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

2 What you need to know before you use Trelegy Ellipta

3 How to use Trelegy Ellipta

4 Possible side effects

5 How to store Trelegy Ellipta

6 Contents of the pack and other information

Step-by-step instructions

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

Don’t 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 (Don’t 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 that you’ll 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. Don’t 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. Don’t 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. Don’t 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.

Don’t 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 ’ in 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 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

Don’t 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. Don’t 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 1,000 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

Common side effects

These 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 side effects

These may affect up to 1 in 100 people:

• irregular heart beat
• faster heart beat
• hoarseness
• weakening of the bones, leading to fractures
• dry mouth.

Rare side effects

• These may affect up to 1 in 1,000 people: allergic reactions (see earlier in Section 4)

Other side effects

Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):

• blurred vision

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 Website: 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.

How to store Trelegy Ellipta

6

Contents of the pack and other information

What Trelegy Ellipta contains

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

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium 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 an 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 either 14 or 30 doses (14 or 30 day supply). Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited 12 Riverwalk

Citywest Business Campus Dublin 24

Ireland

Manufacturer

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street

Ware

Hertfordshire SG12 0DJ UK

2 p repare a dose

Wait to open the cover until you are ready to take /»\ your dose.

Do not shake the inhaler.

► Slide the cover down until you hear a “click”.

Your medicine is now ready to be inhaled.

The dose counter counts down by 1 to confirm.

• If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine. Take it back to your pharmacist for advice.
• Don’t shake the inhaler at any time.

3 i nhale your medicine

► While holding the inhaler away from your mouth, breathe out as far as is comfortable.

Don’t breathe out into the inhaler.

► Put the mouthpiece between your lips, and close your lips firmly around it.

Don’t block the air vent with your fingers.

Your lips fit over the contoured shape of the mouthpiece for inhaling.

Don’t block the air vent with your fingers.

► Take one long, steady, deep breath in. Hold this breath 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 feel the medicine, even when you are using the inhaler correctly.
• If you want to clean the mouthpiece, use a dry tissue, before you close the cover.