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FLUTICASONE PROPIONATE 0.5MG/2ML NEBULES

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE MICRONISED

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Pregnancy and breast-feeding

S209 LEAFLET Flixotide 20150601

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

FLIXOTIDE 0.5mg/2ml NEBULES
(fluticasone propionate)
Your medicine is called Flixotide 0.5mg/2ml Nebules but will be
referred to as Flixotide Nebules throughout the remainder of the
leaflet. Please note that this leaflet also contains information about
other strength of the medicine, Flixotide 2mg/2ml Nebules.
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 section. See section 4.

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
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.
3. HOW TO USE FLIXOTIDE NEBULES
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.

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



Each small plastic container (Nebule®) contains some liquid.

3

How to use Flixotide Nebules



4

Possible side effects

5

How to store Flixotide Nebules

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.

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.

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.

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.

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

Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000
micrograms.
Children (4 to 16 years of age)



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.

Adults and Children over 16 years of age



 The usual starting dose is 1 mg (1000 micrograms) twice a day.
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.

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.

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

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

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

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.
Using Flixotide Nebules with food and drink
You can use Flixotide Nebules at any time of day, with or without
food.

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

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

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.
If you forget to use Flixotide Nebules

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.
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. As the product is sensitive to light
keep the nebulas in the foil pouch in the outer carton. Store
upright. Opened Flixotide Nebules should be stored in the
fridge and used within 12 hours of opening.



Do not use after the expiry date printed on the carton or pouch
label.



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 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.



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.



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

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



Take the next dose when it is due.

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



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 contains


Each Flixotide Nebules containing suspension for inhalation
provides 0.5mg fluticasone propionate in 2 ml normal saline.

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)

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

What Flixotide Nebules looks like and contents of the pack



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



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



Flixotide Nebules are available in pouches containing 5
ampoules with 2 or 4 pouches in a pack.

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


Glaxo Wellcome GmbH & Co. KG-Industriestrasse, 32-36-Bad
Oldesloe, Germany. or



Aspen Bad Oldesloe GmbH- Industriestrasse, 32-36-Bad
Oldesloe, Germany

POM PL No. 19488/0209



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



joint pains

Leaflet revision date: 01 June 2015



indigestion



Flixotide Nebules, and Nebules are registered trademarks of Glaxo
Group Ltd, UK.

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



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.

S209 LEAFLET Flixotide 20150601

S209 LEAFLET Fluticasone Propionate 20150601

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUTICASONE PROPIONATE 0.5mg/2ml NEBULES
Your medicine is called Fluticasone Propionate 0.5mg/2ml Nebules
but will be referred to as Fluticasone Propionate Nebules
throughout the remainder of the leaflet. Please note that this leaflet
also contains information about other strength of the medicine,
Fluticasone Propionate 2mg/2ml Nebules.

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 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.

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 section. See section 4.

What is in this leaflet:

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


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.



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.

1

What Fluticasone Propionate Nebules are and what they are
used for

2

What you need to know before you use Fluticasone Propionate
Nebules

3

How to use Fluticasone Propionate Nebules



Each small plastic container (Nebule®) contains some liquid.

4

Possible side effects

5

How to store Fluticasone Propionate Nebules



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.

1. WHAT FLUTICASONE PROPIONATE NEBULES ARE AND
WHAT THEY ARE USED FOR
Fluticasone Propionate Nebules contain a medicine called
Fluticasone Propionate. Fluticasone Propionate Nebules belong 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.
Fluticasone Propionate 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
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.

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



Fluticasone Propionate Nebules 2.0 mg/2 ml provides you with
a dose of 2000 micrograms.
Children (4 to 16 years of age)
 The usual starting dose is 1 mg (1000 micrograms) twice a day.
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

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.
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.

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

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.

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

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:


 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

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.

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

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.

 Do not take a double dose to make up for the forgotten dose.
If you stop using Fluticasone Propionate Nebules


5. HOW TO STORE FLUTICASONE PROPIONATE NEBULES


Fluticasone Propionate Nebules should not be stored above
30°C. Protect from frost and do not freeze. As the product is
sensitive to light keep the nebulas in the foil pouch in the outer
carton. Store upright. Opened Fluticasone Propionate
Nebules should be stored in the fridge and used within 12
hours of opening.



Do not use after the expiry date printed on the carton or pouch
label.



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.

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:
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)

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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


Each Fluticasone Propionate Nebules containing suspension
for inhalation provides 0.5mg Fluticasone Propionate in 2 ml
normal saline.



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



sore tongue or throat

What Fluticasone Propionate Nebules look like and contents of
the pack



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.
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
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



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).

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



Fluticasone Propionate Nebules are available in pouches
containing 5 ampoules with 2 or 4 pouches in a pack.
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
Fluticasone Propionate Nebules are manufactured by


Glaxo Wellcome GmbH & Co. KG-Industriestrasse, 32-36-Bad
Oldesloe, Germany. or



Aspen Bad Oldesloe GmbH- Industriestrasse, 32-36-Bad
Oldesloe, Germany

POM PL No. 19488/0209
Leaflet revision date: 01 June 2015
S209 LEAFLET Fluticasone Propionate 20150601

Expand view ⇕

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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