RELVAR ELLIPTA 92 mcg/22 mcg INHALATION POWDER (UNIDODIS)

Introduction

Package Leaflet: Information for the Patient

Relvar Ellipta 92 micrograms/22 micrograms inhalation powder (single dose)

Relvar Ellipta 184 micrograms/22 micrograms inhalation powder (single dose)

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

Step-by-step instructions for use

1. What Relvar Ellipta is and what it is used for

Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. There are two different strengths of Relvar Ellipta: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.

The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, as well as for the treatment of asthma in adults and adolescents aged 12 years and older.

The 184/22 micrograms strength is used for the treatment of asthma in adults and adolescents aged 12 years and older. The 184/22 micrograms strength is not approved for the treatment of COPD.

Relvar Ellipta should be used every day and not just when you have difficulty breathing or other symptoms of asthma and COPD. It should not be used to relieve a sudden attack of shortness of breath or wheezing. If you have this type of attack, you should use a fast-acting "rescue" inhaler (such as salbutamol). Contact your doctor if you do not have a fast-acting inhaler.

Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They also reduce swelling (inflammation) and irritation of the small airways in the lungs and gradually relieve breathing problems. Corticosteroids also help prevent asthma attacks and worsening of COPD.

Vilanterol belongs to a group of medicines called long-acting bronchodilators. It works by relaxing the muscles of the small airways in the lungs. This helps to open up the airways and makes it easier for air to get in and out of the lungs. When used regularly, it helps to keep the small airways in the lungs open.

Using these two active substances together every day will help control your breathing problems better than using either medicine on its own.

Asthmais a serious, chronic lung disease in which the muscles around the smaller airways tighten (bronchoconstriction) and become swollen and irritated (inflammation). Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing. Relvar Ellipta has been shown to reduce asthma attacks and symptoms.

Chronic Obstructive Pulmonary Disease (COPD)is a serious, chronic lung disease in which the airways become inflamed and thickened. Symptoms include difficulty breathing, coughing, chest discomfort, and coughing up mucus. Relvar Ellipta has been shown to reduce flare-ups of symptoms in COPD.

2. What you need to know before you use Relvar Ellipta

Do not use Relvar Ellipta

• if you are allergicto fluticasone furoate, vilanterol, or any of the other ingredients of this medicine (listed in section 6)
do not use Relvar Elliptauntil you have talked to your doctor.

Warnings and precautions

Talk to your doctor before you start using Relvar Ellipta:

• if you have liver problems, as you may be more likely to get side effects. If you have moderate or severe liver problems, your doctor will limit your dose to the lowest strength of Relvar Ellipta (92/22 micrograms once daily)
• if you have heart problemsor high blood pressure
• if you have pulmonary tuberculosis (TB)or any other long-standing or untreated infection
• if you have ever been told you have diabetesor high blood sugar levels
• if you have thyroid problems
• if you have low potassium levels in your blood
• if you have blurred vision or other vision problems.

Talk to your doctorbefore using this medicine if you think any of the above applies to you.

While you are using Relvar Ellipta

Sudden breathing problems

If you get chest tightness, coughing, wheezing, or difficulty breathing immediately after using your Relvar Ellipta inhaler:

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

• Talk to your doctor if you get blurred vision or other vision problems.
• Talk to your doctor if you get an increased thirst, passing more urine than usual, or unexplained tiredness (signs of high blood sugar levels).

Lung infection

If you are using this medicine for COPD, you may be more likely to get a lung infection called pneumonia. See section 4 for information on symptoms to look out for while you are using this medicine. Talk to your doctor as soon as possible if you get any of these symptoms.

Children and adolescents

Do not give this medicine to children under 12 years of age for the treatment of asthma, or to children and adolescents of any age for the treatment of COPD.

Other medicines and Relvar Ellipta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Talk to your doctor or pharmacist if you are not sure what your medicine contains.

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

• medicines called beta-blockers, such as metoprolol, used to treat high blood pressureor heart disease
• ketoconazole, used to treat fungal infections
• ritonavir or cobicistat, used to treat HIV
• long-acting beta2-adrenergic agonists, such as salmeterol.

Talk to your doctor or pharmacistif you are taking any of these medicines.

Some medicines may increase the effects of Relvar Ellipta, so your doctor may want to monitor you closely if you are taking these medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are pregnant, do not use this medicine unless your doctor tells you to.

It is not known if this medicine passes into breast milk. Talk to your doctorbefore using Relvar Ellipta if you are breast-feeding. If you are breast-feeding, do not use this medicine unless your doctor tells you to.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Relvar 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 Relvar Ellipta

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

Asthma

The recommended dosefor the treatment of asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily, at the same time each day.

If you have severe asthma, your doctor may decide that you should use one inhalation of the higher strength inhaler (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose should also be used once daily, at the same time each day.

COPD

The recommended dosefor the treatment of COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily, at the same time each day.

The higher strength of Relvar Ellipta (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.

Relvar Ellipta is for inhalation only.

Use Relvar Ellipta at the same time each day, as it is effective for 24 hours

It is very important that you use this medicine every day, as prescribed by your doctor. This will help you to not have symptoms during the day or night.

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

If you feel like you are getting short of breath or wheezing more often than usual, or if you are using your fast-acting "rescue" inhaler more often than usual, talk to your doctor.

How to use Relvar Ellipta

For full instructions on how to use Relvar Ellipta, see the "Step-by-step instructions for use" at the end of this leaflet.

Relvar Ellipta is for inhalation only. You do not need to prepare Relvar Ellipta in any special way, even the first time you use it.

If your symptoms do not improve

If your symptoms (shortness of breath, wheezing, coughing) do not improve or get worse, or if you are using your fast-acting "rescue" inhaler more often than usual: talk to your doctor as soon as possible.

If you use more Relvar Ellipta than you should

If you accidentally inhale more Relvar Ellipta than your doctor has prescribed, talk to your doctor or pharmacist. If possible, show them the inhaler, packaging, or this leaflet. You may notice that your heart beats faster than usual, feel shaky, or get a headache.

If you have used more medicine than you should for a long time, it is especially important that you talk to your doctor or pharmacist.This is because higher doses of Relvar Ellipta may reduce the amount of steroid hormones produced by your body.

If you forget to use Relvar Ellipta

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

If you get wheezing or shortness of breath, or develop any other symptoms of an asthma attack, use your fast-acting "rescue" inhaler(such as salbutamol), and talk to your doctor.

Do not stop using Relvar Ellipta without talking to your doctor

Use this medicine for as long as your doctor tells you to. It will only work if you use it every day. Do not stop using it unless your doctor tells you to, even if you feel better.

If you have any questions about using Relvar Ellipta, 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

Allergic reactions are rare (may affect up to 1 in 1,000 people)

If you get any of the following symptoms after using Relvar Ellipta, stop using this medicine and talk to your doctor immediately:

• skin rash (hives) or redness
• 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).

Sudden breathing problems

Sudden breathing problems after using Relvar Ellipta are rare.

If your breathing or wheezing gets worse immediately after using this medicine, stop using itand get medical help immediately.

Pneumonia (lung infection)in patients with COPD (common side effect, may affect up to 1 in 10 people).

If you get any of the following symptoms while using Relvar Ellipta, talk to your doctor. They could be symptoms of a lung infection:

• fever or chills
• increased production of mucus, change in the color of the mucus
• increased coughing or difficulty breathing.

Other side effects:

Very common side effects

May affect more than 1 in 10people:

• headache
• common cold.

Common side effects

May affect up to 1 in 10people:

• thrush (candidiasis), a fungal infection in the mouth or throat. Rinsing your mouth with water immediately after using Relvar Ellipta may help prevent this side effect
• bronchitis (inflammation of the airways)
• infection of the sinuses or throat
• flu
• pain or irritation in the back of the mouth and throat
• sinusitis (inflammation of the sinuses)
• itching, runny nose, or stuffy nose
• coughing
• changes in your voice
• weakening of the bones, which may cause fractures
• stomach pain
• back pain
• fever
• joint pain
• muscle spasms.

Uncommon side effects

May affect up to 1 in 100people:

• irregular heartbeat
• blurred vision
• high blood sugar levels (hyperglycemia).

Rare side effects

May affect up to 1 in 1,000people:

• fast heartbeat (tachycardia)
• awareness of your heartbeat (palpitations)
• shakiness
• anxiety.

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 Relvar 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 carton, 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 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 and the date that you should throw the inhaler away. The date should be written as soon as the inhaler is removed from the tray.

Do not store above 25°C.

If you store it in the refrigerator, let the inhaler come to room temperature for at least one hourbefore you use it.

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. Container Contents and Additional Information

Composition of Relvar Ellipta

• The active ingredients are fluticasone furoate and vilanterol.
• For the 92/22 microgram dose: each inhalation provides a delivered dose (dose that comes out of the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• For the 184/22 microgram dose: each inhalation provides a delivered dose (dose that comes out of the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• The other ingredients are lactose monohydrate (see section 2 “Relvar Ellipta contains lactose”) and magnesium stearate.

Appearance of the Product and Container Contents

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

The Ellipta inhaler is a light grey inhaler with a yellow mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a foil lid. The tray contains a desiccant sachet to reduce moisture in the container. Once the tray lid is opened, discard the desiccant sachet, do not ingest or inhale it. The inhaler does not need to be stored in the foil laminate tray once it has been opened.

Relvar Ellipta is available in inhalers containing 14 or 30 doses (for 14 or 30 days of treatment) and in clinical packs of 90 doses (3 inhalers of 30 doses, for 90 days of treatment). 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 Relvar Ellipta, you do not need to check that it is working correctly, it comes ready to use. Just follow these step-by-step instructions.

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

When you take the inhaler out of the tray, it will be in the "closed" position. Do not open the inhaleruntil you are readyto inhale a dose of medicine.When the tray is opened, you should write the "Discard by" date on the space provided on the inhaler label. The "Discard by" date is 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 the refrigerator, allow the inhaler to come to room temperature for at least 1 hour before use.

The step-by-step instructions for the 30-dose Ellipta inhaler (30 days of treatment) also apply to the 14-dose Ellipta inhaler (14 days of treatment).

1. Read the following instructions before using the inhaler

If you open and close the cover without inhaling the medicine, you will lose a dose.

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

Before opening the cover, wait until you are ready to inhale a dose. Do not shake the inhaler.

• Slide the cover down until you hear a "click".

The medicine is now ready to be inhaled.

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 medicine.Take it to your pharmacist and ask for help.

1. Inhale the medicine

• Hold the inhaler away from your mouth, breathe out as much as is comfortable. Do notbreathe out into the inhaler.
• Place the mouthpiece between your lips, and close your lips firmly around the mouthpiece.Do notblock the ventilation slots with your fingers.

• Take a long, steady, deep breath in. Hold your breath for as long as is comfortable (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

You may not be able to taste or feel the medicine, even when you use the inhaler correctly.

If you want to clean the mouthpiece, use a dry tissue beforeclosing the cover.

1. Close the inhaler and rinse your mouth

• Slide the cover back up as far as it will go to cover the mouthpiece.

• Rinse your mouth with water, after using the inhaler, do not swallow.

This will make it less likely that you will experience side effects such as mouth or throat ulcers.