Symbicort 80 micrograms/2.25 micrograms/inhalation suspension for inhalation under pressure

Patient Information Leaflet

Introduction

Patient Information Leaflet

Symbicort 80 micrograms/2.25 micrograms per inhalation, suspension for inhalation in pressurised container

Budesonide/formoterol fumarate dihydrate

Please read all of this 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are 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

What Symbicort is

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

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

What Symbicort is used for

Symbicort is used to treat asthma and may be prescribed either alone or together with another separate "reliever" inhaler:

Some patients are prescribed two inhalers for asthma: the Symbicort inhaler and a separate "reliever" inhaler:

• They use Symbicort daily, which helps prevent asthma symptoms from occurring.
• They use their "reliever inhaler" when they experience asthma symptoms to help them breathe more easily.

Some patients are prescribed Symbicort as the only inhaler for asthma:

• They use Symbicort daily, which helps prevent asthma symptoms from occurring.
• They also use Symbicort when they need additional doses to relieve asthma symptoms, helping them breathe more easily and, if agreed with their doctor, also to prevent asthma symptoms (for example, when exercising or when exposed to other allergens). They do not need a separate inhaler for this purpose.

How Symbicort works

• Budesonide works by reducing and preventing inflammation in the lungs.
• Formoterol fumarate dihydrate works by relaxing the muscles in the airways, helping you breathe more easily.

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

Talk to 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 heart disease (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.

Talk to your doctor if you experience blurred vision or other visual disturbances while using Symbicort.

Children

Do not use this medicine in children under 12 years of age.

Use in athletes

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

Other medicines and Symbicort

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

• Beta-blockers for high blood pressure, such as atenolol or propranolol.
• Eye drops, such as timolol for glaucoma.
• Medicines to treat a fast or irregular heartbeat, such as quinidine.
• Medicines such as digoxin, commonly used to treat heart failure.
• Diuretics for the treatment of high blood pressure, such as furosemide.
• Oral steroid medicines, such as prednisolone.
• Xanthine medicines, such as theophylline or aminophylline. These are commonly used to treat asthma.
• Other bronchodilators, such as salbutamol.
• Antidepressants, such as amitriptiline and nefazodone.
• Phenothiazine medicines, such as chlorpromazine and prochlorperazine.
• Medicines to treat HIV infection, such as ritonavir.
• 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 and breastfeeding

• Inform your doctor before using this medicine if you are pregnant or planning to become pregnant. Consult your doctor before using Symbicort – 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 contact your doctor immediately.
• If you are breastfeeding, talk to your doctor before using Symbicort.

Driving and using machines

The influence of Symbicort on the ability to drive and use machines is none or

negligible.

3. How to use Symbicort

Follow exactly the instructions for administering this medicine as 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 asthma symptoms at that time.
• Your doctor will want to regularly check how your asthma symptoms are progressing.
• Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before surgery).

Symbicort may be prescribed for asthma either alone or together with a separate reliever inhaler. You should take two inhalations of Symbicort to obtain a full dose. The amount of Symbicort you should use and when to use it will depend on what has been prescribed for you.

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

a) Use of Symbicort and another separate inhaler for symptom relief

Use Symbicort daily. This helps prevent asthma symptoms.

Adults (over 18 years)

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

Adolescents (12 to 17 years)

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

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

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

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

b) Use of Symbicort as the only inhaler for asthma

Use Symbicort in this way only if your doctor has instructed you to do so and if you are over 12 years old.

Use Symbicort daily. This helps prevent the onset of asthma symptoms. You may take:

• 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 daily.

Also use Symbicort as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent the onset of asthma symptoms (for example, during exercise or exposure to allergens).

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

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

Normally, a daily dose higher than 16 inhalations is not required. However, your doctor may allow you to take up to 24 inhalations per day for a limited period.

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

Do not take more than 24 inhalations in 24 hours.

If you are exercising and notice asthma symptoms, use Symbicort as described here. It is important that you talk to your doctor about using Symbicort to prevent asthma symptoms; both the frequency of your exercise and your exposure to allergens could 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 oral steroid tablets for a long time, your doctor may want to carry out occasional blood tests. When your dose of oral steroid tablets is reduced, you may feel generally unwell, even though your lung symptoms may be improving. Symptoms may include:

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

Contact your doctor immediately if you experience symptoms such as:

• headache
• fatigue
• nausea
• vomiting.

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

Use in children

There are other formulations of this medicine 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 you wheeze, 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 is worsening or you often wake up at night with asthma symptoms.
• You start to feel chest tightness in the morning, or chest tightness lasts longer than usual.
• These signs may indicate that your asthma is not adequately controlled, and you may need a different or additional treatment immediately.

Information about your new Symbicort inhaler

• Before using your new Symbicort inhaler, remove it from the aluminium foil wrapper. Discard both the wrapper and the desiccant inside the wrapper. Do not use the inhaler if the desiccant has come out of the package.
• The inhaler should be used within 3 months after removal from the aluminium foil wrapper. Write the expiry date (3 months from removal from the wrapper) in the blank space provided on the inhaler label, to remind you when to stop using the inhaler.
• The image shows the parts of the inhaler, which will already be assembled when you receive it. If the container becomes loose, reinsert it into the inhaler and continue using it.

Preparing Symbicort

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

• If you are using your new Symbicort 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 sides. The cap strap will remain attached to the inhaler.
3. Hold the inhaler in an upright position. Then press the dose counter (on the top of the inhaler) to release a spray into the air. You may use one or both hands, as shown in the pictures.
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 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 gently pressing the protrusions on the sides. Check that the mouthpiece is not blocked.
3. Hold the inhaler in an upright position (you may use one or both hands). Breathe out gently.
4. Gently place the mouthpiece between your teeth. Close your lips.
5. Breathe in slowly and deeply through your mouth. Firmly press the counter (on the top of the inhaler) to release a spray. Hold your breath momentarily while pressing the counter. Breathe in at the same time as pressing 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 inhalation, 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 the 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 liquids.
• Do not separate the cartridge from the inhaler.

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

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

• Each time you take an inhalation or release a spray into the air, the arrow begins counting down towards zero ('0').

• When the arrow first enters the yellow area, approximately 20 inhalations remain.

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

If you use more Symbicort than you should

It is important 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 following an overdose may include tremors, headache, and rapid heartbeat.

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

If you forget to use Symbicort

• If you forget one of your Symbicort doses, take the recommended dose 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 forgotten doses.

If you stop using Symbicort

Before stopping the use of Symbicort, you must consult your doctor or pharmacist. If you stop using Symbicort, your asthma symptoms 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 will experience 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 breathing difficulties (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 breathing difficulties immediately after using your Symbicort inhaler. If you experience any of these symptoms, stop using Symbicort immediately and use your separate "reliever inhaler" if available. Consult 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:

Frequent (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 each morning and evening dose of Symbicort.
• Mild throat irritation, cough, hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (feeling unwell).
• Fast 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 immediately 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 behaviour, particularly in children.
• Chest pain or tightness (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 normal production of steroid hormones in the body, 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 eye lens)
• 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 effect, talk to your doctor or pharmacist, even if it is an effect 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, aluminum pouch, or cartridge label after “EXP”. The expiry date refers to the last day of the month indicated.
• The inhaler should be used within 3 months after removing it from the aluminum pouch. Please write the expiry date (3 months from the date of opening the pouch) in the blank space provided on the inhaler label to remind you when to stop using the inhaler.
• As with most pressurized inhaled medicines, the effect of this medicine may be reduced when the canister is cold. For best results, the medicine should be at room temperature before use.
• Do not refrigerate or freeze. Protect from frost and direct sunlight.
• Always replace the mouthpiece cap and snap it into place after using the inhaler.
• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging 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 cartridge. 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 80 micrograms of budesonide and 2.25 micrograms of formoterol fumarate dihydrate.

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

This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.8 g of apaflurane (HFC-227ea), equivalent to 0.035 tonnes of CO2 (global warming potential GWP = 3,220).

Appearance of the product and contents of the pack

Symbicort is an inhaler containing your medicine. The medicine, a white-coloured inhalation suspension, is contained in a pressurised cartridge with an attached dose indicator. The cartridge is fitted into a red plastic adapter with a white plastic mouthpiece and an integrated grey plastic cap. Each inhaler contains 60 or 120 inhalations after it has been prepared for use. Each inhaler is individually packed in an aluminium foil pouch containing a desiccant.

Symbicort 80 micrograms/2.25 micrograms/inhalation pressurised inhalation suspension (budesonide/formoterol fumarate dihydrate) is available in packs containing one inhaler.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer:

AstraZeneca Dunkerque Production

224, Avenue de la Dordogne BP 41

59640 Dunkerque (France)

This medicine is authorised in the Member States of the European Economic Area under 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;
Estonia: 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: Symbicort aërosol 100/3, 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

Date of the most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/