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FLIXOTIDE 2 MG/2 ML NEBULES

Active substance(s): FLUTICASONE PROPIONATE MICRONISED

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PATIENT INFORMATION LEAFLET

2370
04.06.15[7]

Flixotide® 2 mg/2 ml Nebules®
(fluticasone propionate)
This medicine is available using the above name but will be referred to
as Flixotide throughout the following leaflet
Flixotide Nebules is also available in strength of 0.5 mg/2ml.
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.
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 contains 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)
 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.
 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 2.0 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

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 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.
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.
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)
 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)
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 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
 Keep out of the sight and reach of children.
 Do not open the foil blisters until the nebules are required. Opened
nebules should be stored in a refrigerator and used within 12 hours of
opening. Shake before use. Do not store above 30ºC. Protect from
frost and do not freeze. Store in the outer carton and store in an
upright positon.
 Nebules removed from the foil pack should be protected from light and
used within 28 days.
 If the foil pack has not been opened, 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
 If the suspension becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what
to do.
 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 substance is fluticasone propionate
 Each Nebule containing suspension for inhalation provides 2 mg of
fluticasone propionate in 2 ml normal saline.
 Other ingredients are polysorbate 20, sorbitan monolaurate,
monosodium phosphate dihydrate, dibasic sodium phosphate
anhydrous, sodium chloride and water for injection.
What Flixotide looks like and contents of the pack
Flixotide Nebules are available as opaque plastic ampoules with a twist
off tab containing white, opaque, freely dispersed suspension sealed in
foil blisters.
Each pack contains 10 Nebules individually packed in foil blisters
Product Licence Holder and Manufacturer
Flixotide Nebules are manufactured by Aspen Bad Oldesloe GmbH.,
Industriestrabe 32-36, 23843 Bad Oldesloe, Germany and procured
from within the EU by Product Licence holder Star Pharmaceuticals Ltd.,
5 Sandridge close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2370

Leaflet revision and issue date (Ref.) 04.06.15[7]
Flixotide Nebules, Nebules and Nebule are trademarks of the
GlaxoSmithKline group of companies.

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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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