Revinty Ellipta

Package leaflet: Information for the patient

Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, in single-dose container

Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, in single-dose container
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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Revinty Ellipta is and what it is used for
2. What you need to know before using Revinty Ellipta
3. How to use Revinty Ellipta
4. Possible side effects
5. How to store 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 available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterolo 22 micrograms.

The 92/22 microgram strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and of asthma in adults and adolescents aged 12 years and older.
The 184/22 microgram strength is used to treat asthma in adults and adolescents aged 12 years and older.
The 184/22 microgram strength is not approved for the treatment of COPD.

Revinty Ellipta must be used every day, and not only when you have breathing problems or other symptoms of COPD or asthma. It must not be used to relieve a sudden attack of breathlessness or shortness of breath. If such an attack occurs, you must use a fast-acting 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 referred to as steroids. Corticosteroids reduce inflammation. They reduce swelling and irritation in the small airways of the lungs, thereby gradually improving breathing difficulties. Corticosteroids also help prevent asthma attacks and exacerbations of COPD.

Vilanterol belongs to a group of medicines called long-acting bronchodilators. It relaxes the muscles in the small airways of the lungs. This helps to open the airways and makes it easier for air to flow into and out of the lungs. When taken regularly, it helps keep the small airways open.

Regular use of the two active substances in combination provides better control of breathing difficulties than regular use of each active substance alone.

Asthma is a serious, chronic respiratory disease in which the muscles surrounding the smaller airways tighten (bronchoconstriction) and become inflamed. Symptoms come and go, and include shortness of breath, wheezing, chest tightness, and cough. 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 breathlessness, cough, chest discomfort, and cough with mucus. Revinty Ellipta has been shown to reduce exacerbations of COPD symptoms.

2. What you need to know before using Revinty Ellipta

Do not use Revinty Ellipta

• If you are allergic to fluticasone furoate, vilanterol, or any of the other ingredients of this medicine (listed in section 6).
• If you think any of these apply to you, do not use Revinty Ellipta before consulting your doctor.

Warnings and precautions
Talk to your doctor before using Revinty Ellipta:

• if you have liver disease, as you may be more likely to experience side effects. If you have moderate or severe liver disease, your doctor will recommend the lowest dose of Revinty Ellipta (92/22 micrograms once daily).
• if you have heart problems or high blood pressure.
• if you have tuberculosis, or any untreated or longstanding infection.
• if you have been told you have diabetes or high blood sugar levels.
• if you have thyroid gland problems.
• if you have low potassium levels in your blood.
• if you experience blurred vision.

Talk to your doctor before using this medicine if you think any of the above apply to you.
While using Revinty Ellipta
Immediate breathing difficulties
If you experience chest tightness, cough, wheezing, or shortness of breath immediately after using
the Revinty Ellipta inhaler:
stop using this medicine and contact your doctor immediately, as you may be experiencing a serious condition called paradoxical bronchospasm.

• Talk to your doctor if you experience blurred vision or other visual disturbances.
• Talk to your doctor if you experience increased thirst, frequent urination, or unexplained tiredness (signs of high blood sugar levels).

Lung infection
If you are using this medicine for COPD, you may have an increased risk of developing a lung infection known as pneumonia. See section 4 for information about symptoms to watch for while using this medicine. Inform your doctor as soon as possible if you develop 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. If you are unsure what is contained in your medicine, consult your doctor or pharmacist.
Some medicines may affect how this medicine works, or may increase the likelihood of side effects.
These include:

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

Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide to monitor you more closely if you are taking any of these medicines, as they may increase the side effects of Revinty Ellipta.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Do not use this medicine during pregnancy unless your doctor tells you it is safe to do so.
It is not known whether the components of this medicine pass into breast milk. If you are breastfeeding, you must consult a doctor before using Revinty Ellipta. Do not use this medicine while breastfeeding unless your doctor tells you it is safe to do so.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Revinty Ellipta contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use Revinty Ellipta

Always use this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Asthma
The recommended dose for 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.
For severe asthma, your doctor may prescribe one inhalation of the higher strength
(184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose should also
be taken once daily at the same time each day.
COPD
The recommended dose for 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 inhaled use by oral inhalation.
Use Revinty Ellipta at the same time each day, as it works for 24 hours.
It is very important to use this medicine every day as directed by your doctor. This will help prevent
symptoms during both day and night.
Revinty Ellipta must not be used to relieve a sudden attack of breathlessness or wheezing.
If you have such an attack, you must use a fast-acting inhaler (such as salbutamol).
If you feel short of breath or wheezy more often than usual, or if you are using your fast-acting inhaler
more than usual, consult your doctor.
How to use Revinty Ellipta
See the “Step-by-step instructions for use” after section 6 of this leaflet for detailed information.
Revinty Ellipta is for inhaled use. It does not need to be prepared in any special way, even the first
time you use it.
If symptoms do not improve
If symptoms (breathlessness, wheezing, coughing) do not improve or worsen, or if you are using your
fast-acting inhaler more often than usual, contact your doctor as soon as possible.
If you use more Revinty Ellipta than you should
If you accidentally use more Revinty Ellipta than your doctor has prescribed, contact your doctor or
pharmacist. If possible, show them the inhaler, the packaging, or this leaflet. You may notice that your
heart beats faster than usual, that you feel shaky, or that you have a headache.
If you have used more than instructed and for a prolonged period of time, it is especially important
that you contact your doctor or pharmacist. This is because high doses of Revinty Ellipta
can reduce the amount of steroid hormones naturally produced by the body.
If you forget to use Revinty Ellipta
Do not inhale a double dose to make up for a forgotten dose. Simply take the next dose at your
usual time the following day.
If you become breathless or wheezy, or if you experience any other symptoms of an asthma attack,
use your fast-acting inhaler (such as salbutamol), then consult your doctor.
Do not stop using Revinty Ellipta without medical advice
Use this medicine for the length of time recommended by your doctor. It will remain effective as long as
you continue using it. Do not stop unless your doctor advises you to, even if you feel better.
If you have any questions about how to use 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, after taking Revinty Ellipta, you experience any of the following symptoms, stop taking this
medicine and contact your doctor immediately.

• Rash ( urticaria ) or redness
• Swelling, sometimes of the face or mouth ( angioedema )
• If you become very breathless, cough, or have difficulty breathing
• Sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)

Immediate breathing difficulties
Immediate breathing difficulties after using Revinty Ellipta are rare.
If your breathing or wheezing worsens immediately after using this medicine, stop using it
and seek immediate medical help.

Pneumonia (lung infection) (common side effect, may affect up to 1 in 10 people)
Tell your doctor if you experience any of the following symptoms while using Revinty Ellipta – they may be signs of a lung infection:

• Fever or chills
• Increased mucus production, changes in the colour of mucus
• Worsening cough or worsening breathing difficulties

Other side effects:

Very common side effects
May affect more than 1 in 10 people:

• Headache
• Common cold

Common side effects
May affect up to 1 in 10 people:

• Painful, raised patches in the mouth or throat caused by a fungal infection ( candidiasis ). Rinsing your mouth with water immediately after using Revinty Ellipta may help prevent this side effect.
• Inflammation of the lungs ( bronchitis )
• Sinus or throat infection
• Influenza
• Pain and irritation at the back of the mouth and throat
• Inflammation of the sinuses ( sinusitis )
• Itching, runny or blocked nose
• Cough
• Voice disorders
• Weakening of the bones that may lead to fractures
• Stomach ache
• Back pain
• Fever
• Joint pain
• Muscle spasms

Uncommon side effects
May affect up to 1 in 100 people:

• Irregular heartbeat
• Blurred vision
• Increased blood sugar levels ( hyperglycaemia )

Rare side effects
May affect up to 1 in 1,000 people:

• Rapid heartbeat ( tachycardia )
• Awareness of your heartbeat ( palpitations )
• Tremor
• Anxiety

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Revinty Ellipta

Keep the 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 refers to the last day of that month.
Keep the inhaler in the sealed tray to protect it from moisture, and remove it from the tray only
immediately before first use.
Once the tray has been opened, the inhaler can be used for 6 weeks from the date the tray was opened.
Write the date on which the inhaler should be discarded on the label in the designated space.
This date should be recorded as soon as the inhaler is removed from the tray.
Do not store above 25°C.
If stored in a refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Revinty Ellipta contains

• The active substances are fluticasone furoate and vilanterol.
• For the 92/22 mcg dose: each single inhalation provides an inhaled dose (dose released from the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatoate).
• For the 184/22 mcg dose: each single inhalation provides an inhaled dose (dose released from the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatoate).
• The other components are lactose monohydrate (See section 2, “Revinty Ellipta contains lactose”) and magnesium stearate.

Description of the appearance of Revinty Ellipta and contents of the pack
Revinty Ellipta is an inhalation powder in a single-dose container.
The Ellipta inhaler consists of a light grey inhaler with a yellow mouthpiece cap and a dose counter. It is packaged in an aluminium laminate tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the packaging. Once the tray lid is opened, discard the desiccant – do not eat or inhale it. After opening, the inhaler does not need to be stored in the aluminium laminate tray.
Revinty Ellipta is available in packs of 1 inhaler containing 14 or 30 doses (14-day or 30-day supply) and multipacks containing 90 doses (3 inhalers of 30 doses each) (90-day supply).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tél/Tel: + 32 (0) 10 85 52 00 Tel: +370 52 691 947
[email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” EООД GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: +359 2 454 0950 Belgique/Belgien
[email protected] Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: + 420 222 001 111 Tel.: +36 23501301
[email protected] [email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
BERLIN-CHEMIE AG GlaxoSmithKline BV
Tel.: +49 (0) 30 67070 Tel: + 31 (0) 33 2081100

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti GlaxoSmithKline AS
Tel: +372 667 5001 Tlf: + 47 22 70 20 00
[email protected]

Ελλάδα Österreich
Guidotti Hellas A.E. GlaxoSmithKline Pharma GmbH
Τηλ: +30 210 8316111-13 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
FAES FARMA, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 460 153 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
MENARINI France BIAL, Portela & Ca. SA.
Tél: + 33 (0)1 45 60 77 20 Tel: + 351 22 986 61 00
[email protected]

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. GlaxoSmithKline Trading Services Limited
Tel: +385 1 4821 361 Tel: +40 800672524
[email protected]

Ireland Slovenija
GlaxoSmithKline Trading Services Limited Berlin-Chemie / A. Menarini Distribution
Tel: + 353 (0)1 4955000 Ljubljana d.o.o.
Tel: +386 (0)1 300 2160
[email protected]

Ísland Slovenská republika
Vistor hf. Berlin-Chemie / A. Menarini Distribution
Sími: + 354 535 7000 Slovakia s.r.o.
Tel: +421 2 544 30 730
[email protected]

Italia Suomi/Finland
A. Menarini Industrie Farmaceutiche Riunite s.r.l. GlaxoSmithKline Oy
Tel: +39055 56801 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
[email protected]

Other sources of information
More detailed information on this medicine 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 Revinty Ellipta, there is no need to check whether it works correctly, and no special preparation is required. Simply follow these step-by-step instructions.

Your pack of Revinty Ellipta contains

The inhaler is packaged in a tray. Do not open the tray until you are ready to start using the medicine. When you are ready to use the inhaler, open the lid by pulling the tab. The tray contains a desiccant sachet to reduce moisture. Discard this desiccant sachet without opening, eating, or inhaling it.

Desiccant
When the inhaler is removed from its tray, it will be in the “closed” position. Do not open the inhaler until you are ready to inhale a dose of medicine. After opening the tray, write the “Discard by” date on the label of the inhaler in the designated space. The “Discard by” date is 6 weeks after the date the tray was opened. The inhaler must not be used after this date. The tray may be discarded after first opening.
If stored in the refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
The step-by-step instructions below for the Ellipta inhaler containing 30 doses (30-day supply) also apply to the Ellipta inhaler containing 14 doses (14-day supply).

1. Read the following before starting

If the inhaler mouthpiece is opened and closed without inhaling the medicine, the dose will be lost.
The missed dose will remain securely inside the inhaler but will no longer be available for inhalation.
It is not possible to accidentally inhale the medicine or receive a double dose in a single inhalation.

2. Preparing a dose

Wait to open the cap until you are ready to inhale the dose. Do not shake the
inhaler.

• Slide the cap downward until you hear a 'click'.

“Click”
The medicine is now ready to inhale.
The dose counter counts down by 1 as confirmation.

• If the dose counter does not count down when you hear the 'click', the inhaler will not release the medicine. Return it to the pharmacist for advice.

3. Inhale the medicine

• With 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 your lips firmly around it. Do NOT block the air holes with your fingers.

• Breathe in slowly, steadily, and deeply through your mouth. Hold your breath as long as possible (at least 3–4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

You may not taste or feel the medicine, even when using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry cloth, before closing the cap.

4. Close the inhaler and rinse your mouth

• Slide the cover fully upwards to cover the mouthpiece.

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

This will reduce the likelihood of developing unwanted effects such as mouth or throat pain.