Prospecto: information for the user

LAVENTAIR ELLIPTA55micrograms/22microgramspowder for inhalation (single-dose)
umeclidinium/vilanterol

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to other people who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this prospect. See section 4.

1.What is LAVENTAIR ELLIPTA and how it is used

2.What you need to know before starting to use LAVENTAIR ELLIPTA

3.How to use LAVENTAIR ELLIPTA

4.Possible adverse effects

1. Storage of LAVENTAIR ELLIPTA
2. Contents of the package and additional information

Step-by-step usage instructions

What is LAVENTAIRELLIPTA

LAVENTAIR ELLIPTA contains two active ingredients, bromide of umeclidinium and vilanterol. These belong to the group of medicines known as bronchodilators.

What is LAVENTAIRELLIPTA used for

LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease(COPD)in adults.COPDis a chronic disease, which worsens slowly and is characterized by difficulty breathing.

In COPD the muscles surrounding the airways contract. This medicine prevents the contraction of these muscles in the lungs, facilitating the entry and exit of air from the lungs.

When used regularly, it helps to control breathing difficulties and reduces the effects of COPD on daily life.

LAVENTAIR ELLIPTAshould not be used to relieve a sudden attack of choking or wheezing (whistling sounds when breathing).

If you have this type of attack, you should use a rapid-acting rescue inhaler (such as salbutamol).If you do not have a rapid-acting inhaler, contact your doctor.

No useLAVENTAIR ELLIPTA:

-if you areallergicto umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).

If you think this applies to you,do not usethis medicine until you have spoken to your doctor.

Warnings and precautions

Consult your doctor before starting to use this medicine:

• if you haveasthma(Do not use LAVENTAIR ELLIPTA for the treatment of asthma)
• if you haveheart problemsorhigh blood pressure

• if you have acondition calledangle-closure glaucoma

-if you havean enlarged prostate,difficulty passing urineor ablockage in the bladder

-if you haveepilepsy

-if you havethyroid problems

-if you have alow level of potassium in your blood

-if you havediabetes

-if you havesevere liver problems.

Consult your doctorif you think any of the above conditions apply to you.

Urgent breathing difficulties
If you have chest tightness, cough, wheezing or difficulty breathing immediately after using your LAVENTAIR ELLIPTA inhaler:

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

Eye problems during treatment with LAVENTAIR ELLIPTA

If you have eye pain or discomfort, blurred vision for a time, halos around lights or coloured images associated with eye redness during treatment withLAVENTAIR ELLIPTA:

stop using this medicine and seek medical help immediately,as these signs may be due to an acute angle-closure glaucoma attack.

Children and adolescents

Do not administer this medicine tochildren or adolescents under 18 years.

Other medicines and LAVENTAIR ELLIPTA

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. If you are unsure about the contents of your medicine, consult your doctor or pharmacist.

Some medicines may affect the way this medicine works, or make it more likely that you will have side effects. These include:

• medicines calledbeta-blockers(such as propranolol), used in the treatment ofhigh blood pressureor otherheart conditions
• ketoconazole oritraconazole, to treatfungus infections
• clarithromycin ortelithromycin, to treatbacterial infections
• ritonavir, to treatHIV
• medicines that lower the levels of potassium in the blood, such as somediureticsor some medicines forasthma(such as methylxanthines or steroids)
• other long-acting medicines for similar respiratory problems, such as tiotropium, indacaterol. Do not use LAVENTAIR ELLIPTA if you are already using these medicines.

Consult your doctor or pharmacistif you are taking any of these medicines. Your doctor may perform regular checks if you are taking any of these medicines, as they may increase the side effects of LAVENTAIR ELLIPTA.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant,consult your doctorbefore using this medicine.If you are pregnant, do not use this medicine unless your doctor tells you to.

The components ofLAVENTAIR ELLIPTAare not known to be excreted in breast milk.Consult your doctorbefore using LAVENTAIR ELLIPTA if you are breastfeeding. If you are breastfeeding, do not use this medicine unless your doctor tells you to.

Driving and operating machinery

It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or operate machinery.

LAVENTAIR ELLIPTAcontainslactose

If your doctor has told you that you havea certain sugar intolerance, consult them before using this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult with your doctor or pharmacist.

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 medication lasts 24 hours.

Do not use more doses than your doctor has indicated.

Use LAVENTAIR ELLIPTAregularly

It is very important that you use LAVENTAIR ELLIPTA every day, as your doctor has indicated. This will help you not to have symptoms throughout the day and night.

Do notuse LAVENTAIR ELLIPTAto relieve a sudden attack of shortness of breath or wheezing.If you have this type of attack, use a rescue inhaler with quick action (such as salbutamol).

How to use the inhaler

To get the complete information, read the “Step-by-Step Instructions for Use” at the end of this leaflet.

LAVENTAIR ELLIPTA is for inhalation. To use LAVENTAIR ELLIPTA,inhal it into your lungs through your mouth using the ELLIPTA inhaler.

If symptoms do not improve

If your symptoms of COPD (shortness of breath, wheezing, cough) do not improve or worsen, or if you are using your rescue inhaler with quick action more often than usual:

contact your doctor as soon as possible.

If you use more LAVENTAIR ELLIPTAthan you should

If you accidentally use too much medication,contact your doctor or pharmacist immediately,as you may need medical attention. If possible, show them the inhaler, the packaging or this leaflet. You may notice that your heart beats faster than normal, have visual disturbances, a dry mouth or headache.

If you forgot to use LAVENTAIR ELLIPTA

Do not inhale a double dose to compensate for the missed doses.Inhale the next dose at your usual time.If you have wheezing or shortness of breath, use your rescue inhaler with quick action (such as salbutamol) and seek medical advice.

If you interrupt treatment with LAVENTAIR ELLIPTA

Use this medication for the time your doctor has recommended. It will only be effective for the time you continue to use it. Do not stop using it until your doctor tells you to, even if you feel better, as your symptoms may worsen.

If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions

If you experience any of the following symptoms after taking LAVENTAIR ELLIPTA, stop using this medicine and inform your doctor immediately.

Less common side effects (may affect up to 1 in 100 people):

• skin rash (hives) or redness.

Rare side effects (may affect up to 1 in 10,000 people):

• swelling, sometimes of the face or mouth (angioedema)
• increased wheezing (whistling sound when breathing), cough or difficulty breathing
• sudden feeling of weakness or dizziness (which may cause collapse or loss of consciousness).

Urgent breathing difficulties
Urgent breathing difficulties after using LAVENTAIR ELLIPTA are rare. If you experience chest tightness, cough, wheezing or difficulty breathing immediately after using this medicine:

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

Other side effects

Frequent (may affect up to 1 in 10 people)

• urination that is frequent and painful (may be a symptom of urinary tract infection)
• combination of sore throat and runny nose
• sore throat
• sensation of pressure or pain in the cheeks and forehead (may be a symptom of sinusitis)
• headache
• cough
• dullness or irritation in the back of the mouth and throat
• constipation
• dry mouth
• upper respiratory tract infection.

Less common (may affect up to 1 in 100 people)

• irregular heartbeat
• rapid heartbeat
• feeling the heartbeat (palpitations)
• muscle spasms
• trembling
• alteration of taste
• hoarseness.

Rare (may affect up to 1 in 10,000 people)

• blurred vision
• increased intraocular pressure
• decreased vision or eye pain (possible signs of glaucoma)
• difficulty and pain when urinating, which may be signs of bladder obstruction or urinary retention.

Not known(frequency cannot be estimated from available data):

• dizziness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, tray, and inhaler, after CAD. The expiration date is the last day of the month indicated.

Keep the inhaler inside 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 the tray is opened.Write the date when the inhaler should be discardedin the designated space on the inhaler label. The date should be noted as soon as the inhaler is removed from the tray.

Do not store at a temperature above 30°C.

If stored in the refrigerator, let the inhaler return to room temperature at least one hour before using it.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition ofLAVENTAIR ELLIPTA

The active ingredients are bromide ofumeclidinium and vilanterol.

Each inhalation provides a released dose (the dose that comes out of the mouthpiece) of 55 micrograms of umeclidinium (equivalent to 65 micrograms of bromide of umeclidinium) and 22 micrograms of vilanterol (as trifenatate).

The other components are lactose monohydrate (see section “LAVENTAIR ELLIPTA contains lactose” in section 2)and magnesium stearate.

Appearance of the product and contents of the pack

LAVENTAIR ELLIPTA is a powder for inhalation (single-dose).

The Ellipta inhaler device is made of a clear grey plastic body, a red mouthpiece cover and a dose counter. It is packaged in a laminated aluminium tray. The tray contains a desiccant to reduce the humidity of the pack.

The active ingredients are presented as a white powder in separate blisters within the inhaler. LAVENTAIR ELLIPTA is available in packs of 1 inhaler containing 7 or 30 doses and in multiple packs containing 90 doses (3 inhalers of 30 doses). Some pack sizes may only be marketed.

Marketing authorisation holder:

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublín 24

Irlanda

Responsible for manufacturing:

Glaxo Wellcome Production

Zone Industrielle No.2,

23 Rue Lavoisier,

27000 Evreux,

Francia

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Last update of the summary of product characteristics:

Other sources of information

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

Step-by-step instructions for use

What is the Ellipta inhaler?

The first time you use LAVENTAIR ELLIPTA, you do not need to check that the inhaler is working correctly, as it contains pre-measured doses and is ready to use directly.

Your LAVENTAIR ELLIPTA inhaler pack contains:

The inhaler is packaged in a tray.Do not open the tray until you are ready to start using your new inhaler. When you are ready to use the inhaler, remove the cap to open the tray. The tray contains a desiccant, to reduce the humidity. Discard the desiccant bag,do not open it, ingest it or inhale it.

When you remove the inhaler from 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.When you open the tray, you should note the date of “Dispose of” in the space provided for it on the inhaler label. The date of “Dispose of” is 6 weeks from the date of opening the tray.

After this date the inhaler should not be used any more. The tray can be disposed of after the first opening.

If you store it in the fridge, let the inhaler reach room temperature for at least one hour before use.

The step-by-step instructions for using the inhaler provided below can be used for both the 30-dose inhaler (30 days of treatment) and the 7-dose inhaler (7 days of treatment).

1. Read this information before starting

If the inhaler cap 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 to be inhaled.

You cannot accidentally administer an additional dose or a double dose by inhaling.

1. Preparing a dose

Wait until you open the inhaler cap until you are ready to inhale a dose.

Do not shake the inhaler.

• Slide the cap down until you hear a ‘click’.

Now, the medicine is ready to be inhaled.

As confirmation, the dose counter decreases by1unit.

• If the dose counter does not decrease when you hear the ‘click’, the inhaler will not release the dose of medicine.

Take it to the pharmacist and ask for help.

1. Inhale your medicine

• While holding the inhaler away from your mouth, breathe out as much as possible.

Do not breathe out into the inhaler.

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

Do not block the ventilation slots with your fingers.

• Breathe in deeply and continuously for at least 3-4 seconds.
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

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

Beforeyou close the cap, the mouthpiece of the inhaler can be cleaned using adry tissue.

1. Closing the inhaler

Slide the cap up to the top to cover the mouthpiece.