RILAST FORTE TURBUHALER 320 micrograms/9 micrograms INHALATION POWDER

Introduction

Package Leaflet: Information for the User

Rilast forte Turbuhaler 320 micrograms/9 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

1. What Rilast forte Turbuhaler is and what it is used for
2. What you need to know before you use Rilast forte Turbuhaler
3. How to use Rilast forte Turbuhaler
4. Possible side effects
5. Storing Rilast forte Turbuhaler
6. Contents of the pack and other information

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

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

• Budesonide belongs to a group of medicines called “corticosteroids”, and acts 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 acts by relaxing the muscles of the airways, making it easier for you to breathe.

Asthma

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

• Use Rilast 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 Rilast forte Turbuhaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Do not use Rilast forte Turbuhaler:

if you are allergic to budesonide, formoterol, or 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 starting to use Rilast forte Turbuhaler if:

• You have diabetes.
• You have any lung infection.
• You have high blood pressure, or have ever had any heart disease (including irregular heartbeats, 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 medicine contains formoterol, which may produce a positive result in doping tests.

Use of Rilast forte 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 using 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 for an irregular heartbeat (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 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 forte 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 forte Turbuhaler unless your doctor has told you to.
• If you become pregnant while using Rilast forte Turbuhaler, do not stop using it, and consult your doctor immediately.
• If you are breastfeeding, talk to your doctor before using Rilast forte Turbuhaler.

Driving and using machines

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

Rilast forte Turbuhaler contains lactose

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

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

3. How to use Rilast forte Turbuhaler

• Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.
• It is important to use Rilast forte Turbuhaler daily, even if you do not have symptoms of asthma or COPD at that time.
• If you are using Rilast 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 Rilast 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 doctor reduces your oral steroid tablets, even though your lung symptoms may be improving. In this case, some symptoms like stuffy or runny nose, weakness, or pain in the muscles and joints, and skin rash (hives) may come back temporarily. If any of these symptoms worry you, or if you get any other symptoms like headache, tiredness, nausea, or vomiting, contact your doctor. If you develop allergic or arthritic symptoms, you may need to take another medicine. You should consult your doctor if you are concerned about whether you should continue using Rilast forte Turbuhaler.

Your doctor may consider adding steroid tablets to your usual treatment during stressful periods (for example, when you have a chest infection or before an operation).

Important information about asthma or COPD symptoms:

If, while using Rilast forte Turbuhaler, you feel 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 at night with asthma symptoms.
• You start to feel 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 a different or additional treatment immediately.

Asthma:

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

Adults (from 18 years onwards):

• 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 old):

• 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 Rilast Turbuhaler for children from 6 to 11 years old.

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

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 talking to your doctor or nurse first.

Use your other “reliever inhaler” when you experience asthma symptoms.Always carry your “reliever inhaler” with you to use when you need it. Do not use Rilast forte Turbuhaler to treat asthma symptoms, but use your reliever inhaler instead.

Chronic Obstructive Pulmonary Disease (COPD):

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

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

Preparing your new Rilast forte Turbuhaler inhaler

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

• Unscrew and lift the cover that covers the Turbuhaler. You will hear a small “click” when you unscrew the cover.
• Hold your Rilast forte Turbuhaler inhaler upright with the red lock at the bottom.
• Turn the red lock as far as it will go in one direction, and then turn it as far as it will go 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 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 cover that covers the Turbuhaler. You will hear a small “click” when you unscrew the cover.
2. Hold your Rilast forte Turbuhaler inhaler with the red lock at the bottom.

1. Do not hold the mouthpiece when loading your Rilast forte Turbuhaler inhaler. To load it with a dose, turn the red lock as far as it will go in one direction.

Then turn it as far as it will go 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 forte Turbuhaler inhaler is now ready to use. Load it only when you are about to use it.

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

1. Remove your Rilast forte Turbuhaler inhaler from your mouth and breathe out gently. The amount of medicine inhaled is very small, which means you will not taste anything after inhalation. However, if you have followed the instructions for use, 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 cover firmly after use.

1. Rinse your mouth with water after the 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 the Rilast forte Turbuhaler inhaler and should not be removed. Do not use the Rilast forte Turbuhaler inhaler if it is damaged or if the mouthpiece has come off the Rilast forte Turbuhaler inhaler.

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

Cleaning your Rilast 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 how many doses (inhalations) are left in your Rilast forte Turbuhaler inhaler, starting from 60 doses when it is full.

• The dose indicator is marked in intervals of 10, 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 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 Rilast forte Turbuhaler inhaler.

Note:

• Although your Rilast forte Turbuhaler inhaler may be empty, the red lock will continue to turn, and you will still hear the characteristic “click”.
• The sound you hear when you shake your Rilast forte Turbuhaler inhaler is not produced by the medicine, but by a desiccant, so it will not indicate how much medicine is left in your Rilast forte Turbuhaler inhaler.
• If you load your Rilast 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 Rilast forte Turbuhaler than you should

It is important that you use the dose that is stated in the package leaflet or that 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, contact the Toxicology Information Service: 91 5620420, stating the medicine and the amount taken.

If you forget to use Rilast forte Turbuhaler

• If you forget to take a dose of Rilast forte Turbuhaler, 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 nottake 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 all people suffer from them.

If you experience any of the following situations, stop using Rilast 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 from 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 Rilast 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 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 Rilast forte Turbuhaler.
• Thrush (fungal infection) in the mouth; this effect is less likely if you rinse your mouth with water after using your Rilast 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 Rilast 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 Rilast 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 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).
• 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 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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rilast forte Turbuhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rilast 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

Rilast 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 rotating wheel. The rotating wheel contains a Braille code with the number 6 as an identification digit.

Rilast 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:

Laboratorio TAU, 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 Leaflet: June 2020

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