2. What should I know before I use ARNUITY ELLIPTA?
Do not use if you have ever had an allergic reaction to ARNUITY ELLIPTA or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Do not give this
medicine to a child under the age of 5 years.
3. What if I am taking other medicines?
Some medicines may interfere with ARNUITY ELLIPTA and affect how it works.
4. How do I use ARNUITY ELLIPTA?
The usual dose of ARNUITY ELLIPTA is one inhalation once a day. Use ARNUITY ELLIPTA
at the same time each day.
5. What should I know while using ARNUITY ELLIPTA?
|
Things you should do
|
Remind any Healthcare Professional (HCP) you visit that you are using ARNUITY ELLIPTA.
Contact your doctor if you are concerned about any side effects.
Tell your doctor immediately, if you become or intent to become pregnant while using
ARNUITY ELLIPTA.
Tell your doctor if you feel you are getting breathless or wheezy more often than
normal, or if you are using your quick-acting inhaler (such as VENTOLIN/salbutamol)
more than usual.
|
|
Things you should not do
|
Do not stop using this medicine suddenly or change the dosage without checking with
your doctor.
Do not take any other medicines to help you breathe without checking with your doctor.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how ARNUITY ELLIPTA affects
you.
|
|
Looking after your medicine
|
Do not open the foil lid until you are ready to use the inhaler for the first time.
Once ARNUITY ELLIPTA has been removed from the tray you may store it for a maximum
period of one month or when the counter reads "0", whichever comes first.
Store it in a cool dry place (below 30˚C) away from moisture, heat, or sunlight.
If you store it in the refrigerator, allow the inhaler to return to room temperature
at least 1 hour before you use it.
|
6. Are there any side effects?
Less serious side effects include headache, infection of the nose sinuses or throat,
influenza, pain and irritation in the back of the mouth and throat, pressure or pain
in the cheeks and forehead, itchy, runny or blocked nose, cough, hoarseness, bronchitis,
back pain, oral thrush, weakening of the bones, rounded face or slowing of growth
in children and adolescents. Serious side effects include allergic reaction, blurred
vision or eye pain, cataracts, or immediate breathing difficulties and wheezing.
Active ingredient:
fluticasone furoate 50, 100 or 200 micrograms per inhalation
Consumer Medicine Information (CMI)
This leaflet provides important information about using ARNUITY ELLIPTA. You should also speak to your Healthcare Professional (HCP) if you would like further
information or if you have any concerns or questions about using ARNUITY ELLIPTA.
Where to find information in this leaflet:
1. Why am I using ARNUITY ELLIPTA?
ARNUITY ELLIPTA contains the active ingredient fluticasone furoate. Fluticasone furoate belongs to a group of medicines called inhaled corticosteroids,
often simply called steroids.
ARNUITY ELLIPTA is used to treat asthma in patients 5 years and over.
Asthma is a condition affecting the lungs. Symptoms of asthma include shortness of
breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are
bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation
(swelling and irritation of the airways).
Inhaled corticosteroids are used to reduce inflammation. They reduce the swelling
and irritation in the small air passages in the lungs and so ease breathing problems.
Inhaled corticosteroids also help prevent attacks of asthma.
When ARNUITY ELLIPTA is used regularly, it can help to control your breathing difficulties.
ARNUITY 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 inhaler (such
as VENTOLIN/salbutamol).
Your doctor may have prescribed ARNUITY ELLIPTA for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
This medicine is not addictive.
This medicine is available only with a prescription.
2. What should I know before I use ARNUITY ELLIPTA?
Warnings
Do not use ARNUITY ELLIPTA if:
you are allergic (hypersensitive) to fluticasone furoate, or any of the ingredients
listed at the end of this leaflet.
you are allergic (hypersensitive) to lactose or milk protein.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have liver disease, as you may be more likely to have side effects, and your doctor
may need to lower your dose. ARNUITY ELLIPTA is not recommended for use in children
under 12 years of age with liver disease.
are being or have ever been treated for tuberculosis (TB) or pneumonia.
have eye problems, such as glaucoma or cataracts.
have weak bones (osteoporosis)
have any long-standing or untreated infections or have recently been exposed to chickenpox
or measles or been around anyone who has chickenpox or measles.
have been diagnosed with an intolerance to milk protein.
take any medicines for any other condition.
Your doctor should give you a personal Action Plan to help manage your asthma. This
plan will include what medicines to take regularly to control your asthma, as well
as what "reliever" medicines to use when you have sudden attacks of breathlessness
or wheezing. Ask your doctor or pharmacist if you have any questions about your Action
Plan.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
ARNUITY ELLIPTA is not usually recommended for use during pregnancy. Your doctor will
weigh up the benefits to you against the potential risks to your baby when considering
the use of ARNUITY ELLIPTA during your pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether the ingredients of ARNUITY ELLIPTA can pass into breast milk.
Children
Do not give this medicine to a child under the age of 5 years.
Safety and effectiveness in children younger than 5 years has not been established.
3. What if I am taking other medicines?
Tell your Healthcare Professional (HCP) if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with ARNUITY ELLIPTA and affect how it works or make
it more likely that you will have side effects.
These medicines include:
ketoconazole, to treat fungal infections.
ritonavir, to treat viral infections.
Medicines which are similar to ARNUITY ELLIPTA should not be used together as an overdose
may result.
Check with your Healthcare Professional (HCP) if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect ARNUITY ELLIPTA.
4. How do I use ARNUITY ELLIPTA?
How much to use:
Always use ARNUITY ELLIPTA exactly as your doctor has told you to. Check with your
Healthcare Professional (HCP) if you are not sure.
Adults and adolescents (aged 12 years and over):
The dose for asthma is one inhalation of ARNUITY ELLIPTA 100 micrograms once daily
OR one inhalation of ARNUITY ELLIPTA 200 micrograms once daily, at the same time each
day.
Your doctor will decide which strength of ARNUITY ELLIPTA is required to treat your
asthma.
If you have liver disease, your doctor may decide that the maximum dose you should
use is one inhalation of ARNUITY ELLIPTA 100 micrograms once daily, at the same time
each day.
Children (aged 5 to less than 12 years):
The dose for asthma is one inhalation of ARNUITY ELLIPTA 50 micrograms once daily,
at the same time each day.
ARNUITY ELLIPTA is not recommended for children less than 5 years of age. ARNUITY
ELLIPTA has not been tested in children in this age group.
ARNUITY ELLIPTA is not recommended for use in children under 12 years of age with
liver disease.
When to use ARNUITY ELLIPTA
Use ARNUITY ELLIPTA once daily, at the same time each day. It is very important that
you use ARNUITY ELLIPTA every day, as instructed by your Healthcare Professional (HCP).
This will help to keep you free of symptoms throughout the day and night.
Use ARNUITY ELLIPTA for as long as your HCP recommends. It will only be effective
as long as you are using it. Do not stop unless your HCP advises you to, even if you
feel better.
How to use ARNUITY ELLIPTA
To use ARNUITY ELLIPTA, you breathe it into your lungs through your mouth using the
Ellipta inhaler.
The full instructions for using ARNUITY ELLIPTA are present on a leaflet inside the
pack.
ARNUITY ELLIPTA is ready to use straight away. No preparation or checks of the inhaler
are required.
Do not open ARNUITY ELLIPTA until you are ready to inhale a dose of medicine.
Step 1: Prepare a dose
Wait to open the cover until you are ready to take your dose. Slide the cover down
until you hear a "click".
If the dose counter does not count down as you hear the "click", the inhaler will
not deliver the medicine. Take it back to your pharmacist for advice.
Do not shake the inhaler at any time.
Step 2: Inhale your medication
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 for about 3-4 seconds or as
long as is comfortable.
Remove the inhaler from your mouth.
Breathe out slowly and gently away from the mouthpiece.
You may not be able to taste or feel the medicine, even when you are using the inhaler
correctly.
After using ARNUITY ELLIPTA, you may clean the mouthpiece using a dry tissue, before
you close the cover.
Step 3: Close the inhaler and rinse your mouth
Slide the cover upwards as far as it will go, to cover the mouthpiece.
Rinse your mouth out with water without swallowing after you have used the inhaler
if possible. This will make it less likely that you will develop a sore mouth or throat
as side effects.
If you forget to use ARNUITY ELLIPTA
ARNUITY ELLIPTA should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and use your next
dose when you are meant to.
Otherwise, use it as soon as you remember, then go back to using it as you normally
would.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your Healthcare Professional (HCP).
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack,
use your fast-acting inhaler (e.g., VENTOLIN/salbutamol) and seek medical advice.
If you use too much ARNUITY ELLIPTA (overdose)
If you think that you have used too much ARNUITY ELLIPTA, you may need urgent medical
attention. You may notice that your heart is beating faster than usual, you feel shaky
or have a headache.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you have used larger doses than instructed for a long period of time, it is particularly
important that you ask your Healthcare Professional (HCP) for advice. This is because
larger doses of ARNUITY ELLIPTA may reduce the amount of steroid hormones produced
naturally by your body.
5. What should I know while using ARNUITY ELLIPTA?
Things you should do
Remind any Healthcare Professional (HCP) you visit that you are using ARNUITY ELLIPTA,
especially if you are about to be started on any new medicine.
Use ARNUITY ELLIPTA 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.
Check with your doctor if you are unsure about which medicines for asthma you should
continue taking while being treated with ARNUITY ELLIPTA.
Continue to use a quick-acting inhaler (e.g., VENTOLIN/salbutamol) during an acute
episode.
If you are about to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
experience blurred vision or other visual disturbances.
become pregnant while using ARNUITY ELLIPTA
feel that your breathing or wheezing gets worse straight after using ARNUITY ELLIPTA.
Stop using it immediately.
Things you should not do
Do not stop using this medicine suddenly or change the dosage without medical advice.
Do not use ARNUITY ELLIPTA to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
If you are currently on oral or injectable corticosteroids, do not stop taking these
suddenly without checking with your doctor.
Do not take any other long-acting inhalers which contain corticosteroids.
Do not take any other medicines for your breathing problems without checking with
your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ARNUITY
ELLIPTA affects you.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Action Plan
If you have an Action Plan for your asthma that you have agreed with your doctor,
follow it closely at all times.
Looking after your medicine
Store in the original package container in order to protect from moisture and do not
open the foil lid until ready to inhale for the first time.
If you store in a refrigerator, allow the inhaler to return to room temperature for
at least an hour before use.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 30˚C.
Do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
Ask your pharmacist to safely throw away ARNUITY ELLIPTA one month after you open
the foil tray or when the counter reads "0", whichever comes first. Write the date
the inhaler should be discarded on the label in the space provided. The date should
be added as soon as the inhaler has been removed from the tray.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
To reduce the chance of side effects, your doctor will prescribe the lowest effective
dose of ARNUITY ELLIPTA to control your asthma.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor before you decide to stop taking any of
your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ARNUITY ELLIPTA contains
|
Active ingredient
|
Fluticasone furoate
|
|
Other ingredients
|
Lactose monohydrate (contains milk protein)
|
|
Potential allergens
|
Lactose or milk protein
Fluticasone furoate
|
Each dose contains 50, 100 or 200 micrograms of the active ingredient fluticasone
furoate. The amount depends on which strength of ARNUITY ELLIPTA you have been give.
Do not use this medicine if you are allergic to any of these ingredients.
What ARNUITY ELLIPTA looks like
The Ellipta device itself is a plastic inhaler with a light grey body, a pale orange
mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a
peelable foil lid.
The active substances are in separate blisters in powder form inside the device. There
are either 14 or 30 blisters on each strip, and so each device contains either 14
or 30 doses depending on which pack size you have been given.
The tray contains a desiccant sachet, to reduce the moisture in the packaging. Once
you have opened the lid of the tray, throw the desiccant away - do not open, eat or
inhale it.
ARNUITY ELLIPTA 50 micrograms AUST R 300141
ARNUITY ELLIPTA 100 micrograms AUST R 231095
ARNUITY ELLIPTA 200 micrograms AUST R 231103
Who distributes ARNUITY ELLIPTA
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
Trademarks are owned by or licensed to the GSK group of companies.
© 2024 GSK group of companies or licensor.
This leaflet was prepared in September 2024.
Version 6.0