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

Package leaflet: Information for the user

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, 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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, adolescents, and children over 6 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.

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 different inhalers: Rilast Turbuhaler and a separate inhaler “for symptom relief”.

  • They use Rilast Turbuhaler daily, which helps prevent the onset of asthma symptoms.
  • They use their “reliever inhaler” when they experience asthma symptoms, to help them breathe.

• Some patients are prescribed Rilast Turbuhaler as the only inhaler for asthma.

  • They use Rilast Turbuhaler daily, which helps prevent the onset of asthma symptoms.
  • They also use Rilast Turbuhaler when they need additional doses to relieve asthma symptoms, helping them breathe, and do not require a separate inhaler for this purpose.

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

Do not use Rilast Turbuhaler:

if you are allergic to budesonide, formoterol, or any of the other ingredients 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 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 cause a positive result in doping control tests.

Use of Rilast Turbuhaler with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 amitriptiline) and the antidepressant nefazodone;

• phenothiazine medicines (such as chlorpromazine and prochlorperazine);

• medicines known as “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 with your doctor before using Rilast Turbuhaler.

Driving and using machines

The effect of Rilast on the ability to drive and use machinery is none or negligible.

Rilast Turbuhaler contains lactose

Rilast Turbuhaler contains lactose, which is 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 usually not problematic for people with lactose intolerance.

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

3. How to use Rilast Turbuhaler

• Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
• It is important to use Rilast Turbuhaler daily, even if you do not have asthma symptoms at that time.
• Your doctor will want to regularly check how your asthma 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 occasional blood tests. 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. Please consult your doctor if you are concerned about whether you should continue using Rilast 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 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 worsening or you often 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 condition 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) Use of Rilast Turbuhaler and another inhaler separately for symptom relief”.

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

• Use of 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 daily.
• Your doctor may prescribe up to a maximum of 4 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Adolescents (12 to 17 years of age):

• The usual dose is 1–2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Children (6 to 11 years of age):

• The usual dose is 2 inhalations twice daily.

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 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.

• Use of 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 prevents 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.

Also use Rilast Turbuhaler as a “reliever inhaler” to treat asthma symptoms when they occur:

• 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 inhaler 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 they may need to change your treatment.

Never exceed a total of 12 inhalations in 24 hours.

If you experience asthma symptoms during physical exercise, use Rilast Turbuhaler as described above. Do not use it immediately before exercise to prevent symptoms.

Preparing your new Rilast Turbuhaler inhaler

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

• Unscrew and lift the cap covering the Turbuhaler. You will hear a small “click” when the cap is unscrewed.
• Hold your Rilast Turbuhaler inhaler upright 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 directions, you will hear a characteristic “click”. It does not matter whether the “click” is heard on the first or second turn.
• Turn the red screw fully in both directions 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 the cap covering the Turbuhaler. You will hear a small “click” when the cap is unscrewed.
2. Hold your Rilast Turbuhaler inhaler upright with the red screw at the bottom.

1. Do not hold the mouthpiece when loading your Rilast Turbuhaler inhaler. To load a dose, 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 directions, you will hear a characteristic “click”. It does not matter whether the “click” is heard on 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.

1. Keeping your Rilast Turbuhaler inhaler away from your mouth, slowly exhale from your mouth (without discomfort). Do not blow into your Rilast Turbuhaler inhaler.
2. Gently place the mouthpiece between your teeth, close your lips, and inhale deeply and forcefully through your mouth. Do not bite or press hard on the mouthpiece.

1. Remove your Rilast Turbuhaler inhaler from your mouth and exhale 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.
2. If you need to take another inhalation, repeat steps 2 to 6.
3. Replace the cap firmly after use.

1. Rinse your mouth with water after 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 come off.

As with all inhalers, caregivers must ensure that children 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. 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 10-dose intervals, so not all doses are 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 is 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 produced by a drying agent, not the medication, and therefore does not indicate how much medication remains.
• If you accidentally load your Rilast Turbuhaler inhaler more than once before inhaling, you will still inhale only one dose, although the indicator will count all loaded doses.

If you use more Rilast Turbuhaler than you should

It is important to use the dose indicated in the leaflet or 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. Telephone: 91 5620420, stating the medicine and the amount ingested.

If you forget to use Rilast Turbuhaler

• If you miss a dose of Rilast Turbuhaler, continue your treatment as recommended 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 missed doses.

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 will experience 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 a sudden feeling of fainting, which may indicate you are having an allergic reaction. This is rare, affecting fewer than 1 in 1,000 patients.
• High-pitched whistling sounds ("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 is very rare, 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 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 Rilast Turbuhaler.
• Mild throat irritation, cough, hoarseness.
• Headache.

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.
• Behavioural changes, 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 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 eye lens).
• Glaucoma (increased pressure in the eye).
• 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, 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 System of Pharmacovigilance 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 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 should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a 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 Turbuhaler

The active substances 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).

Nature of the product and pack contents

Rilast Turbuhaler is an inhaler containing your medicine. The inhaled powder is white in colour. Each inhaler contains 120 doses and consists of a white body and a red rotating mouthpiece. The rotating mouthpiece 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio TAU, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer:

AstraZeneca AB

S-151 36 Södertälje

Sweden

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country	Brand name and concentration
Spain	Rilast Turbuhaler 80 μg/4.5 μg /inhalation powder for inhalation
Italy	Assieme Mite 80 μg/4.5 μg/inhalation
Portugal	Assieme Turbohaler 80 μg/4.5 μg/inhalation
Sweden	Gardette mite 80 μg/4.5 μg/inhalation

Date of the most recent review 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/