REVINTY ELLIPTA 184 micrograms/22 micrograms inhalation powder (single dose)

Introduction

Package Leaflet: Information for the Patient

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

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

Step-by-step instructions for use

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

Revinty Ellipta contains two active substances: fluticasone furoate and vilanterol. There are two different strengths of Revinty 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.

Revinty 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 to breathe in and out. When used regularly, it helps to keep the small airways in the lungs open.

Using these two active substances together regularly will help you control your breathing difficulties better than either medicine on its own.

Asthmais a serious, chronic lung disease in which the muscles around the smaller airways tighten (bronchoconstriction) and become inflamed (inflammation). Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing. Revinty 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. Revinty Ellipta has been shown to reduce flare-ups of symptoms associated with COPD.

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

Do not use Revinty Ellipta

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

Warnings and precautions

Talk to your doctor before you start using Revinty 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 Revinty 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 diabetes or 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 changes in your vision.

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

While you are using Revinty Ellipta

Immediate breathing problems

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

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

• Talk to your doctor if you get blurred vision or other changes in your vision.
• Talk to your doctor if you get increased thirst, urinate more often, or feel tired for no reason (signs of high blood sugar levels).

Lung infection

If you are using this medicine to treat COPD, you may be at a higher risk of developing 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 Revinty 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 the way this medicine 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 Revinty Ellipta, so your doctor may want to monitor you closely if you are taking these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 Revinty Ellipta if you are breastfeeding. If you are breastfeeding, 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.

Revinty 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 Revinty 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 is also 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 Revinty Ellipta (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.

Revinty Ellipta is for inhalation only.

Use Revinty 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.

Revinty 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 worse or are using your fast-acting "rescue" inhaler more often than usual, talk to your doctor.

How to use Revinty Ellipta

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

Revinty Ellipta is for inhalation only. You do not need to prepare Revinty 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 Revinty Ellipta than you should

If you accidentally inhale more Revinty 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 normal, 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 get advice from your doctor or pharmacist. This is because higher doses of Revinty Ellipta may reduce the amount of steroid hormones produced by your body.

If you forget to use Revinty Ellipta

Do not inhale 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 Revinty Ellipta without talking to your doctor

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.

If you have any questions about using 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

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

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

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

Immediate breathing problems

Immediate breathing problems after using Revinty Ellipta are rare.

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

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 Revinty Ellipta, talk to your doctor. They could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• 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:

• mouth thrush (candidiasis), a fungal infection of the mouth or throat. Rinsing your mouth with water immediately after using Revinty Ellipta may help prevent this side effect
• bronchitis (inflammation of the lungs)
• sinus or throat infection
• 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)
• noticing 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 Revinty 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 shown.

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 you open the tray on the inhaler label in the space provided. 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 use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Revinty 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 “Revinty Ellipta contains lactose”) and magnesium stearate.

Appearance of the Product and Container Contents

Revinty 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 laminated aluminum tray with a foldable aluminum lid. The tray contains a desiccant sachet to reduce moisture in the container. Once the lid of the tray is opened, discard the desiccant, do not ingest or inhale it. The inhaler does not need to be stored in the laminated aluminum tray once it has been opened.

Revinty Ellipta is available in inhaler packs 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 Authorization 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 by contacting the local representative of the marketing authorization 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 website: http://www.ema.europa.eu.

Step-by-Step Instructions for Use

What is the Ellipta Inhaler?

The first time you use Revinty Ellipta, you do not need to check that it is working correctly, as it comes ready to use. Simply follow these step-by-step instructions for use.

Your Revinty 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 medication. 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 notopen, ingest, or inhale it.

When you remove the inhaler from the tray, it will be in the "closed" position. Do not open the inhaler until you are ready to inhale a dose of medication.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 anymore. The tray can be discarded after the first opening.

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

The step-by-step instructions for use shown below 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 medication, you will lose the 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 administer an extra dose or a double dose through an 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 medication 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 medication.Take it to your pharmacist and ask for help.

1. Inhale the medication

• Keep the inhaler away from your mouth, exhale as much as is reasonably possible. Do notexhale into the inhaler.
• Place the mouthpiece between your lips, and close them 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 possible (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Exhale slowly and gently.

You may not be able to taste or feel the medication, even when using 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 up to the top to protect the mouthpiece.

• Rinse your mouth with water, once you have used the inhaler, do not swallow.

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