Leaflet: information for the user

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

Budesonide/formoterol fumarate dihydrate

Read 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, 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 Turbuhaler is and what it is used for

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

3.How to use Rilast Turbuhaler

4.Possible side effects

1. Storage of Rilast Turbuhaler

6. Contents of the pack and additional information.

Rilast Turbuhaler is an inhaler used for the treatment of asthma in adults, adolescents, and children over 6 years old. It contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”, and it acts by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta 2 adrenergic agonists” or “bronchodilators”, and it acts by relaxing the muscles of the airways, making it easier for you to breathe.

This medication is not suitable for patients with severe asthma. It may be prescribed for asthma in two different forms.

This medication is not suitable for patients with severe asthma. It may be prescribed for asthma in two different forms.

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

• They use Rilast Turbuhaler daily, which helps to prevent the occurrence of asthma symptoms.
• They use their “relief inhaler” when they experience asthma symptoms, to facilitate breathing.

b) Some patients are prescribed Rilast Turbuhaler as a single inhaler for asthma.

• They use Rilast Turbuhaler daily, which helps to prevent the occurrence of asthma symptoms.
• They also use Rilast Turbuhaler when additional doses are needed for symptom relief, to facilitate breathing, and they do not need another inhaler separately for this purpose.

No use Rilast Turbuhaler:

if you are allergic to budesonide, formoterol or to any of the other ingredients of this medicine (including lactose, which contains 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 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 levels of potassium in the blood.

• You have severe liver problems.

Inform 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 control tests.

Use of Rilast Turbuhaler with other medicines

Inform your doctor or pharmacist if you are using, have used recently or might have to use any other medicine.

Particularly, 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 rapid or irregular heartbeats (for example quinidina);

• medicines like digoxin, used commonly to treat heart failure;

• diuretics (such as furosemida), used for the treatment of high blood pressure;

• oral steroids (such as prednisolona);

• xanthine medicines (such as theophylline or aminophylline), used commonly for asthma;

• other bronchodilators (such as salbutamol);

• tricyclic antidepressants (such as amitriptilina) and the antidepressant nefazodona;

• phenothiazine medicines (such as chlorpromazina and proclorperazina);

• medicines called “HIV protease inhibitors” (such as ritonavir) for the treatment of HIV/AIDS;

• medicines to treat infections (such as ketoconazol, itraconazol, voriconazol, posaconazol, claritromicina and telitromicina);

• medicines for Parkinson's disease (such as levo-dopa);

• medicines for thyroid problems (such as levo-tiroxina).

If you find yourself 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 to undergo general anaesthesia for a surgical operation or dental treatment.

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery

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

Rilast Turbuhaler contains lactose

Rilast Turbuhaler contains lactose, which is a type of sugar. If your doctor has told you that you suffer from an intolerance to certain sugars, consult with him before using this medicine. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance.

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

• Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 check regularly how your asthma symptoms are going.

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 do a blood test from time to time. You may feel unwell in general when the number of oral steroid tablets is reduced, even if your lung symptoms are improving.In that case, some symptoms may temporarily reappear such ascongestion orrunny nose, weakness ormuscle and joint painand skin rash (urticaria).If any of these symptoms worry you, or if you experience any other such as headache, fatigue, nausea or vomiting, contact your doctor.If allergic or arthritic symptoms develop, you may need to take another medication. 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 regular 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 feel difficulty breathing or emit "puffs" with breathing, 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 often wake up at night with asthma symptoms.
• You start feeling chest tightness in the morning, or chest tightness lasts longer than usual.

These signs may indicate that your disease is not well controlled and you may need immediate different or additional treatment.

Asthma:

Rilast Turbuhaler can 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:

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

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

a) Using Rilast Turbuhaler and another reliever 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 (12-17 years old):

• 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.

Children (6-11 years old):

• The usual dose is 2 inhalations, twice a day.

It is not recommended to use Rilast Turbuhaler in children under 6 years old.

Your doctor (or nurse) will help you manage your asthma. They will adjust the dose of this medication to the lowest dose that controls your asthma. However, do not adjust the dose without first talking to your doctor or nurse.

Use your other “reliever inhaler” when asthma symptoms appear.Always keep this “reliever” inhaler with you so you can use it when you need it. Do not use Rilast Turbuhaler to treat asthma symptoms, but your reliever inhaler.

b) Using Rilast Turbuhaler as a single inhaler for asthma:

Use Rilast Turbuhaler in this way only if your doctor has instructed you to and if you are 12 years old or older.

Use Rilast Turbuhaler daily, as it prevents the onset of asthma symptoms. You can use:

- 1 inhalation in the morningand1 inhalation at night

or

- 2 inhalations in the morning

or

- 2 inhalations at night.

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

• 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 a time.

Always keep your Rilast Turbuhaler inhaler with you so you can use it when you need it.

Normally, a total dose of more than 8 inhalations per day is not required. However, your doctor may allow you to use up to 12 inhalations per day for a limited period of time.

If you usually need to use 8 or more inhalations per day, contact your doctor or nurse, as they may need to change your treatment.

Do not take more than 12 inhalations in total in 24 hours.

If you are exercising and notice asthma symptoms, use Rilast Turbuhaler as described before, do not use it just before exercise to prevent symptoms.

Preparing your new Rilast Turbuhaler inhaler

Before using yournewRilast Turbuhaler inhalerfor the first time, you must prepare it in the following way:

• Unscrew and lift the cap that covers the Turbuhaler.You will hear a small “click” when the cap is unscrewed.
• Hold your Rilast Turbuhaler inhaler in a vertical positionwith the red ring at the bottom.
• Turn the red ring until it clicks in one direction and then back again in the other direction (it does not matter which direction first). You will hear a characteristic “click” in one of the two directions. It does not matter if the “click” is heard in the first or second turn.
• Turn the red ring in both directions.
• At this point, your Rilast Turbuhaler inhaler is already 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 cap that covers the Turbuhaler. You will hear a small “click” when the cap is unscrewed.

2.Hold your Rilast Turbuhaler inhaler in a vertical positionwith the red ring at the bottom.

3. Do not hold the mouthpiece when loading your Rilast Turbuhaler inhaler. To load your Rilast Turbuhaler inhaler with a dose, gire the red ring until it clicks in one direction.

Later turn it back again until it clicks in the other direction (it does not matter which direction first). You will hear a characteristic “click” in one of the two directions. It does not matter if the “click” is heard in the first or second turn. At this point, your Rilast Turbuhaler inhaler is ready to use. Load your Rilast Turbuhaler inhaler only when you are going to use it.

4. Keeping your Rilast Turbuhaler inhaler away, slowly exhale the air from your mouth (without it being uncomfortable). Do not blowa through your Rilast Turbuhaler inhaler.

5. Place the mouthpiece gently between your teeth, close your lips and inhaleenergetically and deeplythrough your mouth. Do not bite or press the mouthpiece hard.

6.Remove your Rilast Turbuhaler inhaler from your mouth and exhale slowly.The amount of medication inhaled is very small, which means you will not notice any taste after inhalation. However, if you have followed the use instructions, you can be sure that you have inhaled the dose and that the medication has reached your lungs.

7. If you need to take another inhalation, repeat steps 2 to 6.

8. Put the cap back firmly after use.

9.After daily morning and/or evening doses, rinse your mouth with water. Do not swallow.

Do not try to remove the mouthpiece or turn it unnecessarily, as it is fixed to your Rilast Turbuhaler inhaler and should not be removed. Do not use your Rilast Turbuhaler inhaler if it is damaged or if the mouthpiece has come loose from your Rilast Turbuhaler inhaler.

As with all inhalers, caregivers must ensure that children who have been 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, without usingwater or liquids.

When to start using a new inhaler

• The dose indicator informs you about the number of doses (inhalations) remaining in your Rilast Turbuhaler inhaler, starting from 120 doses when it is full.

• The dose indicator is marked in intervals of 10 in 10 doses, so not all doses are shown.
• When the red background of the indicator window first appears, there are approximately 20 doses left. When there are the last 10 doses left, the background of the indicator window is red, and when the 0 has reached the middle of the indicator window, you should start using a new Rilast Turbuhaler inhaler.

Note:

• Although your Rilast Turbuhaler inhaler is empty, the ring will continue to turn and you will continue to hear the characteristic “click”.
• The sound you hear when shaking your Rilast Turbuhaler inhaler is not produced by the medication, but by a drying agent, so it will not indicate how much medication is left in your Rilast Turbuhaler inhaler.
• If you load your Rilast 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 Turbuhaler than you should

It is essential to use the dose indicated in the leaflet or the dose 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.Phone:91 5620420, indicating the medication and the amount ingested.

If you forget to use Rilast Turbuhaler

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

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

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

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

• Your face becomes swollen, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting, indicating that you may be experiencing 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 any of these symptoms occur, stop using your Rilast Turbuhaler inhaler immediately and use your "relief 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 side effects:

Frequent (may affect up to 1 in 10 patients)

• Palpitations (note the heartbeats), tremors. When these effects appear, they are usually mild and disappear as you continue using your Rilast Turbuhaler.
• Oral thrush (fungal infection); this effect is less likely if you rinse your mouth with water after using your Rilast Turbuhaler.
• Mild throat irritation, cough, hoarseness.
• Headache.

Infrequent (may affect up to 1 in 100 patients)

• Restlessness, anxiety, 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.
• Asthma attack (contraction of the respiratory tract muscles, causing wheezing). If this occurs suddenly just after using Rilast 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 (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 eye 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: https://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 packaging or on the label of your inhaler after EXP. The expiration date is the last day of the month indicated.
• This medication does not require special conditions for conservation.
• Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rilast Turbuhaler

The active principles 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).

Appearance of the product and contents of the package

Rilast Turbuhaler is an inhaler that contains your medication. The inhalation powder is white in color. Each inhaler contains 120 doses and is composed of a white body and a red rotating dial. The rotating dial contains a Braille code with the number 6 as the identification digit.

Rilast Turbuhaleris available in packages of 1, 2, 3, 10, or 18 inhalers, which contain 60 or 120 doses.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

The marketing authorization holder is:

Laboratorio TAU, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The manufacturer responsible is:

AstraZeneca AB

S-151 36 Södertälje

Sweden

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

Last review date of this leaflet: June 2020

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