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FLIVEO INHALER 125 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): FLUTICASONE PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Fliveo® Inhaler 50 micrograms per actuation pressurised inhalation, suspension
Fliveo® Inhaler 125 micrograms per actuation pressurised inhalation, suspension
Fliveo® Inhaler 250 micrograms per actuation pressurised inhalation, suspension
fluticasone propionate
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
asthma 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 asthma
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Fliveo Inhaler is and what it is used for
2. What you need to know before you use Fliveo Inhaler
3. How to use Fliveo Inhaler
4. Possible side effects
5. How to store Fliveo Inhaler
6. Contents of the pack and other information

1. WHAT FLIVEO INHALER IS AND WHAT IT IS USED FOR
Fliveo Inhaler contains the active substance fluticasone propionate.
Fluticasone is a corticosteroid (often just called steroid). It has an
anti-inflammatory action which reduces asthma-related swelling and
irritation in the lungs. Only a very small dose of steroid is needed
because it is inhaled straight into your lungs.
Your doctor has prescribed this medicine to help prevent breathing
problems such as asthma. Fluticasone propionate is sometimes called
a ‘preventer’.
Fliveo Inhaler is not used to treat Chronic Obstructive Pulmonary
Disease (COPD).
You must use Fliveo Inhaler every day as directed by your doctor, even
if you are not currently experiencing any breathing problems. This will
make sure that it works properly in controlling your asthma. It takes
4-7 days for this medicine to work fully.
Fliveo Inhaler helps to prevent breathlessness and wheezing. It does
not relieve sudden attacks of breathlessness or wheezing. If this
happens you need to use a rapid-acting ‘reliever’ (‘rescue’) inhaler,
such as salbutamol. You should have your rapid-acting ‘rescue’
inhaler with you at all times.
Fliveo Inhaler 50  micrograms is used to treat asthma in adults
and children and adolescents aged 4 to 18 years. Fliveo Inhaler
50 micrograms is not recommended for children less than 4 years
of age.
Fliveo Inhaler 125 micrograms and Fliveo Inhaler 250 micrograms are
used to treat asthma in adults and adolescents over 16 years of age.
Fliveo Inhaler 125 micrograms and Fliveo Inhaler 250 micrograms
are not recommended for adolescents and children 16 years of age
and younger.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLIVEO
INHALER
Do not use Fliveo Inhaler:
• If you are allergic to fluticasone propionate or the other ingredient
in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or asthma nurse before using Fliveo
Inhaler if you have ever had:
• Tuberculosis (TB).
• Diabetes mellitus (because fluticasone may increase your blood
sugar level).
• Thinning of the bones.
• Eye problems (cataract and glaucoma).
• Growth problems (in children and adolescents).
• Cushing’s Syndrome (associated with upper body weight gain,
rounding of the face, thinning of the skin and bones, depression,
and various non-specific effects such as headache and fatigue).
• Adrenal suppression or an adrenal crisis.
• Treatment with steroid tablets/injections or high dose inhalers for a
long period of time.
If you are not sure if any of the above applies to you, talk to your doctor,
pharmacist or asthma nurse before using Fliveo Inhaler.
If you develop a chest (lung) infection during treatment (e.g. viral,
fungal, or bacterial), make sure that you tell your doctor, or nurse, that
you are taking this medicine and have asthma.
If you use high doses of Fliveo inhaler for a long period of time, it
may affect the way your body produces its own steroid hormones.
This can lead to symptoms of increased steroid hormones in the
body (a condition known as Cushing’s syndrome), or reduce the
amount of steroid hormones produced by the adrenal gland (adrenal
suppression). Other effects include thinning of the bones, eye problems
(such as cataracts or glaucoma), possible behaviour changes (for
example depression or aggression) and slowing of growth in children
and adolescents. For more information on these possible side effects,
see ‘If you stop using Fliveo Inhaler’ (in Section 3) and ‘Possible side
effects’ (Section 4).
Children and adolescents
Fliveo Inhaler should not be used in children less than 4 years of
age.
Fliveo Inhaler 50 micrograms can be used to treat asthma in children
and adolescents aged 4 to 18 years.
Fliveo Inhaler 125 micrograms and Fliveo Inhaler 250 micrograms can
be used to treat asthma in adolescents over 16 years of age. Fliveo
Inhaler 125 micrograms and Fliveo Inhaler 250 micrograms are not
recommended for use in adolescents and children 16 years of age
and younger.
Other medicines and Fliveo Inhaler
Tell your doctor, pharmacist or asthma nurse if you are taking, have
recently taken or might take any other medicines, including medicines
used for asthma and other inhalers and any non-prescription
medicines. This is because Fliveo Inhaler may not be suitable to be
taken with some other medicines as some medicines may increase the
amount of fluticasone propionate in your body and this can increase
the risk of you developing side effects or may make side effects worse.
Tell your doctor if you are taking any of the following medicines before
starting to use Fliveo Inhaler:
• Medicines used to treat viral infections such as ritonavir and other
protease inhibitors.
• Antibiotics such as erythromycin or clarithromycin (called
macrolide antibiotics).
• Antifungal tablets such as ketoconazole or itraconazole.
• Steroid tablets or steroid injections, even if you have just finished
taking these. Your doctor might have given you a steroid warning
card, as there is a possibility of impaired adrenal function, especially
at times when your asthma is worse, or you have a chest infection
or another illness, after a serious accident or if you have surgery.
Your doctor may decide to give you extra steroids during this time.
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before using Fliveo Inhaler.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or
are planning to have a baby, ask your doctor, pharmacist or asthma
nurse for advice before using this medicine.

Driving and using machines
Fliveo Inhaler is unlikely to affect your ability to drive or use machines.

3. HOW TO USE FLIVEO INHALER
Fliveo Inhaler is available in three different strengths. Your doctor will
have decided which strength you need. Always use this medicine exactly
as your doctor, pharmacist or asthma nurse has told you to, or as
described in this leaflet. Check with your doctor, pharmacist or asthma
nurse if you are not sure.
• Use Fliveo Inhaler every day until your doctor advises you to stop. Do
not take more than the dose your doctor or asthma nurse has told
you to take. If you are not sure how much Fliveo Inhaler you should
be taking, check with your doctor, pharmacist or asthma nurse.
• Do not stop taking Fliveo Inhaler or reduce the dose that you take
without talking to your doctor first.
• Fliveo Inhaler should be inhaled through the mouth into the lungs.
Your doctor will decide what dose you need to take. The starting dose
needs to be appropriate for the severity of your disease. Your doctor will
work with you to decrease your dose to the lowest dose that effectively
controls your asthma. Your doctor will want to check your symptoms
regularly and do some lung function tests.
Dosage
Adults and adolescents over 16 years of age
If you have mild asthma, the recommended starting dose of Fliveo Inhaler
is 100 micrograms (two puffs of Fliveo Inhaler 50 micrograms) twice
daily.
If you have moderate or severe asthma, the recommended starting
dose of Fliveo Inhaler is 250 micrograms (two puffs of Fliveo Inhaler
125 micrograms or one puff of Fliveo Inhaler 250 micrograms) to
500 micrograms (four puffs of Fliveo Inhaler 125 micrograms or two
puffs of Fliveo Inhaler 250 micrograms) twice daily.
In some cases, your doctor or asthma specialist may prescribe a higher
dose. The maximum dose is 1,000 micrograms (eight puffs of Fliveo
Inhaler 125 micrograms or four puffs of Fliveo Inhaler 250 micrograms)
twice daily.
Children 4 to 12 years of age and adolescents 13 to 16 years of age
Only Fliveo Inhaler 50 micrograms can be used in children 4 to 12 years
of age and adolescents 13 to 16 years of age.
Fliveo Inhaler 125 micrograms and Fliveo Inhaler 250 micrograms
are NOT recommended for use by children 4 to 12 years of age and
adolescents 13 to 16 years of age.
The recommended starting dose of Fliveo Inhaler is 50 micrograms (one
puff of Fliveo Inhaler 50 micrograms) to 100 micrograms (two puffs of
Fliveo Inhaler 50 micrograms) twice daily.
In some cases, your doctor may prescribe a higher dose. The maximum
dose in children 4 to 12 years of age and adolescents 13 to 16 years
of age is 200 micrograms (four puffs of Fliveo Inhaler 50 micrograms)
twice daily.
Whilst your child is taking this medicine, your doctor will also check your
child’s height regularly.
Children under 4 years
Fliveo Inhaler is not recommended for children less than 4 years of
age.
Please make sure you know how many actuations (puffs) you need to
take and how and when to take them. This information should be on the
pharmacist’s label on the carton in which you received your inhaler. If it
is not, or you are not sure, ask your doctor, pharmacist or asthma nurse.
If your asthma or breathing gets worse, tell your doctor straight away.
You may find that you feel more wheezy, your chest feels tight more often
or you may need to use more of your rapid-acting ‘reliever’ medicine or
you may feel that your medicine is working less well than usual. If any
of these happen, you should continue to take Fliveo Inhaler but do not
increase the number of puffs that you take unless advised by your
doctor. Talk to your doctor immediately as your chest condition may
be getting worse and you could become seriously ill. You may need
additional treatment. If required, your doctor may recommend that you
use more of this medicine or may prescribe corticosteroids in tablet form.
If you have been using high doses of an inhaled steroid for a long time,
your doctor may decide to give you extra steroids, either by increasing
the dose of your inhaler or by prescribing steroid tablets for you to take
during stressful times, such as after a car accident or before surgery.
Also, patients who have been on high doses of steroids, including
Fliveo Inhaler, for a long time, must not stop taking their medicine
without talking to their doctor. Suddenly stopping treatment can make
you feel unwell. For more information, see ‘If you stop using Fliveo
Inhaler’ later in the leaflet.
Instructions for use
• Your doctor, asthma nurse or pharmacist should show you how to
use your inhaler. They should check how you use your inhaler from
time to time. If you do not use your Fliveo Inhaler properly, or if you
do not use it as prescribed, the medicine will not help your asthma
as it should.
• The medicine is contained in a pressurised canister in a plastic casing
with a mouthpiece.
• Fliveo Inhaler produces a fine mist, which must be inhaled through
your mouth into your lungs.
Make sure that you know how to use this inhaler properly by reading
this section. If you have any problems ask your doctor, pharmacist or
asthma nurse.
Testing your inhaler (also known as ‘priming’ the inhaler)
1. When using your inhaler for the first time, test that it is working.
Remove the mouthpiece cover by gently squeezing the sides with
your thumb and forefinger and pull apart (figure A).
2. To make sure that the inhaler works, shake it well (figure B), point the
mouthpiece away from you and press the canister firmly to release
a puff into the air. Repeat these steps at least two times, shaking the
inhaler before releasing each puff. If you have not used your inhaler
for one day or more you should release two puffs of medicine into
the air.
3. If the inhaler gets very cold, the metal canister should be taken out
of the plastic actuator and warmed in your hands for a few minutes
before use. Do not use anything else to warm it up.
Using your inhaler

A

B

C

D

E

1. You should either stand up or sit upright when using your inhaler.
2. Remove the mouthpiece cover. Check that the inside and outside
of the mouthpiece are clean and free of loose objects (figure A).
If it needs cleaning, read the instructions under “Cleaning your
inhaler” later in this leaflet.
3. Shake the inhaler well prior to use to make sure that any loose
objects are removed and that the contents of the inhaler are evenly
mixed (figure B).
4. Hold the inhaler upright with your thumb on the base, below the
mouthpiece. Breathe out as far as is comfortable (figure C).
5. Immediately place the mouthpiece in your mouth between your
teeth, and close your lips around it. Be careful not to bite the
mouthpiece.
6. Breathe in slowly and deeply through your mouth. Just after
starting to breathe in, press down firmly on the top of the inhaler
to release a puff of medicine while still breathing in steadily and
deeply (figure D).
7. Hold your breath, take the inhaler from your mouth, and take your
finger from the top of the inhaler. Continue holding your breath
for a few seconds, or as long as is comfortable (figure E). Then
breathe out slowly.
Breathing Technique
Do not rush steps 4, 5, 6 and 7.
It is important that you breathe in as slowly as possible just before
using your inhaler. You should use your inhaler whilst standing in
front of a mirror for the first few times. If you see a ‘mist’ or spray
coming from the top of your inhaler or the sides of your mouth,
you should start again from step 3.
8. If your doctor has told you to take another puff, keep the inhaler
upright, and wait about half a minute before repeating steps
3 to 7.
9. After using Fliveo Inhaler, you should rinse your mouth out with
water and spit out, and/‌or brush your teeth. This should reduce
the risk of infections in the mouth (e.g. thrush) and hoarseness
of the voice.
10. Once you have finished using the inhaler, always replace the
mouthpiece cover to keep out dust. Replace the cover by firmly
clicking it into position.
If you find it difficult to use your inhaler and you have difficulty
breathing in immediately before you press down on the top of your
inhaler to release a puff of medicine while you are still breathing in
or if you are taking high doses of this medicine, either your doctor or
your asthma nurse may recommend that you use a spacer device,
such as a Volumatic® spacer device, with your inhaler.
A spacer device should always be used by children taking this
medicine. A spacer device with a face mask may be more suitable
for younger children.
Only the Volumatic® spacer device should be used with Fliveo
Inhaler. Other spacing devices should not be used with Fliveo
Inhaler and you should not switch from one spacer device to
another.
Your doctor, asthma nurse or pharmacist should show you how to
use the spacer device with your inhaler and how to care for your
spacer device and will answer any questions you may have.
It is important that if you or your child are using a spacer device with
Fliveo Inhaler that you do not stop using it without talking to your
doctor or asthma nurse first.
If you stop using a spacer device your doctor may need to change
the dose of medicine required to control your asthma. Always talk to
your doctor before making any changes to your asthma treatment.
People with weak hands, or children, may find it easier to operate
the inhaler with both hands, by putting both forefingers on the top of
the inhaler, and both thumbs on the bottom below the mouthpiece.
Younger children may need help from a parent or carer when using
the inhaler.
Cleaning your inhaler:
Your inhaler should be cleaned at least once a week, to prevent it
from blocking.
1. Remove the mouthpiece cover.
2. Do not remove the canister from the plastic casing.
3. Wipe the inside and outside of the mouthpiece and the plastic
casing with a dry cloth or tissue.
Do not put the metal canister in water.
4. Discharge one actuation (puff) to waste before next use.
5. Replace the mouthpiece cover.
If you use more Fliveo Inhaler than you should
It is important to use Fliveo Inhaler as stated on the pharmacist’s label
or as advised by your doctor. If you accidentally take a larger dose
than recommended, talk to your doctor as soon as possible. Do not
change your dose without seeking medical advice.
If you have used high doses for a long period of time, you should talk
to your doctor for advice. This is because high doses of this medicine
may reduce the amount of steroid hormones produced by the adrenal
gland (adrenal suppression).
If you forget to use Fliveo Inhaler
If you forget to use Fliveo Inhaler, take your next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
If you stop using Fliveo Inhaler
It is very important that you take Fliveo Inhaler every day as directed.
Keep taking it until your doctor tells you to stop. Do not stop or
suddenly reduce your dose of Fliveo Inhaler. This could make your
asthma worse.
If you do suddenly stop taking Fliveo Inhaler or reduce your dose,
particularly if you have been using high doses for a long period of
time, this may reduce the amount of steroid hormones produced by
the adrenal gland (adrenal suppression), which can cause side effects.
These side effects may include any of the following:
• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits).
When your body is under stress, for example from fever, trauma (such
as a car accident), infection, or surgery, adrenal suppression can get
worse and you may experience any of the side effects listed above.
If you get any side effects, or you are unwell or need to go into
hospital, talk to your doctor or pharmacist and tell them that you are
taking this medicine. Your doctor or pharmacist may also give you a
‘steroid warning card’, which you should carry with you at all times.
To prevent these side effects occurring, your doctor may prescribe
extra corticosteroids in tablet form.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or asthma nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them. To reduce the chance of side effects, your
doctor will prescribe the lowest dose of this medicine to control your
asthma.
If you get any of the following symptoms after using this medicine,
talk to your doctor or, if serious, go to the nearest hospital
emergency department immediately:
Very rare (may affect up to 1 in 10,000 people):
• Signs of an allergic reaction: you may notice itching, a rash
(hives) and swelling, usually of the face, lips, mouth, tongue or
throat, which may cause difficulty in swallowing or breathing,
or you may suddenly feel your heart beating very fast or you
feel faint and light headed (which may lead to collapse or loss

of consciousness). If this happens stop using this inhaler and
contact your doctor straightaway,
• Breathing difficulties or wheezing that gets worse immediately
after inhaling Fliveo Inhaler. If this happens stop using this
inhaler and contact your doctor straightaway. Use your rapidacting ‘reliever’ inhaler to help your breathing.
Other side effects have also been reported. If any of these trouble
you, talk to your doctor, pharmacist or asthma nurse:
Very common (may affect more than 1 in 10 people):
• Thrush (sore, creamy-yellow, raised patches) in the mouth or
throat, also known as oral candidiasis.
Your doctor may prescribe an antifungal medication to treat the
thrush.
Common (may affect up to 1 in 10 people):
• Sore tongue, throat and hoarse voice.
• Bruising.
Problems with your mouth and throat can be reduced by doing
certain things straight after taking your medicine. These are brushing
your teeth, rinsing your mouth or gargling with water and spitting it
out. Tell your doctor or pharmacist if you have these problems, but
do not stop using this medicine unless you are told to.
Uncommon (may affect up to 1 in 100 people):
• Allergic skin rash.
Rare (may affect up to 1 in 1,000 people):
• A fungal infection of the oesophagus (the tube that connects the
mouth and stomach). You may have a dry mouth and have pain
or difficulty on swallowing.
Very rare (may affect up to 1 in 10,000 people):
• Sleeping problems or feeling worried (anxious), changes in
behaviour such as being over-excited, restless or irritable (these
effects are more likely to occur in children),
• Increased level of sugar (glucose) in your blood,
• Aching, swollen joints and muscle pain,
• Heartburn/‌indigestion (dyspepsia).
Using high doses of fluticasone propionate for a long period of time
can cause:
• A reduction in the amount of steroid hormones produced by the
adrenal gland (adrenal suppression), which if severe or if your
body is stressed (fever, infection, trauma, surgery) can lead to
adrenal crisis and you may become very ill. You may feel tired,
you may feel sick or actually be sick, have pain in the stomach
or a headache, notice weight loss or you may not want to eat, or
you may have very low blood sugar which could lead to loss of
consciousness or fits,
• Symptoms of increased amounts of steroid hormones in the body
(Cushing’s syndrome). You may notice upper body weight gain,
rounding of the face, thinning of the skin (which may bruise very
easily or you may have stretch marks on the thighs, stomach, legs
etc.),
• Thinning of your bones,
• Eye problems such as cataracts (clouding of the eye lens) and
glaucoma (raised pressure in the eye) which may cause blurred
vision,
• Slowing of growth in children and adolescents.
Your doctor will help stop these side effects from happening by
making sure that you use the lowest dose of this medicine which
controls your symptoms.
A serious lung infection (pneumonia) has been reported in people
with chronic obstructive pulmonary disease (COPD) using fluticasone
propionate. COPD is a long-term lung disease that causes shortness
of breath, coughing and frequent chest infections. The term COPD
includes conditions known as chronic bronchitis and emphysema. If
you have difficulty breathing, have a fever, and/‌or have a cough which
produces thick mucus which may be yellow, green or brownish or
have blood in it, talk to your doctor straight away.
Not known (frequency cannot be estimated from the available
data):
• Depression, restlessness, nervousness or aggression (mainly in
children),
• Nose bleeds.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or asthma
nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the MHRA’s Yellow Card
Scheme (https:/‌/yellowcard.mhra.gov.uk). By reporting side effects,
you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLIVEO INHALER
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 and canister after EXP. The expiry date refers to the last day
of that month.
Store below 25°C. Do not refrigerate or freeze. Protect from frost
and direct sunlight.
As with most inhaled medicines in pressurised canisters, the effect
of this medicine may decrease when the canister is cold (see section
3 ‘Using your inhaler’).
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C. Do not pierce, break or burn the
canister, even if apparently empty.
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 Fliveo Inhaler contains
The active substance in Fliveo Inhaler is fluticasone propionate. Each
metered dose (ex-valve) contains 50, 125 or 250 micrograms of
fluticasone propionate. This is equivalent to a delivered dose (exactuator) of 44, 110 or 220 micrograms of fluticasone propionate
respectively.
The other ingredient is the propellant: norflurane (HFA 134a).
What Fliveo Inhaler looks like and the contents of the pack
Fliveo Inhaler 50  micrograms consists of a white to off-white
suspension in an aluminium canister sealed with a metering valve,
inside a light orange actuator with a white dust cap.
Fliveo Inhaler 125 micrograms consists of a white to off-white
suspension in an aluminium canister sealed with a metering valve,
inside an orange actuator with a white dust cap.
Fliveo Inhaler 250 micrograms consists of a white to off-white
suspension in an aluminium canister sealed with a metering valve,
inside a dark brown actuator with a white dust cap.
Each canister contains 120 metered actuations (puffs).
Marketing Authorisation Holder
Prosonix Limited
The Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, UK
Manufacturer
Pharmaserve North West Limited, 9  Arkwright Road, Astmoor
Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK
This medicinal product is authorised in the Member States of the EEA
under following names:
Sweden: Fliveo ® 50  mikrogram, 125  mikrogram,
250 mikrogram
United Kingdom: Fliveo® Inhaler 50 micrograms, 125 micrograms,
250 micrograms
This leaflet was last revised in November 2015
VOLUMATIC is a registered trade mark of Glaxo Group Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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