Simbicort

Leaflet accompanying the packaging: information for the user

Symbicort, (160 micrograms + 4.5 micrograms)/inhalation dose, inhalation aerosol, suspension
Budesonide + Formoterol fumarate dihydrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 the symptoms of their illness 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 and what is it used for
• 2. Important information before using Symbicort
• 3. How to use Symbicort
• 4. Possible side effects
• 5. How to store Symbicort
• 6. Contents of the packaging and other information

1. What is Symbicort and what is it used for

Symbicort is an inhaler medicine used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 and over. COPD is a chronic respiratory disease in the lungs that is often caused by smoking. Symbicort 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.

The medicine should not be used as an inhaler for immediate relief of symptoms.

2. Important information before using Symbicort

When not to use Symbicort:

Warnings and precautions

Before starting to use Symbicort, you should talk to your doctor or pharmacist if you have:

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

Children and adolescents

Symbicort should not be used in children and adolescents under the age of 18.

Symbicort and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking, or have recently taken, and about any medicines you plan to take.
Particularly, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (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.
• 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 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).
• HIV protease inhibitors (such as 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 (such as levodopa).
• Medicines used in thyroid diseases (such as levothyroxine).

A person taking any of the listed medicines or having doubts about taking other medicines should consult a doctor or pharmacist before using Symbicort.
You should also inform your doctor or pharmacist if you are planning to undergo general anesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or plans to become pregnant, she should tell her doctor before using Symbicort - Symbicort should not be used without a doctor's recommendation.
• If a patient treated with Symbicort becomes pregnant, she should not stop taking Symbicort, but should immediately consult her attending physician.
• A breastfeeding patient should discuss with her attending physician before using Symbicort.

Driving and using machines

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

3. How to use Symbicort

• This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
• It is important to use Symbicort every day, even if you do not have COPD symptoms at that time.

The usual dose of the medicine is 2 inhalations twice a day. Symbicort should not be used in children and adolescents under the age of 18.
If the patient is taking oral steroids for COPD, when introducing Symbicort, 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 their respiratory symptoms may worsen. Symptoms such as a runny nose, cough, weakness or muscle or joint pain and rash may occur. If any of these symptoms bother the patient or if symptoms such as headache, fatigue, nausea or vomiting occur, they should contact their doctor immediately. Other medicines may need to be used if symptoms of allergy or arthritis occur. If the patient has any doubts about continuing to use Symbicort, 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 COPD symptoms

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

• The patient has difficulty breathing or wakes up at night with a feeling of shortness of breath.
• The patient has a feeling of chest tightness in the morning after getting up or the feeling of chest tightness lasts longer than usual.
• These symptoms may indicate inadequate control of COPD and immediate use of other or additional treatment may be necessary.

Patients with COPD may also be prescribed other bronchodilators by their doctor, such as anticholinergic medicines (e.g. tiotropium bromide and ipratropium bromide).

Information about Symbicort

• Before starting to use Symbicort, it should be removed from the foil packaging. The foil packaging and the desiccant inside should be discarded. If the desiccant has come out of its bag, the inhaler should not be used.
• After removing the inhaler from the foil, it can be used for 3 months. The expiration date (3 months after opening the foil packaging) should be written on the inhaler label to help remember when to stop using the inhaler.
• The parts of the inhaler are shown in the picture. The inhaler is already assembled in the packaging. It should not be disassembled into parts. If the container loosens, it should be reattached to the inhaler and the inhaler can be used further.

Preparing the Symbicort inhaler for use

The inhaler should be prepared for use in the following situations:

• When using a new Symbicort inhaler for the first time.

• If the inhaler has not been used for more than 7 days.
• If the inhaler has been dropped.

To prepare the inhaler for use, follow the instructions below:

• 1. Shake the inhaler vigorously for at least 5 seconds to mix the contents of the canister with the aerosol.
• 2. Remove the protective cap from the mouthpiece by gently pressing the tabs on the side. The strap on the cap will remain attached to the inhaler.
• 3. Hold the inhaler upright. Then press the counter (at the top of the inhaler) to perform one spray into the air. You can use one or both hands, as shown in the pictures.

• 4. Release the pressure on the finger or fingers on the counter.
• 5. Wait 10 seconds, shake the device vigorously and repeat steps 3 and 4.
• 6. The inhaler is now ready for use.

Using the inhaler

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

• 1. Shake the inhaler vigorously for at least 5 seconds to mix the contents of the canister

with the aerosol.

• 2. Remove the protective cap from the mouthpiece by gently pressing the tabs on the side. Check that the mouthpiece is not blocked.
• 3. Hold the inhaler upright (with one or both hands). Perform a slow

exhalation.

• 4. Place the inhaler mouthpiece gently between your teeth. Close your mouth (enclose the mouthpiece with your lips).
• 5. Start to breathe in slowly and deeply through your mouth. Press the counter (at the top of the inhaler) firmly to perform a spray. Continue to breathe in for a while after pressing the counter. Breathing in at the same time as pressing the counter ensures that the medicine reaches the lungs.
• 6. Hold your breath for 10 seconds or as long as you can without feeling uncomfortable.
• 7. Before exhaling, release the pressure on your finger on the counter and remove the inhaler from your mouth. Hold the inhaler upright.
• 8. Then perform a slow exhalation. To perform another inhalation, shake the inhaler vigorously for at least 5 seconds, and then repeat steps 3 to 7.
• 9. Put the protective cap back on the mouthpiece.
• 10. Rinse your mouth with water after taking the morning and evening doses of the medicine. Do not swallow the water.

Using a spacer
The doctor, nurse or pharmacist may suggest using a spacer (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). You should follow the instructions in the leaflet accompanying the spacer packaging.

Cleaning the Symbicort inhaler

• The inner and outer surface of the mouthpiece should be wiped with a dry cloth at least once a week.
• Do not use water or other liquids and do not detach the medicine canister from the inhaler.

How to know when to replace Symbicort with a new one?

• The counter at the top of the inhaler shows how many sprays are left in the Symbicort inhaler. Initially, it shows 120 sprays when the canister is full.
• Each time the patient takes a dose or performs a spray into the air, the arrow moves, counting down to zero ("0").
• When the arrow is in the yellow marked area, it means that about 20 sprays are left.

• When the arrow reaches "0", the use of the Symbicort inhaler should be stopped. It may seem that the inhaler is not empty and that it still works. However, if its use is continued, the patient will not receive the correct dose of the medicine.

Using a higher than recommended dose of Symbicort

In the event of using a higher than recommended dose of Symbicort, you should consult a doctor or pharmacist. The following symptoms may occur: tremors, headaches and rapid heart rate.

Missing a dose of Symbicort

• If a dose of the 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.

Stopping the use of Symbicort

Before stopping the use of Symbicort, you should consult a doctor or pharmacist.
Stopping the use of Symbicort may worsen COPD symptoms.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

You should stop using Symbicort immediately and contact your doctor if you experience any of the following symptoms:

• Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing), rash 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, you should stop using Symbicort immediately and use a rescue inhaler. You should contact your 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)

• Pounding heart (feeling of heartbeat), tremors. If such symptoms occur, they are usually mild and usually disappear during continued use of Symbicort.
• Thrush (fungal infection) in the mouth. The occurrence of thrush is less likely if the patient rinses their mouth with water after using Symbicort.
• Mild throat irritation, cough and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD. You should tell your doctor if any of the following symptoms occur while using Symbicort; they may be symptoms of a lung infection:
• Fever or chills.
• Increased production of sputum, change in sputum 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 (vomiting).
• Rapid heart rate.
• Bruises on the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (constriction of the airway muscles, manifested by wheezing). If wheezing occurs immediately after using the medicine, you should stop using Symbicort and contact your 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 or 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 they are 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)
• slowing of growth rate in children and adolescents
• effect 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symbicort

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the label, cardboard box and foil after EXP. The expiration date refers to the last day of the specified month.
• Like most pressurized inhalers, the effect of this medicine may decrease when the canister is cold. To get the best results, this medicine should be stored at room temperature before use. Do not store in the refrigerator or freeze. Protect from frost and direct sunlight.
• After removing the inhaler from the foil, it can be used for 3 months. The expiration date (3 months after opening the foil packaging) should be written on the inhaler label to help remember when to stop using the inhaler.
• After using the inhaler, the protective cap should always be put back on the mouthpiece and snapped into place.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment. Warning:The canister contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the canister. Even if the canister appears to be empty, do not crush, puncture or burn it.

6. Contents of the packaging and other information

What Symbicort contains

The active substances of Symbicort are budesonide and formoterol fumarate dihydrate. Each spray (inhalation dose) of Symbicort contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
The other ingredients of the medicine are: apafluran (HFA 227), povidone and macrogol. The inhaler does not contain chlorofluorocarbons.
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.6 g of apafluran (HFC-227ea), which corresponds to 0.034 tons of CO2 equivalent (global warming potential GWP = 3220).

What Symbicort looks like and contents of the packaging

Symbicort is an inhaler medicine. The pressurized canister, with a dose indicator, contains a white suspension for inhalation. The canister is equipped with a red plastic actuator with a white plastic mouthpiece and an integrated gray plastic protective cap. Each inhaler contains 120 sprays (inhalation doses) after preparation for use. Each inhaler is individually packaged in a foil pouch containing a desiccant.
Symbicort, (160 micrograms + 4.5 micrograms)/inhalation dose, inhalation aerosol, suspension (Budesonide + Formoterol fumarate dihydrate) is available in packaging containing one inhaler.

Marketing authorization holder and manufacturer

Marketing authorization holder:
AstraZeneca AB
151 85 Södertälje
Sweden
Manufacturer:
AstraZeneca Dunkerque Production
224 Avenue de la Dordogne
59640 Dunkerque
France

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

Date of last revision of the leaflet:January 2025