Symbicort Turbuhaler 160 micrograms/4.5 micrograms/inhalation powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Symbicort Turbuhaler 160 micrograms/4.5 micrograms/inhalation powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read the entire leaflet carefully before you start using this medicine, as 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 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 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 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

Symbicort Turbuhaler may be prescribed for asthma in two different ways.

• Some patients are prescribed two different inhalers: Symbicort Turbuhaler and another 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 more easily.

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

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

Chronic Obstructive Pulmonary Disease (COPD)

Symbicort Turbuhaler can also be used to treat symptoms of COPD in adults. COPD is a chronic lung airway disease, usually caused by smoking.

2. What you need to know before using Symbicort Turbuhaler

Do not use Symbicort Turbuhaler:

• if you are allergic to budesonide, formoterol, or to 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 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 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 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 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 Turbuhaler unless your doctor tells you to.
• If you become pregnant while being treated with Symbicort Turbuhaler, do not stop using it and consult your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Symbicort Turbuhaler.

Driving and using machines

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

Symbicort Turbuhaler contains lactose

Symbicort 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 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 or COPD symptoms at that time.
• If you are using Symbicort Turbuhaler for asthma, your doctor will want to regularly monitor 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 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 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 or COPD 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 is worsening or you often wake up at night with asthma symptoms.
• You begin to experience chest tightness in the morning, or chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled, and you may need 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 occurrence of asthma symptoms.

Adults (aged 18 years and over)

• 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 (aged 12 to 17 years)

• 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.

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

Symbicort 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 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 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 helps prevent the occurrence 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.

Your doctor may increase your dose to 2 inhalations twice daily.

Also use Symbicort Turbuhaler 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 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 regularly 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. It is important that you discuss with your doctor the use of Symbicort Turbuhaler to prevent asthma symptoms; both the frequency of your exercise and the frequency of your exposure to allergens could influence the treatment prescribed for you.

Chronic obstructive pulmonary disease (COPD)

• Use only in adults (over 18 years of age).
• The usual dose is 2 inhalations twice daily.

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

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 unscrewing the cap.
• Hold your Symbicort 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 (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.
• Your Symbicort Turbuhaler inhaler is now loaded and ready for use.

How to inhale

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

1. Unscrew and lift the cap covering the Turbuhaler. You will hear a small “click” when unscrewing the cap.
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 into your Symbicort Turbuhaler inhaler, 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. Your Symbicort Turbuhaler inhaler is now 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 from your mouth (without discomfort). Do not blow through your Symbicort Turbuhaler inhaler.
2. Gently place the mouthpiece 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 that you have inhaled the dose and that the medicine 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 your 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 become detached from the inhaler.

As with all inhalers, caregivers must ensure that children prescribed Symbicort Turbuhaler correctly perform the inhalation technique 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 you the number of doses (inhalations) remaining in your Symbicort Turbuhaler inhaler, starting from 30, 60, or 120 doses when full.

• The dose indicator is marked in intervals of 10 doses (for 60- and 120-dose inhalers) and in intervals of 15 doses (for the 30-dose inhaler). Therefore, the dose indicator does not show every single dose.
• 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 drying agent, 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 stated in this leaflet or the one 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. Telephone: 91 5620420, stating the medicine and the amount ingested.

If you forget to use Symbicort Turbuhaler

• If you miss a dose of Symbicort Turbuhaler, resume your 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 not take a double dose to make up for missed doses.

If you have any other 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 sudden feeling of faintness, which may indicate you are having an allergic reaction. This is rare, 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 Symbicort Turbuhaler immediately and use your "reliever inhaler". Contact your doctor immediately, as you may need to change your treatment. This is very rare, affecting fewer than 1 in 10,000 patients.

Other possible adverse effects:

Common (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.
• Pneumonia (lung infection) in patients with COPD.

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

• Fever or chills.
• Increased mucus production, change in mucus color.
• Worsening cough or increased 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 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, especially in children.
• Pain or tightness in the chest (angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the body's normal production of steroid hormones, 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 lens)
• glaucoma (increased pressure in the eye)
• growth retardation in children and adolescents
• effects on the adrenal glands (small glands located next to 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. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Symbicort Turbuhaler

The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

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

Appearance of the product and contents of the pack

Symbicort Turbuhaler is an inhaler containing your medicine. The inhalation powder is white. Each inhaler contains 30, 60, or 120 doses and consists of a white body and a red rotating screw. The rotating screw features 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 containing 1 inhaler with 30 doses, or in packs containing 1, 2, 3, 10, or 18 inhalers with 60 or 120 doses.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization 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 European Economic Area member states under the following names:

Germany: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; Austria: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; Belgium: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; Bulgaria: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Cyprus: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Croatia: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Denmark: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Slovakia: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Slovenia: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Spain: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation powder for inhalation; Estonia: Symbicort Turbuhaler 160 μg/4.5 μg; Finland: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; France: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Greece: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Netherlands: Symbicort Turbuhaler 200 μg/6 μg/inhalation; Hungary: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Ireland: Symbicort Turbohaler 200 μg/6 μg/inhalation; Iceland: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Italy: Symbicort 160 μg/4.5 μg/inhalation; Latvia: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Lithuania: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Luxembourg: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; Malta: Symbicort Turbohaler 200 μg/6 μg/inhalation; Norway: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Poland: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Portugal: Symbicort Turbohaler 160 μg/4.5 μg/inhalation; United Kingdom: Symbicort Turbohaler 200 μg/6 μg/inhalation; Czech Republic: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Romania: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation; Sweden: Symbicort Turbuhaler 160 μg/4.5 μg/inhalation

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

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/

You can access detailed and up-to-date information on how to administer this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access the same information at the following internet address: https://cima.aemps.es/info/63958

Area for the two-dimensional code