LaventaIR Ellipta 55 micrograms/22 micrograms powder for inhalation (single dose)
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
LAVENTAIR ELLIPTA 55 micrograms/22 micrograms powder for inhalation (single dose)
umeclidinium/vilanterol
Read the entire leaflet carefully before you start using this medicine, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What LAVENTAIR ELLIPTA is and what it is used for
- What you need to know before using LAVENTAIR ELLIPTA
- How to use LAVENTAIR ELLIPTA
- Possible side effects
- How to store LAVENTAIR ELLIPTA
- Contents of the pack and other information
Step-by-step instructions for use
1. What LAVENTAIR ELLIPTA is and what it is used for
What LAVENTAIR ELLIPTA is
LAVENTAIR ELLIPTA contains two active substances, umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.
What LAVENTAIR ELLIPTA is used for
LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic, slowly worsening disease characterized by difficulty breathing.
In COPD, the muscles surrounding the airways tighten. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to flow in and out of the lungs.
When used regularly, it helps control breathing difficulties and reduces the impact of COPD on your daily life.
LAVENTAIR ELLIPTA must not be used to relieve a sudden attack of breathlessness or wheezing (whistling sounds when breathing). If you experience such attacks, you must use a fast-acting "rescue" inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.
2. What you need to know before using LAVENTAIR ELLIPTA
Do not use LAVENTAIR ELLIPTA:
- if you are allergic to umeclidinium, vilanterol, or 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 this medicine until you have consulted your doctor.
Warnings and precautions
Talk to your doctor before starting to use this medicine:
- if you have asthma (Do not use LAVENTAIR ELLIPTA for the treatment of asthma)
- if you have heart problems or high blood pressure
- if you have an eye condition called closed-angle glaucoma
- if you have an enlarged prostate, difficulty passing urine, or a bladder obstruction
- if you have epilepsy
- if you have thyroid gland problems
- if you have low potassium levels in your blood
- if you have diabetes
- if you have severe liver problems.
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 LAVENTAIR 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 LAVENTAIR ELLIPTA
If you experience eye pain or discomfort, blurred vision, seeing halos or colored images, or eye redness while being treated with LAVENTAIR ELLIPTA:
stop using this medicine and seek immediate medical help, as these symptoms may indicate an acute attack of closed-angle glaucoma.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and LAVENTAIR 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 medication, 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, used to treat HIV
- medicines that reduce potassium levels in the blood, such as certain diuretics or some medicines used to treat asthma (such as methylxanthines or steroids)
- other long-acting medicines for similar respiratory conditions, for example, tiotropium, indacaterol. Do not use LAVENTAIR 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 need to monitor you closely, as these medicines may increase the risk of side effects from LAVENTAIR 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 LAVENTAIR ELLIPTA are excreted in breast milk. If you are breastfeeding, consult your doctor before using LAVENTAIR ELLIPTA. Do not use this medicine while breastfeeding unless your doctor tells you to.
Driving and using machines
It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or operate machinery.
LAVENTAIR 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 LAVENTAIR ELLIPTA
Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
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 LAVENTAIR ELLIPTA regularly
It is very important that you use LAVENTAIR ELLIPTA every day, as directed by your doctor. This will help you to remain symptom-free throughout the day and night.
Do not use LAVENTAIR ELLIPTA 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.
LAVENTAIR ELLIPTA is for inhalation use. To use LAVENTAIR ELLIPTA, inhale it into your lungs through your mouth using the ELLIPTA inhaler.
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 LAVENTAIR ELLIPTA than you should
If you accidentally use too much medicine, contact your doctor or pharmacist immediately, as you may require medical attention. If possible, show them the inhaler, the packaging, or this leaflet. You may notice that your heart beats faster than normal, visual disturbances, dry mouth, or headache.
If you forget to use LAVENTAIR ELLIPTA
Do not inhale a double dose to make up for a missed dose. Take your next dose at the usual time. If you experience wheezing or breathlessness, use your fast-acting "rescue" inhaler (such as salbutamol) and seek medical advice.
If you stop treatment with LAVENTAIR ELLIPTA
Use this medicine for the length of time recommended by your doctor. It will only be effective for as long as you continue to take it. Do not stop using it unless your doctor tells you to, even if you feel better, because 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 will experience them.
Allergic reactions
If you experience any of the symptoms listed below after taking LAVENTAIR ELLIPTA, stop using this medicine and contact your doctor immediately.
Uncommon adverse effects (may affect up to 1 in 100 people):
- skin rash (hives) or redness.
Rare adverse effects (may affect up to 1 in 1,000 people):
- swelling, sometimes of the face or mouth (angioedema)
- increased wheezing (a whistling sound when breathing), coughing, or difficulty breathing
- sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness).
Urgent breathing difficulties
Urgent breathing difficulties after using LAVENTAIR ELLIPTA are rare. If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using this medicine:
stop using this medicine and seek immediate medical attention, as you may have a serious condition called paradoxical bronchospasm.
Other adverse effects
Frequent (may affect up to 1 in 10 people)
- frequent and painful urination (may be a sign of urinary tract infection)
- combination of sore throat and runny nose
- sore throat
- feeling of pressure or pain in the cheeks and forehead (may be a sign of sinus inflammation called sinusitis)
- headache
- cough
- pain and irritation in the back of the mouth and throat
- constipation
- dry mouth
- upper respiratory tract infection.
Uncommon (may affect up to 1 in 100 people)
- irregular heartbeat
- faster heartbeat
- awareness of your heartbeat (palpitations)
- muscle spasms
- tremor
- taste disturbance
- hoarseness.
Rare (may affect up to 1 in 1,000 people)
- blurred vision
- increased intraocular pressure
- decreased vision or eye pain (possible signs of glaucoma)
- difficulty and pain when urinating, which may be signs of bladder obstruction or urinary retention.
Not known (frequency cannot be estimated from available data):
- dizziness.
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 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 LAVENTAIR ELLIPTA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, 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, counted from the date the tray was opened. Write the date on which the inhaler should be discarded in the space provided for this on the inhaler label. This date should be recorded as soon as the inhaler is removed from the tray.
Do not store above 30 °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 any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of LAVENTAIR ELLIPTA
The active substances are umeclidinium bromide and vilanterol.
Each inhalation delivers a released dose (the dose emitted from the mouthpiece) of 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatoate).
The other components are lactose monohydrate (see section 2, “LAVENTAIR ELLIPTA contains lactose”) and magnesium stearate.
Nature of the product and contents of the container
LAVENTAIR ELLIPTA is an inhalation powder (single dose).
The Ellipta inhaler device consists of a light grey plastic body, a red mouthpiece cover, and a dose counter. It is packaged in a laminated aluminum tray. The tray contains a desiccant bag to reduce moisture within the package.
The active substances are presented as a white powder in separate blisters inside the inhaler. LAVENTAIR ELLIPTA is available in packs containing 1 inhaler with either 7 or 30 doses, and in multiple packs containing 90 doses (3 inhalers of 30 doses each). 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
For more information about this medicine, contact 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 |
| 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 Tel: + 33 (0)1 45 60 77 20 | Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00 |
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 361 | 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. Sími: + 354 535 7000 | Slovakia Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730 |
Italy A.Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: + 39 (0)55 56801 | Finland/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 |
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 LAVENTAIR ELLIPTA, you do not need to check that the inhaler is working correctly, as it contains pre-measured doses and is ready to use straight away.
Your LAVENTAIR 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 inhaler. 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 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 stored in the refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
The step-by-step inhaler instructions provided below apply to both the 30-dose inhaler (30 days of treatment) and the 7-dose inhaler (7 days of treatment).
- Read this information before starting
If the inhaler cap 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 deliver an extra or double dose by inhaling again.
- Prepare a dose
Wait to open the inhaler cap until you are ready to inhale a dose.
Do not shake the inhaler.
- Slide the cap 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 dose.
Take it to your pharmacist and ask for assistance.
- Inhale your medicine
- While holding 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 vents with your fingers.
- Breathe in deeply, steadily, and for as long as possible. 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.
Before closing the cap, the inhaler mouthpiece may be cleaned using a dry tissue.
- Close the inhaler
Slide the cap upward fully to cover the mouthpiece.