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

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the user

Flixonase Nasule Drops 400
micrograms (1mg/ml), Nasal
Drop Suspension
(fluticasone propionate)
The name of this product is Flixonase Nasule
Drops 400 micrograms (1mg/ml), Nasal Drop
Suspension but will be referred to as Flixonase
Nasule Drops throughout 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
• this helps to relieve itching, sneezing and your
blocked or runny nose.
Flixonase Nasule Drops are used to treat:
• Small growths inside the nose (polyps)
• Symptoms associated with nasal obstruction.
Flixonase Nasule Drops are provided in small plastic
containers (Nasules).
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.
Pregnancy and breast-feeding
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.
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.

How much to use - adults (over 16 years of age)
• 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.

How to put the drops in
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.

What the plastic container looks like

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

Using your Flixonase Nasule drops
1. Open the foil pack 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.

3. Put the remaining containers back into the foil
pack 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.

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.

If you use more Flixonase Nasule Drops than you
should
Tell your doctor if you use more than you were told
to.
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.
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 life-threatening 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:
Very common (affects more than 1 in 10 people)
• Nose bleeds.
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.

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,
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 Flixonase Nasule Drops
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Do not freeze.
• Protect from light.
• Store Flixonase Nasule Drops in their foil wrapper
and in the carton 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.
6 Further information
What Flixonase Nasule Drops contain
• Each container contains 400 micrograms of
fluticasone propionate, giving a strength of 1
milligram per millilitre.
• The other ingredients are polysorbate 20, sorbitan
laurate, sodium dihydrogen phosphate dihydrate,
disodium phosphate anhydrous, sodium chloride,
water for injections.
What Flixonase Nasule Drops looks like and
contents of the pack
Flixonase Nasule Drops are available as white to offwhite powder in a clear aqueous solution, mixed to
create cloudy suspension sealed in strips of single
dose containers in foil wrapping. Flixonase Nasule
Drops are provided as a strip of 7 Nasules in an
aluminium foil pouch. Each carton contains 28
Nasules (4 strips of 7 Nasules).

Procured from within the EU by PL Holder
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride,
G75 0SN
Manufacturer
Glaxo Operations UK Ltd, Barnard Castle, Durham
DL12 8DT
PL 39467/0164 Flixonase Nasule Drops 400
micrograms (1mg/ml), Nasal Drop Suspension
Leaflet last revised 25/04/2014
®Registered trademarks of the Glaxo Group Ltd

POM

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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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