Symbicort 160 micrograms/4.5 micrograms/inhalation suspension for inhalation in pressurised container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Symbicort 160 micrograms/4.5 micrograms/inhalation suspension for inhalation under pressure

Budesonide/formoterol fumarate dihydrate

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

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

Contents of the leaflet

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

1. What Symbicort is and what it is used for

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

• Budesonide belongs to a group of medicines called "corticosteroids" and works by reducing and preventing inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting beta2-adrenergic agonists" or "bronchodilators" and works by relaxing the muscles in the airways, helping you to breathe more easily.

Do not use this medicine as a "reliever" inhaler.

2. What you need to know before using Symbicort

Do not use Symbicort:

• if you are allergic to budesonide, formoterol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• You have diabetes.
• You have a lung infection.
• You have high blood pressure, or have ever had a heart condition (including irregular heartbeat, 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 blurred vision or other visual disturbances.

Use in athletes

This medicine contains formoterol, which may lead to a positive result in doping control tests.

Children and adolescents

Symbicort is not recommended for children and adolescents under 18 years of age.

Other medicines and Symbicort

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines to treat fast or irregular heartbeat (e.g. quinidine).
• Medicines such as digoxin, commonly used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Oral steroid medicines (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), commonly 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).
• Medicines known as “HIV protease inhibitors” (such as ritonavir) used to treat HIV virus.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

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

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

Pregnancy, breast-feeding and fertility

• Inform your doctor before using this medicine if you are pregnant or planning to become pregnant; do not use Symbicort unless your doctor tells you to.
• If you become pregnant while being treated with Symbicort, do not stop using it and consult your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Symbicort.

Driving and using machines

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

3. How to use Symbicort

• Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
• It is important to use Symbicort daily, even if you do not have COPD symptoms at the time.

The recommended dose is 2 inhalations twice daily. The use of Symbicort is not recommended in children and adolescents under 18 years of age.

If you have been taking 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 carry out occasional blood tests. When your dose of oral steroids is reduced, you may feel generally unwell, even though your lung symptoms may be improving. In such cases, temporary symptoms such as nasal congestion or runny nose, muscle or joint weakness or pain, and skin rash (urticaria) may occur. Contact your doctor if any of these symptoms concern you, or if you develop other symptoms such as headache, fatigue, nausea, or vomiting. If symptoms of allergy or arthritis appear, you may need to take another medicine. Consult your doctor if you are concerned about whether you should continue using Symbicort.

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

Important information about COPD symptoms

If, while using Symbicort, you experience difficulty breathing or develop wheezing, 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 due to shortness of breath.
• You begin to experience 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 a different or additional treatment immediately.

Your doctor may prescribe other bronchodilators, for example anticholinergics (such as 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 wrapper. Discard both the wrapper and the desiccant included inside the wrapper. Do not use the inhaler if the desiccant has left the package.
• The inhaler must be used within 3 months after removal from the aluminum foil wrapper. Write on the inhaler label the expiration date (3 months from the date it was removed from the wrapper) 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.

Preparation of Symbicort

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

• If you are using your new Symbicort inhaler for the first time.
• If you have not used it for more than 7 days.
• If 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 gently pressing the protrusions on the side. The cap strap will remain attached to the inhaler.
3. Hold the inhaler in an upright position. Then press down on the dose counter (on the top of the inhaler) to release one spray into the air. You may use one or both hands, as shown in the pictures.

4. Remove your finger(s) from the dose counter.
5. Wait 10 seconds, shake well, and repeat steps 3 and 4.
6. Your inhaler is now ready for use.

How to use your inhaler

Each time you need to use your inhaler, 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 gently pressing on the side tabs. Check that the mouthpiece is not blocked.
3. Hold the inhaler upright (you may use one or both hands). Breathe out gently.
4. Place the mouthpiece gently between your teeth. Close your lips around it.
5. Breathe in slowly and deeply through your mouth. At the same time, firmly press down on the dose counter (on the top of the inhaler) to release a puff. Continue inhaling as you press the counter to ensure the medicine reaches your lungs.
6. Hold your breath for 10 seconds, or as long as is comfortable for you.
7. Before breathing out, release your finger from the counter and remove the inhaler from your mouth. Keep the inhaler in an upright position.
8. Breathe out gently. Before taking another puff, shake the inhaler well for at least 5 seconds and repeat steps 3 to 7.
9. Replace the mouthpiece cap.
10. Rinse your mouth with water after your morning and evening daily doses. Do not swallow the water.

Use of a spacer device

Your doctor, nurse, or pharmacist may recommend using a spacer device (for example, Aerochamber Plus Flow Vu or Aerochamber Plus). Follow the instructions provided in the leaflet included with the spacer device.

Cleaning Symbicort

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

How can I tell when I need to replace my Symbicort inhaler?

• The counter on the top shows how many inhalations remain in your Symbicort inhaler. It starts at 120 inhalations when full.

• Each time you take an inhalation—or release one into the air—the arrow begins counting down toward zero ('0').
• When the arrow first enters the yellow area, this means approximately 20 inhalations remain.

• When the arrow reaches '0', you should stop using the inhaler. The inhaler may not feel empty and may still seem to work, but you will not receive the correct amount of medication if you continue to use it.

If you use more Symbicort than you should

If you have used more Symbicort than recommended, contact your doctor or pharmacist. The most common symptoms and signs after an overdose include tremors, headache, and rapid heartbeat.

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

If you forget to use Symbicort

• If you miss a dose of Symbicort, continue your treatment as soon as you remember. However, if it is almost time for your next dose, do not worry about the missed dose.
• Do not take a double dose to make up for a missed dose.

If you stop using Symbicort

Before stopping the use of Symbicort, you must consult your doctor or pharmacist. If you stop using Symbicort, symptoms and signs of COPD may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following, stop using Symbicort and consult your doctor immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing), or hives together with difficulty breathing (angioedema), and/or a sudden feeling of faintness, which may indicate an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• High-pitched "wheezing" or difficulty breathing immediately after using your inhaler. If you experience any of these symptoms, stop using Symbicort immediately and use your "reliever inhaler". Contact your doctor immediately, as your treatment may need to be changed. This occurs very rarely, affecting fewer than 1 in 10,000 patients.

Other possible adverse effects:

Common (may affect up to 1 in 10 patients)

• Palpitations (awareness of heartbeat), tremors, or chills. If these occur, they are usually mild and tend to disappear with continued use of Symbicort.
• Oral thrush (fungal infection in the mouth); 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, as they could indicate a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus color.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 patients)

• Restlessness, agitation, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (feeling unwell).
• Rapid heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of the muscles in the airways, causing "wheezing"). If wheezing occurs suddenly right after using Symbicort, stop using it and consult your doctor immediately.
• Low levels of potassium 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 tightness (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 normal production of steroid hormones, especially if high doses are used for long periods. These effects include:

• changes in bone mineral density (thinning of the bones)

• cataracts (loss of transparency of the lens in the eye)

• glaucoma (increased eye pressure)

• growth retardation in children and adolescents

• effects on the adrenal glands (small glands located above the kidneys).

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Symbicort

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, the aluminium pouch, or the label after EXP. The expiry date refers to the last day of the month indicated.
• As with most pressurized inhaled medicines, the effect of this medicine may decrease when the container is cold. For optimal performance, the medicine should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• The inhaler should be used within 3 months after removing it from the aluminium pouch. Write the expiry date (3 months from opening the pouch) on the inhaler label to remind you when to stop using the inhaler.
• Always replace the mouthpiece cap and close it properly after using the inhaler.
• Medicines must not be disposed of via wastewater or household waste. Return used containers and unused medicines to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

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

6. Contents of the pack and other information

Composition of Symbicort

The active substances 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 medicine contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of apaflurane (HFC-227ea), equivalent to 0.034 tonnes of CO2 (global warming potential GWP = 3,220).

Nature of the product and contents of the pack

Symbicort is an inhaler containing your medicine. The pressurized canister with attached dose indicator contains a white suspension for inhalation. The canister is fitted into 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 packed in an aluminium foil pouch containing a desiccant.

Symbicort 160 micrograms/4.5 micrograms/inhalation, suspension for inhalation in pressurized container (budesonide/formoterol fumarate dihydrate) is available in packs containing one inhaler.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder is:

Laboratorio AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The Manufacturer is:

AstraZeneca Dunkerque Production

224, Avenue de la Dordogne BP 41

59640 Dunkerque (France)

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

Date of the last review of this leaflet: January 2025

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