Label: information for the patient

RoluftaEllipta55microgramspowder for inhalation (single-dose)
umeclidinium (umeclidinium)

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others 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 label. See section 4.

Step-by-step usage instructions

What is Rolufta Ellipta

Rolufta Ellipta contains the active ingredient umeclidinium (as bromide), which belongs to a group of medications calledbronchodilators.

What is Rolufta Ellipta used for

This medication is used to treatchronic obstructive pulmonary disease(COPD)in adults. COPD is a chronic disease that worsens gradually, and in which, over time, 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 impede airflow.

This medication 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.

Rolufta 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, use a rapid-acting rescue inhaler (such as salbutamol). If you do not have a rescue inhaler, contact your doctor.

No use Rolufta Ellipta

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

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

Warnings and precautions

Consult your doctor before starting to use Rolufta Ellipta:

• if you haveasthma(do not use Rolufta Ellipta to treat asthma)
• if you haveheart problems
• if you have a eye problem 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 Rolufta Ellipta inhaler:

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

Eye problems during treatment with Rolufta Ellipta

If you experience eye pain or discomfort, blurred vision for a time, halos or colored images associated with eye redness during treatment with Rolufta Ellipta:stop using this medicine and seek medical help immediatelyas these signsmay be due to an acute angle-closure glaucoma attack.

Children and adolescents

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

Rolufta Ellipta contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with himbefore using this medicine.

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 RoluftaElliptaregularly

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

Do notuse this medication to relieve asudden attack of cough 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 Rolufta Ellipta is by inhalation.To use RoluftaEllipta, inhale it into your lungs through your mouth using the Ellipta inhaler.

If symptoms do not improve

If your symptoms of COPD (cough, wheezing, sputum) do not improve or worsen, or if you are using your quick-acting rescue inhaler more frequently than usual:

contact your

doctor as soon as possible.

If you use more RoluftaElliptathan 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 RoluftaEllipta

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 cough, use your quick-acting rescue inhaler (for example salbutamol), and seek medical advice.

If you interrupt treatment with RoluftaEllipta

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 may cause side effects, although not everyone will experience them.

Allergic reactions

If after using Rolufta Ellipta, you have any of the following symptoms, stop using this medicine and immediately inform your doctor:

Uncommon(may affectup to 1 in 100people):

• itching
• skin rash (hives) or redness.

Rare(may affectup to 1 in 1,000people):

• asthma-like symptoms (whistling sound when 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 (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(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 1,000people):

• eye pain.

Frequency not known(thefrequencycannot be estimated from the available data):

• decreased visionn 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, 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 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 humidity 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 on which 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, let the inhaler return to room temperature at least one hour before using it.

Medicines 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 Rolufta ElliptaEllipta

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 section “Rolufta Ellipta contains lactose” in section 2) and magnesium stearate.

Appearance of the product and contents of the pack

Rolufta 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 tray with a foldable aluminium sheet. The tray contains a desiccant bag to reduce humidity in the pack.

The active ingredient is presented as a white powder in a blister inside the inhaler.

Rolufta Ellipta is available in packs of one inhaler containing 7or 30doses and in multiple packs of 90 doses (3 inhalers of 30doses). Only some pack sizes may be marketed.

Marketing authorisation holder:

GlaxoSmithKline Trading Services 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 Rolufta 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 Rolufta 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 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 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 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 to be inhaled.

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 it 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 air vents with your fingers.

• Breathe in deeply and slowly. 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.