Relvar Ellipta 92 mcg/22 mcg powder for inhalation (single-dose)
Spain
Table of Contents
Package leaflet: Information for the user
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 the entire 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 pass it on 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 the side effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Relvar Ellipta is and what it is used for
- What you need to know before using Relvar Ellipta
- How to use Relvar Ellipta
- Possible side effects
- How to store Relvar Ellipta
- 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 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.
Relvar 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 simply referred to 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 more effectively 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. 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, cough, chest discomfort, and cough with mucus production. Relvar Ellipta has been shown to reduce flare-ups of symptoms associated with COPD.
2. What you need to know before using Relvar Ellipta
Do not use Relvar Ellipta
- if you are allergic to fluticasone furoate, vilanterol, or any of the other ingredients of this medicine (listed in section 6)
- if any of the above applies to you, do not use Relvar Ellipta until you have consulted your doctor.
Warnings and precautions
Talk to your doctor before starting to use Relvar 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 Relvar 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 blood potassium levels
- 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 Relvar Ellipta
Immediate breathing difficulties
If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Relvar 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 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).
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 about 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 asthma treatment to children under 12 years of age, or for COPD treatment to children and adolescents of any age.
Other medicines and Relvar Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Talk to your doctor or pharmacist if you are unsure about what your medicine contains.
Some medicines may 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 Relvar 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, talk to your doctor before using this medicine. Do not use this medicine during pregnancy unless your doctor tells you to.
It is not known whether this medicine is excreted in breast milk. If you are breastfeeding, talk to your doctor before using Relvar 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 operate machinery.
Relvar Ellipta contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, talk to them before using this medicine.
3. How to use Relvar Ellipta
Follow exactly the instructions for using 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 Relvar Ellipta (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Relvar Ellipta is administered by oral inhalation.
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 directed by your doctor. This will help prevent symptoms both during the day and at night.
Relvar Ellipta must not be used to relieve a sudden attack of breathlessness or wheezing. If you have such attacks, you must use a fast-acting "reliever" inhaler (such as salbutamol).
If you feel breathless or wheezy more often than usual, or if you are using your fast-acting "reliever" inhaler more frequently than normal, see your doctor.
How to use Relvar Ellipta
For complete information, read the “Step-by-step instructions for use” included after section 6 of this leaflet.
Relvar 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 "reliever" inhaler more often than usual: contact your doctor as soon as possible.
If you use more Relvar Ellipta than you should
If you accidentally inhale more Relvar Ellipta than prescribed by your doctor, consult your doctor or pharmacist. If possible, show them the inhaler, the packaging, or this leaflet. You may notice your heart beating faster than normal, feel shaky, or have a headache.
If you have used more medicine than prescribed over a prolonged period, it is especially important to seek advice from your doctor or pharmacist. This is because higher doses of Relvar Ellipta may reduce the amount of steroid hormones naturally produced by your body.
If you forget to use Relvar 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 "reliever" inhaler (for example, salbutamol), and seek medical advice.
Do not stop using Relvar Ellipta without consulting
Use this medicine for as long as your doctor has advised. It will only be effective for as long as you continue to use 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 experiences them.
Allergic reactions
Allergic reactions are rare (may affect up to 1 in 1,000 people).
If, after taking Relvar Ellipta, you experience any of the following symptoms, stop using this medicine and contact your doctor immediately:
- skin rash (hives) or redness
- swelling, sometimes of the face or mouth (angioedema)
- increased wheezing (a high-pitched sound when breathing), cough, 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 Relvar 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 Relvar Ellipta, consult your doctor. These could be symptoms of a lung infection:
- fever or chills
- increased mucus production, change in the color of sputum
- increased cough or increased difficulty breathing.
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, white patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing the mouth with water immediately after using Relvar Ellipta may help prevent this adverse effect
- inflammation of the lungs (bronchitis)
- infection of the sinuses or throat
- flu
- pain and irritation at the back of the mouth and throat
- sinus inflammation
- itching, runny or blocked nose
- cough
- voice changes
- weakening of bones which 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 levels (hyperglycaemia).
Rare adverse effects
May affect up to 1 in 1,000 people:
- rapid heartbeat (tachycardia)
- awareness of your heartbeat (palpitations)
- tremor
- anxiety.
Reporting of adverse effects
If you experience any 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 Relvar 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 after 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 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 the refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Relvar Ellipta
- The active substances are fluticasone furoate and vilanterol.
- For the 92/22 microgram dose: each inhalation provides a delivered dose (dose released from the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatoate).
- For the 184/22 microgram dose: each inhalation provides a delivered 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 “Relvar Ellipta contains lactose”) and magnesium stearate.
Nature of the product and contents of the pack
Relvar 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. Once opened, the inhaler does not need to be stored in the laminated aluminium tray.
Relvar Ellipta is available in packs containing one inhaler with 14 or 30 doses (for a 14- or 30-day treatment) and in hospital packs of 90 doses (3 inhalers with 30 doses each, for a 90-day treatment). Some pack sizes may not 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
Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation 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 |
| 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 Menarini Hellas A.E. Tel: +30 210 83161 11-13 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain GlaxoSmithKline, S.A. Tel: + 34 900 202 700 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France Laboratory GlaxoSmithKline Tel.: + 33 (0)1 39 17 84 44 Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 361 | Portugal GlaxoSmithKline – Pharmaceutical Products, Lda. Tel: + 351 21 412 95 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 GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741111 | Finland/Finland GlaxoSmithKline Oy Tel/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 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 Relvar 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.
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 sachet, to reduce moisture. Discard the desiccant sachet; 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, record the “Discard after” date in the space provided 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 stored in the refrigerator, allow the inhaler 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 remain securely 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 until you hear a “click”.
The medicine is now ready to inhale.
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 for assistance.
- Inhale the medicine
- Keep the inhaler away from your mouth and breathe out as far as is comfortable. 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 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 make it less likely that side effects such as mouth or throat ulceration occur.