Product Information for the User

Symbicort 8080 micrograms/2.25micrograms/inhalation suspension for inhalation in a pressurized container

Budesonide/formoterol fumarate dihydrate

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

What is Symbicort

Symbicort is an inhaler used for the treatment of asthma in adults and adolescents between 12 and 17 years of age. It contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta2-adrenergic agonists” or “bronchodilators”.

What is Symbicort used for

Symbicort is used to treat asthma and may be prescribed alone or with another inhaler “for symptom relief” separately:

Some patients are prescribed two inhalers for asthma: the Symbicort inhaler and another inhaler separately “for symptom relief”

• They use Symbicort daily, which helps to prevent the occurrence of asthma symptoms.
• They use their “relief inhaler” when they experience asthma symptoms to facilitate breathing.

Some patients are prescribed Symbicort as a single inhaler for asthma

• They use Symbicort daily, which helps to prevent the occurrence of asthma symptoms.
• They also use Symbicort when additional doses are needed for symptom relief, facilitating breathing and, if agreed with the doctor, also to prevent the occurrence of asthma symptoms (for example, when exercising or exposed to other allergens). They do not need another inhaler separately for this purpose.

How Symbicort works

• Budesonide acts by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate acts by relaxing the muscles of the airways, which helps you to breathe more easily.

Do not use Symbicort:

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

Warnings and precautions

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

• Takes diabetes.
• Has any lung infection.
• Has high blood pressure, or has ever had any heart disease (including irregular heartbeats, rapid pulse, narrowed arteries, or heart failure).
• Has thyroid or adrenal gland problems.
• Has low potassium levels in the blood.
• Has severe liver problems.

Consult your doctor if you experience blurry vision or other visual disturbances while using Symbicort.

Children

Do not use this medication in children under 12 years.

Use in athletes

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

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:

• Medications beta-blockers for high blood pressure, such as atenolol or propranolol.
• Eye drops, such as timolol for glaucoma.
• Medications to treat rapid or irregular heartbeats, such as quinidine.
• Medications like digoxin, used regularly to treat heart failure.
• Diuretics for the treatment of high blood pressure, such as furosemide.
• Oral steroids, such as prednisolone.
• Xanthine medications, such as theophylline or aminophylline. They are commonly used to treat asthma.
• Other bronchodilators, such as salbutamol.
• Antidepressants, such as amitriptyline and nefazodone.
• Phenothiazine medications, such as chlorpromazine and prochlorperazine.
• Medications to treat HIV infection, such as ritonavir.
• 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 and breastfeeding

• Inform your doctor before using this medication if you are pregnant, or plan to become pregnant; Consult your doctor before using Symbicort - 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, talk to 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• It is essential to use Symbicort daily, even if you do not present signs of asthma at that moment.
• Your doctor will want to check regularly how your asthma symptoms are going.
• Your doctor may consider adding steroid tablets to your regular treatment during stressful periods (for example, when you have a chest infection or before surgery).

Symbicort may be prescribed for asthma alone or with another reliever inhaler. You must make two inhalations of Symbicort to get a complete dose. The amount of Symbicort you should use and when you should use it will depend on what you have been prescribed.

1. If you have been prescribed Symbicort and a separate reliever inhaler, read the section “a) Using Symbicort and another inhaler separately for symptom relief”.
2. If you have been prescribed Symbicort as a single inhaler, read the section “b) Using Symbicort as a single inhaler for asthma”.

a)Using Symbicort and another inhaler separately for symptom relief

Use Symbicort daily.This helps prevent asthma symptoms.

Adults (over 18 years)

• The usual dose is 2-4 inhalations, twice a day.
• Your doctor may prescribe up to a maximum of 8 inhalations, twice a day.
• If your asthma symptoms are well controlled, your doctor may ask you to use the medication once a day.

Adolescents (12-17 years)

• The usual dose is 2-4 inhalations, twice a day.
• If your asthma symptoms are well controlled, your doctor may ask you to use the medication once a day.

Your doctor (or nurse) will help you manage your asthma. They will adjust the dose of this medication to the lowest dose that controls your asthma. However, do not adjust or stop the dose without first talking to your doctor (or nurse).

Use your other “reliever inhaler” when asthma symptoms appear.

• Always keep this “reliever inhaler” with you so you can use it when you need it.
• Do not use Symbicort to treat asthma symptoms, but your reliever inhaler instead.

b)Using Symbicort as a single inhaler for asthma

Use Symbicort in this way only if your doctor has told you to and if you are over 12 years.

Use Symbicort daily. This helps prevent asthma symptoms. You can do:

• 2 inhalations in the morning and 2 inhalations at night.
• 4 inhalations in the morning.
• 4 inhalations at night.

Your doctor may increase the dose to 4 inhalations, twice a day.

Also use Symbicort as a “reliever” to treat asthma symptoms when they appear and to prevent asthma symptoms (for example, when exercising or exposed to allergens).

• If you have asthma symptoms, do 2 inhalations and wait a few minutes.
• If you do not feel better, do another 2 inhalations.
• Do not do more than 12 inhalations at a time.

Always keep your Symbicort inhaler with you so you can use it when you need it.

Normally, you do not need a daily dose of more than 16 inhalations. However, your doctor may allow you to do up to 24 inhalations a day for a limited period.

If you usually need to use 16 or more inhalations a day, go to your doctor or nurse, as they may need to change your treatment.

Do not do more than 24 inhalations in 24 hours.

If you are exercising and notice asthma symptoms, use Symbicort as described here. It is essential to talk to your doctor about using Symbicort to prevent asthma symptoms; both the frequency of your exercise and the frequency of your exposure to allergens may influence the treatment prescribed for you.

Symbicort and steroid tablets

If you have been taking steroid tablets for asthma, your doctor may reduce the number of tablets you take once you start treatment with Symbicort. If you have been taking steroid tablets orally for a long time, your doctor may want to do a blood test from time to time. When your doctor reduces the number of oral steroid tablets, you may feel general discomfort, even if your lung symptoms are improving. The symptoms may be:

• nasal congestion or dripping
• weakness
• joint or muscle pain
• skin rash (urticaria).

Consult your doctor immediately if you experience symptoms such as:

• headache
• fatigue
• nausea
• vomiting.

If you experience any of the above symptoms, consult your doctor immediately; you may need to take another medication. Talk to your doctorif you are concerned about whether you should continue using Symbicort.

Use in children

There are other presentations of this medication that are suitable for children; consult your doctor or pharmacist.

Important information about your asthma symptoms

If while using Symbicort you feel difficulty breathing or making a “whistling” sound with your breathing, you must continue using it and contact your doctor as soon as possible, as you may need additional treatment.

Consult your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma symptoms.
• You start feeling chest tightness in the morning, or the chest tightness lasts longer than usual.
• These signs may indicate that your asthma is not adequately controlledand you may need immediate different or additional treatment.

Information about your new Symbicort inhaler

• Before using your new Symbicort inhaler, take it out of the aluminum foil wrapper. Throw away the wrapper as well as the drying agent inside the wrapper. Do not use the inhaler if the drying agent has come out of the package.
• The inhaler must be used within 3 months of having taken it out of the aluminum foil wrapper. Write the expiration date (3 months from having taken it out of the wrapper) on the available space on the inhaler label to remind you when to stop using the inhaler.
• The image shows the parts that the inhaler is composed of, which will already be assembled when given to you. If the container comes loose, put it back in the inhaler and continue using it.

Preparing Symbicort

Symbicort 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 fallen.

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 cap from the mouthpiece 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 spray into the air. You can use one or both hands, as shown in the photos.
4. Remove 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 make an inhalation

Each time you need to make 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 cap from the mouthpiece 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 hand or both). Exhale gently.
4. Place the mouthpiece gently between your teeth. Close your lips.
5. Breathe in slowly and deeply through your mouth. Press the counter (on the top of the inhaler) firmly to release a spray. Hold your breath for a moment while pressing the counter. Breathe in 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 making another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3-7.
9. Put the cap back on the mouthpiece.
10. Wash your mouth with water after your daily morning and evening doses. Do not swallow.

Using a spacer chamber

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

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.
• Do not separate the cartridge from the inhaler.

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

• The counter on top tells you how many inhalations are left in your Symbicort inhaler. It starts with 60 or 120inhalations when it is full.

• Each time you make an inhalation, or release it into the air, the arrow starts a countdown to zero ('0').

• When the arrow enters the yellow area for the first time, it means there are about 20 inhalations left.

• When the arrow reaches the “0”, you must stop using your Symbicort inhaler. You may not feel that the inhaler is empty and it may seem to still work, but you will not receive the correct amount of medication if you continue using it.

If you use more Symbicort than you should

It is essential to inhale your dose as indicated on the pharmacist's label or as recommended by your doctor. Do not use more doses than prescribed without consulting your doctor.

If you have used more Symbicort than you should, consult your doctor or pharmacist. The most common symptoms and signs that may occur after an overdose are tremors, headache, and rapid heartbeat.

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

If you forgot to use Symbicort

• If you forget one of your Symbicort doses, 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 notuse a double dose to compensate for the missed doses.

If you interrupt treatment with Symbicort

Before stopping using Symbicort, you must consult your doctor or pharmacist. If you stop using Symbicort, your asthma symptoms 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:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or the appearance of hives accompanied by difficulty breathing (angioedema) and/or a sudden feeling of faintness, which indicates that you may be experiencing an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• Acute wheezing or difficulty breathing immediately after using your Symbicort inhaler.If any of these symptoms occur, stop using Symbicort immediately and use your "relief inhaler" if available. Consult your doctor immediately, as it may be necessary to change your treatment.This occurs very rarely, affecting fewer 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 to use Symbicort.
• Oral thrush (fungal infection); this effect is less likely if you rinse your mouth with water after your daily morning and evening doses of Symbicort.
• Mild throat irritation, cough, hoarseness.

• Dizziness.

Less frequent (may affect up to 1 in 100 patients)

• Restlessness, agitation, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Accelerated heart rate.
• Bruising on the skin.
• Muscle cramps.

• Blurred vision.

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

• Rash, itching.
• Asthma 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 (angina pectoris).
• Increased blood glucose levels.
• Alterations in taste, such as an unpleasant taste in the mouth.
• 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 intraocular 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 not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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 packet, or cartridge label after “CAD”. The expiration date is the last day of the month indicated.
• 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) in the blank space available on the inhaler label to remind you when to stop using the inhaler.
• 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.
• Always put the mouthpiece cap back on and reattach it to its position after using the inhaler.
• Medications should not be thrown away through drains or 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 122°F (50°C). Do not pierce the cartridge. 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 80micrograms of budesonide and 2.25micrograms 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 10.8g of apaflurane (HFC-227ea) corresponding to 0.035tonnes of CO2equivalent (global warming potential GWP = 3220).

Appearance of the product and contents of the package

Symbicort is an inhaler that contains its medication. The medication, a white inhalation suspension, is presented in a pressure cartridge with a dose indicator attached. The cartridge is mounted on a red plastic adapter with a white plastic mouthpiece and an integrated grey plastic cap.Each inhaler contains 60 or 120inhalations after it has been prepared for use.Each inhaler is individually packaged in an aluminum foil wrapper containing a desiccant.

Symbicort 80micrograms/2.25micrograms/inhalation inhalation suspension in a pressurized container (budesonide/formoterol fumarate dihydrate) is available in packages containing a single inhaler.

Only some package sizes may be commercially available.

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:

Austria: Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation Druckgasinhalation, Suspension; Belgium:Symbicort 80 microgram/2,25 microgram/inhalatie, aërosol, suspensie; Symbicort 80 microgrammes/2,25 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé; Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation, Druckgasinhalation, Suspension;Bulgaria:????????? 80 ??????????/2,25 ??????????/?????????? ????????? ??? ???????? ?? ?????????;Cyprus:Symbicort 80 μικρογραμμ?ρια/2,25 μικρογραμμ?ρια/ψεκασμ?;Croatia:Symbicort 80 mikrograma/2,25 mikrograma po potisku, stlaceni inhalat, suspenzija;Denmark:Symbicort 80 mikrogram/2.25 mikrogram/inhalation;Slovakia:Symbicort 80 mikrogramov/2,25 mikrogramov/inhalacná dávka,inhalacná suspenzia v tlakovom obale;Slovenia:Symbicort 80 mikrogramov/2,25 mikrograma na vdih, inhalacijska suspenzija pod tlakom;Spain: Symbicort 80 microgramos/2,25 microgramos/inhalación suspensión para inhalación en envase a presión;Estoniaa: Symbicort;Finland:Symbicort 80 mikrog/2.25 mikrog/inhalaatio; France: Symbicort 100/3 microgrammes par inhalation, suspension pour inhalation en flacon préssurisé; Greece:Symbicort 80 μικρογραμμ?ρια/2,25 μικρογραμμ?ρια/ψεκασμ?;Netherlands:Symbicortaërosol100/3, 100 microgram/3 microgram per dosis,aërosol, suspensie;Hungary: Symbicort 2,25 mikrogramm/80 mikrogramm/ adag túlnyomásos inhalációs szuszpenzió;Iceland:Symbicort 80 míkrógrömm/2,25 míkrógrömm/inhalation;Italy: Symbicort;Latvia:Symbicort 80 mikrogrami/2.25 mikrogrami/ inhalacija, izsmidzinajuma, aerosols inhalacijam zem spiediena;Lithuania:Symbicort 80 mikrogramu/2,25 mikrogramo/išpurškime suslegtoji ikvepiamoji suspensija;Luxembourg:Symbicort 80 microgrammes/2,25 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé;Malta:Symbicort 100 micrograms/3 micrograms/inhalation, pressurised inhalation, suspension;Norway:Symbicort 80 mikrogram/2.25 mikrogram/inhalasjon;Poland: Symbicort;Portugal:Symbicort 80 microgramas/2,25 microgramas/inalação Suspensão pressurizada para inalação;United Kingdom:Symbicort 100 micrograms/3 micrograms per actuation pressurised inhalation, suspension;Czech Republic:Symbicort 80 micrograms/2,25 micrograms/inhalation, suspension in pMDI;Romania: Symbicort 80 micrograme/2,25 micrograme/inhala?ie, suspensie de inhalat presurizata;Sweden:Symbicort 80 mikrogram/2.25 mikrogram/inhalation

Last review date of this leaflet: January 2025

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