RILAST TURBUHALER 80 micrograms/4.5 micrograms INHALATION POWDER

Introduction

Package Leaflet: Information for the User

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

Budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Rilast Turbuhaler is and what it is used for
2. What you need to know before you use Rilast Turbuhaler
3. How to use Rilast Turbuhaler
4. Possible side effects
   1. Storage of Rilast Turbuhaler

1. Contents of the pack and further information.

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

Rilast Turbuhaler is an inhaler used for the treatment of asthma in adults, adolescents, and children over 6 years. 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 your airways, making it easier to breathe.

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 inhalers: Rilast Turbuhaler and another inhaler for “relief of symptoms”.
• They use Rilast Turbuhaler every day to help prevent asthma symptoms from occurring.
• They use their “reliever inhaler” when they have asthma symptoms, to help them breathe more easily.

• Some patients are prescribed Rilast Turbuhaler as their only inhaler for asthma.
• They use Rilast Turbuhaler every day to help prevent asthma symptoms from occurring.
• They also use Rilast Turbuhaler when they need extra doses for relief of asthma symptoms, to help them breathe more easily, and do not need a separate inhaler for this purpose.

2. What you need to know before you use Rilast Turbuhaler

Do not use Rilast Turbuhaler:

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

Warnings and precautions

Consult your doctor or pharmacist before you start using Rilast Turbuhaler if:

• You have diabetes.

• You have a lung infection.

• You have high blood pressure or have ever had any heart problems (including irregular heartbeats, fast pulse, narrowing of the arteries, or heart failure).

• You have problems with your thyroid or adrenal glands.

• You have low levels of potassium in your blood.

• You have severe liver problems.

Consult your doctor if you have blurred vision or other visual disturbances.

Use in athletes

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

Using Rilast Turbuhaler with other medicines

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

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

• beta-blocker medicines (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);

• medicines to treat fast or irregular heartbeats (such as quinidine);

• medicines like digoxin, which are 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) for the treatment of HIV;

• medicines for treating 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 not sure, ask your doctor or pharmacist before using Rilast Turbuhaler.

Also, tell your doctor or pharmacist if you are going to have a general anesthetic for a surgical operation or for dental treatment.

Pregnancy, breastfeeding, and fertility

• Tell your doctor before using this medicine if you are pregnant, or planning to become pregnant; do not use Rilast Turbuhaler unless your doctor tells you to.
• If you become pregnant while using Rilast Turbuhaler, do not stop using it, and consult your doctor immediately.
• If you are breastfeeding, talk to your doctor before using Rilast Turbuhaler.

Driving and using machines

Rilast Turbuhaler has no or negligible influence on the ability to drive and use machines.

Rilast Turbuhaler contains lactose

Rilast Turbuhaler contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine. The amount of lactose in this medicine is normally not enough to cause problems in people who are intolerant to lactose.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions in patients who are allergic to milk proteins.

3. How to use Rilast Turbuhaler

• Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
• It is essential to use Rilast Turbuhaler daily, even if you do not have asthma symptoms at that time.
• Your doctor will want to check your asthma 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 Rilast 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 the number of oral steroid tablets is reduced, even if your lung symptoms are improving. In that case, some symptoms such as 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 any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor. 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 Rilast 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 an operation).

Important information about asthma symptoms:

If, while using Rilast 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 often wake up 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 disease is not adequately controlled, and you may need immediate different or additional treatment.

Asthma:

Rilast 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 indicated:

• If your doctor has prescribed Rilast Turbuhaler and another reliever inhaler separately, read the section "a) Using Rilast Turbuhaler and another reliever inhaler separately for symptom relief".

• If your doctor has prescribed Rilast Turbuhaler as the only inhaler, read the section "b) Using Rilast Turbuhaler as the only inhaler for asthma".

• Using Rilast Turbuhaler and another reliever inhaler separately for symptom relief:

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

Adults (from 18 years old):

• The usual dose is 1-2 inhalations, twice a day.
• Your doctor may prescribe up to a maximum of 4 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 old):

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

Children (from 6 to 11 years old):

• The usual dose is 2 inhalations, twice a day.

Rilast Turbuhaler is not recommended for children under 6 years old.

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 Rilast Turbuhaler to treat asthma symptoms, but use your reliever inhaler.

• Using Rilast Turbuhaler as the only inhaler for asthma:

Use Rilast Turbuhaler in this way only if your doctor has indicated it and if you are over 12 years old.

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

• 1 inhalation in the morning and 1 inhalation at night

or

• 2 inhalations in the morning

or

• 2 inhalations at night.

Also, use Rilast Turbuhaler as a "reliever inhaler" to treat asthma symptoms when they appear:

• 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 a time.

Always carry your Rilast Turbuhaler inhaler with you to use when needed.

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

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

Never take more than 12 inhalations in total in 24 hours.

If you are exercising and notice asthma symptoms, use Rilast Turbuhaler as described above, do not use it right before exercise to prevent the onset of symptoms.

Preparing your new Rilast Turbuhaler inhaler

Before using your newRilast 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 Rilast 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". It does not matter if the "click" is heard on the first or second turn.
• Turn the red lock in both directions again.
• At this point, your Rilast 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 Rilast Turbuhaler inhaler upright with the red lock at the bottom.

1. Do not hold the mouthpiece when loading your Rilast Turbuhaler inhaler. To load your Rilast Turbuhaler inhaler 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 Rilast Turbuhaler inhaler is now ready to use. Load your Rilast Turbuhaler inhaler only when you are about to use it.

1. Keeping your Rilast Turbuhaler inhaler away, slowly exhale the air from your mouth (without discomfort). Do not blow through your Rilast Turbuhaler inhaler.
2. Place the mouthpiece gently between your teeth, close your lips, and breathe in strongly and deeply through your mouth. Do not bite or press the mouthpiece hard.

1. Remove your Rilast Turbuhaler inhaler from your mouth and exhale the air gently. The amount of medication inhaled is very small, which means you will not notice any taste after inhalation. However, if you have followed the instructions for use, 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. Put the cap back on firmly after use.

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

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

As with all inhalers, caregivers should ensure that children who have been prescribed Rilast Turbuhaler perform the inhalation technique correctly, as described above.

Cleaning your Rilast 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 Rilast Turbuhaler inhaler, starting from 120 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, and when the 0 has reached the middle of the window, you should start using a new Rilast Turbuhaler inhaler.

Note:

• Although your Rilast 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 Rilast Turbuhaler inhaler is not produced by the medication but by a desiccant, so it will not indicate how much medication is left in your Rilast Turbuhaler inhaler.
• If you load your Rilast 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 Rilast Turbuhaler than you should

It is essential to use the dose indicated in the prospectus or the one your doctor has prescribed. 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. Phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to use Rilast Turbuhaler

• If you forget any of the Rilast 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 side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you experience any of the following situations, stop using Rilast 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, which indicates that you may be suffering an allergic reaction. This occurs rarely, affecting less than 1 in 1,000 patients.
• You have acute wheezing or difficulty breathing immediately after using your inhaler. If you experience any of these symptoms, stop using your Rilast 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 less than 1 in 10,000 patients.

Other possible side 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 Rilast Turbuhaler.
• Thrush (fungal infection) in the mouth; this effect is less likely if you rinse your mouth with water after using Rilast Turbuhaler.
• Mild throat irritation, cough, hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Rapid heartbeat.
• Bruises on the skin.

• Muscle cramps.

• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of the muscle in the airways, causing wheezing). If this happens suddenly just after using Rilast 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.
• Changes in taste, such as unpleasant mouth taste.
• Changes in blood pressure.

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

• changes in bone mineral density (decrease in bone mass).
• cataracts (loss of transparency of the lens in the eye).
• glaucoma (increased eye pressure).
• delayed growth 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 steroid tablets.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rilast Turbuhaler

• Keep this medication out of sight and reach of children.
• Do not use this medication 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 medication does not require special storage conditions.
• Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rilast Turbuhaler

The active ingredients 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).

Appearance of the product and package contents

Rilast Turbuhaler is an inhaler that contains your medication. The inhalation powder is white. Each inhaler contains 120 doses and consists of a white body and a red turning lock. The turning lock contains Braille code with the number 6 as an identification digit.

Rilast Turbuhaler is available in packages of 1, 2, 3, 10, or 18 inhalers, which contain 60 or 120 doses.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

The holder is:

Laboratorio TAU, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The manufacturer is:

AstraZeneca AB

S-151 36 Södertälje

Sweden

This medicationis authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: June 2020

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