Trelegy Ellipta

Patient Information Leaflet: Information for the User

Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, in

single-dose container
fluticasone furoate/umeclidinium/vilanterol
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Trelegy Ellipta is and what it is used for
2. What you need to know before using 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 known as corticosteroids, often simply referred to as steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.
What Trelegy Ellipta is used for
Trelegy Ellipta is used for the treatment of chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic condition characterized by breathing difficulties that tend to worsen over time.
In COPD, the muscles surrounding the airways tighten, making breathing difficult. This medicine relaxes the muscles in the lungs, reducing swelling and irritation in the small air passages, thereby making it easier for air to flow in and out of the lungs. When used regularly, Trelegy Ellipta helps control breathing difficulties and reduces the impact of COPD on daily life.
Trelegy Ellipta must be used every day and not only when experiencing breathing problems or other symptoms of COPD. It must not be used to relieve a sudden attack of breathlessness or wheezing.
If such an attack occurs, a fast-acting inhaler (such as salbutamol) should be used. Contact your doctor if you do not have a fast-acting inhaler.

2. What you need to know before using Trelegy Ellipta

Do not use Trelegy Ellipta:

• If you are allergic to fluticasone furoate, umeclidinium, vilanterol or to 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 infection
• if you have an eye condition called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty passing urine, or urinary blockage
• if you suffer from epilepsy
• if you have thyroid gland problems
• if you have low levels of potassium in your blood
• if you have a history of diabetes
• if you have experienced blurred vision or other visual disturbances

Talk to your doctor if you think any of these apply to you.
Immediate breathing difficulties
If, immediately after using your Trelegy Ellipta inhaler, you experience tightness in the chest, coughing, wheezing, or shortness of breath:
stop using this medicine and seek immediate medical help, as you may have a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Trelegy Ellipta
If, during treatment with Trelegy Ellipta, you experience eye pain or discomfort, temporary blurred vision, halos around lights, or colored images, associated with eye redness:
stop using this medicine and seek immediate medical help, as these may be symptoms of an acute attack of narrow-angle glaucoma.
Lung infection
Since you are using this medicine for COPD, you may be at increased risk of developing a lung infection known as pneumonia. See section 4, “Possible side effects”, for information on symptoms to watch for while using this medicine.
Inform your doctor as soon as possible if you experience any of these symptoms.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.
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 unsure what your medicine contains, speak to your doctor or pharmacist.
Some medicines may affect the action of this medicine or make it more likely that you will experience side effects.
These include:

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

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Do not use this medicine during pregnancy unless your doctor tells you to do so.
It is not known whether the components of this medicine pass into breast milk. If you are breastfeeding, consult your doctor before using Trelegy Ellipta. Do not use this medicine while breastfeeding unless your doctor tells you to do so.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery.
Trelegy Ellipta contains lactose
If you have been diagnosed with an intolerance to certain sugars, talk to your doctor before using this medicine.

3. How to use Trelegy Ellipta

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one inhalation once daily, at the same time each day. You must inhale this medicine only once a day because the effect lasts for 24 hours.
Do not use more than your doctor has told you to.
Use Trelegy Ellipta regularly
It is very important that you use Trelegy Ellipta every day as prescribed by your doctor. This will help you stay symptom-free throughout the day and night.
Trelegy Ellipta must not be used to relieve symptoms of a sudden attack of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol).
How to use the inhaler
See the "Step-by-step instructions" at the end of this leaflet for detailed information.

Trelegy Ellipta is for inhalation use only.

Once the tray is opened, Trelegy Ellipta is ready to use.
If symptoms do not improve
If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or worsen, or if you are using your rapid-acting inhaler more frequently,
contact your doctor as soon as possible.
If you use more Trelegy Ellipta than you should
If you accidentally take more medicine than your doctor has prescribed, contact your doctor or pharmacist immediately for advice. You may need medical monitoring. If possible, show them your inhaler, the packaging, or this patient information leaflet. You may notice your heart beating faster than usual, feel shaky, experience visual disturbances, dryness of the mouth, or headache.
If you forget to use Trelegy Ellipta
Do not inhale a double dose to make up for a missed dose. Simply take the next dose at your usual time the following day. If you become breathless or wheezy, use your rapid-acting inhaler (such as salbutamol), then consult your doctor.
If you stop using Trelegy Ellipta
Use this medicine for the length of time recommended by your doctor. Do not stop unless advised by your doctor, even if you feel better; your symptoms may worsen.
If you have any questions about how to use 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 (may affect up to 1 in 1,000 people).
If you experience any of the following symptoms after taking Trelegy Ellipta, stop using it and inform your doctor immediately:

• Skin rash or redness, hives
• Swelling, sometimes of the face or mouth (angioedema)
• Sneezing, coughing or breathing difficulties
• Sudden feeling of weakness or dizziness (may lead to collapse or loss of consciousness)

Immediate breathing difficulties
If your breathing or wheezing gets worse immediately after using this medicine, stop using it and seek immediate medical help.

Pneumonia (lung infection) in patients with COPD (common side effect)
Inform your doctor if you experience any of the following symptoms while using Trelegy Ellipta – these could be signs of a lung infection:

• Fever or chills
• Increased mucus production, changes in mucus colour
• Worsening cough or worsening breathing difficulties

Other side effects

Common (may affect up to 1 in 10 people)

• Painful raised patches in the mouth or throat due to a fungal infection (candidiasis). Rinsing the mouth with water immediately after using Trelegy Ellipta may help prevent this side effect
• Infection of the nose, sinuses or throat
• Upper respiratory tract infection
• Itching, runny or blocked nose
• Pain at the back of the mouth and throat
• Sinus inflammation
• Lung inflammation (bronchitis)
• 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 heartbeat
• Increased heart rate
• Hoarseness
• Weakening of the bones, which may lead to fractures
• Dry mouth
• Altered taste
• Blurred vision
• Increased eye pressure
• Eye pain

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

• Allergic reactions (see above in Section 4)
• Difficulty passing urine (urinary retention)
• Pain or discomfort when urinating (dysuria)
• Awareness of heartbeat (palpitations)
• Anxiety
• Tremor
• Muscle spasms
• High blood sugar levels (hyperglycaemia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trelegy Ellipta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, tray, and inhaler after "EXP.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the inhaler within the sealed tray to protect it from moisture, and only remove it immediately before first use. Once the tray has been opened, the inhaler may be used for 6 weeks from the date the tray was opened. Write the date on which the inhaler should be discarded on the label in the designated space. This date should be added as soon as the inhaler is removed from the tray.
If stored in a refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What Trelegy Ellipta contains
The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Each single inhalation delivers a dose (released from 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 trifenilate).
The other components are lactose monohydrate (see section 2 under the heading ‘Trelegy Ellipta contains lactose’) and magnesium stearate.

Description of the appearance of Trelegy Ellipta and contents of the pack
Trelegy Ellipta is a pre-dispensed inhalation powder.
The Ellipta inhaler consists of a light grey plastic body, a beige-coloured mouthpiece cap, and a dose counter. It is packaged in a laminated aluminium tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the package.
The active substances are present as white powder in separate blister strips inside the inhaler. Trelegy Ellipta is available in packs containing 1 inhaler with either 14 or 30 doses (14-day or 30-day supply), and in multiple packs containing 90 doses (3 inhalers of 30 doses each, 90-day supply). Not all pack sizes may be marketed.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 52 691 947
[email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” EООД GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 2 454 0950 Belgique/Belgien
[email protected] Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: + 420 222 001 111 Tel.: + 36 23501301
[email protected] [email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti GlaxoSmithKline AS
Tel: + 372 667 5001 Tlf: + 47 22 70 20 00
[email protected]

Ελλάδα Österreich
Menarini Hellas A.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 83161 11-13 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. GlaxoSmithKline Trading Services Limited
Tel: + 385 1 4821 361 Tel: + 40 800672524
[email protected]

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited Berlin-Chemie / A. Menarini Distribution
Tel: + 353 (0)1 4955000 Ljubljana d.o.o.
Tel: + 386 (0)1 300 2160
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o.
Tel: + 421 2 544 30 730
[email protected]

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic GlaxoSmithKline Trading Services Limited
Tel: + 371 67103210 Tel: + 44 (0)800 221441
[email protected] [email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Step-by-step instructions

What is the inhaler?
When you first use Trelegy Ellipta, there is no need to check that the inhaler is working correctly; the inhaler contains pre-dispensed doses and is ready for immediate use.

Your pack of Trelegy Ellipta contains

The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale your dose of medicine. When you are ready to use the inhaler, remove the cover to open the tray. The tray contains a desiccant sachet to reduce moisture. Discard this desiccant sachet without opening, swallowing, or inhaling it.

Desiccant
When the inhaler is removed from its sealed tray, it will be in the “closed” position. Do not open the inhaler until you are ready to inhale a dose of medicine. Write the “Discard after” date on the label and on the inhaler packaging in the designated space. The “Discard after” date is 6 weeks after the date the tray was opened. After this date, the inhaler must not be used. The tray may be discarded after first opening.
If stored in the refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
The step-by-step instructions below for the Ellipta inhaler apply to both the 30-dose pack (30-day supply) and the 14-dose pack (14-day supply).

1. Read below before starting

If the inhaler cap is opened and closed without inhaling the medicine, the dose will be lost.
The missed dose will remain securely inside the inhaler, but will no longer be available for inhalation.
It is not possible to accidentally take extra medicine or a double dose in a single inhalation.

For the 14-dose inhaler, the counter will also turn half red when fewer than 10 doses remain, and will stay half red, displaying the number 0, after the last dose has been used.
If the cap is opened again, the counter will turn completely red.

2. Preparing a dose

Do not open the cap until you are ready to take the dose.
Do not shake the inhaler.

• Slide the cap down until you hear a 'click'.

The medicine is now ready to inhale.
The dose counter will decrease by 1 unit to confirm.

• If the dose counter does not decrease by 1 when you hear the 'click', the inhaler will not release the medicine. Return it to the pharmacist for advice.
• Do not shake the inhaler at any time.

“Click”

3. Inhaling the medicine

• With the inhaler away from the mouth, breathe out as much as possible. Do not breathe out into the inhaler.
• Place the mouthpiece between your lips and close your lips firmly around it. Do not block the air vents with your fingers.

• Breathe in slowly and steadily through the mouth, deeply and for as long as possible. Hold this breath for as long as possible (at least 3–4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

The medicine or its taste may not be noticeable, even when using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry cloth, before closing the cover.

4. Close the inhaler and rinse your mouth

• Slide the cap upwards until it fully covers the mouthpiece.

• Rinse your mouth with water after using the inhaler; do not swallow. This will reduce the likelihood of developing unwanted effects such as mouth or throat irritation.