Patient Leaflet Updated 05-Jan-2023 | GlaxoSmithKline UK
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Package leaflet: Information for the user
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
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.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What ANORO ELLIPTA is and what it is used for
2. What you need to know before you use ANORO ELLIPTA
3. How to use ANORO ELLIPTA
4. Possible side effects
5. How to store ANORO ELLIPTA
6. Contents of the pack and other information
Step-by-step instructions
1. What ANORO ELLIPTA is and what it is used for
What ANORO ELLIPTA is
ANORO ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.
What ANORO ELLIPTA is used for
ANORO 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.
ANORO 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 ANORO ELLIPTA
Do not use ANORO ELLIPTA:
If you think this applies to you, don’t use this medicine until you have checked with your doctor.
Warnings and precautions
Talk to your doctor before using this medicine:
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 ANORO 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 ANORO 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 ANORO 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 ANORO 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.
Some medicines may affect how this medicine works, or make it more likely that you’ll have side effects.
These include:
Tell your doctor or pharmacist if you are taking any of these.
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. 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 ANORO ELLIPTA can pass into breast milk. If you are breast- feeding, you must check with your doctor before you use ANORO ELLIPTA. Don’t use this medicine if you are breast-feeding unless your doctor tells you that you can.
Driving and using machines
It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines.
ANORO 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 ANORO 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.
Don’t use more than your doctor tells you to use.
Use ANORO ELLIPTA regularly
It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.
ANORO 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).
How to use the inhaler
See ‘Step-by-step instructions’ in this leaflet for full information.
ANORO ELLIPTA is for inhalation use. To use ANORO 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 ANORO 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 feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
If you forget to use ANORO ELLIPTA
Don’t inhale an extra 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 reliever inhaler (such as salbutamol), then seek medical advice.
If you stop using ANORO ELLIPTA
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.
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 ANORO ELLIPTA stop using this medicine and tell your doctor immediately.
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1 000 people):
Immediate breathing difficulties
Immediate breathing difficulties after using ANORO ELLIPTA are rare. If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:
Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Other side effects
Common
(may affect up to 1 in 10 people)
Uncommon
(may affect up to 1 in 100 people)
Rare
(may affect up to 1 in 1 000 people)
Not known
(frequency cannot be estimated from the available data)
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.
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store ANORO 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 dispose of medicines no longer required. This will help to protect the environment.
6. Contents of the pack and other information
What ANORO ELLIPTA contains
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 ‘ANORO ELLIPTA contains lactose’) and magnesium stearate.
What ANORO ELLIPTA looks like and contents of the pack
ANORO 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.
Marketing Authorisation Holder:
Manufacturer:
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Product name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder pre-dispensed
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This leaflet was last revised in 12/2022
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Step-by-step instructions
What is the inhaler?
The first time you use ANORO 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 ANORO ELLIPTA inhaler carton contains
Your leaflet has a pictogram in this location showing the components of the pack, which are:
Carton
Leaflet
Tray
Tray lid
Inhaler
Desiccant
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.
Your leaflet has a pictogram in this location showing a hand removing the tray lid from the tray and the desiccant being placed in a waste bin.
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).
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.
Your leaflet has a pictogram in this location showing the closed inhaler. The pictogram has two labels, which have the following information:
Cover
Each time you open this, you prepare one dose of medicine
Dose counter
This shows how many doses of medicine are left in the inhaler.
Before the inhaler is 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.
2) Prepare a dose
Wait to open the cover until you are ready to inhale your dose.
Do not shake the inhaler.
Your leaflet has a pictogram in this location showing the inhaler held in a pair of hands, with the inhaler cover slid to the fully open position.
A dialogue bubble has the word “Click”, representing the sound the inhaler makes when the cover is slid to the fully open position.
The dose counter shows 29, which is demonstrates how it counts down by 1 when 1 dose is prepared.
The diagram shows the contoured shape of the mouthpiece and air vent visible when the cover is slid to the fully open position.
Your medicine is now ready to be inhaled.
The dose counter counts down by 1 to confirm.
3) Inhale your medicine
Your leaflet has a pictogram in this location showing a person holding the open inhaler and placing the mouthpiece of the inhaler in their mouth. The pictogram has the following label:
Your lips fit over the contoured shape of the mouthpiece for inhaling.
Do not block the air vent with your fingers.
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.
4) Close the inhaler
Your leaflet has a pictogram in this location showing the inhaler with the lid in the closed position. The dose counter shows 29, which is the number of doses remaining in the inhaler.
Slide the cover upwards as far as it will go, to cover the mouthpiece.
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