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FLUTICASONE PROPIONATE 2MG/2ML NEBULES

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Using Flixotide Nebules with food and drink

S428 LEAFLET Flixotide 20160622

PACKAGE LEAFLET: INFORMATION FOR USER
®

FLIXOTIDE 2mg/2ml NEBULES
(fluticasone propionate)
Your medicine is known as Flixotide 2 mg/2ml Nebules but will be
referred to as Flixotide Nebules throughout the following leaflet.
Information regarding the other strength of Flixotide Nebules is also
be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

You can use Flixotide Nebules at any time of day, with or without
food.
Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for advice
before taking this medicine.
Driving and using machines
Flixotide Nebules are not likely to affect you being able to drive or
use any tools or machines.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, nurse or
pharmacist.

3. HOW TO USE FLIXOTIDE NEBULES



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, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

Flixotide Nebules come in two different strengths. Your doctor will
have decided which strength you need. Always use this medicine
exactly as your doctor has told you. Check with your doctor, nurse
or pharmacist if you are not sure.
Using this medicine


Do not inject or swallow the liquid. Flixotide Nebules should
only be inhaled using your jet nebuliser. Using Flixotide Nebules
with ultrasonic nebulisers is not generally recommended.



The jet nebuliser produces a fine mist which you breathe in
through a mouthpiece or face mask.



Do not let the liquid, or the mist produced by the nebuliser
get into your eyes. You can wear glasses or goggles to protect
them.

5. How to store Flixotide Nebules



Each small plastic container (Nebule ) contains some liquid.

6. Contents of the pack and other information



The liquid is put into a nebuliser. This makes a fine mist for you
to breathe in through a face mask or mouthpiece. Use of a
mouthpiece prevents the medicine affecting the skin of your
face, which may occur if you use a face mask over a long
period of time. If you prefer to use a face mask, or you are using
a face mask for your child, then you must protect the skin on
your (or your child’s) face with a barrier cream or wash your (or
your child’s) face thoroughly after treatment.



Use your nebuliser in a well-ventilated room as some of the mist
will be released into the air and may be breathed in by others.



It takes a few days for this medicine to work and it is very
important that you use it regularly.

What is in this leaflet:
1. What Flixotide Nebules are and what they are used for
2. What you need to know before you use Flixotide Nebules
3. How to use Flixotide Nebules
4. Possible side effects

1. WHAT FLIXOTIDE NEBULES ARE AND WHAT THEY ARE
USED FOR
Flixotide Nebules contain a medicine called fluticasone propionate.
Fluticasone propionate belongs to a group of medicines called
corticosteroids (often just called steroids). A very small dose of
steroid is needed when it is inhaled. This is because it is inhaled
straight to your lungs.
Flixotide Nebules work by reducing swelling and irritation in the
lungs. It has what is called an ‘anti-inflammatory action’.
Flixotide Nebules help to prevent asthma attacks in people who
need regular treatment. This is why they are sometimes called
‘preventers’. They need to be used regularly, every day.
Flixotide Nebules will not help treat sudden asthma attacks where
you feel breathless.


A different medicine is used for treating sudden attacks (called
a ‘reliever’).



If you have more than one medicine, be careful not to confuse
them.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXOTIDE
NEBULES
Do not use:


if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in Section 6)

Do not use Flixotide Nebules if any of the above apply to you. If you
are not sure, talk to your doctor, nurse or pharmacist before using
Flixotide Nebules.
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before taking Flixotide
Nebules if:


you have ever been treated for tuberculosis (TB)



you are using Flixotide Nebules at the same time as taking
steroid tablets. Also if you have just finished taking steroid
tablets. In both cases, you should carry a steroid warning card
until your doctor tells you not to carry one

If you are not sure if any of the above applies to you, talk to your
doctor, nurse or pharmacist before using Flixotide Nebules.

®

Adults and Children over 16 years of age


The usual starting dose is 0.5 to 2.0 mg (500 to 2000
micrograms) twice a day.



Flixotide Nebules 0.5 mg/2 ml provides you with a dose of 500
micrograms.



Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000
micrograms.

Flixotide Nebules 2 mg/2 ml are not for use in children under
16 years of age.
It is recommended that children being treated with steroids,
including Flixotide Nebules have their height checked regularly by
their doctor.
If you are using high doses of an inhaled steroid for a long
time you may sometimes need extra steroids for example
during stressful circumstances such as a road traffic accident
or before an operation. Your doctor may decide to give you
extra steroid medicines during this time.
Patients who have been on high doses of steroids, including
Flixotide Nebules for a long time, must not stop taking their
medicine suddenly without talking to their doctor. Suddenly
stopping treatment can make you feel unwell and may cause
symptoms such as vomiting, drowsiness, nausea, headache,
tiredness, loss of appetite, low blood sugar level and fitting.
Using your Nebules
1. the Nebules are in a foil pack. Do not open the pack until you
need to use them
2. hold the top of the Nebule you have just removed. Twist the
body to open it

Other medicines and Flixotide Nebules
Tell your doctor, nurse or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. This includes herbal medicines.
Remember to take this medicine with you if you have to go into
hospital.
In particular tell your doctor or pharmacist if you are taking any of
the following:


a type of antiviral medicine known as a ‘protease inhibitor’ (such
as ritonavir)



medicines used to treat fungal infections (such as
ketoconazole)

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Flixotide Nebules.

3. put the open end of the Nebule into the nebuliser bowl and
squeeze slowly to empty the content



4. assemble the nebuliser and use it as directed
5. repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules
Do not dilute the contents of a Nebule unless you are told to by
your doctor


if your doctor has told you to dilute the solution, empty the
contents of the Nebule into the nebuliser bowl



add the amount of sterile sodium chloride 0.9% solution your
doctor has told you to use



put the top on the nebuliser bowl and shake gently to mix the
contents.

If dilution is necessary then only sterile sodium chloride 0.9%
solution should be used.
After use


use a fresh Nebule for each dose. Only open a new one when
you are ready to use it. If there is any liquid left over, throw it
away. Do not save it to use again



throw away any solution remaining in the nebuliser bowl



clean your nebuliser in the recommended way

If you use more Flixotide Nebules than you should
If you use more than you were told, talk to your doctor as soon as
possible.
It is important that you take your dose as stated on the pharmacist’s
label or as advised by your doctor. You should not increase or
decrease your dose without seeking medical advice.

something called ‘Cushing’s syndrome’. This happens when
you have too much steroid in your body and it can cause
thinning of your bones and eye problems (such as cataracts
and glaucoma which is high pressure in the eye).

Your doctor will help stop this happening by making sure you use
the lowest dose of steroid which controls your symptoms.
Although the frequency is not known, the following side effects may
also occur:


depression, feeling restless or nervous. These effects are more
likely to occur in children



nosebleeds

Talk to your doctor as soon as possible if:


after 7 days of using Flixotide Nebules your shortness of breath
or wheezing does not get better, or gets worse



you or your child is on high doses of inhaled steroid and
become unwell with vague symptoms such as tummy ache,
sickness, diarrhoea, headache or drowsiness. This can happen
during an infection such as a viral infection or stomach upset. It
is important that your steroid is not stopped suddenly as this
could make your asthma worse and could also cause problems
with the body’s hormones.

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

If you forget to use Flixotide Nebules


Take the next dose when it is due.



Do not take a double dose to make up for the forgotten dose.

5. HOW TO STORE FLIXOTIDE NEBULES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Flixotide Nebules should not be stored above 30°C. Protect
from frost and do not freeze. Keep the container in the outer
carton in order to protect from light. Store upright.



Flixotide Nebules removed from the foil wrap should be
protected from light and used within 28 days.



Opened Flixotide Nebules should be stored in the fridge and
used within 12 hours of opening.



Do not use Flixotide Nebules after the expiry date which is
stated on the pack after ‘EXP’. The date refers to the last day of
that month.



Do not leave the suspension in your nebuliser once you have
finished a treatment.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you stop using Flixotide Nebules


Do not stop treatment even if you feel better unless told to do
so by your doctor.

If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you notice any of the following serious side effects, stop
using this medicine and talk to your doctor straight away. You
may need urgent medical treatment.






allergic reactions (may affect up to 1 in 100 people) – the signs
include skin rashes, redness, itching or weals like nettle rash or
hives
severe allergic reactions (may affect up to 1 in 10,000 people) the signs include swelling of your face, lips, mouth, tongue or
throat which may cause difficulty in swallowing or breathing,
itchy rash, feeling faint and light headed and collapse
your breathing or wheezing gets worse straight after using your
inhaler.

Other side effects include:

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flixotide Nebules contain


Each Flixotide Nebules containing suspension for inhalation
provides 2mg fluticasone propionate in 2 ml normal saline.



Flixotide Nebules also contain the following: polysorbate 20,
sorbitan monolaurate, monosodium phosphate dihydrate,
dibasic sodium phosphate anhydrous, sodium chloride and
water for injection.

Very common (may affect more than 1 in 10 people)


thrush in the mouth and throat

Common (may affect up to 1 in 10 people)

What Flixotide Nebules look like and contents of the pack



sore tongue or throat





hoarseness of voice

Flixotide Nebules are opaque plastic ampoules with a 'twist off
tab containing whitish, opaque freely dispersed suspension
sealed in pouches.



Flixotide Nebules are available in 2 pouches containing 10
nebules 5 in each.

Problems with your mouth and throat can be reduced by doing
certain things straight after inhaling your dose. These are brushing
your teeth, rinsing your mouth or gargling with water and spitting it
out. Tell your doctor if you have these problems with your mouth or
throat, but do not stop treatment unless you are told to.
The following side effects have also been reported in patients with
Chronic Obstructive Pulmonary Disease (COPD):




Pneumonia and bronchitis (lung infection). Tell your doctor if
you notice any of the following symptoms: increased sputum
production, change in sputum colour, fever, chills, increased
cough, increased breathing problems.
Bruising.

Rare (may affect up to 1 in 1,000 people)


thrush (candidiasis) in the oesophagus

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Flixotide Nebules are manufactured by


Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843
Bad Oldesloe, Germany. OR



Glaxo Operations UK Ltd (Trading as GlaxoWellcome
Operations), Harmire Road, Barnard Castle, Durham, DL12
8DT, United Kingdom.

Very rare (may affect up to 1 in 10,000 people)


sleeping problems or feeling worried, over-excited and irritable.
These effects are more likely to occur in children



joint pains



indigestion



level of sugar (glucose) in your blood may be increased



the way steroids are produced by your body may be affected
when using Flixotide Nebules. This is more likely to happen if
you use high doses for a long period of time. This can cause:



children and young people to grow more slowly.

POM

PL 19488/0428

Leaflet revision date: 22 June 2016
®

Flixotide is a registered trademark of Glaxo Group Ltd, UK.
S428 LEAFLET Flixotide 20160622

S428 LEAFLET Fluticasone Propionate 20160622

PACKAGE LEAFLET: INFORMATION FOR USER

FLUTICASONE PROPIONATE 2mg/2ml NEBULES
Your medicine is known as Fluticasone Propionate 2 mg/2ml
Nebules but will be referred to as Fluticasone Propionate Nebules
throughout the following leaflet.
Information regarding the other strength of Fluticasone Propionate
Nebules is also be present in this leaflet.
Read all of this leaflet carefully before you start taking 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, nurse or
pharmacist.



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, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

Using Fluticasone Propionate Nebules with food and drink
You can use Fluticasone Propionate Nebules at any time of day,
with or without food.
Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for advice
before taking this medicine.
Driving and using machines
Fluticasone Propionate Nebules are not likely to affect you being
able to drive or use any tools or machines.
3. HOW TO USE FLUTICASONE PROPIONATE NEBULES
Fluticasone Propionate Nebules come in two different strengths.
Your doctor will have decided which strength you need. Always use
this medicine exactly as your doctor has told you. Check with your
doctor, nurse or pharmacist if you are not sure.
Using this medicine


1. What Fluticasone Propionate Nebules are and what they are
used for

Do not inject or swallow the liquid. Fluticasone Propionate
Nebules should only be inhaled using your jet nebuliser. Using
Fluticasone Propionate Nebules with ultrasonic nebulisers is not
generally recommended.



2. What you need to know before you use Fluticasone Propionate
Nebules

The jet nebuliser produces a fine mist which you breathe in
through a mouthpiece or face mask.



Do not let the liquid, or the mist produced by the nebuliser
get into your eyes. You can wear glasses or goggles to protect
them.



Each small plastic container (Nebule ) contains some liquid.



The liquid is put into a nebuliser. This makes a fine mist for you
to breathe in through a face mask or mouthpiece. Use of a
mouthpiece prevents the medicine affecting the skin of your
face, which may occur if you use a face mask over a long
period of time. If you prefer to use a face mask, or you are using
a face mask for your child, then you must protect the skin on
your (or your child’s) face with a barrier cream or wash your (or
your child’s) face thoroughly after treatment.



Use your nebuliser in a well-ventilated room as some of the mist
will be released into the air and may be breathed in by others.



It takes a few days for this medicine to work and it is very
important that you use it regularly.

What is in this leaflet:

3. How to use Fluticasone Propionate Nebules
4. Possible side effects
5. How to store Fluticasone Propionate Nebules
6. Contents of the pack and other information
1. WHAT FLUTICASONE PROPIONATE NEBULES ARE AND
WHAT THEY ARE USED FOR
Fluticasone Propionate Nebules contain a medicine called
fluticasone propionate. Fluticasone propionate belongs to a group of
medicines called corticosteroids (often just called steroids). A very
small dose of steroid is needed when it is inhaled. This is because it
is inhaled straight to your lungs.
Fluticasone Propionate Nebules work by reducing swelling and
irritation in the lungs. It has what is called an ‘anti-inflammatory
action’.

®

Fluticasone Propionate Nebules help to prevent asthma attacks in
people who need regular treatment. This is why they are sometimes
called ‘preventers’. They need to be used regularly, every day.

Adults and Children over 16 years of age


The usual starting dose is 0.5 to 2.0 mg (500 to 2000
micrograms) twice a day.

Fluticasone Propionate Nebules will not help treat sudden asthma
attacks where you feel breathless.



Fluticasone Propionate Nebules 0.5 mg/2 ml provides you with
a dose of 500 micrograms.



A different medicine is used for treating sudden attacks (called
a ‘reliever’).



Fluticasone Propionate Nebules 2.0 mg/2 ml provides you with
a dose of 2000 micrograms.



If you have more than one medicine, be careful not to confuse
them.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FLUTICASONE PROPIONATE NEBULES
Do not use:


if you are allergic to Fluticasone Propionate Nebules or any of
the other ingredients of this medicine (listed in Section 6)

Do not use Fluticasone Propionate Nebules if any of the above
apply to you. If you are not sure, talk to your doctor, nurse or
pharmacist before using Fluticasone Propionate Nebules.
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before taking Fluticasone
Propionate Nebules if:


you have ever been treated for tuberculosis (TB)



you are using Fluticasone Propionate Nebules at the same time
as taking steroid tablets. Also if you have just finished taking
steroid tablets. In both cases, you should carry a steroid
warning card until your doctor tells you not to carry one

If you are not sure if any of the above applies to you, talk to your
doctor, nurse or pharmacist before using Fluticasone Propionate
Nebules.

Fluticasone Propionate Nebules 2 mg/2 ml are not for use in
children under 16 years of age.
It is recommended that children being treated with steroids,
including Fluticasone Propionate Nebules have their height checked
regularly by their doctor.
If you are using high doses of an inhaled steroid for a long
time you may sometimes need extra steroids for example
during stressful circumstances such as a road traffic accident
or before an operation. Your doctor may decide to give you
extra steroid medicines during this time.
Patients who have been on high doses of steroids, including
Fluticasone Propionate Nebules for a long time, must not stop
taking their medicine suddenly without talking to their doctor.
Suddenly stopping treatment can make you feel unwell and
may cause symptoms such as vomiting, drowsiness, nausea,
headache, tiredness, loss of appetite, low blood sugar level
and fitting.
Using your Nebules
1. the Nebules are in a foil pack. Do not open the pack until you
need to use them
2. hold the top of the Nebule you have just removed. Twist the
body to open it

Other medicines and Fluticasone Propionate Nebules
Tell your doctor, nurse or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. This includes herbal medicines.
Remember to take this medicine with you if you have to go into
hospital.
In particular tell your doctor or pharmacist if you are taking any of
the following:


a type of antiviral medicine known as a ‘protease inhibitor’ (such
as ritonavir)



medicines used to treat fungal infections (such as
ketoconazole)

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Fluticasone Propionate Nebules.

3. put the open end of the Nebule into the nebuliser bowl and
squeeze slowly to empty the content



4. assemble the nebuliser and use it as directed
5. repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules
Do not dilute the contents of a Nebule unless you are told to by
your doctor


if your doctor has told you to dilute the solution, empty the
contents of the Nebule into the nebuliser bowl



add the amount of sterile sodium chloride 0.9% solution your
doctor has told you to use



put the top on the nebuliser bowl and shake gently to mix the
contents.

If dilution is necessary then only sterile sodium chloride 0.9%
solution should be used.
After use


use a fresh Nebule for each dose. Only open a new one when
you are ready to use it. If there is any liquid left over, throw it
away. Do not save it to use again



throw away any solution remaining in the nebuliser bowl



clean your nebuliser in the recommended way

If you use more Fluticasone Propionate Nebules than you
should
If you use more than you were told, talk to your doctor as soon as
possible.
It is important that you take your dose as stated on the pharmacist’s
label or as advised by your doctor. You should not increase or
decrease your dose without seeking medical advice.

something called ‘Cushing’s syndrome’. This happens when
you have too much steroid in your body and it can cause
thinning of your bones and eye problems (such as cataracts
and glaucoma which is high pressure in the eye).

Your doctor will help stop this happening by making sure you use
the lowest dose of steroid which controls your symptoms.
Although the frequency is not known, the following side effects may
also occur:


depression, feeling restless or nervous. These effects are more
likely to occur in children



nosebleeds

Talk to your doctor as soon as possible if:


after 7 days of using Fluticasone Propionate Nebules your
shortness of breath or wheezing does not get better, or gets
worse



you or your child is on high doses of inhaled steroid and
become unwell with vague symptoms such as tummy ache,
sickness, diarrhoea, headache or drowsiness. This can happen
during an infection such as a viral infection or stomach upset. It
is important that your steroid is not stopped suddenly as this
could make your asthma worse and could also cause problems
with the body’s hormones.

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

If you forget to use Fluticasone Propionate Nebules


Take the next dose when it is due.

5. HOW TO STORE FLUTICASONE PROPIONATE NEBULES



Do not take a double dose to make up for the forgotten dose.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Fluticasone Propionate Nebules should not be stored above
30°C. Protect from frost and do not freeze. Keep the container
in the outer carton in order to protect from light. Store upright.

If you stop using Fluticasone Propionate Nebules


Do not stop treatment even if you feel better unless told to do
so by your doctor.



If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.

Fluticasone Propionate Nebules removed from the foil wrap
should be protected from light and used within 28 days.



Opened Fluticasone Propionate Nebules should be stored in the
fridge and used within 12 hours of opening.

4. POSSIBLE SIDE EFFECTS



Do not use Fluticasone Propionate Nebules after the expiry date
which is stated on the pack after ‘EXP’. The date refers to the
last day of that month.



Do not leave the suspension in your nebuliser once you have
finished a treatment.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you notice any of the following serious side effects, stop
using this medicine and talk to your doctor straight away. You
may need urgent medical treatment.


allergic reactions (may affect up to 1 in 100 people) – the signs
include skin rashes, redness, itching or weals like nettle rash or
hives



severe allergic reactions (may affect up to 1 in 10,000 people) the signs include swelling of your face, lips, mouth, tongue or
throat which may cause difficulty in swallowing or breathing,
itchy rash, feeling faint and light headed and collapse



your breathing or wheezing gets worse straight after using your
inhaler.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluticasone Propionate Nebules contain


Each Fluticasone Propionate Nebules containing suspension for
inhalation provides 2mg Fluticasone Propionate in 2 ml normal
saline.



Fluticasone Propionate Nebules also contain the following:
polysorbate 20, sorbitan monolaurate, monosodium phosphate
dihydrate, dibasic sodium phosphate anhydrous, sodium
chloride and water for injection.

Other side effects include:
Very common (may affect more than 1 in 10 people)


thrush in the mouth and throat

Common (may affect up to 1 in 10 people)


sore tongue or throat



hoarseness of voice

Problems with your mouth and throat can be reduced by doing
certain things straight after inhaling your dose. These are brushing
your teeth, rinsing your mouth or gargling with water and spitting it
out. Tell your doctor if you have these problems with your mouth or
throat, but do not stop treatment unless you are told to.

What Fluticasone Propionate Nebules look like and contents of
the pack


Fluticasone Propionate Nebules are opaque plastic ampoules
with a 'twist off tab containing whitish, opaque freely dispersed
suspension sealed in pouches.



Fluticasone Propionate Nebules are available in 2 pouches
containing 10 nebules 5 in each.

The following side effects have also been reported in patients with
Chronic Obstructive Pulmonary Disease (COPD):




Pneumonia and bronchitis (lung infection). Tell your doctor if
you notice any of the following symptoms: increased sputum
production, change in sputum colour, fever, chills, increased
cough, increased breathing problems.

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Bruising.

Rare (may affect up to 1 in 1,000 people)

Manufacturer



Fluticasone Propionate Nebules are manufactured by

thrush (candidiasis) in the oesophagus

Very rare (may affect up to 1 in 10,000 people)


sleeping problems or feeling worried, over-excited and irritable.
These effects are more likely to occur in children



joint pains



indigestion



level of sugar (glucose) in your blood may be increased



the way steroids are produced by your body may be affected
when using Fluticasone Propionate Nebules. This is more likely
to happen if you use high doses for a long period of time. This
can cause:



children and young people to grow more slowly.



Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843
Bad Oldesloe, Germany. OR



Glaxo Operations UK Ltd (Trading as GlaxoWellcome
Operations), Harmire Road, Barnard Castle, Durham, DL12
8DT, United Kingdom.

POM PL 19488/0428
Leaflet revision date: 22 June 2016
S428 LEAFLET Fluticasone Propionate 20160622

Expand Transcript

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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