Rilast Forte Turbuhaler 320 micrograms/9 micrograms/inhalation powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rilast forte Turbuhaler 320 micrograms/9 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 must 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.

Leaflet contents

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

For asthma, your doctor will prescribe two different inhalers: Rilast forte Turbuhaler and another separate inhaler "for symptom relief".

• Use Rilast forte Turbuhaler daily, as it helps prevent asthma symptoms from occurring.
• Use your "reliever inhaler" when you experience asthma symptoms, to help ease breathing.

Do not use Rilast forte Turbuhaler as a reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Do not use Rilast forte Turbuhaler:

if you are allergic to budesonide, formoterol, or any of the other components 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 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 result in a positive doping test.

Use of Rilast forte Turbuhaler with other medicines

Inform 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 amitriptyline) 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 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 unsure, ask your doctor or pharmacist before using Rilast forte 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 Rilast forte Turbuhaler unless your doctor tells you to.
• If you become pregnant while being treated with 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 use of machines

The influence of Rilast forte on the ability to drive and operate machinery is none or negligible.

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 certain sugars, consult him before using this medicine. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance.

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

3. How to use Rilast forte Turbuhaler

• Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
• It is important to use Rilast forte Turbuhaler daily, even if you do not have asthma or COPD symptoms at that time.
• If you are using Rilast forte 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 Rilast forte 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. If allergic or arthritic symptoms develop, you may need to take another medication. Please consult your doctor if you are concerned about whether you should continue using Rilast forte 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 Rilast forte 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:

Use Rilast forte Turbuhaler daily, as it helps prevent asthma symptoms from occurring.

Adults (aged 18 years and older):

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

A lower-strength Rilast Turbuhaler is available for children aged 6–11 years.

Rilast forte 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 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 Rilast forte Turbuhaler to treat asthma symptoms; instead, use your reliever inhaler.

Chronic obstructive pulmonary disease (COPD):

• Use only in adults (over 18 years of age).
• The usual dose is 1 inhalation, twice daily.

Your doctor may also prescribe other bronchodilator medications, such as anticholinergics (e.g., 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, prepare it as follows:

• Unscrew and lift off the cap covering the Turbuhaler. You will hear a small “click” when the cap is unscrewed.
• Hold your Rilast forte Turbuhaler vertically with the red screw ring at the bottom.
• Turn the red screw ring fully in one direction, then turn it fully in the opposite direction (the order does not matter). In one of these two turns, 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 ring fully in both directions again.
• Your Rilast forte 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 off the cap covering the Turbuhaler. You will hear a small “click” when the cap is unscrewed.
2. Hold your Rilast forte Turbuhaler with the red screw ring at the bottom.

3. Do not hold the mouthpiece when loading your Rilast forte Turbuhaler. To load a dose, turn the red screw ring fully in one direction.

Then turn it fully in the opposite direction (the order does not matter). In one of these two turns, you will hear a characteristic “click.” It does not matter whether the “click” is heard during the first or second turn. Your Rilast forte Turbuhaler is now ready for use. Only load it when you are about to use it.

4. Keeping your Rilast forte Turbuhaler away from your mouth, slowly breathe out (without discomfort). Do not blow into the Rilast forte Turbuhaler.
5. Gently place the mouthpiece between your teeth, close your lips around it, and inhale quickly and deeply through your mouth. Do not bite or press hard on the mouthpiece.

6. Remove the Rilast forte Turbuhaler 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 confident that you have inhaled the dose and that the medicine has reached your lungs.
7. If you need to take another inhalation, repeat steps 2 to 6.
8. Replace the cap firmly after use.

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

Do not attempt to remove or turn the mouthpiece unnecessarily, as it is fixed to the Rilast forte Turbuhaler and must not be removed. Do not use the Rilast forte Turbuhaler if it is damaged or if the mouthpiece has detached from the inhaler.

As with all inhalers, caregivers should ensure that children prescribed Rilast forte Turbuhaler use the correct inhalation technique as described above.

Cleaning your Rilast forte 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 Rilast forte Turbuhaler, starting from 60 doses when full.

• The dose indicator is marked in intervals of 10 doses, so not every single dose is displayed.
• 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 turns completely red. When the "0" reaches the middle of the window, you should start using a new Rilast forte Turbuhaler.

Note:

• Even when your Rilast forte Turbuhaler is empty, the screw ring will still turn and you will still hear the characteristic “click.”
• The sound heard when shaking your Rilast forte Turbuhaler 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 Rilast forte Turbuhaler more than once before inhaling your dose, you will still inhale only one dose, although the indicator will count all doses loaded.

If you use more Rilast forte Turbuhaler than you should

It is important to use the dose stated in this leaflet or as 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: 91 5620420, indicating the medicine and the amount ingested.

If you forget to use Rilast forte Turbuhaler

• If you forget a dose of Rilast forte Turbuhaler, resume your 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 a missed dose.

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 Rilast forte 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 fainting, which may indicate you are having an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• High-pitched whistling sounds 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 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 occur, they are usually mild and disappear with continued use of Rilast forte Turbuhaler.

• Oral 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.

Inform your doctor if you experience any of the following symptoms while using Rilast forte 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)

• Agitation, restlessness, 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 Rilast forte 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 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 lens in the eye).
• 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: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the pack 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. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rilast forte Turbuhaler

The active substances 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).

Nature of the product and contents of the pack

Rilast forte Turbuhaler is an inhaler containing your medicine. The inhalation powder is white in colour. Each inhaler contains 60 doses and consists of a white body and a red rotating mouthpiece. The rotating mouthpiece has a Braille code with the number 6 as the identification digit.

Rilast forte Turbuhaler is available in packs of 1, 2, 3, 10 or 18 inhalers, each containing 60 doses.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation 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 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: June 2020

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