Leaflet: information for the user

Symbicort 160 micrograms/4.5 micrograms/inhalation suspension for inhalation in a pressurized container

Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Symbicort is and what it is used for

2. What you need to know before you start using Symbicort

3. How to use Symbicort

4. Possible side effects

5. Storage of Symbicort

6. Contents of the container and additional information

Symbicort is an inhaler used for the symptomatic treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. COPD is a chronic disease of the respiratory airways of the lungs, often caused by tobacco smoke.It contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”, and acts by reducing and preventing lung inflammation.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta2adrenergic agonists” or “bronchodilators”, and acts by relaxing the muscles of the respiratory airways, making it easier to breathe.

Do not use this medication as a relief inhaler.

Do not use Symbicort:

• If you are allergic to budesonide, formoterol, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Symbicort if:

• You have diabetes.
• You have any lung infection.
• You have high blood pressure, or have ever had any heart disease (including irregular heartbeats, 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 blurry vision or other visual disturbances.

Use in athletes

This medication contains formoterol, which may produce a positive result in doping control tests.

Children and adolescents

Symbicort is not recommended for children or adolescents under 18 years old.

Other medications and Symbicort

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are using any of the following medications:

• Beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medications to treat rapid or irregular heartbeats (for example quinidina).
• Medications like digoxin, used commonly to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Oral steroids (such as prednisolone).
• Xanthine medications (such as theophylline or aminophylline), used commonly to treat COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medications (such as chlorpromazine and prochlorperazine).
• Medications called “HIV protease inhibitors” (such as ritonavir) for the treatment of HIV/AIDS.
• Medications to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medications to treat Parkinson's disease (such as levodopa).
• Medications to treat thyroid problems (such as levothyroxine).

If you find yourself in any of these situations, or are unsure, ask your doctor or pharmacist before using Symbicort.

Also inform your doctor or pharmacist if you are to undergo general anesthesia for surgery or dental treatment.

Pregnancy, breastfeeding, and fertility

• Inform your doctor before using this medication if you are pregnant, or plan to become pregnant; do not use Symbicort unless your doctor tells you to.
• If you become pregnant during treatment with Symbicort, do not stop using it and consult your doctor immediately.
• If you are breastfeeding, speak with your doctor before using Symbicort.

Driving and operating machinery

The influence of Symbicort on the ability to drive and operate machinery is negligible or insignificant.

• Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.
• It is essential to use Symbicort daily, even if you do not have symptoms of COPD at the moment.

The recommended dose is 2 inhalations twice a day. Symbicort is not recommended for use in children or adolescents under 18 years of age.

If you have been taking oral steroid tablets for COPD, your doctor may reduce the number of tablets you take once you start treatment with Symbicort. If you have been taking oral steroid tablets for a long time, your doctor may want to perform blood tests from time to time. When your doctor reduces the number of oral steroid tablets, you may feel unwell, even if your lung symptoms are improving. In this case, you may temporarily experience symptoms such as congestion, runny nose, weakness, or muscle or joint pain, and skin rash (urticaria). Contact your doctor if any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting. If you experience allergy or arthritis symptoms, you may need to take another medication. You should consult your doctor if you are concerned about whether you should continue using Symbicort.

Your doctor may consider adding oral steroid tablets to your regular treatment during periods of stress (for example, when you have a chest infection or before surgery).

Important information about COPD symptoms

If you experience difficulty breathing or wheezing while using Symbicort, you should continue using it and contact your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing worsens or you wake up frequently at night with symptoms of shortness of breath.
• You start to feel chest tightness in the morning, or chest tightness lasts longer than usual.
• These signs may indicate that your COPD is not well-controlled, and you may need immediate different or additional treatment.

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

Information about your new Symbicort inhaler

• Before using your new Symbicort inhaler, remove it from the aluminum foil packaging. Discard the packaging and the desiccant inside the packaging. Do not use the inhaler if the desiccant has come out of the package.
• The inhaler must be used within 3 months of removing it from the aluminum foil packaging. Write the expiration date (3 months from the date it was removed from the packaging) on the inhaler label to remind you when to stop using the inhaler.
• The image shows the parts that make up the inhaler, which will already be assembled when you receive it. Do not separate the parts. If the container becomes loose, reattach it to the inhaler and continue using it.

Preparing Symbicort

The inhaler needs to be prepared for use in the following situations:

• When you are using your new Symbicort for the first time.
• When you have not used it for more than 7 days.
• When it has been dropped.

To prepare the inhaler for use, follow these instructions:

1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol cartridge.

2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. The cap will remain attached to the inhaler.

3. Hold the inhaler in a vertical position. Then, press the counter (on the top of the inhaler) to release a puff of air. You can use one or both hands, as shown in the pictures.

4. Release your finger(s) from the counter.

5. Wait 10 seconds, shake well, and repeat steps 3 and 4.

6. Your inhaler is now ready for use.

How to take an inhalation

Each time you need to take an inhalation, follow these instructions:

1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol cartridge.
2. Remove the mouthpiece cap by pressing lightly on the protrusions on the side. Check that the mouthpiece is not blocked.
3. Hold the inhaler in a vertical position (you can use one or both hands). Exhale gently.
4. Place the mouthpiece between your teeth. Close your lips.
5. Inhale slowly and deeply through your mouth. Press the counter firmly (on the top of the inhaler) to release a puff of medication. Hold your breath for a moment while pressing the counter. Inhale at the same time as pressing the counter to ensure the medication reaches your lungs.
6. Hold your breath for 10 seconds, or as long as you find comfortable.
7. Before exhaling, release your finger from the counter and remove the inhaler from your mouth. Hold the inhaler in a vertical position.
8. Exhale gently. Before taking another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3-7.
9. Replace the mouthpiece cap.
10. After your morning and evening doses, rinse your mouth with water. Do not swallow.

Using a spacer

Your doctor, nurse, or pharmacist may suggest using a spacer (e.g., Aerochamber Plus Flow Vu or Aerochamber Plus). Follow the instructions provided with the spacer.

Cleaning Symbicort

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or liquids, and do not separate the cartridge from the inhaler.

How to know when to replace your Symbicort inhaler

• The counter on top tells you how many inhalations are left in your Symbicort inhaler. It starts with 120 inhalations when it is full.

• Each time you take an inhalation, or release a puff of air, the arrow starts counting down to zero ('0').
• When the arrow first enters the yellow area, it means there are about 20 inhalations left.

• When the arrow reaches '0', you must stop using your new Symbicort inhaler. You may not feel like the inhaler is empty and it may seem like it still works, but you will not receive the correct amount of medication if you continue using it.

If you use more Symbicort than you should

If you have used more Symbicort than you should, contact your doctor or pharmacist. Common symptoms and signs of an overdose are tremors, headache, and rapid heartbeat.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to use Symbicort

• If you forget a dose of Symbicort, follow the recommended treatment as soon as you remember. However, if it is almost time for your next dose, do not worry about the missed dose.
• Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Symbicort

Before stopping treatment with Symbicort, you should consult your doctor or pharmacist. If you stop using Symbicort, your COPD symptoms and signs may worsen.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the following situations occur, stop using Symbicort and consult your doctor immediately:

• Your face becomes swollen, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or you experience urticaria along with difficulty breathing (angioedema) and/or you feel a sudden sensation of fainting, which indicates that you may be experiencing an allergic reaction. This occurs rarely, affecting less than 1 in 1,000 patients.
• You experience acute wheezing or difficulty breathing immediately after using your inhaler.If any of these symptoms occur, stop using Symbicort immediately and use your "relief inhaler." Contact your doctor immediately, as it may be necessary to change your treatment.This occurs very rarely, affecting less than 1 in 10,000 patients.

Other possible side effects:

Frequent (may affect up to 1 in 10 patients)

• Palpitations (noticing heartbeats), tremors, or chills. These effects, if they occur, are usually mild and disappear as you continue using Symbicort.
• Oral thrush (fungal infection); this effect is less likely if you rinse your mouth with water after using Symbicort.
• Mild throat irritation, cough, hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while inhaling Symbicort, which may be symptoms of a lung infection:

• Fever or chills.

• Increased mucus production, change in mucus color.

• Increased cough or difficulty breathing.

Infrequent (may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Accelerated heart rate.
• Skin hematomas.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of the respiratory tract muscles, causing wheezing). If wheezing occurs suddenly just after using Symbicort, stop using it and consult your doctor immediately.
• Low potassium levels in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behavior, especially in children.
• Chest pain or pressure (angina pectoris).
• Increased blood sugar levels.
• Alterations in taste, such as an unpleasant mouth sensation.
• Variations in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if high doses are used for a long time. These effects include:

• Changes in bone mineral density (bone thinning)

• Cataracts (loss of transparency of the lens in the eye)
• Glaucoma (increased eye pressure)
• Delayed growth in children and adolescents
• Effects on the adrenal glands (small glands located near the kidneys).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the carton, aluminum foil pouch, or label after CAD. The expiration date is the last day of the month indicated.
• Like most inhaled medications in pressurized containers, the effect of this medication may decrease when the container is cold. For best results, this medication should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• It should be used within 3 months after removing the inhaler from its aluminum packaging. Write the expiration date (3 months from opening the packaging) on the inhaler label to remind you when to stop using the inhaler.
• Always replace the mouthpiece cap and secure it in its position after using the inhaler.
• Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Warning: The cartridge contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container. The cartridge should not be broken, pierced, or burned, even when it appears to be empty.

Composition of Symbicort

The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

The other excipients are apaflurane (HFA 227), povidone, and Macrogol. This inhaler does not contain CFCs.

This medication contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of apaflurane (HFC-227ea) corresponding to 0.034 tonnes of CO2 equivalent (global warming potential GWP = 3 220).

Appearance of the product and contents of the package

Symbicort is an inhaler that contains its medication. The pressurized cartridge with a dose indicator attached, contains a white suspension for inhalation. The cartridge is mounted on a red plastic adapter with a white plastic mouthpiece and an integrated grey plastic cap. Each inhaler contains 120 inhalations after it has been prepared for use. Each inhaler is individually packaged in an aluminum foil wrapper that contains a drying agent.

Symbicort 160 micrograms/4.5 micrograms/inhalation suspension for inhalation in a pressurized container (budesonide/formoterol fumarate dihydrate) is available in packages with a single inhaler.

Marketing authorization holder and manufacturer responsible

The marketing authorization holder is:

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The manufacturer responsible is:

AstraZeneca Dunkerque Production

224, Avenue de la Dordogne BP 41

59640 Dunkerque (France)

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2025

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/