Trelegy Ellipta 92 micrograms / 55 micrograms / 22 micrograms inhalation powder Pre-dispensed – patient leaflet, side effects, dosage

1. WHAT TRELEGY^® ELLIPTA^® IS AND WHAT IT IS USED FOR

What Trelegy^® Ellipta^® is

Trelegy^® Ellipta^® contains three active substances 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 Trelegy^® Ellipta^® is used for

Trelegy^® Ellipta^® is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term condition characterised by breathing difficulties that slowly get worse.

In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.

Trelegy^® Ellipta^® should be used every day and not only when you have breathing problems or other symptoms of COPD. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRELEGY^® ELLIPTA^®

Do not use Trelegy^® Ellipta^®:

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

Warnings and precautions

Talk to your doctor before using Trelegy^® Ellipta^®

• if you have asthma (Do not use Trelegy^® Ellipta^® to treat asthma)
• if you have heart problems or high blood pressure
• if you have liver problems
• if you have tuberculosis (TB) of the lung, or any long standing or untreated infections
• if you have an eye problem called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder
• if you suffer from epilepsy
• if you have thyroid gland problems
• if you have low potassium in your blood
• if you have a history of diabetes

• if you experience blurred vision or other visual disturbances → Check with your doctor if you think any of these may apply to you.

  Immediate breathing difficulties

  If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy^® Ellipta^® inhaler:

  → stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

  Eye problems during treatment with Trelegy^® Ellipta^®

  If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Trelegy^® Ellipta^®:

  → stop using this medicine and seek medical help immediately. These may be signs of an acute attack of narrow-angle glaucoma.

  Infection of the lung

  Because you are using this medicine for COPD, you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 ‘Possible side effects’ for information on symptoms to look out for while you are using this medicine.

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

  Children and adolescents

  Do not give this medicine to children or adolescents below the age of 18 years.

  Other medicines and Trelegy^® Ellipta^®

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.

  Some medicines may affect how this medicine works or make it more likely to have side effects. These include:

  • medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems
  • ketoconazole or itraconazole, to treat fungal infections
  • clarithromycin or telithromycin, to treat bacterial infections
  • ritonavir or cobicistat, to treat HIV infection
  • medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat COPD and asthma (such as methylxanthine or steroids)
  • other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use Trelegy^® Ellipta^® if you already use these medicines. → Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Trelegy^® Ellipta^®.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you can.

It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Trelegy^® Ellipta^®. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Trelegy^® Ellipta^® contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

3. HOW TO USE TRELEGY^® ELLIPTA^®

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours.

Do not use more than your doctor tells you to use.

Use Trelegy^® Ellipta^® regularly

It is very important that you use Trelegy^® Ellipta^® every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.

Trelegy^® Ellipta^® should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).

How to use the inhaler

See ‘Step-by-step instructions’ at the end of this leaflet for full information. Trelegy^® Ellipta^® is for inhalation use.

Once the tray is opened Trelegy^® Ellipta^® is ready to use.

If your symptoms do not improve

If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:

→ contact your doctor as soon as possible.

If you use more Trelegy^® Ellipta^® than you should

If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you 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 make up for a forgotten dose. Just inhale your next dose at the usual time.

If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.

If you stop using Trelegy^® Ellipta^®

Use this medicine for as long as your doctor recommends. Do not stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

Allergic reactions to Trelegy^® Ellipta^® are rare (they may affect up to 1 in 1000 people).

If you have any of the following symptoms after taking Trelegy^® Ellipta^®, stop using it and tell your doctor immediately:

• skin rash or redness, hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema)
• wheezing, coughing or having difficulty in breathing
• suddenly feeling weak or light headed (may lead to collapse or loss of consciousness)

Immediate breathing difficulties

If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately. Pneumonia (infection of the lung) in COPD patients (common side effect)

Tell your doctor if you have any of the following while using Trelegy^® Ellipta^® – these could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or increased breathing difficulties

Other side effects

Common (may affect up to 1 in 10 people)

• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Trelegy^® Ellipta^® may help prevent this side effect.
• infection of the nose, sinuses or throat
• infection of the upper airways

• itchy, runny or blocked nose

  • pain in the back of the mouth and throat
  • inflammation of the sinuses
  • inflammation of the lungs (bronchitis)
  • flu (influenza)
  • common cold
  • headache
  • cough
  • painful and frequent urination (may be signs of a urinary tract infection)
  • joint pain
  • back pain
  • constipation.

Uncommon (may affect up to 1 in 100 people)

• irregular heart beat
• faster heart beat
• hoarseness
• weakening of the bones, leading to fractures
• dry mouth
• taste disturbance
• blurred vision
• increased eye pressure
• eye pain.

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (see earlier in Section 4)
• difficulties passing urine (urinary retention)
• pain or discomfort passing urine (dysuria)
• awareness of hearbeat (palpitations)
• anxiety
• tremor
• muscle spasms
• increased in blood sugar (hyperglycaemia)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRELEGY^® ELLIPTA^®

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
• If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
• If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Trelegy^® Ellipta^® contains

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

Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). The other ingredients are lactose monohydrate (see section 2 under ‘Trelegy^® Ellipta^® contains lactose’) and magnesium stearate.

What Trelegy^® Ellipta^® looks like and contents of the pack

Trelegy^® Ellipta^® is a white inhalation powder, pre-dispensed. The Ellipta^® inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the packaging.

The active substances are present as a white powder in separate blister strips inside the inhaler. Each inhaler contains 30 doses (30 day supply).

Manufactured by Glaxo Wellcome Production, Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France.

Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., Unit 2-3, Townsend Industrial Estate, Waxlow Road, London, NW10 7NU, UK.

Revision date: 04.03.2026

PL 16378/1411 POM

Trelegy^® and Ellipta^® are registered trademarks of Glaxo Group Limited.

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Beachcourse,

Tel: 020 8896 9054 for help. Ref. number: 1411

Step-by-step instructions

What is the inhaler?

The first time you use Trelegy^® Ellipta^® you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.

Your Trelegy^® Ellipta^® inhaler carton contains

The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale a dose of your medicine. When you are ready to use your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away — do not open, eat or inhale it.