Prospecto: information for the user

Elebrato Ellipta 92micrograms/55micrograms/22micrograms powder for inhalation, single-dose

furoate of fluticasone/umeclidinium/vilanterol

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isElebrato Elliptaand for what it is used

2. What you need to know before starting to useElebrato Ellipta

3. How to useElebrato Ellipta

4. Possible adverse effects

5. Storage ofElebrato Ellipta

6. Contents of the package and additional information

Step-by-step usage instructions

What is Elebrato Ellipta

Elebrato Ellipta contains three active ingredients called fluticasone furoate, umecidinium bromide, and vilanterol.

Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids.

Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.

What is Elebrato Ellipta used for

Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease that worsens slowly and is characterized by difficulty breathing.

In COPD, the muscles surrounding the airways contract, making it difficult to breathe. This medicine relaxes the muscles of the lungs, reducing inflammation and irritation in the smaller airways and facilitating the entry and exit of air from the lungs. When used regularly, it helps control breathing difficulties and reduces the effects of COPD on daily life.

Elebrato Ellipta should be used daily and not just when breathing problems or other COPD symptoms occur. It should not be used to relieve a sudden attack of choking or wheezing.If you have this type of attack, use a rapid-acting inhaler (such as salbutamol). If you do not have a rapid-acting inhaler, contact your doctor.

No use Elebrato Ellipta

• if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Elebrato Ellipta

• if you haveasthma(do not use Elebrato Ellipta to treat asthma)
• if you haveheart problemsorhigh blood pressure
• if you haveliver problems
• if you havepulmonary tuberculosis(TB)or any other long-standing or untreated infection
• if you have a condition calledangle-closure glaucoma
• if you havean enlarged prostate,difficulty urinatingor ablockage in the bladder
• if you suffer fromepilepsy
• if you havethyroid problems
• if you have a low level ofpotassiumin your blood
• if you have a history ofdiabetes
• if you experience blurred vision or othervisual disturbances.

Consult your doctorif you think any of the above conditions apply to you.

Urgent breathing difficulties
If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Elebrato Ellipta inhaler:

stop using this medicationandseek medical attention immediately,as you may have a serious condition called paradoxical bronchospasm.

Eye problems during treatment withElebrato Ellipta

If you experience eye pain or discomfort, blurred vision for a time, halos, or colored images, as well as eye redness during treatment withElebrato Ellipta:

stop using this medication and seek medical help immediately.Thesesymptoms may be due to an acute angle-closure glaucoma attack.

Pulmonary infection

If you are using this medication to treat COPD, you may be at a higher risk of developing a lung infection known as pneumonia.See section4"Possible side effects"for information on the symptoms you should be aware of while using this medication.

Consult your doctor as soon as possible if you develop any of these symptoms.

Children and adolescents.

This medication should not be administered tochildren or adolescents under 18 years old.

Other medications and Elebrato Ellipta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. If you are unsure of the contents of your medication, consult your doctor or pharmacist.

Some medications may affect the way this medication works, or make it more likely that you will experience side effects. These include:

• medicines calledbeta-blockers(such as propranolol), used to treat high blood pressure or other heart conditions
• ketoconazole or itraconazole, to treat fungal infections
• clarithromycin or telithromycin, to treat bacterial infections
• ritonavir or cobicistat to treat HIV
• medications that lower the level of potassium in the blood, such as some diuretics or some medications to treat COPD and asthma (such as methylxanthines or steroids)
• other long-acting medications to treat similar respiratory problems, such as tiotropium, indacaterol. Do not use Elebrato Ellipta if you are already using these medications.

Consult your doctor or pharmacistif you are taking any of these medications. Your doctor may perform regular checks if you are taking any of these medications, as they may increase the side effects of Elebrato Ellipta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. If you are pregnant, do not use this medication unless your doctor tells you to.

We do not know if the components of Elebrato Ellipta can pass into breast milk. If you are breastfeeding, you should consult your doctor before using Elebrato Ellipta. If you are breastfeeding, do not usethis medication unless your doctor tells you to.

Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

Elebrato Ellipta contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Therecommended doseis one inhalation every day, at the same time each day. You only need one inhalation a day, as the effect of this medication lasts 24 hours.

Do not use more doses than your doctor has indicated.

Use Elebrato Elliptaregularly

It is very important that you use Elebrato Ellipta every day, as your doctor has indicated. This will help you not to have symptoms throughout the day and night.

Elebrato Elliptashould not be used to relieve asudden attack of shortness of breath or wheezing. If you have this type of attack, use a quick-acting rescue inhaler (such as salbutamol).

How to use the inhaler

To get the complete information, read the “Step-by-Step Instructions for Use” at the end of this leaflet.

Elebrato Ellipta is for inhalation use.

Elebrato Ellipta is ready for use once the tray is opened.

If symptoms do not improve

If your symptoms of COPD (shortness of breath, wheezing, cough) do not improve or worsen, or if you are using your quick-acting rescue inhaler more frequently than usual:

contact your doctor as soon as possible.

If you use more Elebrato Elliptathan you should

If you accidentally use more medication than you should,contact your doctor or pharmacist immediately,as you may need medical attention. If possible, show them the inhaler, the packaging or your leaflet. You may notice that your heart beats faster than normal, feel shaky, have visual disturbances, have a dry mouth or have a headache.

If you forget to use Elebrato Ellipta

Do not inhale a double dose to compensate for the missed doses.Inhale the next dose at your usual time. If you have wheezing or shortness of breath, use your quick-acting rescue inhaler (for example, salbutamol), and seek medical advice.

If you interrupt treatment with Elebrato Ellipta

Use this medication for the time your doctor has recommended. Do not stop using it until your doctor tells you to, even if you feel better, as your symptoms may worsen.

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

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

Allergic reactions

Allergic reactions to Elebrato Ellipta are rare (can affect up to 1 in 10,000 people).

If you experience any of the following symptoms after taking Elebrato Ellipta, stop using it and immediately inform your doctor:

• skin rash or redness, hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema)
• whistling, coughing, or difficulty breathing
• sudden weakness or dizziness (which can cause collapse or loss of consciousness).

Urgent respiratory difficulties

If your breathing or whistling worsens immediately after using this medicine, stop using it and seek medical help immediately.

Pneumonia (lung infection)in patients with COPD (frequent side effect)

If you experience any of the following symptoms while using Elebrato Ellipta, consult your doctor. They may be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased coughing or difficulty breathing.

Other side effects

Frequent(can affect up to 1 in 10 people)

• mouth ulcers, bumps (blisters) in the mouth or throat caused by a fungal infection (candidiasis).Rinsing your mouth with water immediately after using Elebrato Ellipta may help prevent this side effect
• nose, nasal sinuses, or throat infection
• upper respiratory tract infection
• itching, runny nose, or stuffy nose
• posterior throat and mouth pain
• nasal sinus inflammation
• lung inflammation (bronchitis)
• common cold
• headache
• cough
• painful and frequent urination (may be signs of urinary tract infection)
• joint pain
• back pain
• constipation.

Rare(can affect up to 1 in 10,000 people)

• irregular heartbeat
• rapid heartbeat
• snoring
• bone weakening that can cause fractures.
• dry mouth
• altered taste
• blurred vision
• increased eye pressure
• eye pain.

Very rare(can affect up to 1 in 10,000 people)

• allergic reactions (see above in Section 4)
• difficulty urinating (urinary retention)
• pain or discomfort while urinating (dysuria)
• awareness of heartbeats (palpitations)
• anxiety
• trembling
• muscle spasms
• increased blood sugar (hyperglycemia).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep the inhaler inside the sealed tray to protect it from moisture and only remove it immediately before the first use. Once the tray is opened, the inhaler can be used for a period of 6 weeks, counting from the date of opening the tray. Write the date on which the inhaler should be discarded in the designated space on the inhaler label. The date should be noted as soon as the inhaler is removed from the tray.

If stored in the refrigerator, let the inhaler reach room temperature for at least one hour before use.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medications that you no longer need. This will help protect the environment.

Composition of Elebrato Ellipta

The active principles are fluticasone furoate, umeclidinium bromide, and vilanterol.

Each inhalation provides a released dose (the dose that comes out of the mouthpiece) of 92micrograms of fluticasone furoate, 65micrograms of umeclidinium bromide equivalent to 55micrograms of umeclidinium, and 22micrograms of vilanterol (as trifenatate).

The other components are lactose monohydrate (see section 2 “Elebrato Ellipta contains lactose”) and magnesium stearate.

Appearance of the product and contents of the pack

Elebrato Ellipta is a powder for inhalation (single-dose).

The Ellipta inhaler is made up of a grey plastic body, a pink mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium blister pack with a foldable aluminium lid. The blister pack contains a desiccant to reduce humidity in the pack.

The active ingredient is presented as a white powder in separate strips of blister within the inhaler. Elebrato Ellipta is available in packs of 1 inhaler containing 14 or 30 doses (for a 14 or 30day treatment) and in clinical packs containing 90 doses (3 inhalers of 30 doses, for a 90day treatment). Only some pack sizes may be marketed.

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited.

12 Riverwalk

Citywest Business Campus

Dublín 24

Irlanda

Responsible for manufacturing:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

Francia

For further information about this medicinal product, please consult the representative in the country where the medicinal product is placed on the market:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europea.eu.

Step-by-step instructions for use

What is the inhaler?

The first time you use Elebrato Ellipta, you do not need to ensure that the inhaler is working correctly, as it contains pre-measured doses and is ready to use directly.

Your Elebrato Ellipta inhaler pack contains:

The inhaler is packaged in a blister pack.Do not open the blister pack until you are ready to inhale a dose of the medicine. When you are ready to use the inhaler, remove the lid to open the blister pack. The blister pack contains a desiccant to reduce humidity. Remove the desiccant bag,do notopen it, ingest it or inhale it.

When you remove the inhaler from its blister pack, it will be in the “closed” position.Do not open the inhaler until you are ready to inhale a dose of the medicine. You should note the date of “Dispose of” on the space provided on the inhaler label and the pack. The date of “Dispose of” is 6 weeks from the date of opening the blister pack.After this date the inhaler must not be used any more.The blister pack can be disposed of once you open it.

If you store it in the fridge, let the inhaler reach room temperature for at least one hour before use.

The step-by-step instructions for using the inhaler provided below can be used for both the 30-dose Ellipta inhaler (30day treatment) and the 14-dose Ellipta inhaler (14day treatment).

1. Read the following instructions before using the inhaler

If the inhaler mouthpiece cover opens and closes without inhaling the medicine, the dose will be lost.The lost dose will be retained safely inside the inhaler, but will not be available to be inhaled.

You cannot accidentally administer an additional dose or a double dose by inhaling.

For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left and then show half red with the number 0 after the last dose used. The dose counter will appear completely red if the mouthpiece cover is opened again.

1. Prepare a dose

When you are ready to inhale a dose, open the inhaler mouthpiece cover.

Do not shake the inhaler.

• Slide the mouthpiece cover down until you hear a ‘click’.

Now, the medicine is ready to be inhaled.

As confirmation, the dose counter decreases by1unit.

• If the dose counter does not decrease when you hear the ‘click’, the inhaler will not release the dose of medicine.Take it to your pharmacist and ask for help.
• Do not shake the inhaler at any time.

1. Inhale the medicine

• While holding the inhaler away from your mouth, breathe out as much as possible.

Do not breathe into the inhaler.

• Place the mouthpiece between your lips and close your lips firmly around the mouthpiece.

Do not block the ventilation holes with your fingers.

• Breathe in deeply and continuously for at least 3-4 seconds.
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

You may not be able to taste or notice the medicine, even when using the inhaler correctly.

Beforeclosing the mouthpiece cover, the inhaler mouthpiece can be cleaned using adry tissue.

1. Close the inhaler and rinse your mouth

• Slide the mouthpiece cover up to the top to cover the mouthpiece.

• Rinse your mouth with water after using the inhaler, do not swallow.

This will make it less likely that you will experience side effects such as mouth or throat ulcers.