Elipta Ellipta 92 micrograms/55 micrograms/22 micrograms powder for inhalation (single dose)
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Elebrato Ellipta 92micrograms/55micrograms/22micrograms inhalation powder, single dose
fluticasone furoate/umeclidinium/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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Elebrato Ellipta is and what it is used for
- What you need to know before you use Elebrato Ellipta
- How to use Elebrato Ellipta
- Possible side effects
- How to store Elebrato Ellipta
- Contents of the pack and other information
Step-by-step instructions for use
1. What Elebrato Ellipta is and what it is used for
What Elebrato Ellipta is
Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide, and vilanterol.
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply referred to as steroids.
Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.
What Elebrato Ellipta is used for
Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease that slowly worsens over time and is characterized by causing difficulty in breathing.
In COPD, the muscles surrounding the airways tighten, making it difficult to breathe. This medicine relaxes the muscles in the lungs, reduces swelling and irritation in the smaller airways, and helps air flow in and out of the lungs more easily. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on your daily life.
Elebrato Ellipta must be used daily and not only when you have breathing problems or other 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 inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.
2. What you need to know before using Elebrato Ellipta
Do not use Elebrato Ellipta
- if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before starting to use Elebrato Ellipta
- if you have asthma (do not use Elebrato Ellipta to treat asthma)
- if you have heart problems or high blood pressure
- if you have liver problems
- if you have pulmonary tuberculosis (TB) or any other long-standing or untreated infection
- if you have a condition called narrow-angle glaucoma
- if you have an enlarged prostate, difficulty passing urine, or a bladder obstruction
- if you suffer from epilepsy
- if you have thyroid gland problems
- if your blood potassium levels are low
- if you have a history of diabetes
- if you experience blurred vision or other visual disturbances.
Talk to your doctor if you think any of the above conditions apply to you.
Urgent breathing difficulties If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Elebrato Ellipta inhaler:
stop using this medicine and seek immediate medical attention, as you may have a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Elebrato Ellipta
If you experience eye pain or discomfort, blurred vision, seeing halos or colored images, or redness of the eyes during treatment with Elebrato Ellipta:
stop using this medicine and seek immediate medical help. These symptoms may be due to an acute attack of narrow-angle glaucoma.
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, "Possible side effects," 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
This medicine must not be given to children or adolescents under 18 years of age.
Other medicines and Elebrato Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. If you are unsure about the contents of your medicine, consult your doctor or pharmacist.
Some medicines may affect how this medicine works, or increase the likelihood of side effects. These include:
- medicines called beta-blockers (such as propranolol), used to treat high blood pressure or other heart conditions
- ketoconazole or itraconazole, used to treat fungal infections
- clarithromycin or telithromycin, used to treat bacterial infections
- ritonavir or cobicistat, used to treat HIV
- medicines that lower potassium levels in the blood, such as certain diuretics or certain medicines used to treat COPD and asthma (e.g. methylxanthines or steroids)
- other long-acting medicines for similar respiratory conditions, such as tiotropium or indacaterol. Do not use Elebrato Ellipta if you are already taking these medicines.
Talk to your doctor or pharmacist if you are taking any of these medicines. Your doctor may carry out careful monitoring if you are taking any of these medicines, as they may increase the side effects of Elebrato Ellipta.
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. If you are pregnant, do not use this medicine unless your doctor tells you to.
It is unknown whether the components of Elebrato Ellipta pass into breast milk. If you are breastfeeding, you should consult your doctor before using Elebrato Ellipta. 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.
Elebrato Ellipta contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this medicine.
3. How to use Elebrato Ellipta
Follow exactly the dosing instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one inhalation every day, at the same time each day. You only need one inhalation per day, as the effect of this medicine lasts for 24 hours.
Do not use more doses than your doctor has prescribed.
Use Elebrato Ellipta regularly
It is very important that you use Elebrato Ellipta every day as directed by your doctor. This will help you to remain symptom-free throughout the day and night.
Elebrato 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 "rescue" inhaler (such as salbutamol).
How to use the inhaler
For complete information, read the "Step-by-step instructions for use" at the end of this leaflet.
Elebrato Ellipta is for inhalation use only.
Elebrato Ellipta is ready to use once the tray is opened.
If symptoms do not improve
If your COPD 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 Elebrato Ellipta than you should
If you accidentally use more medicine than you should, contact your doctor or pharmacist immediately, as you may require medical attention. If possible, show them the inhaler, packaging, or this leaflet. You may notice your heart beating faster than normal, feel shaky, experience visual disturbances, have a dry mouth, or develop a headache.
If you forget to use Elebrato Ellipta
Do not inhale a double dose to make up for a missed dose. Inhale the next dose at your usual time. If you experience wheezing or breathlessness, use your fast-acting "rescue" inhaler (e.g., salbutamol), and seek medical advice.
If you stop using Elebrato Ellipta
Use this medicine for as long as your doctor has recommended. Do not stop using it unless your doctor tells you to, even if you feel better, as your symptoms may worsen.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Allergic reactions
Allergic reactions to Elebrato Ellipta are rare (may affect up to 1 in 1,000 people).
If you experience any of the following symptoms after taking Elebrato Ellipta, stop using it and contact your doctor immediately:
- skin rash or redness, hives (urticaria)
- swelling, sometimes of the face or mouth (angioedema)
- wheezing, coughing, or difficulty breathing
- sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness).
Urgent breathing difficulties
If your breathing or wheezing worsens immediately after using this medicine, stop using it and seek medical help immediately.
Pneumonia (lung infection) in COPD patients (common adverse effect)
If you experience any of the following symptoms while using Elebrato 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 coughing or worsening shortness of breath.
Other adverse effects
Common (may affect up to 1 in 10 people)
- mouth ulcers, lumps (bumps) in the mouth or throat caused by a fungal infection (candidiasis). Rinsing the mouth with water immediately after using Elebrato Ellipta may help prevent this adverse effect
- infection of the nose, sinuses, or throat
- upper respiratory tract infection
- itching, runny or blocked nose
- pain at the back of the mouth and throat
- sinus inflammation
- lung inflammation (bronchitis)
- influenza
- common cold
- headache
- cough
- painful and frequent urination (may be signs of urinary tract infection)
- joint pain
- back pain
- constipation.
Uncommon (may affect up to 1 in 100 people)
- irregular heartbeat
- faster heartbeat
- hoarseness
- weakening of the bones that may lead to fractures
- dry mouth
- taste disturbance
- blurred vision
- increased eye pressure
- eye pain.
Rare (may affect up to 1 in 1,000 people)
- allergic reactions (see above in Section 4)
- difficulty urinating (urinary retention)
- pain or discomfort when urinating (dysuria)
- awareness of heartbeats (palpitations)
- anxiety
- tremor
- muscle spasms
- increased blood sugar (hyperglycaemia).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Elebrato 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 after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30 ºC.
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 up to 6 weeks from the date the tray was opened. Write the date on which the inhaler should be discarded in the space provided for this purpose on the inhaler label. This date should be recorded as soon as the inhaler is removed from the tray.
If stored in the refrigerator, allow the inhaler to reach 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 dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Elebrato Ellipta
The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Each inhalation provides a delivered dose (dose emitted from the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium, and 22 micrograms of vilanterol (as trifenatoate).
The other components are lactose monohydrate (see section 2, “Elebrato Ellipta contains lactose”) and magnesium stearate.
Nature and contents of the container
Elebrato Ellipta is a powder for inhalation (single dose).
The Ellipta inhaler consists of a light grey plastic body, a beige mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium tray with a peelable aluminium lid. The tray contains a desiccant sachet to reduce moisture within the package.
The active substance is presented as a white powder in separate blister strips inside the inhaler. Elebrato Ellipta is available in packs containing 1 inhaler with 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). Only certain pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France
For further information about this medicinal product, please contact 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 |
|
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
| Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00
|
Ireland GlaxoSmithKline (Ireland) 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. Sími: + 354 535 7000 | Slovakia Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: + 421 2 544 30 730 |
Italy
Tel: +39 (0)55 56801 | Finland GlaxoSmithKline Oy Puh/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 | United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221441 |
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.europea.eu.
Step-by-step instructions for use
What is the inhaler?
The first time you use Elebrato Ellipta, you do not need to ensure that the inhaler is working correctly, as it contains pre-measured doses and is ready for immediate use.
Your Elebrato Ellipta inhaler pack contains:
The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale a dose of the medicine. When you are ready to use the 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 its tray, it will be in the “closed” position. Do not open the inhaler until you are ready to inhale a dose of the medicine. You must record the “Discard after” date in the designated space on the inhaler label and on the outer carton. 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 once opened.
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 for using the inhaler provided below apply to both the 30-dose Ellipta inhaler (30 days of treatment) and the 14-dose Ellipta inhaler (14 days of treatment).
- Read the following instructions before using the inhaler
If the inhaler’s lid is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be safely retained within the inhaler but will not be available for inhalation.
It is not possible to accidentally administer an additional or double dose by inhaling again.
For the 14-dose inhaler, the dose counter will also show half in red when fewer than 10 doses remain, and then display half red with the number 0 after the last dose is used. The dose counter will appear completely red if the lid is opened again.
- Prepare a dose
When you are ready to inhale a dose, open the inhaler’s lid.
Do not shake the inhaler.
- Slide the lid downward until you hear a ‘click’.
The medicine is now ready to be inhaled.
As confirmation, the dose counter decreases by 1 unit.
- If the dose counter does not decrease when you hear the ‘click’, the inhaler will not release the dose of medicine. Take it to your pharmacist for assistance.
- Do not shake the inhaler at any time.
- Inhale the medicine
- While holding the inhaler away from your mouth, breathe out as fully 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 vents with your fingers.
- Take a long, continuous, and deep breath in. 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.
Before closing the lid, the inhaler’s mouthpiece may be cleaned using a dry tissue.
- Close the inhaler and rinse your mouth
- Slide the lid upward fully to cover the mouthpiece.
- Rinse your mouth with water after using the inhaler; do not swallow.
This will reduce the likelihood of adverse effects such as mouth or throat ulcers.