptoms such as headache, fatigue, nausea, or vomiting occur, they should contact their doctor immediately. It may be necessary to use other medicines if allergy or arthritis symptoms occur. If the patient has doubts about continuing to use Symbicort Turbuhaler, they should consult their doctor.
The doctor may consider adding oral steroids to the usual treatment during periods of stress (e.g., chest infection or before surgery).

Important information about asthma symptoms

If the patient experiences shortness of breath or wheezing while using Symbicort Turbuhaler, they should continue using Symbicort Turbuhaler but contact their doctor as soon as possible, as additional treatment may be necessary.

The patient should contact their doctor immediately if:

• they experience breathing difficulties or wake up at night with an asthma attack.
• they have a feeling of chest tightness in the morning after getting up or if the feeling of chest tightness persists longer than usual. These symptoms may indicate inadequate asthma control, and immediate use of other or additional treatment may be necessary.

Asthma

Symbicort Turbuhaler can be used to treat asthma in two different ways. The dose and frequency of use of Symbicort Turbuhaler depend on the recommended method of use.
a)
If the doctor has prescribed Symbicort Turbuhaler and a separate emergency inhaler, the patient should read the instructions in the section below marked with the symbol "a) Using Symbicort Turbuhaler and a separate emergency inhaler".
b)
If the doctor has prescribed Symbicort Turbuhaler as the only inhaler for asthma, the patient should read the instructions marked with the symbol "b) Using Symbicort Turbuhaler as the only inhaler for asthma".
a) Using Symbicort Turbuhaler and a separate emergency inhaler
Use Symbicort Turbuhaler daily.Using Symbicort Turbuhaler helps prevent the occurrence of asthma symptoms.

Adults (18 years and older)

• The usual dose of the medicine is 1 or 2 inhalations twice a day.
• The doctor may increase the dose to 4 inhalations twice a day.
• If asthma symptoms are well-controlled, the doctor may recommend taking the medicine once a day.

Adolescents (12-17 years old)

• The usual dose of the medicine is 1 or 2 inhalations twice a day.
• If asthma symptoms are well-controlled, the doctor may recommend taking the medicine once a day.

Children (6-11 years old)

• The usual dose of the medicine is 2 inhalations twice a day.

Symbicort Turbuhaler is not recommended for use in children under 6 years of age.
During treatment, the doctor will help the patient with proper asthma treatment. The doctor will determine the dose at the lowest level that controls asthma symptoms. The patient should not change the dose of Symbicort Turbuhaler without consulting their doctor.

In case of asthma symptoms, use a separate emergency inhaler

for emergency use.The patient should always carry a separate emergency inhaler with them. Do not use Symbicort Turbuhaler to treat asthma symptoms - use a separate emergency inhaler for this purpose.
b) Using Symbicort Turbuhaler as the only inhaler for asthma
Symbicort Turbuhaler should only be used in this way if prescribed by a doctor and only for patients 12 years of age or older.
Symbicort Turbuhaler should be used daily.This helps prevent the occurrence of asthma symptoms. The medicine can be taken in the following way:

• 1 inhalation in the morning and1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.

The patient should also use Symbicort Turbuhaler as an "emergency inhaler" to treat

asthma symptoms.

• In case of asthma symptoms, take 1 inhalation and wait a few minutes.
• If the patient does not feel better, they should take another inhalation.
• Do not take more than 6 inhalations at a time.

The patient should always carry Symbicort Turbuhaler with them and use it as needed.
A total daily dose greater than 8 inhalations is usually not necessary. However, the doctor may recommend using up to 12 inhalations per day for a certain period.
If the patient regularly needs to use 8 or more inhalations per day, they should contact their doctor. A change in treatment may be necessary.
Do not use more than 12 inhalations per day.
In case of asthma symptoms during physical exertion, use Symbicort Turbuhaler as described above. However, do not use Symbicort Turbuhaler before physical exertion to prevent asthma symptoms.

Preparing the Symbicort Turbuhaler inhaler for first use

Before firstuse of a newSymbicort Turbuhaler inhaler, prepare it for use as follows:

• Remove the cap from the inhaler. When removing the cap, a characteristic rattling sound may be heard.
• Hold the Symbicort Turbuhaler inhaler upright with the red wheel at the bottom.
• Turn the red wheel in one direction until it stops, then turn it in the opposite direction until it stops (the direction in which the wheel is first turned does not matter). A characteristic click will be heard. It does not matter whether the click occurs after the first or second turn.
• Repeat the above step, turning the red wheel in both directions.
• The Symbicort Turbuhaler inhaler is now loaded and ready for use.

Using the inhaler

To perform an inhalation, follow the instructions below each time.

• 1. Remove the cap from the inhaler. When removing the cap, a characteristic rattling sound may be heard.
• 2. Hold the Symbicort Turbuhaler inhaler upright,with the red wheel at the bottom.

• 3. When loading the medicine, do not hold the Symbicort Turbuhaler inhaler by the mouthpiece. To load a dose of medicine, turn the red wheel until it stops in one direction.

Then turn the wheel until it stops in the opposite direction (the direction in which the wheel is first turned does not matter). A characteristic click will be heard. 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 the dose of medicine only immediately before use.

• 4. Hold the Symbicort Turbuhaler inhaler away from the mouth. Perform a gentle exhalation (without effort). Do not exhale through the Symbicort Turbuhaler inhaler mouthpiece.

• 5. Place the mouthpiece of the inhaler gently between the teeth. Close the mouth (enclose the mouthpiece with the lips) and perform a maximum deep and forceful inhalation through the mouth. Do not chew or bite the mouthpiece.

• 6. Remove the Symbicort Turbuhaler inhaler from the mouth. Perform a calm exhalation.The amount of medicine in one inhalation is very small, so the taste of the medicine may not be noticeable after inhalation. However, if the patient follows the instructions, they can be sure that the dose of medicine has been taken and the medicine is in the lungs.
• 7. If a second inhalation is recommended, repeat the steps described in points 2 to 6.
• 8. After use, put the cap back on the inhaler and close it tightly.

• 9. Rinse the mouth with water after taking the dose of medicine in the morning and (or) evening. Do not swallow the water.

Do not remove or turn the mouthpiece. It is connected 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 attached to the inhaler.
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) are left in the Symbicort Turbuhaler inhaler; a full inhaler contains 60 or 120 doses of medicine.

• The dose counter scale is marked every 10 inhalations, so the counter does not show a change after a single dose of medicine is administered.
• The appearance of a red marker on the edge of the dose counter window indicates that there are about 20 doses of medicine left in the inhaler. During the administration of the last 10 doses of medicine, the background of the dose counter window is red. When the number 0 on the red background is in the middle of the dose counter window, it means that a new Symbicort Turbuhaler inhaler should be started.

Note:

• After the inhaler is empty, the wheel will still turn and make a characteristic clicking sound.
• The sound heard when shaking the Symbicort Turbuhaler inhaler is made by the moisture-absorbing medium, not the medicine. Therefore, the contents of the Symbicort Turbuhaler inhaler cannot be assessed based on the sound made by the inhaler when shaken.
• If more than one dose of medicine is loaded by mistake, the patient will still receive only one dose of medicine. However, all loaded doses will be recorded in the dose counter.

Using a higher dose of Symbicort Turbuhaler than recommended

It is essential to take the doses described in the leaflet or recommended by the doctor.
Do not increase the recommended dose without consulting a doctor.
The most common symptoms that may occur after taking a higher dose of Symbicort Turbuhaler than recommended are: tremors, headaches, and rapid heart rate.

Missing a dose of Symbicort Turbuhaler

• If a dose of medicine is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped.
• Do nottake a double dose to make up for a missed dose.

In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop using Symbicort Turbuhaler and contact their doctor immediately if they experience the following symptoms:

• swelling of the face, especially around the mouth (tongue and (or) throat and (or) difficulty swallowing) or hives occurring at the same time as difficulty breathing (angioedema) and (or) sudden feeling of weakness (fainting). This may indicate an allergic reaction. It occurs rarely, in less than 1 in 1000 patients.
• Sudden worsening of wheezing and shortness of breath occurring immediately after inhalation of the medicine.

If any of these symptoms occur, the patient should stop using Symbicort Turbuhaler and use their emergency inhaler.

The patient should contact their doctor immediately, as a change in treatment may be necessary.

Such symptoms occur very rarely, in less than 1 in 10,000 patients.

Other possible side effects:

Common (may occur in up to 1 in 10 patients)

• Palpitations (feeling of heartbeat), tremors. If such symptoms occur, they are usually mild and usually disappear during continued use of Symbicort Turbuhaler.
• Thrush (fungal infection) in the mouth. The occurrence of thrush is less likely if the patient rinses their mouth with water after using Symbicort Turbuhaler.
• Mild throat irritation, cough, and hoarseness.
• Headache.

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

• Anxiety, nervousness, or restlessness.
• Sleep disturbances.
• Dizziness.
• Nausea (nausea).
• Rapid heart rate.
• Bruises on the skin.
• Muscle cramps.
• Blurred vision.

Rare (may occur in up to 1 in 1000 patients)

• Rash, itching.
• Bronchospasm (bronchial muscle spasm manifesting as wheezing). If wheezing occurs immediately after using the medicine, the patient should stop using Symbicort Turbuhaler and contact their doctor immediately.
• Low potassium levels in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behavior, especially in children.
• Chest pain and feeling of chest tightness (symptoms of 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 production of steroid hormones in the body, especially if used for a long time in high doses. The 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 much lower when using inhaled corticosteroids than when taking corticosteroids in tablets.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Symbicort Turbuhaler

• The medicine should be stored out of 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 the month stated.
• There are no special storage instructions for the medicine.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Symbicort Turbuhaler contains

The active substances of the medicine are budesonide and formoterol. Each inhalation dose of Symbicort Turbuhaler contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
The other ingredient of the medicine is lactose monohydrate (which contains milk proteins).

What Symbicort Turbuhaler looks like and contents of the pack

Symbicort Turbuhaler is an inhaler medicine. The inhalation powder is white. Each inhaler contains 60 or 120 doses of medicine. The inhaler has a white body and a red wheel. On the wheel, there is a Braille code with the number 6, which allows identification and distinguishes the medicine from other AstraZeneca inhalers.
Symbicort Turbuhaler is available in packs containing 1, 2, 3, 10, or 18 inhalers, each containing 60 (or 120) doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB
151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Forskargatan 18
151 36 Södertälje
Sweden

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

For more detailed information, please contact the representative of the marketing authorization holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warsaw
tel.: +48 22 245 73 00
fax: +48 22 485 30 07
Date of last revision of the leaflet:October 2023
Detailed and up-to-date information about this product is available by scanning the QR code on the Patient Information Leaflet and the outer packaging of the medicine with a smartphone. The same information is also available on the website: www.turbuhaler.pl
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