SYMBICORT FORTE TURBUHALER 320 micrograms/9 micrograms INHALATION POWDER

Introduction

Leaflet: information for the user

Symbicort forte Turbuhaler 320 micrograms/9 micrograms/inhalation powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read the entire leaflet carefully before starting to use this medication 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Symbicort forte Turbuhaler is and what it is used for
2. What you need to know before starting to use Symbicort forte Turbuhaler
3. How to use Symbicort forte Turbuhaler
4. Possible side effects
5. Storage of Symbicort forte Turbuhaler
6. Package contents and additional information

1. What Symbicort forte Turbuhaler is and what it is used for

Symbicort forte Turbuhaler is an inhaler used for the treatment of asthma in adults and adolescents between 12 and 17 years of age. It is also used for the symptomatic treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults over 18 years of age. It contains two different medications: budesonide and formoterol fumarate dihydrate.

It is used to treat asthma and COPD.

• Budesonide belongs to a group of medications called "corticosteroids", and it works by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medications called "long-acting beta2 adrenergic agonists" or "bronchodilators", and it works by relaxing the muscles of the airways, making it easier for you to breathe.

Asthma

For asthma, your doctor will prescribe two different inhalers: Symbicort forte Turbuhaler and another inhaler for "relief of symptoms".

• Use Symbicort forte Turbuhaler daily, as it helps prevent the onset of asthma symptoms.
• Use your "reliever inhaler" when you experience asthma symptoms, to facilitate breathing.

Do not use Symbicort forte Turbuhaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Symbicort forte Turbuhaler can also be used to treat COPD symptoms in adults. COPD is a chronic disease of the pulmonary airways, usually caused by smoking.

2. What you need to know before starting to use Symbicort forte Turbuhaler

Do not use Symbicort forte Turbuhaler:

• if you are allergic to budesonide, formoterol, or any other component of this medication (listed in section 6), which includes lactose (containing small amounts of milk proteins).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Symbicort forte Turbuhaler 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, narrowing of the arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low potassium levels in your blood.
• You have severe liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

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

Other medications and Symbicort forte Turbuhaler

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

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

• Beta-blocker medications (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medications to treat rapid or irregular heartbeat (such as quinidine).
• Medications like digoxin, commonly used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Oral steroid medications (such as prednisolone).
• Xanthine medications (such as theophylline or aminophylline), commonly used for 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 AIDS.
• Medications for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medications for Parkinson's disease (such as levodopa).
• Medications 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 forte Turbuhaler.

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

The influence of Symbicort forte Turbuhaler on the ability to drive and use machines is negligible.

Symbicort forte Turbuhaler contains lactose

Symbicort forte Turbuhaler contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication. The amount of lactose in this medication is not normally expected to cause problems in people with lactose intolerance.

The excipient lactose contains small amounts of milk proteins that may cause allergic reactions in patients with cow's milk protein allergy.

3. How to use Symbicort forte Turbuhaler

• Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
• It is essential to use Symbicort forte Turbuhaler daily, even if you do not have symptoms of asthma or COPD at that time.
• If you are using Symbicort forte Turbuhaler for asthma, your doctor will want to check your symptoms regularly.

If you have been taking steroid tablets for asthma or COPD, your doctor may reduce the number of tablets you take once you start treatment with Symbicort forte Turbuhaler. If you have been taking oral steroid tablets for a long time, your doctor may want to do a blood test from time to time. You may feel unwell when your oral steroid tablets are reduced, even if your lung symptoms are improving. In this case, some symptoms like nasal congestion or runny nose, weakness or muscle and joint pain, and skin rash (hives) may temporarily reappear. If any of these symptoms concern you, or if you experience others like headache, fatigue, nausea, or vomiting, contact your doctor immediately. If allergic or arthritic symptoms develop, you may need to take another medication. You should consult your doctor if you are concerned about whether you should continue using Symbicort forte Turbuhaler.

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

Important information about asthma or COPD symptoms

If while using Symbicort forte Turbuhaler you experience difficulty breathing or 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 is getting worse or you wake up often at night with asthma symptoms.
• You start to feel chest tightness in the morning, or the chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled, and you may need immediate different or additional treatment.

Asthma

Use Symbicort forte Turbuhaler daily, as it helps prevent the onset of asthma symptoms.

Adults (from 18 years)

• The usual dose is 1 inhalation, twice a day.
• Your doctor may prescribe up to a maximum of 2 inhalations, twice a day.
• If your symptoms are well-controlled, your doctor may ask you to use the medication once a day.

Adolescents (from 12 to 17 years of age)

• The usual dose is 1 inhalation, twice a day.
• If your symptoms are well-controlled, your doctor may ask you to use the medication once a day.

There is a lower concentration of Symbicort Turbuhaler for children aged 6-11 years.

Symbicort forte Turbuhaler is not recommended for use in children under 6 years of age.

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 the dose without talking to your doctor or nurse first.

Use your other "reliever inhaler" when asthma symptoms appear.Always carry this "reliever inhaler" with you to use when needed. Do not use Symbicort forte Turbuhaler to treat asthma symptoms, but use your reliever inhaler instead.

Chronic Obstructive Pulmonary Disease (COPD)

• Use only in adults (over 18 years).
• The usual dose is 1 inhalation, twice a day.

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

Preparing your new Symbicort forte Turbuhaler inhaler

Before using your newSymbicort forte Turbuhaler inhaler for the first time, you must prepare it as follows:

• Unscrew and lift the cap that covers the Turbuhaler. You will hear a small "click" when you unscrew the cap.
• Hold your Symbicort forte Turbuhaler inhaler upright with the red lock at the bottom.
• Turn the red lock all the way in one direction and then turn it all the way in the other direction (it does not matter which direction first). In one of the two directions, you should hear a characteristic "click".
• Turn the red lock in both directions again.
• At this point, your Symbicort forte Turbuhaler inhaler is now loaded and ready to use.

How to take an inhalation

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

1. Unscrew and lift the cap that covers the Turbuhaler. You will hear a small "click" when you unscrew the cap.
2. Hold your Symbicort forte Turbuhaler inhaler with the red lock at the bottom.

1. Do not hold the mouthpiece when loading your Symbicort forte Turbuhaler inhaler. To load it with a dose, turn the red lock all the way in one direction.

Then turn it all the way in the other direction (it does not matter which direction first). In one of the two directions, you should hear a characteristic "click". It does not matter if the "click" is heard on the first or second turn. At this point, your Symbicort forte Turbuhaler inhaler is ready to use. Load your Symbicort forte Turbuhaler inhaler only when you are about to use it.

1. Keeping your Symbicort forte Turbuhaler inhaler away from you, slowly breathe out (without discomfort). Do not blow through the Symbicort forte Turbuhaler inhaler.
2. Place the mouthpiece gently between your teeth, close your lips, and breathe in forcefully and deeply through your mouth. Do not bite or press hard on the mouthpiece.

1. Remove your Symbicort forte Turbuhaler inhaler from your mouth and breathe out gently. The amount of medication inhaled is very small, so you may not notice any taste after inhalation. However, if you have followed the instructions, you can be sure that you have inhaled the dose and that the medication has reached your lungs.
2. If you need to take another inhalation, repeat steps 2 to 6.
3. Replace the cap firmly after use.

1. Rinse your mouth with water after the daily morning and/or evening doses. Do not swallow.

Do not attempt to remove the mouthpiece or turn it unnecessarily, as it is fixed to the Symbicort forte Turbuhaler inhaler and should not be removed. Do not use the Symbicort forte Turbuhaler inhaler if it is damaged or if the mouthpiece has come off the Symbicort forte Turbuhaler inhaler.

As with all inhalers, caregivers should ensure that children prescribed Symbicort forte Turbuhaler perform the inhalation technique correctly, as described above.

Cleaning your Symbicort forte Turbuhaler inhaler

Clean the outside of the mouthpiece once a week with a dry cloth, without using water or liquids.

When to start using a new inhaler

• The dose indicator tells you about the number of doses (inhalations) left in your Symbicort forte Turbuhaler inhaler, starting from 60 doses when it is full.

• The dose indicator is marked in intervals of 10 doses, so not all doses are shown.
• When the red background first appears on the edge of the indicator window, there are approximately 20 doses left. When there are fewer than 10 doses left, the background of the indicator window is red; when the 0 has reached the middle of the window, you should start using a new Symbicort forte Turbuhaler inhaler.

Note:

• Although your Symbicort forte Turbuhaler inhaler is empty, the lock will continue to turn, and you will still hear the characteristic "click".
• The sound you hear when you shake your Symbicort forte Turbuhaler inhaler is not produced by the medication but by a desiccant, so it will not indicate how much medication is left in your Symbicort forte Turbuhaler inhaler.
• If you load your Symbicort forte Turbuhaler inhaler more than once by mistake before inhaling your dose, you will still inhale a single dose, although the indicator will count all the doses loaded.

If you use more Symbicort forte Turbuhaler than you should

It is essential to use the dose indicated in the leaflet or prescribed by your doctor. Do not increase your dose without consulting your doctor.

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: 91 5620420, indicating the medication and the amount ingested.

If you forget to use Symbicort forte Turbuhaler

• If you forget any of the Symbicort forte Turbuhaler 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 make up for missed doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Your face swells, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives along with breathing difficulties (angioedema) and/or a sudden feeling of fainting, indicating that you may be suffering 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 you experience any of these symptoms, stop using your Symbicort forte Turbuhaler inhaler immediately and use your "relief inhaler". Contact your doctor immediately, as you may need to change your treatment.This occurs very rarely, affecting less than 1 in 10,000 patients.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 patients)

• Palpitations (noticing heartbeats), tremors. When these effects appear, they are usually mild and disappear when continuing to use your Symbicort forte Turbuhaler.
• Thrush (fungal infection) in the mouth; this effect is less likely if you rinse your mouth with water after using your Symbicort Forte Turbuhaler inhaler.
• Mild throat irritation, cough, hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Tell your doctor if you experience any of the following symptoms while inhaling Symbicort forte Turbuhaler, as they may be symptoms of a lung infection:

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

Infrequent (may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Accelerated heart rate.
• Bruises on the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of the airway muscles, causing "wheezing"). If this occurs suddenly just after using Symbicort forte Turbuhaler, 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 tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant mouth taste.
• Changes in blood pressure.

Inhaled corticosteroids may affect the body's normal production of steroid hormones, especially when used in high doses for a long time. These effects include:

• changes in bone mineral density (bone thinning)
• cataracts (loss of lens transparency in the eye)
• glaucoma (increased eye pressure)
• growth retardation 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 corticosteroid tablets.

Reporting adverse effects

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

5. Storage of Symbicort forte Turbuhaler

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date shown on the packaging or on the label of your inhaler after EXP. The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Symbicort forte Turbuhaler

The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.

The excipient is lactose monohydrate (which contains milk proteins).

Appearance of the product and package contents

Symbicort forte Turbuhaler is an inhaler that contains your medicine. The inhalation powder is white. Each inhaler contains 60 doses and consists of a white body and a red rotary wheel. The rotary wheel contains a Braille code with the number 6 as an identification digit, to differentiate it from other AstraZeneca inhalation medicines.

Symbicort forte Turbuhaler is available in packages of 1, 2, 3, 10, or 18 inhalers, each containing 60 doses.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

The holder is:

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The manufacturer is:

AstraZeneca AB

S-151 36 Södertälje

Sweden

This medicine is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: February 2021

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