Laventair Ellipta (previously Laventair)
umeclidinium bromide, vilanterol
umeclidinium/vilanterol
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
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 LAVENTAIR ELLIPTA is and what it is used for
What you need to know before you use 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
LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.
LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term condition characterised by breathing difficulties that slowly get worse.
In COPD the muscles around the airways tighten. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.
If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.
- if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
If you think this applies to you, don’t use this medicine until you have checked with your doctor.
Talk to your doctor before using this medicine:
- if you have asthma (Don’t use LAVENTAIR ELLIPTA to treat asthma)
if you have heart problems or high blood pressure
if you have an eye problem called narrow-angle glaucoma
if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
if you suffer from epilepsy
if you have thyroid gland problems
if you have diabetes
if you have severe liver problems
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your LAVENTAIR ELLIPTA inhaler:
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with LAVENTAIR ELLIPTA:
Do not give this medicine to children or adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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’ll have side effects. These include:
medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems
ketoconazole or itraconazole, to treat fungal infections
clarithromycin or telithromycin, to treat bacterial infections
ritonavir, to treat HIV infection
medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids)
other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Don’t use LAVENTAIR ELLIPTA if you already use these medicines.
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 using 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 LAVENTAIR ELLIPTA can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA. Don’t use this medicine if you are breast-feeding unless your doctor tells you that you can.
It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.
LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
See ‘Step-by-step instructions’ in this leaflet for full information.
LAVENTAIR ELLIPTA is for inhalation use. To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
If your COPD 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 too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Don’t stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
If you have any 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.
If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Uncommon side effects (may affect up to 1 in 100 people):
skin rash (hives) or redness
Rare side effects (may affect up to 1 in 1,000 people):
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 LAVENTAIR ELLIPTA are rare. If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:
These may affect up to 1 in 10 people:
painful and frequent urination (may be signs of a urinary tract infection)
combination of sore throat and runny nose
sore throat
feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
headache
cough
pain and irritation in the back of the mouth and throat
constipation
dry mouth
infection of the upper airways.
These may affect up to 1 in 100 people:
irregular heart beat
faster heart beat
awareness of heart beat (palpitations)
rash
tremor
taste disturbance
hoarseness.
These may affect up to 1 in 1,000 people:
blurred vision
increase of the measured eye pressure
decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary retention.
Frequency cannot be estimated from the available data:
dizziness.
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 carton, tray and inhaler after ‘EXP’. The expiry date refers to the last day of that month.
Keep the inhaler inside the sealed tray in order 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.
Do not store above 30°C.
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 dispose of medicines no longer required. This will help to protect the environment.
The active substances are umeclidinium bromide and vilanterol.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose’) and magnesium stearate.
LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed.
The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce moisture in the packaging.
The active substances are present as a white powder in separate blisters inside the inhaler. Each inhaler contains either 7 or 30 doses. Multipacks containing 90 (3 inhalers of 30) doses are also available. Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Citywest Business Campus Dublin 24
Ireland
Glaxo Wellcome Production Zone Industrielle No.2,
23 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.
GSK Services Sp. z o.o.
Tel: + 34 900 460 153
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
A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56801
GlaxoSmithKline (Ireland) Limited
Τηλ: +357 80070017
SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
The first time you use LAVENTAIR ELLIPTA you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
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 open the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 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.
Take it back to your pharmacist for advice.
Take one long, steady, deep breath in. Hold this breath in for as long as possible (at least 3-4 seconds).
Remove the inhaler from your mouth.
Breathe out slowly and gently.
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.
Slide the cover upwards as far as it will go, to cover the mouthpiece.