Leaflet: information for the user

ANORO ELLIPTA 55 micrograms/22 micrograms powder for inhalation (single-dose)

umeclidinium/vilanterol

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Step-by-step usage instructions

What is ANORO ELLIPTA

ANORO ELLIPTA contains two active ingredients, umecidinium bromide and vilanterol. These belong to a group of medications called bronchodilators.

What is ANORO ELLIPTA used for

ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease that worsens slowly and is characterized by difficulty breathing.(COPD)COPD causes the muscles surrounding the airways to contract. 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.

ANORO 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 rapid-acting inhaler, contact your doctor.

Do not use ANORO ELLIPTA:

• if you areallergicto umeclidinium, vilanterol, or any of the other components of this medication (listed in section 6).

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

Warnings and precautions

Consult your doctor before starting to use this medication:

• if you haveasthma(Do not use ANORO ELLIPTA for asthma treatment)
• if you haveheart problemsorhigh blood pressure
• if you have an eye problem calledangle-closure glaucoma
• if you havean enlarged prostate, difficulty urinatingora blockage in the bladder
• if you haveepilepsy
• if you havethyroid problems
• if you have a low level ofpotassiumin your bloodlow
• 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 experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your ANORO ELLIPTA inhaler:

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

Eye problems during ANORO ELLIPTA treatment

If you experience eye pain or discomfort, blurred vision for a time, halos, or colored images associated with eye redness during ANORO ELLIPTA treatment:

stop using this medication 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 medication tochildren or adolescents under 18 years old.

Other medications and ANORO ELLIPTA

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

Some medications may affect the way this medication works, or make it more likely that you will experience side effects. These include:

• medications called beta-blockers (such as propranolol), used in the treatment ofhigh blood pressureorother heart diseases
• ketoconazole or itraconazole, to treatfungus infections
• clarithromycin or telithromycin, to treatbacterial infections
• ritonavir, to treatHIV
• medications that lower potassium levels in the blood, such as some diuretics or some asthma medications (such as methylxanthine or steroids)
• other long-acting medications for similar respiratory problems, such as tiotropium, indacaterol. Do not use ANORO ELLIPTA if you are already using these medications.

Consult your doctor or pharmacistif you are taking any of these medications. Your doctor may perform thorough checks if you are taking any of these medications, as they may increase the side effects of ANORO 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 medication. If you are pregnant, do not use this medication unless your doctor tells you to.

The components of ANORO ELLIPTA are unknown to be excreted in breast milk.If you are breastfeeding, consult your doctorbefore using ANORO ELLIPTA. If you are breastfeeding, do not use this medication unless your doctor tells you to.

Driving and operating machinery

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

ANORO ELLIPTA contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult them before using this medication.

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 ANORO ELLIPTA regularly

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

Do notuse ANORO ELLIPTA to relieve asudden attack of choking 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.

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

If symptoms do not improve

If your symptoms of COPD (choking, wheezing, coughing) 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 ANORO 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 this leaflet. You may notice that your heart beats faster than normal, have visual disturbances, a dry mouth or a headache.

If you forgot to use ANORO 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 choking, use your rescue inhaler with quick action (such as salbutamol) and seek medical advice.

If you interrupt treatment with ANORO 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 ANORO ELLIPTA, stop using this medicine and immediately inform your doctor.

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

• skin rash (hives) or redness.

Very rare side effects (may affect up to 1 in 1,000 people):

• swelling, sometimes of the face or mouth (angioedema)
• increased wheezing (a 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 ANORO 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)

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

Possible(may affect up to 1 in 100 people)

• irregular heartbeat
• rapid heartbeat
• feeling of heartbeats (palpitations)
• muscle spasms
• tremor
• alteration of taste
• hoarseness.

Rare(may affect up to 1 in 1,000 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.

Unknown(the frequency cannot be estimated from available data)

• dizziness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. 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 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.

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 ANORO ELLIPTA

The active ingredients are umeclidinium bromide 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 umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).

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

Appearance of the product and contents of the pack

ANORO ELLIPTA is a dry powder inhaler (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 blister pack. The blister pack 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. ANORO ELLIPTA is available in packs containing 1 inhaler with 7 or 30 doses and in multiple packs containing 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

Dublin 24

Ireland

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

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 ANORO 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 ANORO 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 to reduce the humidity of the pack.Do not remove the desiccant, do not open it, do not ingest it, or inhale it.

When you remove the inhaler from 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 label of the inhaler. The date of “Dispose of” is 6 weeks from the date of opening of the blister pack.

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

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

The step-by-step instructions for use of 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 cap of the inhaler is opened and closed without inhaling the medicine, the dose will be lost.

The lost dose will be retained safely within the inhaler, but will not be available for inhalation.

It is not possible to accidentally administer an additional dose or a double dose by inhaling.

1. Preparing a dose

Wait until you are ready to open the cap of the inhaler 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.

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.