InfoCons Consumer Protection informs you – Elebrato Ellipta – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacis t or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Elebrato Ellipta is and what it is used for

What Elebrato Ellipta is Elebrato 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 gro up of medicines called bronchodilators .

What Elebrato Ellipta is used for

Elebrato Ellipt a 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.

Elebrato 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 sa lbutamol). If you do not have a quick -acting inhaler contact your doctor.

⚠️ 2. What you need to know before you use Elebrato Ellipta

Do not use Elebrato Ellipta

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

33 Warnings and precautions Talk to your docto r before using Elebrato Ellipta

• if you have asthma (Do not use Elebrato 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 blockage 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 brea thing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Elebrato 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 Elebrato 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 Elebrato 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 se ction 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 a dolescents below the age of 18 years .

Other medicines and Elebrato 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) 34 – other long -acting medicines s imilar to this medicine that are used to treat breathing problems , e.g. tiotropium, indacatero l. Do not use Elebrato 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 Elebrato 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 pregnan t unless your doctor tells you that you can.

It is not known wheth er the ingredients of this medicine can pass into breast milk . If you are breast -feeding, you must check with your doctor before you use Elebrato 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 t o drive or use machines.

Elebrato Ellipta contains lactose

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

💊 3. How to use Elebrato 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 Elebrato Ellipta regularly It is very important that you use Elebrato Ellipta every day, as instructed by your doctor . This will help to keep you free of symptoms throughout the day and night.

Elebrato 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.

Elebrato Ellipta is for inhalation use.

Once the t ray is opened Elebrato 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 Elebrato Ellipta than you should

If you accidentally use too much o f 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 Elebrato Ellipta

Do not inhale a double dose to make up for a forgotten dose . Just inhal e 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 Elebrato 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 an y 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 Elebrato Ellipta are rare (they may affect up to 1 in 1 000 people).

If you have any of the following symptoms after taking Elebrato 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 wors e 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 Elebrato 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 Elebrato 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 heart beat (palpitations)
• anxiety
• tremor
• muscle spasms
• increase in blood sugar ( hyperglycaemia ).

Reporting of side effects

If you get any side effects, talk to your doctor , pharmacis t or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Elebrato Ellipta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton , 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 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 inhal er 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 store d in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.

Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Elebrato 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 o ther ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose’ ) and magnesium stearate.

What Elebrato Ellipta looks like and contents of the pack

Elebrato 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 sub stances are present as a white powder in separate blister strips inside the inhaler.

Elebrato Ellipta is available in packs of 1 inhaler containing either 14 or 30 doses (14 or 30 day supply) and in multipacks containing 90 (3 inhalers of 30) doses (90 day supply) . Not all pack sizes may be marketed .

Marketing Authorisation Holder

GlaxoSmithKline Trading Services L imited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland

Manufacturer

Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier 27000 Evreux France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0) 10 85 52 00 Lietuva UAB “BERLIN -CHEMIE MENARINI BALTIC” Tel: + 370 52 691 947 lt@berlin -chemie.com България “Берлин -Хеми/А. Менарини България” EООД Teл.: + 359 2 454 0950 bcsofia@berlin -chemie.com Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien Tél/Tel: + 32 (0) 10 85 52 00 Česká republika GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111 [email protected] Magyarország Berlin -Chemie/A. Menarini Kft.

Tel.: + 36 23501301 bc-hu@berlin -chemie.com Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Trading Services Limited Tel: + 356 80065004 Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070 Nederland GlaxoSmithKline BV Tel: + 31 (0) 33 2081100 Eesti OÜ Berlin -Chemie Menarini Eesti Tel: + 372 667 5001 ee@berlin -chemie.com Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 Ελλάδα Guidotti Hellas A.E .

Τηλ: + 30 210 8316111 -13 Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 [email protected] España FAES FARMA, S.A.

Tel: + 34 900 460 153 [email protected] Polska GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000 France Menarini France Tél: + 33 (0)1 45 60 77 20 Portugal BIAL, Portela & Ca. SA.

Tel: + 351 22 986 61 00 [email protected] Hrvatska Berlin -Chemie Menarini Hrvatska d.o.o.

Tel: + 385 1 4821 361 office -croatia@berlin -chemie.com România GlaxoSmithKline Trading Services Limited Tel: + 40 800672524 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 Slovenija Berlin -Chemie / A. Menarini Distribution Ljubljana d.o.o.

Tel: + 386 (0)1 300 2160 slovenia@berlin -chemie.com Ísland Vistor hf.

Sími: +354 535 7000 Slovenská republika Berlin -Chemie / A. Menarini Distribution Slovakia s.r.o.

Tel: + 421 2 544 30 730 slovakia@berlin -chemie.com Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Tel: +39 (0)55 56801 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Κύπρος GlaxoSmithKline Trading Services Limited Τηλ: + 357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija SIA Berlin -Chemie/Menarini Baltic Tel: + 371 67103210 lv@berlin -chemie.com United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221441 [email protected] This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

40 Step -by-step instructions What is the inhaler?

The first time you use Elebrato 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 Elebrato 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.

When you take the inhaler out of the 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 by” date on the inhaler label and the carton in the space provided . The “Discard by” date is 6 weeks from the dat e you open the tray . After this date the inhaler should no longer be used . The tray can be discarded after first opening.

If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.

This leaflet Carton Tray lid Inhaler Desiccant Tray Desiccant 41 The step-by-step instructions for use of the inhaler provided below can be used for either the 30 -dose (30-day supply) or the 14-dose (14-day supply) Ellipta inhaler.

1) Read this before you start If you open and close the cover without inhaling the me dicine, yo u will lose the dose.

The lost dose will be securely held inside the inhaler, but it will no longer be available.

It is not possible to accidentally take extra medicine or a double dose in one inhalation.

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

2) Prepare 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”.

Dose counter This shows how many doses of medicine are left in the inhaler.

Before the inhaler has been used, it shows exactly 30 doses.

It counts down by 1 each time you open the cover.

When fewer than 10 doses are left, half of the dose counter shows red.

After you have used the last dose, half of the dose counter shows red and the number 0 is displayed . Your inhaler is now empty.

If you open the cover after this, the dose counter will change from half red to completely red.

Cover Each time you open this, you prepare one dose of medicine.

Mouthpiece Air vent “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.
• Do not shake the inhaler at any time .

3) Inhale your medicine

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

Do not breathe out into the inhaler.

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

Do not 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 in haler correctly.

If you want to clean the mouthpiece, use a dry tissue , before you close the cover.

4) Close the inhaler and rinse your mouth

• Slide the cover upwards as far as it will go, to cover the mouthpiece.

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

Do not block the air vent with your fingers.

• Rinse your mouth with water after you have used the inhaler , do not swallow .

This will make it less likely that you will develop a sore mouth or throat as side effects.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Elebrato Ellipta (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1237).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.