Revinty Ellipta
fluticasone furoate, vilanterol
Fluticasone furoate/vilanterol
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.
What Revinty Ellipta is and what it is used for
What you need to know before you use Revinty Ellipta
How to use Revinty Ellipta
Possible side effects
How to store Revinty Ellipta
Contents of the pack and other information Step-by-step instructions
Revinty Ellipta contains two active substances: fluticasone furoate and vilanterol. Two different strengths of Revinty Ellipta are available: 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, and asthma in adults and adolescents 12 years and over.
The 184/22 micrograms strength is used to treat asthma in adults and adolescents aged 12 years and older. The 184/22 micrograms strength is not approved for the treatment of COPD.
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.
Vilanterol belongs to a group of medicines called long acting bronchodilators. It relaxes the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small air passages to remain open.
When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone.
Asthma is a serious, long term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and swollen and irritated (inflammation). Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. Revinty Ellipta has been shown to reduce flare-ups and symptoms of asthma.
if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6).
Talk to your doctor before you use Revinty Ellipta:
if you have liver disease, as you may be more likely to have side effects. If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Revinty Ellipta (92/22 micrograms once daily).
if you have heart problems or high blood pressure.
if you have tuberculosis (TB) of the lung, or any long standing or untreated infections.
if you have ever been told you have diabetes or high blood sugar.
if you have thyroid gland problems.
if you have low potassium in your blood.
if you experience blurred vision or other visual disturbances.
Contact your doctor if you experience blurred vision or other visual disturbances.
Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness (signs of high blood sugar).
If your breathing or wheezing gets worse straight after using Revinty Ellipta, stop using it and get medical help immediately.
If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 for information on symptoms to look out for while you are using this medicine. Tell your doctor as soon as possible if you develop any of these symptoms.
Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicinesn. If you are not sure what your medicine contains talk to your doctor or pharmacist.
Some medicines may affect how this medicine works, or make it more likely that you will have side effects. These include:
beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
ketoconazole, to treat fungal infections.
ritonavir or cobicistat, to treat HIV infections.
- long-acting beta2-adrenergic agonists, such as salmeterol
Revinty Ellipta.
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. Don’t use this medicine if you are pregnant unless your doctor tells you that you can.
It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast- feeding, you must check with your doctor before you use Revinty Ellipta. Don’t use this medicine if you are breast-feeding unless your doctor tells you that you can.
If you are breast-feeding, check with your doctor before you use Revinty Ellipta.
This medicine is unlikely to affect your ability to drive or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, or to milk protein, contact to your doctor before using this medicine.
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 fluticasone furoate and 22 micrograms of vilanterol). This dose is also used once daily at the same time each day.
The higher strength of Revinty Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Revinty Ellipta is for inhalation use.
It is very important that you use this medicine every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.
If you feel you are getting breathless or wheezy more often than normal, or if you are using your quick- acting inhaler more than usual, see your doctor.
See ‘Step-by-step instructions’ after section 6 of this leaflet for full information.
Revinty Ellipta is for inhalation use. You do not need to prepare Revinty Ellipta in any special way, not even the first time you use it.
If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often
If you accidentally use more Revinty Ellipta than your doctor has instructed, talk to your doctor or pharmacist. You may notice that your heart is beating faster than usual, you feel shaky or have a headache.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice.
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better.
If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions are rare (may affect up to 1 in 1,000 people).
If you have any of the following symptoms after taking Revinty Ellipta stop taking this medicine and tell your doctor immediately.
skin rash (hives) or redness
swelling, sometimes of the face or mouth (angioedema)
becoming very wheezy, coughing or having difficulty in breathing
suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
Immediate breathing difficulties after using Revinty Ellipta are rare.
If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.
fever or chills
increased mucus production, change in mucus colour
increased cough or increased breathing difficulties Other side effects include:
These may affect more than 1 in 10 people:
headache
common cold
These may affect up to 1 in 10 people:
sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Revinty Ellipta may help stop this side effect developing.
inflammation of the lungs (bronchitis)
infection of the nose sinuses or throat
flu (influenza)
pain and irritation in the back of the mouth and throat
inflammation of the sinuses
itchy, runny or blocked nose
cough
voice disorders
weakening of the bones, leading to fractures
stomach pain
back pain
high temperature (fever)
joint pain
muscle spasms
This may affect up to 1 in 100 people:
irregular heartbeat
blurred vision
increase in blood sugar (hyperglycaemia)
These may affect up to 1 in 1,000 people:
heart beating faster (tachycardia)
awareness of heart beat (palpitations)
tremor
anxiety
If you get any side effects, talk to your doctor or pharmacist. 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.
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 after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances are fluticasone furoate and vilanterol.
For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
The other ingredients are lactose monohydrate (See section 2) and magnesium stearate.
Revinty Ellipta is an inhalation powder, pre-dispensed.
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 peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the
packaging. Once you have opened the lid of the tray, throw the desiccant away – do not eat or inhale it. The inhaler does not need to be stored in the foil laminate tray once it has been opened.
The inhaler contains two aluminium foil laminate strips of 14 or 30 doses. Multipacks contain 3 x 30 dose inhalers.
GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Citywest Business Campus
Dublin 24 Ireland
Glaxo Wellcome Production Zone Industrielle No.2,
Rue Lavoisier,
27000 Evreux, France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947
“Берлин-Хеми/А. Менарини България” EООД Teл.: +359 2 454 0950
Tél/Tel: + 32 (0) 10 85 52 00
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline (Ireland) Limited Tel: +356 80065004
BERLIN-CHEMIE AG Tel.: +49 (0) 30 67070
OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001
Guidotti Hellas A.E.
Τηλ: +30 210 8316111-13
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
FAES FARMA, S.A. Tel: + 34 900 460 153
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
MENARINI France
Tél.: + 33 (0)1 45 60 77 20
BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: +385 1 4821 361
office-croatia@berlin-chemie.com
GlaxoSmithKline (Ireland) Limited Tel: +40 800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Tel: +386 01 300 2160
Vistor hf.
Sími: + 354 535 7000
Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Tel: +421 2 544 30 730
Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801
GlaxoSmithKline (Ireland) Limited Τηλ: +357 80070017
SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
When you first use the Ellipta inhaler you do not need to check that it is working properly, and you do not need to prepare it for use in any special way. Just follow these step-by-step instructions.
Tray lid
Inhaler
Carton
This leaflet
Desiccant
Tray
The inhaler is packaged in a tray. Don’t open the tray until you are ready to start using your new inhaler. When you are ready to use your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away – don’t open, eat or inhale it.
Desiccant
When you take the inhaler out of its tray, it will be in the ‘closed’ position. Don’t open the inhaler until you are ready to inhale a dose of medicine. When the tray is opened, write the “Discard by” date on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date you opened the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply).
The lost dose will be securely held inside the inhaler, but it will no longer be available. It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Your medicine is now ready to be inhaled.
The dose counter counts down by 1 to confirm.
You may not be able to taste or feel the medicine, even when you are using the inhaler correctly. If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
This will make it less likely that you will develop a sore mouth or throat as side effects.