ANORO ELLIPTA 55 MCG/22 MCG INHALATION POWDER (SINGLE-DOSE)

Introduction

Package Leaflet: Information for the User

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

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

Step-by-step instructions for use

1. What ANORO ELLIPTA is and what it is used for

What ANORO ELLIPTA is

ANORO ELLIPTA contains two active substances, umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.

What ANORO ELLIPTA is used for

ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease that gets slowly worse over time and makes it difficult to breathe.

In COPD, the muscles around the airways contract. This medicine helps to stop these muscles from contracting in the lungs, making it easier to breathe in and out. When used regularly, it helps to control breathing difficulties and reduces the effects of COPD on daily life.

ANORO ELLIPTA should not be used to relieve a sudden attack of wheezing or shortness of breath.If you have this type of attack, you should use a fast-acting "rescue" inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.

2. What you need to know before you use ANORO ELLIPTA

Do not use ANORO ELLIPTA:

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

If you think any of the above applies to you, do not usethis medicine until you have talked to your doctor.

Warnings and precautions

Talk to your doctor before you start using this medicine:

• if you have asthma(Do not use ANORO ELLIPTA for the treatment of asthma)
• if you have heart problemsor high blood pressure
• if you have a type of eye problem called narrow-angle glaucoma
• if you have enlarged prostate, difficulty passing urineor a blockage in the bladder
• if you have epilepsy
• if you have thyroid problems
• if you have low potassium levels in your blood
• if you have diabetes
• if you have severe liver problems.

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

Urgent breathing problems

If you get chest tightness, cough, wheezing, or difficulty breathing immediately after using your ANORO ELLIPTA inhaler:

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

Eye problems during treatment with ANORO ELLIPTA

If you get eye pain or discomfort, blurred vision for a time, halos around lights, or colored images associated with red eyes during treatment with ANORO ELLIPTA:

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

Children and adolescents

Do not give this medicine to children or adolescents under 18 years.

Other medicines and ANORO 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 is in your medicine, talk to your doctor or pharmacist.

Some medicines may affect how this medicine works or make it more likely that you will get side effects. These include:

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

Talk to your doctor or pharmacistif you are taking any of these medicines. Your doctor may want to monitor you closely if you are taking any of these medicines, as they may increase the risk of side effects with ANORO ELLIPTA.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctorfor 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 ingredients of ANORO ELLIPTA pass into breast milk. Talk to your doctorbefore using ANORO ELLIPTA if you are breastfeeding. If you are breastfeeding, do not use this medicine unless your doctor tells you to.

Driving and using machines

ANORO ELLIPTA is unlikely to affect your ability to drive or use machines.

ANORO ELLIPTA contains lactose

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

3. How to use ANORO ELLIPTA

Use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

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

Do not use more doses than your doctor has recommended.

Use ANORO ELLIPTA regularly

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

Do notuse ANORO ELLIPTA to relieve a sudden attack of wheezing or shortness of breath. If you have this type of attack, you should use a fast-acting "rescue" inhaler (such as salbutamol).

How to use the inhaler

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

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

If your symptoms do not improve

If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or get worse, or if you are using your fast-acting "rescue" inhaler 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 medicine, 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, have changes in vision, dry mouth, or headache.

If you forget to use ANORO ELLIPTA

Do not inhale a double dose to make up for a forgotten dose.Inhale the next dose at your usual time.

If you have wheezing or shortness of breath, use your fast-acting "rescue" inhaler (such as salbutamol) and seek medical advice.

If you stop using ANORO ELLIPTA

Use this medicine for as long as your doctor tells you to. It will only work as long as you use it. Do not stop using it unless 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

If you get any of the following symptoms after using ANORO ELLIPTA, stop using this medicine and tell your doctor immediately.

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

• skin rash (hives) or redness.

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

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

Urgent breathing problems

Urgent breathing problems after using ANORO ELLIPTA are rare. If you get chest tightness, cough, wheezing, or difficulty breathing immediately after using this medicine:

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

Other side effects

Common(may affect up to 1 in 10 people)

• painful or frequent urination (may be a sign of a 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 sign of sinusitis)
• headache
• cough
• pain or irritation in the back of the mouth and throat
• constipation
• dry mouth
• upper respiratory tract infection.

Uncommon(may affect up to 1 in 100 people)

• irregular heartbeat
• faster than normal heartbeat
• awareness of heartbeat (palpitations)
• muscle spasms
• tremors
• change in taste
• hoarseness.

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

• blurred vision
• increased pressure in the eye
• decreased vision or eye pain (possible signs of glaucoma)
• difficulty or pain when urinating, which may be signs of a blockage in the bladder or urinary retention.

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

• dizziness.

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 ANORO 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, tray, and inhaler, after EXP. The expiry date is the last day of the month stated.

Keep the inhaler in the sealed tray to protect it from moisture and only remove it from the tray immediately before first use. Once the tray is opened, the inhaler can be used for 6 weeks. Write the date that you open the tray on the inhaler label in the space provided. The date should be added as soon as the inhaler is removed from the tray.

Do not store above 30°C.

If stored in a refrigerator, allow the inhaler to return to 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. These measures will help protect the environment.

6. Contents of the pack and additional information

Composition of ANORO ELLIPTA

The active substances are umeclidinium bromide and vilanterol.

Each inhalation provides a delivered dose (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 ingredients are lactose monohydrate (see section “ANORO ELLIPTA contains lactose” in section 2) and magnesium stearate.

Appearance and pack contents of the product

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

The Ellipta inhaler device is made up of a light grey plastic body, a red mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium foil blister pack. The pack contains a desiccant sachet to reduce the moisture in the pack.

The active substances are presented as a white powder in separate blisters within the inhaler. ANORO ELLIPTA is available in packs of 1 inhaler containing 7 or 30 doses and in multipacks containing 90 doses (3 inhalers of 30 doses). Not all pack sizes may be marketed.

Marketing authorisation holder:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

D24 YK11

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

You can request more information about this medicinal product from the local representative of the marketing authorisation 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 web site: 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 straight away.

What is in your ANORO ELLIPTA inhaler?

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 lid to open the tray. The tray contains a desiccantsachet, to reduce moisture in the pack. Throw away the desiccant sachet, do notopen it, eat 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 medicine. When the tray is opened, you should write the “Discard by” date on the inhaler label (6 weeks from the date of opening the tray).

After this date, the inhaler should not be used. The tray can be discarded after first opening.

If stored in a refrigerator, allow the inhaler to come to 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 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 it will not be available for inhalation.

It is not possible to accidentally take an extra dose or a double dose with one inhalation.

1. Prepare a dose

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

Do not shake the inhaler.

• Slide the cap down until you hear a “click”.

Now the medicine is ready to inhale.

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 medicine.

Take it back to the pharmacist and ask for help.

1. Inhale your medicine

• Hold the inhaler away from your mouth and breathe out as far as you can.

Do notbreathe out into the inhaler.

• Put the mouthpiece between your lips, and close your lips firmly around it.

Do notblock the ventilation holes with your fingers.

• Take a long, steady, deep breath in through your mouth. Hold your breath for as long as possible (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 you are using the inhaler correctly.

Beforeclosing the cap, the mouthpiece of the inhaler may be cleaned using a dry tissue.

1. Close the inhaler

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