Leaflet: information for the user

Rilast 160 micrograms/4.5 micrograms/inhalation suspension for inhalation in a pressurized container

Budesonide/formoterol fumarate dihydrate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Rilast is and what it is used for

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

3. How to use Rilast

4. Possible side effects

5. Storage of Rilast

6. Contents of the container and additional information

Rilast is an inhaler used for the symptomatic treatmentof Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. COPD is a chronic disease of the respiratory airways of the lungs, often caused by tobacco smoke.It contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”, and acts by reducing and preventing lung inflammation.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta2adrenergic agonists” or “bronchodilators”, and acts by relaxing the muscles of the respiratory airways, making it easier to breathe.

Do not use this medication as a relief inhaler.

Do not use Rilast:

• If you are allergic to budesonide, formoterol, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rilast 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, narrowed 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 blurry vision or other visual disturbances.

Use in athletes

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

Children and adolescents

Rilast is not recommended for children or adolescents under 18 years old.

Other medications and Rilast

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are using any of the following medications:

• Beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medications to treat rapid or irregular heartbeats (for example, quinidina).
• Medications like digoxin, used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Oral steroids (such as prednisolone).
• Xanthine medications (such as theophylline or aminophylline), commonly used to treat COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medications (such as chlorpromazine and prochlorperazine).
• Medications called "HIV protease inhibitors" (such as ritonavir) for the treatment of HIV/AIDS.
• Medications to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medications to treat Parkinson's disease (such as levodopa).
• Medications to treat thyroid problems (such as levothyroxine).

If you find yourself in any of these situations, or are unsure, ask your doctor or pharmacist before using Rilast.

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

Pregnancy, breastfeeding, and fertility

• Inform your doctor before using this medication if you are pregnant, or plan to become pregnant; do not use Rilast unless your doctor tells you to.
• If you become pregnant while taking Rilast, do not stop using it and consult your doctor immediately.
• If you are breastfeeding, talk to your doctor before using Rilast.

Driving and operating machinery

The influence of Rilast on the ability to drive and operate machinery is negligible or insignificant.

• Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
• It is essential to use Rilast daily, even if you do not have symptoms of COPD at that moment.

The recommended dose is 2 inhalations twice a day. It is not recommended to use Rilast in children or adolescents under 18 years of age.

If you have been taking oral steroids for COPD, your doctor may reduce the number of tablets you take once you start treatment with Rilast. If you have been taking oral steroids for a long time, your doctor may want to do a blood test from time to time. When your doctor reduces the number of oral steroids, you may feel unwell in general, even if your lung symptoms are improving. In this case, you may temporarily experience symptoms such as congestion, runny nose, weakness, or muscle or joint pain, and skin rash (urticaria). Contact your doctor if any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting. If you experience allergy or arthritis symptoms, you may need to take another medication. You should consult your doctor if you are concerned about whether you should continue using Rilast.

Your doctor may consider adding oral steroids to your regular treatment during periods of stress (for example, when you have a chest infection or before surgery).

Important information about COPD symptoms

If you experience difficulty breathing or wheezing while using Rilast, 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 wake up frequently at night with symptoms of shortness of breath.
• You start feeling chest tightness in the morning, or the chest tightness lasts longer than usual.
• These signs may indicate that your COPD is not well controlled, and you may need immediate different or additional treatment.

Your doctor may prescribe other bronchodilators, such as anticholinergics (e.g., tiotropium or ipratropium bromide), for your COPD.

Information about your new Rilast inhaler

• Before using your new Rilast inhaler, remove it from the aluminum foil packaging. Discard the packaging and the desiccant inside. Do not use the inhaler if the desiccant has come out of the package.
• The inhaler must be used within 3 months of removing it from the aluminum foil packaging. Write the expiration date (3 months from the date it was removed from the packaging) on the inhaler label to remind you when to stop using the inhaler.
• The image shows the parts that make up the inhaler, which will already be assembled when you receive it. Do not separate the parts. If the container becomes loose, reattach it to the inhaler and continue using it.

Rilast preparation

The inhaler needs to be prepared for use in the following situations:

• When you are using your new Rilast for the first time.
• When you have not used it for more than 7 days.
• When it has been dropped.

To prepare the inhaler for use, follow these instructions:

1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol cartridge.

2. Remove the cap from the mouthpiece by pressing lightly on the protrusions on the side. The cap will remain attached to the inhaler.

3. Hold the inhaler in a vertical position. Then, press the counter (on the top of the inhaler) to release a puff of air. You can use one or both hands, as shown in the photos.

4. Release your finger(s) from the counter.

5. Wait 10 seconds, shake well, and repeat steps 3 and 4.

6. Your inhaler is now ready for use.

How to perform an inhalation

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

1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol cartridge.
2. Remove the cap from the mouthpiece by pressing lightly on the protrusions on the side. Check that the mouthpiece is not blocked.
3. Hold the inhaler in a vertical position (you can use one or both hands). Exhale gently.
4. Place the mouthpiece between your teeth. Close your lips.
5. Inhale slowly and deeply through your mouth. Press the counter (on the top of the inhaler) firmly to release a puff of medication. Hold your breath for a moment while pressing the counter. Inhale at the same time as pressing the counter to ensure the medication reaches your lungs.
6. Hold your breath for 10 seconds, or as long as you find comfortable.
7. Before exhaling, release your finger from the counter and remove the inhaler from your mouth. Hold the inhaler in a vertical position.
8. Exhale gently. Before taking another inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3-7.
9. Replace the cap on the mouthpiece.
10. After your daily morning and evening doses, rinse your mouth with water. Do not swallow.

Use of spacer chamber

Your doctor, nurse, or pharmacist may suggest using a spacer chamber (e.g., Aerochamber Plus Flow Vu or Aerochamber Plus). Follow the instructions provided with the spacer chamber.

Rilast cleaning

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or liquids, and do not separate the cartridge from the inhaler.

How to know when to replace your Rilast inhaler

• The counter on top tells you how many inhalations are left in your Rilast inhaler. It starts with 120 inhalations when it is full.

• Each time you take an inhalation or release a puff of air, the arrow starts counting down to zero ('0').
• When the arrow enters the yellow area for the first time, it means there are about 20 inhalations left.

• When the arrow reaches '0', you should stop using your new Rilast inhaler. You may not feel like the inhaler is empty, and it may seem like it still works, but you will not receive the correct amount of medication if you continue using it.

If you use more Rilast than you should

If you have used more Rilast than you should, contact your doctor or pharmacist. Common symptoms and signs of overdose are tremors, headache, and rapid heartbeat.

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

If you forget to use Rilast

• If you forget a dose of Rilast, 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 compensate for the missed doses.

If you interrupt treatment with Rilast

Before stopping using Rilast, you should consult your doctor or pharmacist. If you stop using Rilast, your COPD symptoms and signs may worsen.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the following situations occur, stop using Rilast and consult your doctor immediately:

• Your face swells, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or you experience urticaria along with difficulty breathing (angioedema) and/or a sudden feeling of dizziness, which indicates that you may be experiencing an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• You experience acute wheezing or difficulty breathing immediately after using your inhaler.If any of these symptoms occur, stop using Rilast immediately and use your "relief inhaler." Contact your doctor immediately, as it may be necessary to change your treatment.This occurs very rarely, affecting fewer than 1 in 10,000 patients.

Other possible side effects:

Frequent (may affect up to 1 in 10 patients)

• Palpitations (noticing heartbeats), tremors, or chills. These effects, if they occur, are usually mild and disappear as you continue using Rilast.
• Mouth thrush (fungal infection); this effect is less likely if you rinse your mouth with water after using Rilast.
• 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 inhaling Rilast, which may be symptoms of a pulmonary infection:

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

Infrequent (may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Accelerated heart rate.
• Skin hematomas.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of the respiratory tract muscles, causing wheezing). If wheezing occurs suddenly just after using Rilast, 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 pressure (angina pectoris).
• Increased blood sugar levels.
• Alterations in taste, such as an unpleasant mouth taste.
• Variations in blood pressure.

Inhaled corticosteroids can 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 (bone thinning)

• Cataracts (loss of transparency of the lens in the eye)
• Glaucoma (increased intraocular 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 oral corticosteroids.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the carton, aluminum foil packet, or label after CAD. The expiration date is the last day of the month indicated.
• Like most inhaled medications in pressurized containers, the effect of this medication may decrease when the container is cold. For best results, this medication should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.
• It should be used within 3 months after removing the inhaler from its aluminum packaging. Write the expiration date (3 months from opening the packaging) on the inhaler label to remind you when to stop using the inhaler.
• Always replace the mouthpiece cap and secure it in its position after using the inhaler.
• Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Warning: The cartridge contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container. The cartridge should not be broken, pierced, or burned, even when it appears to be empty.

Composition of Rilast

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

The other excipients are apaflurane (HFA 227), povidone, and Macrogol. This inhaler does not contain CFCs.

This medication contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of apaflurane (HFC-227ea) corresponding to 0.034 tons of CO2 equivalent (global warming potential GWP = 3,220).

Appearance of the product and contents of the package

Rilast is an inhaler containing the medication. The pressurized cartridge with a dose indicator attached, contains a white suspension for inhalation. The cartridge is mounted on a red plastic adapter with a white plastic mouthpiece and an integrated grey plastic cap. Each inhaler contains 120 inhalations after it has been prepared for use. Each inhaler is individually packaged in an aluminum foil wrapper containing a desiccant.

Rilast 160 micrograms/4.5 micrograms/inhalation suspension for inhalation in a pressurized container (budesonide/formoterol fumarate dihydrate) is available in packages with a single inhaler.

Holder of the marketing authorization and responsible manufacturer

The holder is:

Laboratorio TAU, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The manufacturer is:

AstraZeneca Dunkerque Production

224, Avenue de laDordogne BP 41

59640 Dunkerque (France)

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2025

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