Prospecto: information for the patient

Incruse Ellipta 55microgramspowder forinhalation (single-dose)
umeclidinium (umeclidinium)

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

• Keep this prospectus, 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 even if they 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 prospectus. See section 4.

1. What isIncruseElliptaand what it is used for

2. What you need to know before starting to useIncruseEllipta

3. How to useIncruseEllipta

4. Possible adverse effects

5. Storage ofIncruseEllipta

6. Contents of the package and additional information

Step-by-step usage instructions

What is Incruse Ellipta

Incruse Ellipta contains the active ingredient umeclidinium (as bromide), which belongs to a group of medicines called bronchodilators.

What is Incruse Ellipta used for

This medicine is used to treatchronic obstructive pulmonary disease (COPD)(COPD)in adults. COPD is a chronic disease that worsens slowly, and in which, gradually, the airways and lung sacs become obstructed or damaged, causing difficulty breathing. This difficulty breathing is added to the contraction of the muscles surrounding the airways, which causes these airways to narrow and hinder airflow.

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 control breathing difficulties and reduces the effects of COPD on daily life.

Incruse Ellipta should not be used to relieve a sudden attack of choking or wheezing (whistling sounds while breathing).

If you experience 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.

Do not use Incruse Ellipta

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

If you think the above applies to you,do not usethis medicineuntil you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to use Incruse Ellipta:

• if you haveasthma(do not use IncruseElliptato treat asthma)

-if you haveheart problems

-if you have a eye condition calledangle-closure glaucoma

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

• if you havesevere liver problems.

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

Immediate breathing difficulties
If you experience chest tightness, cough, wheezing or immediate difficulty breathing after using your IncruseElliptainhaler:

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

Eye problems during treatment with Incruse Ellipta

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

stop using this medicine and seek medical help immediately,as these symptoms 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 Incruse 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 what your medicine contains, consult your doctor or pharmacist.

Particularly, inform your doctor or pharmacist if you are taking other long-acting medicines to treat similar respiratory problems to this medicine, for example, tiotropium. Do not use Incruse Ellipta with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend 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 of IncruseElliptaare unknown to be excreted in breast milk.If you are breastfeeding,you must consult your doctorbefore using IncruseEllipta.

If you are breastfeeding, do not usethis medicine unless your doctor tells you to.

Driving and operating machinery

It is unlikely that this medicine will affect your ability to drive or operate machinery.

Incruse Ellipta contains lactose

If your doctor has told you thatyou have a certain sugar intolerance, consult him before using thismedicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult 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 medication lasts 24 hours.

Do not use more doses than your doctor has indicated.

Use Incruse Elliptaregularly

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

Do notuse this medication to relieve asudden attack of coughing or wheezing. If you have this type of attack, use a quick-acting rescue inhaler (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.

The administration of Incruse Ellipta is by inhalation.To use IncruseEllipta, inhale it into your lungs through your mouth using the Ellipta inhaler.

If symptoms do not improve

If your symptoms of COPD (coughing, wheezing, and shortness of breath) do not improve or worsen, or if you are using your quick-acting rescue inhaler more often than usual:contact your doctor as soon as possible.

If you use more Incruse Ellipta than 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 your leaflet. You may notice that your heart beats faster than normal, have visual disturbances, or a dry mouth.

If you forget to use Incruse 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 quick-acting rescue inhaler (for example, salbutamol), and seek medical advice.

If you interrupt treatment with Incruse 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 after using Incruse Ellipta you experience any of the following symptoms,stop using this

medicine and inform your doctor immediately:

Uncommon(may affectup to 1 in 100people):

• itching
• skin rash (hives) or redness.

Rare(may affectup to 1 in 10000people):

• wheezing (a high-pitched sound while breathing), cough or difficulty breathing
• sudden feeling of weakness or dizziness (which may cause collapse or loss of consciousness)

Other side effects:

Common(may affectup to1 in 10people):

• rapid heartbeat
• painful urination and increased frequency (which may be signs of a urinary tract infection)
• common cold
• nasal and throat infection
• cough
• sensation of pressure or pain in the cheeks and forehead (which may be symptoms of sinusitis)
• headache
• constipation
• mouth and throat pain.

Uncommon(may affectup to 1 in 100people):

• irregular heartbeat
• throat pain
• dry mouth
• alteration of taste
• hoarseness.

Rare(may affectup to 1 in 10000people):

• eye pain.

Unknown frequency(the frequencycannot be estimated from the available data):

• decreased vision or eye pain due to elevated intraocular pressure (possible signs of glaucoma)
• blurred vision
• increased intraocular pressure
• difficulty and pain during urination, which may be a sign of bladder obstruction or urinary retention
• dizziness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, evenif it is apossibleside effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on 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 discarded in 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, allow the inhaler to 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 of Incruse Ellipta

The active ingredient is umeclidinium (as bromide).

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

The other components are lactose monohydrate (see the section “Incruse Ellipta contains lactose” in section 2) and magnesium stearate.

Appearance of the product and contents of the pack

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

The Ellipta inhaler is made up of a grey plastic body, a greenish clear mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium blister pack with a fold-out aluminium leaflet. The blister pack contains a desiccant bag to reduce humidity in the pack.

The active ingredient is presented as a white powder in a blister within the inhaler. Incruse Ellipta is available in packs containing one inhaler with 7 or 30 doses and in multiple packs of 90 doses (3 inhalers of 30 doses). Only some pack sizes may 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

The detailed 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 IncruseEllipta, 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 Incruse Ellipta inhaler pack contains:

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

When you take the inhaler out of the blister pack, 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 blister pack, you should note the date of “Dispose of” on the space provided on the inhaler label. The date of “Dispose of” is 6 weeks from the date of opening the blister pack. After this date the inhaler should not be used any more.The blister pack can be disposed of once you have opened it.

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

The step-by-step instructions for use of the Ellipta 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 for inhalation.

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

1. Preparing a dose

Wait until you are ready to open the inhaler cap before inhaling 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 the inhaler to your 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 slowly through your mouth. Keep breathing 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 notice the medicine, even when using the inhaler correctly.

Before closing 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.