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FLIXONASE NASULE DROPS 400 MICROGRAMS (1 MG/ML) NASAL DROPS SUSPENSION

Active substance(s): FLUTICASONE PROPIONATE

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Package Leaflet: Information for the user

TM

• this helps to relieve itching, sneezing and
your blocked or runny nose.

Flixonase
NasuleTM Drops

Flixonase Nasule Drops are used to treat:
• Small growths inside the nose (polyps)
• Symptoms associated with nasal
obstruction.

400 micrograms
(1 mg/ml), nasal drops suspension
(fluticasone propionate)

Flixonase Nasule Drops are provided in small
plastic containers (Nasules).

Your medicine is known as the above name
but will be referred to as Flixonase Nasule
Drops throughout the remainder of this leaflet.
Read all of this leaflet carefully before you
start using this medicine.

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

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

This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.

If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Flixonase Nasule Drops are and what
they are used for
2. Before you use Flixonase Nasule Drops
3. How to use Flixonase Nasule Drops
4. Possible side effects
5. How to store Flixonase Nasule Drops
6. Further information

1. What Flixonase Nasule Drops are and
what they are used for
Flixonase Nasule Drops contain a medicine
called fluticasone propionate. This belongs to
a group of medicines called steroids (also
called ‘corticosteroids’).
• Steroids work by reducing inflammation
• they reduce swelling and irritation in your
nose

2. Before you use Flixonase Nasule Drops
Do not use Flixonase Nasule Drops if:
• you are allergic (hypersensitive) to
fluticasone propionate or any of the other
ingredients of Flixonase Nasule Drops
(listed in section 6).
Take special care with Flixonase Nasule
Drops
Check with your doctor or pharmacist before
using your medicine if:
• you have an infection in your nose.
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before using
Flixonase Nasule Drops.
Flixonase Nasule Drops may lower the normal
production of steroid hormones in your body,
particularly if doses higher than those
recommended are used for a long time. In this
situation people may need to take extra
steroids in times of extreme stress, following
serious injury or before a surgical operation.
It is important therefore that you are taking the
lowest dose of Flixonase Nasule Drops to
control your symptoms. Your doctor will check
you for signs of any problems.
Taking other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. This includes herbal medicines.

Check with your doctor or pharmacist before
using your medicine if:
• you are taking a type of antiviral medicine
known as a protease inhibitor (such as
ritonavir)
• you are taking a medicine used to treat
fungal infections (such as ketoconazole)
• you have had steroids for a long time, either
as an injection or by your mouth.

What the plastic container looks like

Pregnancy and breast-feeding

Using your Flixonase Nasule drops

Do not use Flixonase Nasule Drops if you are
pregnant, or planning to become pregnant, or
if you are breast-feeding, unless your doctor or
pharmacist tells you to.

1. Open the foil wrapping by tearing off one
side. Do not open the pack until the drops
are needed.
2. Take out the strip of plastic containers from
the foil and pull off one container.

Driving and using machines
Flixonase Nasule Drops are not likely to affect
you being able to drive or use any tools or
machines.
3. How to use Flixonase Nasule Drops
Always use Flixonase Nasule Drops exactly as
your doctor has told you to. Don’t exceed the
recommended dose. Check with your doctor or
pharmacist if you’re not sure.
• Do not use in children or young people
under 16 years old.
• Only use in your nose, contact with the
eyes should be avoided.
• It may take a few weeks for this medicine to
work. So keep using it, even though you
may not feel better straight away.
• You should use Flixonase Nasule Drops
every day.

3. Put the remaining containers back into the
foil wrapping and put the pack back in the
box.
4. Flick and shake the plastic container
several times. The contents of the container
must be well mixed before use.
5. Then shake downwards to make sure the
liquid is not in the neck of the container.
6. Hold the bottom tab of the container firmly.
Twist and remove the top tab to open it.

How much to use - adults (over 16 years of
age)
How to put the drops in
• The usual starting dose is one single-use
plastic container (400 micrograms) divided
equally between each nostril, once or twice
a day.
• As your symptoms improve, your doctor
may ask you to use a lower dose.
• If your symptoms do not improve after 4 to
6 weeks your doctor may change your
medicine.

Before you put the drops in, you must choose
one of the positions shown in these pictures.
Although they may not be easy, the positions
will make sure the drops get to where they are
needed.

1. Gently blow your nose to clear it.
2. While standing up, bend right over.

If you stop taking Flixonase Nasule Drops
Do not stop treatment even if you feel better,
unless your doctor tells you to stop. If you do
stop, the symptoms may come back.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

3. If you can’t do this, kneel down and then
bend right over.

4. Put the opened container into one nostril
and gently squeeze.
5. Keep squeezing until the sides of the
container touch each other. This will mean
that about half the dose has been given
(about 6 drops).
6. Repeat this step to use the rest in your
other nostril.
7. Stay with your head down for at least one
minute after putting the drops in.
If these positions are difficult you can lie on a
bed with your head tilted over the edge. After
you have put the drops in, rest your head
sideways on the bed for at least one minute.

Be careful not to get the drops in your eyes
or on broken skin. If you do, rinse your eyes
or skin with water immediately.
If you forget to use Flixonase Nasule Drops
If you miss a dose, just use the next dose
when it is due. Do not use a double dose to
make up for a forgotten dose.

4. Possible side effects
Like all medicines, Flixonase Nasule Drops
can cause side effects, although not
everybody gets them. The following side
effects may happen with this medicine.
Allergic reactions: get a doctor’s help
straight away
A small number of people get allergic
reactions to Flixonase Nasule Drops, which
can develop into a more serious, even lifethreatening problem if not treated. Symptoms
include;
• becoming very wheezy, coughing or having
difficulty with breathing
• suddenly feeling weak or light-headed
(which may lead to collapse or loss of
consciousness)
• swelling around your face, mouth or tongue
• skin rashes or redness.
In many cases, these symptoms will be signs
of less serious side effects. But you must be
aware that they are potentially serious — so, if
you notice any of these symptoms:
See a doctor as soon as possible.
Allergic reactions to Flixonase Nasule Drops
are very rare (these affect less than 1 in
10,000 people).
Other side effects include:

If you use more Flixonase Nasule Drops
than you should

Very common (affects more than 1 in 10
people)
• Nose bleeds.

Tell your doctor if you use more than you were
told to.

Common (affects less than 1 in 10 people)
• A dry or irritated nose or throat.

Very rare (affects less than 1 in 10,000
people)
• Cloudy lens (cataract), increased pressure
in the eye that can cause problems with
vision (glaucoma). These eye problems
occurred in people who used Flixonase
Nasule Drops for a long time.
• Small holes (perforations) in the ridge inside
the nose that separates the nostrils.

• If your medicine become discoloured or
show signs of any deterioration, consult
your doctor or pharmacist who will tell you
what to do.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.

• The active substance is fluticasone
propionate
• The other ingredients are polysorbate 20,
sorbitan laurate, sodium dihydrogen
phosphate dihydrate, disodium phosphate
anhydrous, sodium chloride and water for
injections.

In addition, the production of steroids in your
body may be affected. This is more likely to
happen if you use high doses for a long time.
Your doctor will help stop this happening by
making sure you use the lowest dose of
steroid which controls your symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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

6. Further information
What Flixonase Nasule Drops contain

What Flixonase Nasule Drops looks like
and contents of the pack
Each Nasule contains 400 micrograms of
fluticasone propionate, giving a strength of 1
milligram per millilitre. Each carton contains 4
strips of 7 Nasules (28 Nasules per carton).
Nasules are strips of LPDE single dose
containers supplied within foil wrapping each
containing white, opaque, aqueous
suspension.
PL: 15814/1250

5. How to store Flixonase Nasule Drops





Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from light. Do not freeze.
Keep Flixonase Nasule Drops in their foil
wrapper, in the carton, stored in an upright
position.
• Do not use Flixonase Nasule Drops after
the expiry date which is stated on the label
and carton after ‘EXP’. The expiry date
refers to the last day of that month.
• Discard any unused Flixonase Nasule
Drops 28 days after first opening the foil
wrapper.
• 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.

POM

Manufactured by Glaxo Wellcome Operations,
Barnard Castle, Co. Durham, DL12 8DT, UK
Procured from within the EU and repackaged
by the Product Licence Holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.):
09.02.2016.
Flixonase, Nasule and Nasules are
trademarks of the GlaxoSmithKline group of
companies.
To request a copy of this leaflet in Braille,
large print or audio please call 01923 332 796.

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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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