ELEBRATO ELLIPTA 92/55/22 micrograms inhalation powder (single dose)

Introduction

Package Leaflet: Information for the User

Elebrato Ellipta 92micrograms/55micrograms/22micrograms inhalation powder, single dose

fluticasone furoate/umeclidinium/vilanterol

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, pharmacist, 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.

Contents of the pack

1. What is Elebrato Ellipta and what is it used for
2. What you need to know before you use Elebrato Ellipta
3. How to use Elebrato Ellipta
4. Possible side effects
5. Storing Elebrato Ellipta
6. Contents of the pack and other information

Step-by-step instructions for use

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

What is Elebrato Ellipta

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 group of medicines called bronchodilators.

What is Elebrato Ellipta used for

Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease that gets slowly worse and is characterized by difficulty breathing.

In COPD, the muscles around the airways contract, making it difficult to breathe. This medicine opens up the muscles in the lungs, reducing swelling and irritation in the smaller airways, and makes it easier for air to get in and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the effects of COPD on daily life.

Elebrato Ellipta should be used daily and not only when you have breathing problems or other COPD symptoms. It should not be used to relieve a sudden attack of shortness of breath or wheezing.If you have this type of attack, you should use a fast-acting relief inhaler (such as salbutamol). If you do not have a fast-acting relief 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).

Warnings and precautions

Talk to your doctor before you start using Elebrato Ellipta

• if you have asthma(do not use Elebrato Ellipta to treat asthma)
• if you have heart problemsor high blood pressure
• if you have liver problems
• if you have pulmonary tuberculosis(TB) or any other long-standing or untreated infection
• if you have a condition called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty urinating, or a blockage in the bladder
• if you suffer from epilepsy
• if you have thyroid problems
• if you have low potassium levelsin your blood
• if you have a history of diabetes
• if you experience blurred visionor other visual disturbances.

Talk to your doctorif you think any of the above applies to you.

Urgent breathing difficulties

If you experience chest tightness, coughing, wheezing, or difficulty breathing immediately after using your Elebrato Ellipta inhaler:

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

Eye problems during treatment with Elebrato Ellipta

If you experience eye pain or discomfort, blurred vision for a while, halos around lights, colored images, or redness of the eyes during treatment with Elebrato Ellipta:

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

Lung infection

If you are using this medicine to treat COPD, you may be at a higher risk of developing a lung infection called pneumonia. See section 4 "Possible side effects" for information on symptoms to look out for while using this medicine.

Talk to your doctor as soon as possible if you develop any of these symptoms.

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age.

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 that you will have side effects. These include:

• medicines called beta-blockers (such as propranolol), used to treat high blood pressure or other heart conditions
• ketoconazole or itraconazole, used to treat fungal infections
• clarithromycin or telithromycin, used to treat bacterial infections
• ritonavir or cobicistat, used to treat HIV
• medicines that lower potassium levels in the blood, such as some diuretics or some medicines for treating COPD and asthma (such as methylxanthines or steroids)
• other long-acting medicines for treating respiratory problems similar to this medicine, for example, tiotropium, indacaterol. Do not use Elebrato Ellipta if you are already using these medicines.

Talk to your doctor or pharmacistif you are taking any of these medicines. Your doctor may monitor you closely if you are taking any of these medicines, as they may increase the side effects of Elebrato Ellipta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. If you are pregnant, do not use this medicine unless your doctor tells you to.

It is not known if the components of Elebrato Ellipta can pass into breast milk. If you are breastfeeding, talk to your doctor before using Elebrato Ellipta. If you are breastfeeding, do not use this medicine unless your doctor tells you to.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Elebrato Ellipta contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to them before using this medicine.

3. How to use Elebrato Ellipta

Follow the instructions for using this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist again.

The recommended doseis one inhalation every day, at the same time each day. You only need one inhalation a day, as the effect of this medicine lasts for 24 hours.

Do not use more doses than your doctor has told you to.

Use Elebrato Ellipta regularly

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

Elebrato Ellipta should notbe used to relieve a sudden attack of shortness of breath or wheezing. If you have this type of attack, you should use a fast-acting relief inhaler (such as salbutamol).

How to use the inhaler

To get the full instructions, read the "Step-by-step instructions for use" at the end of this leaflet.

Elebrato Ellipta is for inhalation use only.

Elebrato Ellipta is ready to use once the tray is opened.

If your symptoms do not improve

If your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or get worse, or if you are using your fast-acting relief inhaler more often than usual:

contact your doctor as soon as possible.

If you use more Elebrato Ellipta than you should

If you accidentally use more medicine than you should, contact your doctor or pharmacist immediately, as you may need medical attention. If possible, show them the inhaler, packaging, or this leaflet. You may notice that your heart beats faster than normal, feel shaky, have changes in vision, 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 forgotten doses. Inhale the next dose at your usual time. If you have wheezing or shortness of breath, use your fast-acting relief inhaler (such as salbutamol), and seek medical advice.

If you stop using Elebrato Ellipta

Use this medicine for as long as your doctor recommends. Do not stop using it until your doctor tells 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 Elebrato Ellipta are rare (may affect up to 1 in 1,000 people).

If you get any of the following symptoms after taking Elebrato Ellipta, stop using itand tell your doctor immediately:

• skin rash or redness, hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema)
• wheezing, coughing, or difficulty breathing
• a feeling of weakness or dizziness (which may cause collapse or loss of consciousness).

Urgent breathing difficulties

If your breathing or wheezing gets worse immediately after using this medicine, stop using itand seek medical help immediately.

Pneumonia (lung infection)in patients with COPD (common side effect)

If you get any of the following symptoms while using Elebrato Ellipta, tell your doctor. They could be symptoms of a lung infection:

• fever or chills
• increase in mucus production, change in mucus color
• increase in coughing or difficulty breathing.

Other side effects

Common(may affect up to 1 in 10 people)

• thrush (a fungal infection) in the mouth or throat (candidiasis). Rinsing your mouth with water immediately after using Elebrato Ellipta may help prevent this side effect
• nose, sinus, or throat infection
• upper respiratory tract infection
• itching, runny nose, or blocked nose
• pain in the back of the mouth and throat
• sinusitis
• bronchitis
• flu
• common cold
• headache
• coughing
• painful or 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
• faster heartbeat
• hoarseness
• weakening of the bones which may cause fractures
• dry mouth
• change in 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 urinating (urinary retention)
• pain or discomfort while urinating (dysuria)
• awareness of heartbeats (palpitations)
• anxiety
• shakiness
• muscle spasms
• high blood sugar levels (hyperglycemia).

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 pack after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Keep the inhaler in 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 that the inhaler should be discarded on the space provided on the inhaler label. The date should be written as soon as the inhaler is removed from the tray.

If stored in a refrigerator, let the inhaler reach room temperature for at least one hour before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Elebrato Ellipta

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

Each inhalation provides a delivered dose (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 ingredients are lactose monohydrate (see section 2 "Elebrato Ellipta contains lactose") and magnesium stearate.

Appearance and Container Contents of the Product

Elebrato Ellipta is a powder for inhalation (single-dose).

The Ellipta inhaler consists of a light gray plastic body, a beige mouthpiece cover, and a dose counter. It is packaged in a laminated aluminum tray with a foldable aluminum lid. The tray contains a desiccant sachet to reduce moisture in the container.

The active substance is presented as a white powder in separate blister strips inside the inhaler. Elebrato Ellipta is available in packs of 1 inhaler containing 14 or 30 doses (for 14 or 30 days of treatment) and in clinical packs containing 90 doses (3 inhalers of 30 doses, for 90 days of treatment). Not all pack sizes may be marketed.

Marketing Authorization 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Step-by-Step Instructions for Use

What is the Inhaler?

The first time you use Elebrato Ellipta, you do not need to make sure the inhaler is working correctly, as it contains pre-measured doses and is ready to use directly.

Your Elebrato Ellipta Inhaler Pack Contains:

The inhaler is packaged in a tray. Do not open the tray 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 tray. The tray contains a desiccant sachet to reduce moisture. Dispose of the desiccant sachet, do notopen it, ingest it, or inhale it.

When you take the inhaler out of its tray, 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 write the "Discard by" date in the space provided on the inhaler label and on the carton. The "Discard by" date is 6 weeks from the date you open the tray. After this date, the inhaler should not be used. The tray can be discarded once you open it.

If stored in a refrigerator, let the inhaler reach room temperature for at least 1 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 cover is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be retained safely inside the inhaler but will not be available for inhalation.

It is not possible to accidentally administer an extra dose or a double dose through an inhalation.

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

1. Prepare a Dose

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

Do not shake the inhaler.

• Slide the cover down until you hear a "click".

Now the medicine is ready to be inhaled.

As confirmation, the dose counter decreases by 1unit.

• If the dose counter does not decrease when you hear the "click", the inhaler will not release the dose of the medicine. Take it to the pharmacist and ask for help.
• Do not shake the inhaler at any time.

1. Inhale the Medicine

• While keeping the inhaler away from your mouth, breathe out as much as you can.

Do notbreathe out into the inhaler.

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

Do notblock the ventilation slots with your fingers.

• Take a long, steady, and deep breath in. Hold your breath for as long as you can (at least 3-4 seconds).
• Take the inhaler out of your mouth.
• Breathe out slowly and gently.

You may not be able to taste or feel the medicine, even when using the inhaler correctly.

Beforeclosing the cover, the mouthpiece of the inhaler can be cleaned using a dry tissue.

1. Close the Inhaler and Rinse Your Mouth

• Slide the cover 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 get side effects such as mouth or throat ulcers.