Symbicort Turbuhaler 80 micrograms/4.5 micrograms/inhalation powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Symbicort Turbuhaler 80 micrograms/4.5 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, 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 could 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 Turbuhaler is and what it is used for

2. What you need to know before using Symbicort Turbuhaler

3. How to use Symbicort Turbuhaler

4. Possible side effects

5. How to store Symbicort Turbuhaler

6. Contents of the pack and other information

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

Symbicort Turbuhaler is an inhaler used for the treatment of asthma in adults, adolescents, and children over 6 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 breathe more easily.

This medicine is not suitable for patients with severe asthma. It may be prescribed for asthma in two different ways.

• Some patients are prescribed two different inhalers: Symbicort Turbuhaler and a separate inhaler "for symptom relief".

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

• Some patients are prescribed Symbicort Turbuhaler as the only inhaler for their asthma.

  • They use Symbicort Turbuhaler daily, which helps prevent asthma symptoms from occurring.
  • They also use Symbicort Turbuhaler when they need additional doses to relieve asthma symptoms, helping them breathe, and do not require a separate inhaler for this purpose.

2. What you need to know before using Symbicort Turbuhaler

Do not use Symbicort 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 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, 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 cause a positive result in doping control tests.

Other medicines and Symbicort 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-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 for asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptiline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines known as “HIV protease inhibitors” (such as ritonavir) for the treatment of HIV virus.
• Medicines used 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 Turbuhaler.

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

The effect of Symbicort Turbuhaler on the ability to drive and operate machinery is negligible or none.

Symbicort Turbuhaler contains lactose

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

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

3. How to use Symbicort Turbuhaler

• Follow exactly the dosing 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 Turbuhaler 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.

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 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 the number of oral steroid tablets is reduced, even though your lung symptoms may be improving. In such cases, some symptoms may temporarily reappear, such as nasal congestion or runny nose, weakness or pain in muscles and joints, and skin rash (urticaria). 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 medication. You should consult your doctor if you are concerned about whether you should continue using Symbicort Turbuhaler.

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 asthma symptoms

If, while using Symbicort 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 start experiencing chest tightness in the morning, or the chest tightness lasts longer than usual.

These signs may indicate that your condition is not adequately controlled, and you may need a different or additional treatment immediately.

Asthma

Symbicort Turbuhaler may be prescribed for asthma in two different ways, so the amount to use and when to use it depends on how your doctor has instructed you:

• If your doctor has prescribed Symbicort Turbuhaler and another reliever inhaler separately, read section “a) Use of Symbicort Turbuhaler and another inhaler separately for symptom relief”.

• If your doctor has prescribed Symbicort Turbuhaler as the only inhaler, read section “b) Use of Symbicort Turbuhaler as the only inhaler for asthma”.

• Use of Symbicort Turbuhaler and another inhaler separately for symptom relief

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

Adults (from 18 years of age)

• The usual dose is 1–2 inhalations twice daily.
• Your doctor may prescribe up to a maximum of 4 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Adolescents (from 12 to 17 years of age)

• The usual dose is 1–2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Children (from 6 to 11 years of age)

• The usual dose is 2 inhalations twice daily.

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

• Use of Symbicort Turbuhaler as the only inhaler for asthma

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

Use Symbicort Turbuhaler daily, as it prevents the onset of asthma symptoms. You may use:

• 1 inhalation in the morning and 1 inhalation at night

or

• 2 inhalations in the morning

or

• 2 inhalations at night.

Also use Symbicort Turbuhaler as a “reliever inhaler” to treat asthma symptoms when they occur.

• If you have asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at one time.

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

Normally, a total daily dose greater than 8 inhalations is not required. However, your doctor may allow you to use up to 12 inhalations per day for a limited period.

If you routinely need to use 8 or more inhalations per day, see your doctor or nurse, as they may need to change your treatment.

Never exceed a total of 12 inhalations in 24 hours.

If you are exercising and notice asthma symptoms, use Symbicort Turbuhaler as described above. Do not use it immediately before exercise to prevent symptoms.

Preparing your new Symbicort Turbuhaler inhaler

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

• Unscrew and lift the cap covering the Turbuhaler. You will hear a small “click” when the cap is unscrewed.
• Hold your Symbicort Turbuhaler inhaler upright with the red screw at the bottom.
• Turn the red screw fully in one direction and then back fully in the other direction (it does not matter which direction first). In one of the 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.
• At this point, your Symbicort Turbuhaler inhaler is 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 small “click” when the cap is unscrewed.
2. Hold your Symbicort Turbuhaler inhaler upright with the red screw at the bottom.

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

Then turn it fully in the opposite direction (it does not matter which direction first). In one of the two directions, you will hear a characteristic “click.” It does not matter whether the “click” is heard during the first or second turn. At this point, your Symbicort Turbuhaler inhaler is ready for use. Only load your Symbicort Turbuhaler inhaler when you are about to use it.

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

1. Remove your Symbicort Turbuhaler inhaler from your mouth and breathe out gently. The amount of inhaled medication is very small, meaning you may not taste anything after inhalation. However, if you have followed the instructions correctly, you can be sure 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 morning and/or evening daily doses. Do not swallow the water.

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

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

Cleaning your Symbicort 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 Turbuhaler inhaler, starting from 120 doses when full.

• The dose indicator is marked in intervals of 10 doses, so not every dose is shown.
• 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 is completely red, and when the "0" reaches the middle of the window, you should start using a new Symbicort Turbuhaler inhaler.

Note:

• Even when your Symbicort Turbuhaler inhaler is empty, the red screw will still turn and you will still hear the characteristic “click.”
• The sound heard when shaking your Symbicort Turbuhaler inhaler is not from the medication but from a desiccant, so it does not indicate how much medication remains in the inhaler.
• If you accidentally load your Symbicort 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 Turbuhaler than you should

It is important 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, contact the Toxicology Information Service. Telephone: 91 5620420, stating the medicine and the amount ingested.

If you forget to use Symbicort Turbuhaler

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

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 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 a 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 breathing difficulties immediately after using your inhaler. If you experience any of these symptoms, stop using your Symbicort 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 Turbuhaler.
• Oral thrush (fungal infection in the mouth); this effect is less likely if you rinse your mouth with water after using Symbicort Turbuhaler.
• Mild throat irritation, cough, hoarseness.
• Headache.

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 Turbuhaler, 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).
• 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 eye's lens)
• 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 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 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 the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Symbicort Turbuhaler

The active substances are budesonide and formoterol. Each inhaled dose contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

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

Nature of the product and contents of the container

Symbicort Turbuhaler is an inhaler containing your medicine. The inhaled powder is white in colour. Each inhaler contains 120 doses and consists of a white body and a red rotating base. The rotating base has a Braille code with the number 6 as the identification digit, to distinguish it from other inhaled medicines from AstraZeneca.

Symbicort Turbuhaler is available in packs of 1, 2, 3, 10 or 18 inhalers, containing 60 or 120 doses. 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 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: December 2020

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