Label: information for the user

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

furoate of fluticasone/umeclidinium/vilanterol

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Step-by-step usage instructions

What is Trelegy Ellipta

Trelegy Ellipta contains three active ingredients called fluticasone furoate, umeclidinium 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 Trelegy Ellipta used for

Trelegy 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 lung muscles, 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.

Trelegy 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 experience this type of attack, use a rapid-acting inhaler (such as salbutamol).If you do not have a rapid-acting inhaler, contact your doctor.

Do not use Trelegy Ellipta

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

Warnings and precautions

Consult your doctor before starting to use Trelegy Ellipta

• If you haveasthma(do not use Trelegy 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 haveepilepsy
• If you havethyroid problems
• If you have a low level ofpotassiumin your blood
• If you have a history ofdiabetes
• If you experienceblurred visionor 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 Trelegy Ellipta inhaler:

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

Eye problems during treatment with Trelegy Ellipta

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

Stop using this medication and seek medical help immediately.This 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 section 4"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 to children or adolescents under 18 years of age.

Other medications and Trelegy 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 about the content of your medication, consult your doctor or pharmacist.

Some medications may affect the way this medication works, or make it more likely to cause side effects. These include:

• Medications 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 Trelegy 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 Trelegy 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.

The components of Trelegy Ellipta are unknown to pass into breast milk. If you are breastfeeding, consult your doctor before using Trelegy Ellipta. If you are breastfeeding, do not use this medication unless your doctor tells you to.

Driving and operating machinery

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

Trelegy Ellipta contains lactose

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

Follow exactly the administration instructions of this medication as 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 24hours.

Do not use more doses than your doctor has indicated.

Use Trelegy Elliptaregularly

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

Trelegy Elliptashould not be used to relieve asudden attack of shortness of breath or wheezing. If you have this type of attack, use a rescue inhaler with quick action (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.

Trelegy Ellipta is for inhalation use.

Trelegy Ellipta is ready for use once the blister pack is opened.

If symptoms do not improve

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

contact your doctor as soon as possible.

If you use more Trelegy 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 Trelegy 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 rescue inhaler with quick action (for example, salbutamol), and seek medical advice.

If you interrupt treatment with Trelegy 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 Trelegy Ellipta are rare (can affect up to 1 in 10,000 people).

If you experience any of the following symptoms after taking Trelegy Ellipta, stop using it and inform your doctor immediately:hives (urticaria), swelling, sometimes of the face or mouth (angioedema), wheezing, coughing or difficulty breathing

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

Urgent breathing difficulties

If your breathing or wheezing 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 Trelegy 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 Trelegy Ellipta may help prevent this side effect
• nasal or sinus infection
• upper respiratory tract infection
• runny nose, congestion or stuffy nose
• posterior throat pain and discomfort
• nasal inflammation
• inflammation of the lungs (bronchitis)
• common cold
• headache
• cough
• painful and frequent urination (may be signs of urinary tract infection)
• joint pain
• back pain
• constipation.

Infrequent(can affect up to 1 in 100 people)

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

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
• high blood sugar (hyperglycemia).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. 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 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 the packaging and medications that you no longer need. This will help protect the environment.

Composition of Trelegy Ellipta

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

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

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

Appearance of the product and contents of the pack

Trelegy Ellipta is a dry powder inhaler (single-dose).

The Ellipta inhaler is made of a grey plastic body, a pink mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium blister pack with a folding 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 blisters within the inhaler. Trelegy Ellipta is available in packs containing 1 inhaler with 14 or 30 doses (for a treatment of 14 or 30 days) and in clinical packs containing 90 doses (3 inhalers of 30 doses, for a treatment of 90 days). Only some pack sizes may be marketed.

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible for manufacturing:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

Further 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 Trelegy 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 Trelegy Ellipta inhaler box 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 not open it, ingest it or inhale it.

When you take the inhaler out of 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” in the space provided for it on the inhaler label and on the box. 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 (30 days of treatment) and the 14-dose Ellipta inhaler (14 days of treatment).

1. Read the following instructions before using the inhaler

If the inhaler lid 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 lid is opened again.

1. Prepare a dose

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

Do not shake the inhaler.

• Slide the lid 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 the 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 out into the inhaler.

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

Do not block the air vents with your fingers.

• Breathe in deeply and slowly. Keep breathing in for as long as possible (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 lid, the inhaler mouthpiece can be cleaned using adry tissue.

1. Close the inhaler and rinse your mouth

• Slide the lid 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.