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SYNTARIS NASAL SPRAY

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SYNTARIS® NASAL SPRAY
0.025 % w/v FLUNISOLIDE

If you are pregnant, planning to become
pregnant or breast-feeding. Ask your doctor
for advice before taking any medicine.

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Driving and using machines
Syntaris is not expected to affect your ability
to drive or operate machinery.

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 get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Syntaris is and what it is used for
2. Before you take Syntaris
3. How to take Syntaris
4. Possible side effects
5. How to store Syntaris
6. Further information

1

WHAT SYNTARIS IS AND WHAT IT IS
USED FOR

3

HOW TO TAKE SYNTARIS

Always take Syntaris exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
The label will tell you how much and how
often to take your spray. This may depend on
your symptoms.
The usual dose is:
Adults including the elderly
• Two sprays in each nostril two or three
times daily.
You should spray no more than six sprays
in each nostril per day.
Children over 5 years:
• One spray in each nostril three times daily
You should spray no more than three
sprays in each nostril per day.
Children under 5 years
• Syntaris is not recommended for use in
children under 5 years of age.

Long term treatment (maintenance dose)
Syntaris is one of a group of drugs called
• After the desired clinical effect is obtained
corticosteroids which act by preventing or
the long term treatment should be the
reducing inflammation and therefore eases
smallest amount necessary to control the
your symptoms. Because it is administered in
symptoms. Some patients may be
low doses directly to the area where it is
maintained on as little as one spray to
needed (i.e. the lining of the nose), it's action
each nostril per day.
is generally confined to this site.
Preparing the pump for use
Syntaris is used for the prevention and
Before you use a bottle of Syntaris for the
treatment of perennial (persistent) and
first time, you have to prime the spray pump.
seasonal allergic rhinitis including hay fever
This needs to be done only once, before you
(blocked-up, running and itching nose due to use your first dose.
irritants causing the lining of your nose to
1. Remove the plastic
become inflamed). Syntaris reduces this
1
dust cap as shown in
inflammation and eases your symptoms.
Diagram 1 to uncover
the spray tip. Hold the
BEFORE YOU TAKE SYNTARIS
bottle with two fingers
Do NOT take Syntaris if you:
on the ‘shoulders’ and
• are allergic (hypersensitive) to flunisolide
thumb on the bottom
or any of the other ingredients of this
of the bottle. This is
medicine
shown in Diagram 2.
• have any untreated fungal, bacterial or
2.
Prime
the pump by
viral infections of the nose or eyes.
2
pressing the bottle
Take special care with Syntaris
upwards several times
Talk to your doctor before you start to take
firmly and quickly until
this medicine if you:
a fine spray appears.
• have recently been treated with
This usually requires
corticosteroids
about four to five
• have recently had ulcers in the nose, nose
presses. It is not
bleeds, damage to, or an operation on the
normally necessary to
nose.
prime the pump again during subsequent
use. You may however need to do this
Your doctor may wish to monitor the height
again after cleaning the pump (see section
of a child receiving prolonged treatment with
on cleaning).
Syntaris.
How
to use your medicine
Taking other medicines
3
Follow these instructions:
Please tell your doctor or pharmacist if you
3. Gently blow your nose
are taking or have recently taken any other
to clear the nostrils.
medicines, including medicines obtained
without a prescription.

2

Important information about some of the
ingredients of Syntaris
Syntaris nasal spray contains sorbitol (E420).
If you have been told by your doctor that you 4. Tilt the head forward
4
slightly. Close one
have an intolerance to some sugars, contact
nostril by pressing the
your doctor before taking this medicinal
side as shown in
product.
Diagram 4, and
Syntaris nasal spray contains benzalkonium
carefully insert the
chloride, this irritant may cause skin
spray tip into the other
reactions.
nostril.
Syntaris nasal spray contains butylated
hydroxytoluene (E321) and may cause local
5. Press the bottle firmly
5
skin reactions (e.g. dermatitis), or irritation to
up between thumb and
the eyes and mucous membranes.
fingers whilst gently
breathing in through
Pregnancy and breast-feeding
the nostril.
Syntaris nasal spray is not recommended if
you are in the first 3 months of pregnancy.

6. Now breathe out
through the mouth.

6




After use
7. Wipe the tip of the
pump with a clean
tissue or handkerchief
and replace the dust
cap.

7

Cleaning
8
8. The spray tip should be
cleaned if it becomes
blocked. To do this:
• pull off the plastic
dust cap
• carefully pull off
the spray tip from
the pump
mechanism and soak it in warm water
for a few minutes
• rinse it with cold water, allow to dry
and refit to the pump
• prime the pump as shown in Diagram 2
• replace the dust cap.
Important: Do not try to clean the spray tip
with a pointed object.
If you do not understand any of these
instructions or are in any doubt, ask your
doctor or pharmacist.
If you use more Syntaris than you should
It is important that you take your dose as
stated on the pharmacist’s label or as
advised by your doctor. You should use only
as much as your doctor recommends; using
more or less may make your symptoms worse.
If you (or someone else) take too much
medicine, or swallow any of the spray, or if
you think a child has swallowed any of the
spray contact your nearest hospital casualty
department or your doctor immediately. An
overdose is likely to affect hormone levels in
your body. Please take this leaflet, any
remaining spray, and the container with you
to the hospital or doctor so that they know
which spray has been used.






irritation of the throat, sore throat or
hoarseness, alteration or loss of smell and
taste
perforation of the septum of the nose
(very rare) �
slowed growth in children
aftertaste
nausea and vomiting
allergic reactions such as skin rashes,
itching swelling and redness.

If you feel unwell in any other way, tell your
doctor as soon as you can.
If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5

HOW TO STORE SYNTARIS

Keep out of the reach and sight of children.
You should always put the plastic dust cap
back on when you are not using your
medicine. Store the bottle upright at room
temperature below 30°C.
Do not take the spray after the expiry date
that is stated on the outer packaging. The
expiry date refers to the last day of that
month.
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 each Syntaris spray contains:
• The active ingredient is Flunisolide
25 micrograms (0.025% w/v)
• The other ingredients are propylene
glycol, polyethylene glycol, benzalkonium
chloride, butylated hydroxytoluene (E321),
sorbitol (E420), polysorbate, disodium
edetate, citric acid anhydrous, sodium
citrate dihydrate and purified water.
What Syntaris Nasal Spray looks like and
contents of the pack:
• Syntaris Nasal Spray is a 24 ml bottle
which is amber type III glass or white high
density polyethylene bottle with a metered
pump packaged in an outer carton.
• Syntaris Nasal Spray is packed in bottles
of 24 ml. Each bottle contains approximately
240 sprays.

Marketing Authorisation Holder and
Manufacturer
If you forget to take Syntaris
The marketing authorisation holder is:
If you forget to use your Syntaris spray, use it Norton Healthcare Ltd, T/A IVAX
as soon as you remember, unless it is nearly Pharmaceuticals UK, Ridings Point, Whistler
time to take the next dose. Do not take a
Drive, Castleford, West Yorkshire, WF10 5HX.
double dose to make up for a forgotten dose.
The company responsible for batch release is
If you stop taking Syntaris
NextPharma SAS, 17 route de Meulan,
Do not stop taking your medicine without
78520 Limay, France.
talking to your doctor first even if you feel
better.
This leaflet was last revised: March 2011
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4

PL00530/0705

POSSIBLE SIDE EFFECTS

Like all medicines, Syntaris can cause side
effects, although not everybody gets them.
If the following happens, stop using the
spray and tell your doctor immediately or go
to the casualty department at your nearest
hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
• angioedema, a serious allergic reaction
which causes swelling of the face or throat.
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
The following side effects have been
reported:
• slight stinging or burning or irritation of
the nose
• nose bleed or runny and stuffy nose
TEVA UK Limited

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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