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FLIXONASE NASULE DROPS

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE

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Flixonase® Nasule® Drops 400 micrograms (1mg/ml), nasal drops suspension
(fluticasone propionate)
Patient Information Leaflet
Your medicine is known by the above name but will be referred to as
Flixonase Nasule Drops throughout this leaflet

What the plastic container looks like

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

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.

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).

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.

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.

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.

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

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.

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.

Who makes and repackages your medicine?

If you use more Flixonase Nasule Drops than you should
Tell your doctor if you use more than you were told to.

Your medicine is manufactured by Glaxo Wellcome Operations, Hamire
Road, Barnard Castle, Co. Durham, DL12 8DT, UK. Procured from within
the EU and repackaged by the Product License holder: Primecrown Ltd.,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

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.
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.
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.

5) How to store Flixonase Nasule Drops








Keep all medicines out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Store in the original package in an upright position. Protect from light.
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.
If the nasal suspension becomes discoloured, shows any other signs
of deterioration you should seek the advice of your 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) Further information
What Flixonase Nasule Drops contain
 The active substance is fluticasone propionate. Each Nasule (single
dose container) contains 400 micrograms of fluticasone propionate.
 The other ingredients are polysorbate 20, sorbitan laurate, sodium
dihydrogen phosphate dihydrate, sodium phosphate dibasic
anhydrous, sodium chloride, water for injections.
What Flixonase Nasule Drops looks like and contents of the pack
Flixonase Nasule Drops is a cloudy aqueous suspension contained in
strips of polyethylene single dose (400 micrograms) containers (Nasules),
within foil wrapping.
Each carton contains 4 strips of 7 Nasules (28 Nasules per carton).

PL 10383/2027

POM

Leaflet date: 04.10.2013
Flixonase®, Nasule® and Nasules® are registered 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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