Patient leaflet - Incruse Ellipta 55 micrograms inhalation powder Pre-dispensed
1. What Incruse Ellipta is and what it is used for
What Incruse Ellipta is
Incruse Ellipta contains the
active substance umeclidinium
(as bromide), which belongs to a group
of medicines called bronchodilators.
What Incruse Ellipta is used for
This medicine is used to treat chronic
obstructive pulmonary disease
(COPD) in adults. COPD is a long-term
condition in which the airways and
air-sacs in the lungs gradually become
blocked or damaged, leading to
breathing difficulties that slowly get
worse. Difficulties in breathing is
added to by tightening of the muscles
around the airways, which narrows
the airways and so restricts the flow
of air.
This medicine blocks the tightening of
these muscles, making it easier for air
to get in and out of the lungs. When
used regularly, it can help control your
breathing difficulties and reduce the
effects of COPD on your everyday life.
Incruse 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). If you do not have
a quick-acting inhaler contact
your doctor.
- 2. What you need to know
before you use Incruse Ellipta
Do not use Incruse Ellipta:
if you are allergic to umeclidinium
or any of the other ingredients of this medicine (listed in section 6). ➔ If you think the above applies to
you, do not use this medicine until you have checked with your doctor.
Warnings and precautions
Talk to your doctor before using Incruse Ellipta:
if you have asthma (Do not use
Incruse Ellipta to treat asthma)
- if you have heart problems
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 have severe liver problems ➔ Check with your doctor if you think
any of these may apply to you.
Immediate breathing difficulties
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Incruse Ellipta inhaler:
➔ stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Incruse Ellipta
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Incruse Ellipta: ➔ stop using this medicine and seek
medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Children and adolescents
Do not give this medicine to children or adolescents below the age of 18 years.
Other medicines and Incruse Ellipta
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.
In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to this medicine for breathing problems, e.g. tiotropium. Do not use Incruse Ellipta together with these other medicines.
Pregnancy and breast-feeding
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. Do not use this medicine if you are pregnant unless your doctor tells you so.
It is not known whether the ingredients of Incruse Ellipta can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.
Incruse Ellipta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
3. How to use Incruse Ellipta
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Do not use more than your doctor tells you to use.
Use Incruse Ellipta regularly
It is very important that you use Incruse Ellipta every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.
Do not use this medicine 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).
How to use the inhaler
See ‘Step-by-step instructions for use’ at the end of this leaflet for full information.
Incruse Ellipta is for inhalation use. To use Incruse Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
If your symptoms do not improve
If your COPD symptoms
(breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
➔ contact your doctor as soon as possible.
If you use more Incruse Ellipta than you should
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 have visual disturbances or have a dry mouth.
If you forget to use Incruse Ellipta Do not inhale a double dose to make up for a forgotten dose. Just inhale your next dose at the usual time. If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
If you stop using Incruse Ellipta
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you have any of the following symptoms after taking Incruse Ellipta, stop using this medicine and tell your doctor immediately:
Uncommon (may affect up to 1 in 100 people):
- itching
- skin rash (hives) or redness Rare (may affect up to 1 in
1 000 people):
wheezing, coughing or having
difficulty in breathing
suddenly feeling weak or light
headed (which may lead to collapse or loss of consciousness).
Other side effects
Common (may affect up to 1 in 10 people):
- faster heart beat
painful and frequent urination (may
be signs of a urinary tract infection)
- common cold
- infection of nose and throat
- cough
feeling of pressure or pain in
the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
- headache
- constipation
- mouth and throat pain.
Uncommon (may affect up to 1 in 100 people):
- irregular heart beat
- sore throat
- dry mouth
- taste disturbance
- hoarseness.
Rare (may affect up to 1 in
1 000 people):
- eye pain
Not known (frequency cannot be estimated from the available data):
decrease in vision or pain in your
eyes due to high pressure (possible signs of glaucoma).
- blurred vision
increase of the measured eye
pressure
difficulty and pain when passing
urine – these may be signs of a bladder obstruction or urinary retention
- dizziness
Reporting of side effects
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Incruse Ellipta
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 throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Incruse Ellipta contains
The active substance is umeclidinium (as bromide).
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose’) and magnesium stearate.
What Incruse Ellipta looks like and contents of the pack
Incruse Ellipta is an inhalation powder, pre-dispensed. The Ellipta inhaler consists of a grey plastic body, a light green 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 substance is present as a white powder in a blister inside the inhaler. Incruse Ellipta is available in packs of 1 inhaler containing either 7 or 30 doses and in multipacks containing 90 (3 inhalers of 30) doses. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline UK Limited
79 New Oxford Street
London
WC1A 1DG
United Kingdom
Manufacturer
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Ware
Hertfordshire
SG12 0DJ
United Kingdom
inhalation powder, pre-dispensed umeclidinium
Package leaflet: Information for the patient Slide the cover upwards as far as it will go, to cover the mouthpiece.
If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
4 Close the inhaler 3 Inhale your medicine
While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Do not breathe out into the inhaler.
Put the mouthpiece between your lips, and close your lips firmly around it.
Do not block the air vent with your fingers.
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.
Your lips fit over the
contoured shape of
the mouthpiece for
inhaling.
Do not block the
air vent with your
fingers.
2 Prepare a dose
Wait to open the cover until you are ready to inhale your dose.
Do not shake the inhaler.
Slide the cover down until you hear a “click”. Your medicine is now ready to be inhaled. The dose counter counts down by 1 to confirm.
Mouthpiece
“Click”
Air vent
Dose counter
This shows how many doses of medicine
are left in the inhaler.
Before the inhaler has been used, it shows exactly 30 doses.
It counts down by 1 each time you open
the cover.
When fewer than 10 doses are left, half of the dose counter shows red.
After you have used the last dose, half
of the dose counter shows red and the
number 0 is displayed. Your inhaler is now
empty.
If you open the cover after this, the dose
counter will change from half red to
completely red.
Cover
Each time you
open this, you
prepare one dose of medicine.
Step-by-step instructions for use What is the Ellipta inhaler?
The first time you use Incruse 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.
Your Incruse Ellipta inhaler carton 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 your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture.
Throw this desiccant sachet away – do not open, eat or inhale it.
When you take the inhaler out of 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, write the “Discard by” date on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date you opened the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use. The step-by-step instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30-day supply) or the 7-dose inhaler (7-day supply). Tray lid
Inhaler
Desiccant
Tray
Carton
This leaflet
1 Read this before you start
If you open and close the cover without inhaling the medicine, you will lose the dose.
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.
If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Take it back to your pharmacist for advice.
Desiccant
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Product name Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
Reference numbers 19494/0273 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 02/2025
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