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FLIXOTIDE 2MG/2ML NEBULES

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

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Package leaflet: Information for the user

®

®

Flixotide 2mg/2ml Nebules
(fluticasone propionate)

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.
The name of your medicine is Flixotide 2mg/2ml Nebules but will be
referred to as Flixotide or Flixotide Nebules throughout this leaflet.
What is in this leaflet:
1
What Flixotide is and what it is used for
2
What you need to know before you use Flixotide
3
How to use Flixotide
4
Possible side effects
5
How to store Flixotide
6
Contents of the pack and other information

1. What Flixotide is and what it is 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 works by reducing swelling and irritation in the lungs. It has
what is called an ‘anti-inflammatory action’.
Flixotide helps 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 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
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 if any of the above apply to you. If you are not
sure, talk to your doctor, nurse or pharmacist before using Flixotide.
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before taking Flixotide if:
 you have ever been treated for tuberculosis (TB)
 you are using Flixotide 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.
Other medicines and Flixotide
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) or cobicistat containing products which may increase
the effects of fluticasone propionate. Your doctor may wish to
monitor you carefully if you are taking these medicines.
 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.
Using Flixotide with food and drink
You can use Flixotide 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 is not likely to affect you being able to drive or use any tools
or machines.

3. How to use Flixotide
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.
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 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.
Adults and Children over 16 years of age
 The usual starting dose is 0.5 to 2.0mg (500 to 2000 micrograms)
twice a day.
 Flixotide Nebules 0.5mg/2ml provides you with a dose of 500
micrograms.
 Flixotide Nebules 2.0mg/2ml provides you with a dose of 2000
micrograms.
Flixotide Nebules 2mg/2ml 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
2

the Nebules are in a foil pack. Do not open the pack until
you need to use them
hold the top of the Nebule you have just removed. Twist
the body to open it

3

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

4
5

assemble the nebuliser and use it as directed
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 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
 Take the next dose when it is due.
 Do not take a double dose to make up for the forgotten dose.

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 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 any 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

If you stop using Flixotide
 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.


6.




4. Possible side effects



Like all medicines, this medicine can cause side effects, although not
everybody
gets them.
5.



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)
 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)
 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. 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).






Keep out of the sight and reach of children.
Nebules must be stored in the foil wrap, within the carton.
Do not store above 30°C.
Do not freeze.
Keep the container in the outer carton in order to protect from
light.
Do not use the medicine after the expiry date which is stated on
the carton and pouch labels after ‘Exp’. The expiry date refers to
the last day of that month.
Nebules removed from the foil overwrap should be protected from
light and used within 28 days.
Once the Nebules are opened, store in refrigerator at (2°C-8°C)
and use them within 12 hours after opening.
If the medicine becomes discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
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.

6. Contents of the pack and other information
What Flixotide contains
The active ingredient in Flixotide is fluticasone propionate.
The liquid is a suspension of 2mg of the active ingredient fluticasone
propionate in 2ml buffered, isotonic saline.
The other ingredients are polysorbate 20, sorbitan laurent,
monosodium phosphate dihydrate, disodium phosphate anhydrous,
sodium chloride, water for injections.
What Flixotide looks like and contents of the pack
Each vial contains 2mg fluticasone propionate in 2ml buffered isotonic
saline clear suspension.
The Nebules are as small vials made of polyethylene, for single use.
Each pack contains 10 Nebules. They are provide as a 5 nebules
packaged in a aluminum foil.
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse
32-36, Bad Oldesloe, D-23843, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
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POM
Flixotide 2mg/2ml Nebules ; PL 18799/2877
Leaflet date: 22.06.2017

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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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