Revinty Ellipta 92 micrograms/22 micrograms inhalation powder (single dose)
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Revinty Ellipta 92 micrograms/22 micrograms powder for inhalation (single dose)
Revinty Ellipta 184 micrograms/22 micrograms powder for inhalation (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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- 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 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 microgram 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 microgram strength is used for the treatment of 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 difficulty breathing or other asthma or COPD symptoms. It must not be used to relieve a sudden attack of breathlessness or wheezing. If you experience such attacks, 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 referred to simply as steroids. Corticosteroids reduce inflammation. They also reduce swelling (inflammation) and irritation in the small airways of 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 in the small airways of the lungs. This helps open the airways and makes it easier for air to flow in and out of the lungs. When used regularly, it helps keep the small airways of the lungs open.
Regular use of these two active substances together will help control your breathing difficulties better than either medicine used alone.
Asthma is a serious chronic lung disease in which the muscles surrounding the smaller airways narrow (bronchoconstriction) and the airways become swollen and irritated (inflammation). Symptoms come and go and include difficulty breathing, 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 difficulty breathing, cough, chest discomfort, and cough with mucus production. Revinty Ellipta has been shown to reduce flare-ups 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 to any of the other ingredients of this medicine (listed in section 6)
- if you think any of the above applies to you, do not use Revinty Ellipta until you have consulted your doctor.
Warnings and precautions
Talk to your doctor before starting to use Revinty Ellipta:
- if you have liver problems, as you may be more likely to experience adverse 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 problems or 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 gland problems
- if you have low potassium levels in the blood
- if you experience blurred vision or other visual disturbances.
Talk to your doctor before using this medicine if you think any of the above conditions apply to you.
While using Revinty Ellipta
Immediate breathing difficulties
If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Revinty Ellipta inhaler:
stop using this medicine and seek immediate medical attention, as you may have a serious condition called paradoxical bronchospasm.
- Contact your doctor if you develop blurred vision or other visual disturbances.
- Contact 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 to treat COPD, you may have an increased risk of developing a lung infection known as pneumonia. See section 4 for information on symptoms to watch for while using this medicine. Contact your doctor as soon as possible if you develop any of these symptoms.
Children and adolescents
Do not give this medicine for the treatment of asthma to children under 12 years of age, 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 need to take any other medicines. Consult your doctor or pharmacist if you are unsure about what your medicine contains.
Some medicines can affect how this medicine works, or make it more likely that you will experience side effects. These include:
- medicines called beta-blockers, such as metoprolol, used to treat high blood pressure or heart disease
- ketoconazole, used to treat fungal infections
- ritonavir or cobicistat, used to treat HIV
- long-acting ?2-adrenergic agonists, such as salmeterol.
Talk to your doctor or pharmacist if you are taking any of these medicines.
Some medicines may increase the effects of Revinty Ellipta, so your doctor may 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 become pregnant, consult your doctor before using this medicine. Do not use this medicine during pregnancy unless your doctor tells you to.
It is unknown whether this medicine is excreted in human breast milk. If you are breastfeeding, consult your doctor before using Revinty Ellipta. Do not use this medicine while breastfeeding 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 informed you that you have an intolerance to certain sugars, consult with them before using this medicine.
3. How to use Revinty Ellipta
Follow exactly the dosing instructions for this medicine as given by your doctor. If in doubt, 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, taken at the same time each day.
If you have severe asthma, your doctor may decide that you should use one inhalation from the inhaler containing the higher strength (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose is also 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, taken 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 administered by oral inhalation.
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 prevent symptoms both during the day and at night.
Revinty Ellipta must not be used to relieve a sudden attack of breathlessness or wheezing. If you experience such attacks, you must use a fast-acting "rescue" inhaler (such as salbutamol).
If you feel short of breath or are wheezing more frequently than usual, or if you are using your fast-acting "rescue" inhaler more often than normal, contact your doctor.
How to use Revinty Ellipta
For complete information, read the "Step-by-step instructions for use" included after section 6 of this leaflet.
Revinty Ellipta is for oral inhalation only. No special preparation is required, not even the first time you use it.
If symptoms do not improve
If symptoms (breathlessness, wheezing, cough) do not improve or worsen, 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 Revinty Ellipta than you should
If you accidentally inhale more Revinty Ellipta than your doctor has recommended, consult your doctor or pharmacist. If possible, show them the inhaler, packaging, or this leaflet. You may notice your heart beating faster than normal, feel shaky, or develop a headache.
If you have used more medicine than prescribed for a prolonged period, it is especially important to seek advice from your doctor or pharmacist. This is because higher doses of Revinty Ellipta may reduce the amount of steroid hormones naturally produced by your body.
If you forget to use Revinty Ellipta
Do not inhale a double dose to make up for a missed dose. Take the next dose at your usual time.
If you experience wheezing or breathlessness, or develop any other symptoms of an asthma attack, use your fast-acting "rescue" inhaler (e.g., salbutamol), and seek medical advice.
Do not stop using Revinty Ellipta without consulting
Use this medicine for the length of time prescribed by your doctor. It will only be effective as long as you continue using it. Do not stop using it unless your doctor tells 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
Allergic reactions are rare (may affect up to 1 in 1,000 people).
If you experience any of the following symptoms after taking Revinty Ellipta, stop using this medicine and contact your doctor immediately:
- skin rash (hives) or redness
- swelling, sometimes of the face or mouth (angioedema)
- increased wheezing (high-pitched sound when breathing), coughing, or 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 worsens or your wheezing increases immediately after using this medicine, stop using it and seek medical help immediately.
Pneumonia (lung infection) in patients with COPD (common adverse effect; may affect up to 1 in 10 people).
If you experience any of the following symptoms while using Revinty Ellipta, consult your doctor. These could be symptoms of a lung infection:
- fever or chills
- increased mucus production, change in the color of mucus
- increased coughing or worsening shortness of breath.
Other adverse effects:
Very common adverse effects
May affect more than 1 in 10 people:
- headache
- common cold.
Common adverse effects
May affect up to 1 in 10 people:
- mouth ulcers, bumps in the mouth or throat caused by a fungal infection (candidiasis). Rinsing the mouth with water immediately after using Revinty Ellipta may help prevent this adverse effect
- inflammation of the lungs (bronchitis)
- infection of the sinuses or throat
- influenza (flu)
- pain and irritation at the back of the mouth and throat
- sinus inflammation
- itching, runny or blocked nose
- cough
- voice changes
- weakening of the bones that may lead to fractures
- stomach pain
- back pain
- elevated temperature (fever)
- joint pain
- muscle spasms.
Uncommon adverse effects
May affect up to 1 in 100 people:
- irregular heartbeat
- blurred vision
- increased blood sugar level (hyperglycemia).
Rare adverse effects
May affect up to 1 in 1,000 people:
- fast heartbeat (tachycardia)
- awareness of your heartbeat (palpitations)
- tremor
- anxiety.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Revinty Ellipta
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, tray, and inhaler following EXP. The expiry date refers to the last day of the month indicated.
Keep the inhaler within the sealed tray to protect it from moisture, and only remove it immediately before first use. Once the tray has been opened, the inhaler may be used for a period of 6 weeks, starting from the date the tray was opened. Write the date by which the inhaler should be discarded in the designated space on the label. 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Revinty Ellipta
- The active substances are fluticasone furoate and vilanterol.
- For the 92/22 microgram dose: each inhalation provides a delivered dose (the dose released from 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 (the dose released from the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
- The other components are lactose monohydrate (see section 2 “Revinty Ellipta contains lactose”) and magnesium stearate.
Nature of the product and contents of the pack
Revinty Ellipta is an inhalation powder (single dose).
The Ellipta inhaler consists of a light grey inhaler with a yellow mouthpiece cover and a dose counter. It is packaged in a laminated aluminium tray with a peelable aluminium lid. The tray contains a desiccant bag to reduce moisture within the package. After opening the tray lid, discard the desiccant; do not ingest or inhale it. The inhaler does not need to be stored in the laminated aluminium tray once it has been opened.
Revinty Ellipta is available in packs containing one inhaler with either 14 or 30 doses (for a 14- or 30-day treatment) and in hospital packs containing 90 doses (3 inhalers of 30 doses each, for a 90-day treatment). Some pack sizes may not 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
Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Tel/Tel: + 32 (0) 10 85 52 00 | Lithuania UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 |
Bulgaria “BERLIN-CHEMIE/Bf. MENARINI SOFIA” EAD Tel.: +359 2 454 0950 | Luxembourg/Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgium/Belgium Tel/Tel: + 32 (0) 10 85 52 00 |
Czech Republic GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Hungary Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501301 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta GlaxoSmithKline Trading Services Limited Tel: +356 80065004 |
Germany BERLIN-CHEMIE AG Tel: +49 (0) 30 67070 | Netherlands GlaxoSmithKline BV Tel: + 31 (0) 33 2081100 |
Estonia OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece Guidotti Hellas A.E. Tel: +30 210 8316111-13 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain FAES FARMA, S.A. Tel: + 34 900 460 153 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France MENARINI France Tél: + 33 (0)1 45 60 77 20 Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 361 | Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00 Romania GlaxoSmithKline Trading Services Limited Tel: +40 800672524 |
Ireland GlaxoSmithKline Trading Services Limited Tel: + 353 (0)1 4955000 | Slovenia Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 (0)1 300 2160 |
Iceland Vistor hf. Tel: + 354 535 7000 | Slovakia Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730 |
Italy
| Finland GlaxoSmithKline Oy Tel: + 358 (0)10 30 30 30 |
Cyprus GlaxoSmithKline Trading Services Limited Tel: +357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210 | |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine 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 – it is ready to use straight away. Just 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 medicine. When you are ready to use your inhaler, remove the lid to open the tray. The tray contains a desiccant bag, to reduce moisture. Discard the desiccant bag; do not open, swallow, 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 medicine. When the tray is opened, the “Discard after” date should be recorded in the designated space on the inhaler label. The “Discard after” date is 6 weeks from the date the tray is opened. After this date, the inhaler must not be used. The tray may be discarded after first opening.
If the inhaler has been stored in the refrigerator, allow it to reach room temperature for at least one hour before use.
The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 days of treatment) also apply to the 14-dose Ellipta inhaler (14 days of treatment).
- Read the following instructions before using the inhaler
If you open and close the lid without inhaling the medicine, you will lose a dose.
The lost dose will be safely retained within the inhaler but will not be available for inhalation.
It is not possible to accidentally inhale an extra or double dose.
- Prepare a dose
Before opening the lid, wait until you are ready to inhale a dose. Do not shake the inhaler.
- Slide the lid down fully until you hear a “click”.
The medicine is now ready to be inhaled.
As confirmation, the dose counter will decrease by 1 unit.
- 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 assistance.
- Inhale the medicine
- Keep the inhaler away from your mouth and breathe out as fully as reasonably 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 vents with your fingers.
- Take a long, steady, and deep breath in. Hold your breath for as long as possible (at least 3–4 seconds).
- Remove the inhaler from your mouth.
- Breathe out gently and slowly.
You may not be able to taste or feel the medicine, even when using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry tissue before closing the lid.
- Close the inhaler and rinse your mouth
- Slide the lid up fully to cover and protect the mouthpiece.
- Rinse your mouth with water after using the inhaler, and do not swallow.
This will help reduce the likelihood of side effects such as mouth or throat ulcerations.