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

Package leaflet: Information for the user

Introduction

Package 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 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, consult 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.

Leaflet contents

1. What Symbicort forte Turbuhaler is and what it is used for
2. What you need to know before using Symbicort forte Turbuhaler
3. How to use Symbicort forte Turbuhaler
4. Possible side effects
5. How to store Symbicort forte Turbuhaler
6. Contents of the pack and other 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 aged 12 to 17 years. 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 medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called "corticosteroids" and works by reducing and preventing inflammation in your 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.

Asthma

For asthma, your doctor will prescribe two different inhalers: Symbicort forte Turbuhaler and a separate reliever inhaler for symptom relief.

• Use Symbicort forte Turbuhaler daily, as it helps prevent asthma symptoms from occurring.
• Use your reliever inhaler when you have asthma symptoms, to help you breathe more easily.

Do not use Symbicort forte Turbuhaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Symbicort forte Turbuhaler may also be used for the treatment of COPD symptoms in adults. COPD is a chronic lung airway disease, usually caused by smoking.

2. What you need to know before using Symbicort forte Turbuhaler

Do not use Symbicort forte Turbuhaler:

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

Warnings and precautions

Talk to 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 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 result in a positive doping test.

Other medicines and Symbicort forte Turbuhaler

Tell 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-blocking medicines (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 for asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “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 forte Turbuhaler.

Also inform your doctor or pharmacist if you are due to have 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 forte Turbuhaler unless instructed by your doctor.
• If you become pregnant while being treated with Symbicort forte Turbuhaler, do not stop using it and consult your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Symbicort forte Turbuhaler.

Driving and using machines

The effect of Symbicort forte Turbuhaler on the ability to drive and use machines is negligible or none.

Symbicort forte Turbuhaler contains lactose

Symbicort forte Turbuhaler contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this medicine. The amount of lactose in this medicine is usually not high enough to cause problems in people with lactose intolerance.

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

3. How to use Symbicort forte Turbuhaler

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

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 perform a blood test from time to time. You may feel generally unwell when your dose of oral steroids is reduced, even though your lung symptoms may be improving. In such cases, some symptoms such as nasal congestion or runny nose, weakness or pain in muscles and joints, and skin rash (urticaria) may temporarily reappear. If any of these symptoms concern you, or if you experience others such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. If allergic or arthritic symptoms develop, you may need to take another medicine. 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 usual treatment during periods of stress (for example, 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 worsens or you often wake up at night with asthma symptoms.
• You begin 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 a different or additional treatment immediately.

Asthma

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

Adults (18 years and older)

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

Adolescents (12 to 17 years of age)

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

A lower concentration of Symbicort Turbuhaler is available for children aged 6–11 years.

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

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 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 forte Turbuhaler to treat asthma symptoms; instead, use your reliever inhaler.

Chronic obstructive pulmonary disease (COPD)

• Use only in adults (over 18 years of age).
• The usual dose is 1 inhalation, twice daily.

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

Preparing your new Symbicort forte Turbuhaler inhaler

Before using your new Symbicort forte Turbuhaler inhaler for the first time, prepare it as follows:

• Unscrew and lift the cap covering the Turbuhaler. You will hear a slight "click" when unscrewing the cap.
• Hold your Symbicort forte Turbuhaler inhaler upright with the red screw at the bottom.
• Turn the red screw fully in one direction, then turn it fully in the opposite direction (the order does not matter). In one of these two directions, you will hear a characteristic "click." It does not matter whether the "click" is heard during the first or second turn.
• Turn the red screw fully in both directions again.
• Your Symbicort forte Turbuhaler inhaler is now loaded and ready for use.

How to inhale

Each time you need to inhale, follow these instructions:

1. Unscrew and lift the cap covering the Turbuhaler. You will hear a slight "click" when unscrewing the cap.
2. Hold your Symbicort forte Turbuhaler inhaler with the red screw at the bottom.

3. Do not hold the mouthpiece when loading your Symbicort forte Turbuhaler inhaler. To load a dose, turn the red screw fully in one direction.

Then turn it fully in the opposite direction (the order does not matter). In one of these two directions, you will hear a characteristic "click." It does not matter whether the "click" is heard during the first or second turn. Your Symbicort forte Turbuhaler inhaler is now ready for use. Only load your Symbicort forte Turbuhaler inhaler when you are about to use it.

4. Keeping your Symbicort forte Turbuhaler inhaler away from your mouth, slowly exhale from your mouth (without discomfort). Do not blow through the Symbicort forte Turbuhaler inhaler.
5. Place the mouthpiece gently between your teeth, close your lips around it, and inhale strongly and deeply through your mouth. Do not bite or press hard on the mouthpiece.

6. Remove the Symbicort forte Turbuhaler inhaler from your mouth and exhale gently. The amount of inhaled medicine is very small, meaning you may not taste anything after inhalation. However, if you have followed the instructions correctly, you can be sure that you have inhaled the dose and that the medicine has reached your lungs.
7. If you need to take another inhalation, repeat steps 2 to 6.
8. Replace the cap firmly after use.

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

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

As with all inhalers, caregivers must ensure that children prescribed Symbicort forte Turbuhaler use the correct inhalation technique as described above.

Cleaning your Symbicort forte Turbuhaler inhaler

Clean the outside of the mouthpiece once a week with a dry cloth. Do not use water or liquids.

When to start using a new inhaler

• The dose indicator shows the number of doses (inhalations) remaining in your Symbicort forte Turbuhaler inhaler, starting from 60 doses when full.

• The dose indicator is marked in intervals of 10 doses, so not every dose is displayed.
• When a red background first appears at the edge of the indicator window, approximately 20 doses remain. When the last 10 doses remain, the background of the indicator window turns red. When the "0" reaches the middle of the window, you should start using a new Symbicort forte Turbuhaler inhaler.

Note:

• Even when your Symbicort forte Turbuhaler inhaler is empty, the screw will still turn and you will still hear the characteristic "click."
• The sound heard when shaking your Symbicort forte Turbuhaler inhaler is not from the medication but from a drying agent, so it does not indicate how much medication remains in the inhaler.
• If you accidentally load your Symbicort forte Turbuhaler inhaler more than once before inhaling your dose, you will still inhale only one dose, although the indicator will count all loaded doses.

If you use more Symbicort forte Turbuhaler than you should

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

The most common symptoms and signs following an overdose are tremors, headache, and rapid heartbeat.

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

If you forget to use Symbicort forte Turbuhaler

• If you forget a dose of Symbicort forte Turbuhaler, 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 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 forte Turbuhaler 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 sudden feeling of collapse, which may indicate you are having 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 your Symbicort forte Turbuhaler inhaler immediately and use your "reliever inhaler". Contact your doctor immediately, as you may need to change your treatment. 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. When these effects occur, they are usually mild and disappear with continued use of Symbicort forte Turbuhaler.
• Oral 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.

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

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

Uncommon (may affect up to 1 in 100 patients)

• Restlessness, agitation, 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 this occurs suddenly right after using Symbicort forte Turbuhaler, stop using it and consult your doctor immediately.
• Low blood potassium levels.
• Irregular heartbeat.

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

• Depression.
• Changes in behaviour, 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 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 (reduced bone strength)
• 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 forte Turbuhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging or on the label of your inhaler, following EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Symbicort forte Turbuhaler

The active substances 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 contents of the pack

Symbicort forte Turbuhaler is an inhaler containing your medicine. The inhalation powder is white in colour. Each inhaler contains 60 doses and consists of a white body and a red rotating mouthpiece. The rotating mouthpiece includes a Braille code with the number 6 as the identifying digit, to distinguish it from other AstraZeneca inhaled medicines.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2021

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/