Leaflet: information for the user

Rilast forte Turbuhaler 320 micrograms/9 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 forte Turbuhaler is and what it is used for

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

3.How to use Rilast forte Turbuhaler

4.Possible side effects

5.Storage of Rilast forte Turbuhaler

6. Contents of the pack and additional information

Rilast forte Turbuhaler is an inhaler used for the treatment of asthma in adults and adolescents between 12 and 17 years of age. 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 medications: budesonide and formoterol fumarate dihydrate.

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

Asthma

Your doctor will prescribe two separate inhalers for asthma: Rilast forte Turbuhaler and another inhaler for “relief of symptoms”.

• Use Rilast forte Turbuhaler daily, as it helps to prevent the occurrence of asthma symptoms.
• Use your “relief inhaler” when you experience asthma symptoms, to facilitate breathing.

Do not use Rilast forte Turbuhaler as a relief 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 disease of the pulmonary airways, usually caused by smoking.

Do not use Rilast forte 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 forte 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.

Contact 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 forte 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 using 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 such as digoxin, used commonly to treat heart failure;
• diuretics (such as furosemida), used to treat 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 to treat Parkinson's disease (such as levo-dopa);
• medicines to treat 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 forte 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 forte Turbuhaler unless your doctor tells you to.
• If you become pregnant during treatment with Rilast forte Turbuhaler, do not stop using it and consult your doctor immediately.
• If you are breastfeeding, speak with your doctor before using Rilast forte Turbuhaler.

Driving and operating machines

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

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 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 as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
• It is essential to use Rilast forte Turbuhaler daily, even if you do not have asthma or COPD symptoms at the moment.
• If you are using Rilast forte 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 forte Turbuhaler. If you have been taking oral steroid tablets for a long time, your doctor may want to do blood tests 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 ornasal discharge, weakness ormuscle and joint painand skin rash (urticaria).If any of these symptoms worry you, or if you experience any others 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 forte 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 an operation).

Important information about asthma or COPD symptoms:

If while using Rilast forte 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 asthma or COPD is not adequately controlled and you may need immediate different or additional treatment.

Asthma:

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

Adults (18 years and older):

• The usual dose is1 inhalation, twice a day.
• Your doctor may prescribe up to a maximum of 2 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 old):

• The usual dose is 1 inhalation, twice a day.
• If your symptoms are well controlled, your doctor may ask you to use the medication once a day.

There is a lower concentration of Rilast Turbuhaler for children aged 6-11 years.

Rilast forte 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 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 forte Turbuhaler to treat asthma symptoms, but your reliever inhaler.

COPD (Chronic Obstructive Pulmonary Disease):

• Use only in adults (18 years and older).
• The usual dose is 1 inhalation, twice a day.

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

Preparing your new Rilast forte Turbuhaler inhaler

Before using your new Rilast forte Turbuhaler inhalerfor the first time, you must prepare it as follows:

• Twist and lift the cap that covers the Turbuhaler. You will hear a small "click" when the cap is twisted off.
• Hold your Rilast forte Turbuhaler inhaler in a vertical position with the red ring at the bottom.
• Turn the red ring until it clicks in one direction and then turn it back 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.
• Turn the red ring in both directions.
• At this point, your Rilast forte Turbuhaler inhaler is already loaded and ready to use.

How to perform an inhalation

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

1. Twist and lift the cap that covers the Turbuhaler. You will hear a small "click" when the cap is twisted off.

2.Hold your Rilast forte Turbuhalerinhaler with the red ring at the bottom.

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

Later turn it back 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 forte Turbuhaler inhaler is ready to use. Load it only when you are going to use it.

4.Hold your Rilast forte Turbuhaler inhaler away from you, slowly exhale the air from your mouth (without feeling uncomfortable). Do not blow through the Rilast forte Turbuhaler inhaler.

5. Place the mouthpiece gently between your teeth, close your lips and inhale deeply and energetically through your mouth. Do not bite or press the mouthpiece hard.

6.Remove your Rilast forte Turbuhaler inhaler from your mouth and exhale slowly.The amount of medication inhaled is very small, so 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 firmly back on after use.

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

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

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

Cleaning your Rilast forte Turbuhaler inhaler

Clean the outside of the mouthpiece once a week with a dry cloth, without using water or liquids.

When to start using a new inhaler

• The dose indicator tells you about the number of doses (inhalations) left in your Rilast forte Turbuhaler inhaler, starting from 60 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 dose indicator first appears with a red background on the edge of the window, there are approximately 20 doses left. When there are the last 10 doses left, the background of the window indicator is red, and when the 0 has reached the middle of the window, you must start using a new Rilast forte Turbuhaler inhaler.

Nota:

• Although your Rilast forte Turbuhaler inhaler is empty, the ring will continue to turn and you will continue to hear the characteristic "click".
• The sound you hear when you shake your Rilast forte 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 forte Turbuhaler inhaler.
• If you load your Rilast forte 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 loaded doses.

If you use more Rilast forte Turbuhaler than you should

It is essential 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 that may occur after an overdose are tremors, headache, and rapid heartbeat.

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

If you forgot to use Rilast forte Turbuhaler

• If you forget a dose of Rilast forte 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 notuse 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 can cause side effects, although not everyone will experience them.

If any of the following situations occur, 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 urticariaalong with difficulty breathing (angioedema) and/or sudden feeling of fainting, which indicates that you may be experiencing an allergic reaction. This occurs rarely, affecting less than 1 in 1,000 patients.
• Wheezing or difficulty breathing immediately after using your inhaler.If any of these symptoms occur, stop using your Rilast forte 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 when continuing to use your Rilast forte Turbuhaler.
• Oral thrush (fungal infection); 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 yourdoctor if you have any of the following symptoms while inhaling Rilast forte Turbuhaler, they may be symptoms of a lung 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)

• Restlessness, anxiety, 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.
• Asthma bronchospasm (contraction of the airway muscles, causing "wheezing"). If this occurs suddenly just after using Rilast forte 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 or pressure (angina pectoris).
• Increased blood sugar levels.
• Alterations in taste, such as unpleasant mouth taste.
• Changes 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 leaflet. 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 storage conditions.
• Medications should not be disposed of through drains or in the 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 forte Turbuhaler

The active principles 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).

Appearance of the product and contents of the packaging

Rilast forte Turbuhaler is an inhaler that contains your medication. The inhalation powder is white in color. Each inhaler contains 60 doses and is composed of a white body and a red rotating collar. The rotating collar contains a Braille code with the number 6 as the identification digit.

Rilast forte Turbuhaler is available in packaging of 1, 2, 3, 10, or 18 inhalers, which contain 60 doses.

Only some packaging 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 medicine is authorized in the member states of the European Economic Area with the following trade names:

Last review date of this leaflet: June 2020

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