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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rilast Turbuhaler 160 micrograms/4.5 micrograms per 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 should not give it to others, 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 Turbuhaler is and what it is used for
2. What you need to know before using Rilast Turbuhaler
3. How to use Rilast Turbuhaler
4. Possible side effects
5. How to store Rilast Turbuhaler
6. Contents of the pack and other 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 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

Rilast Turbuhaler may be prescribed for asthma in two different ways:

• Some patients are prescribed two different inhalers: Rilast Turbuhaler and another separate inhaler “for symptom relief”.

  • They use Rilast 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 Rilast Turbuhaler as the only inhaler for asthma.

  • They use Rilast Turbuhaler daily, which helps prevent asthma symptoms from occurring.
  • They also use Rilast Turbuhaler when they need additional doses to relieve 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 a separate inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)

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

2. What you need to know before using Rilast Turbuhaler

Do not use Rilast Turbuhaler:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rilast 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 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 result in a positive doping test.

Use of Rilast 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 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 Rilast Turbuhaler.

Also inform your doctor or pharmacist if you are due 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 Turbuhaler unless your doctor tells you to.
• If you become pregnant while being treated with Rilast Turbuhaler, do not stop using it and consult your doctor immediately.
• If you are breastfeeding, speak to your doctor before using Rilast Turbuhaler.

Driving and using machines

The influence of Rilast on the ability to drive and use machines is none or negligible.

Rilast Turbuhaler contains lactose

Rilast Turbuhaler contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before using this medicine. The amount of lactose in this medicine is generally not expected to 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 Turbuhaler

• Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
• It is important to use Rilast Turbuhaler daily, even if you do not have symptoms of asthma or COPD at that time.
• If you are using Rilast Turbuhaler for asthma, your doctor will want to check regularly 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 Turbuhaler. If you have been taking oral steroid tablets for a long time, your doctor may want to carry out 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 medicine. 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 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 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 worsens or you often wake up at night with asthma symptoms.
• You begin 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

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 instructed you:

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

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

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

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

Adults (18 years and older):

• 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 (12 to 17 years of age):

• 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.

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

Rilast Turbuhaler is not recommended for 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 Rilast Turbuhaler to treat asthma symptoms—use your reliever inhaler instead.

• Using Rilast Turbuhaler as the only inhaler for asthma:

Use Rilast Turbuhaler in this way only if your doctor has instructed you to do so and if you are over 12 years of age.

Use Rilast Turbuhaler daily, as it helps prevent the onset 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 a day.

Also use Rilast Turbuhaler as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent asthma symptoms from developing (for example, during exercise or exposure to other 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 once.

Always keep your Rilast Turbuhaler 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 your treatment may need to be changed.

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

If you are exercising and notice asthma symptoms, use Rilast Turbuhaler as described above. It is important that you discuss with your doctor the use of Rilast Turbuhaler to prevent asthma symptoms; both how often you exercise and how frequently you are exposed 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 a day.

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

Preparing your new Rilast Turbuhaler inhaler

Before using your new Rilast 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 Turbuhaler inhaler in an upright position 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 these two turns, you will hear a characteristic "click". It does not matter whether the "click" occurs during the first or second turn.
• Turn the red screw fully in both directions once again.
• Your Rilast 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 Turbuhaler inhaler in an upright position with the red screw at the bottom.

3. Do not hold the mouthpiece when loading your Rilast Turbuhaler inhaler. To load a dose into your Rilast Turbuhaler, 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 these two turns, you will hear a characteristic "click". It does not matter whether the "click" occurs during the first or second turn. Your Rilast Turbuhaler inhaler is now ready for use. Only load your Rilast Turbuhaler inhaler when you are about to use it.

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

6. Remove your Rilast Turbuhaler inhaler from your mouth and breathe out gently. The amount of medication inhaled 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 full dose and that the medication has reached your lungs.
7. If another inhalation is needed, repeat steps 2 to 6.
8. Replace the cap firmly after use.

9. Rinse your mouth with water after the 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 Rilast Turbuhaler inhaler and must not be removed. Do not use your Rilast Turbuhaler inhaler if it is damaged or if the mouthpiece has become detached.

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

Cleaning your Rilast Turbuhaler inhaler

Clean the outer surface 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 Turbuhaler inhaler, starting from 120 doses when full.

• The dose indicator is marked in increments of 10 doses, so not every dose is displayed.
• When a red background first appears at the edge of the indicator window, approximately 20 doses remain. When only 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 Turbuhaler inhaler.

Note:

• Even when your Rilast Turbuhaler inhaler is empty, the red screw will still turn and you will still hear the characteristic "click".
• The sound heard when shaking your Rilast Turbuhaler inhaler is not caused by the medication but by a drying agent, so it does not indicate how much medication remains in the inhaler.
• If you accidentally load your Rilast Turbuhaler inhaler more than once before inhaling, you will still inhale only one dose, although the dose counter will count all doses loaded.

If you use more Rilast Turbuhaler than you should

It is important to use the dose indicated in the package leaflet or as prescribed by your doctor. 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 at telephone number: 91 5620420, stating the medication and the amount ingested.

If you forget to use Rilast Turbuhaler

• If you miss a dose of Rilast Turbuhaler, continue 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 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 fainting, which may indicate you are having an allergic reaction. This occurs rarely, affecting less 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 Rilast Turbuhaler 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:

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 Rilast Turbuhaler.
• Oral thrush (fungal infection in the mouth); this effect is less likely if you rinse your mouth with water after using your Rilast 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 Turbuhaler, as they may 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 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 behavior, especially in children.
• Chest pain or tightness (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 eye pressure).
• growth retardation in children and adolescents.
• effects on the adrenal glands (small glands located above 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, consult 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 Turbuhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack or on the label of your inhaler after 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. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rilast 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).

Nature of the product and contents of the pack

Rilast Turbuhaler is an inhaler containing your medicine. The inhalation powder is white. Each inhaler contains 120 doses and consists of a white body and a red rotating sleeve.

The rotating sleeve bears a Braille code with the number 6 as the identification digit.

Rilast Turbuhaler is available in packs of 1, 2, 3, 10 or 18 inhalers containing 60 or 120 doses.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

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

Country	Brand name and concentration
Spain	Rilast Turbuhaler 160 μg/4.5 μg /inhalation powder for inhalation
Italy	Assieme 160 μg/4.5 μg/inhalation
Portugal	Assieme Turbohaler 160 μg/4.5 μg/inhalation
Sweden	Gardette 160 μg/4.5 μg/inhalation

Date of the last revision of this leaflet: June 2020

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