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VANTAGE ALLERGY 2% EYE DROPS

Active substance(s): SODIUM CROMOGLYCATE

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sodium cromoglicate
PACKAGE LEAFLET: INFORMATION
FOR THE USER

The name of your medicine is
Sodium Cromoglicate Eye Drops,
which will be referred to as ‘Sodium
Cromoglicate Drops’ throughout
this leaflet.
Read all of this leaflet carefully
before you start using this medicine
because it contains important
information for you.
Always use this medicine exactly as
described in this leaflet or as your
pharmacist has told you.
• Keep this leaflet. You may need
to read it again.
• Ask your pharmacist if you need
more information or advice.
• If you get any side effects, talk to
your pharmacist. This includes
any possible side effects not
listed in this leaflet.
• You must talk to a doctor if you
do not feel better or if you feel
worse within a few days.

If you suffer from hay fever, you can
also help control your symptoms by
trying to ensure low exposure to
pollen when hay fever symptoms
are expected. For example, keep
windows closed, do not cut grass,
stay indoors as much as possible.

2

WHAT YOU NEED TO KNOW
BEFORE YOU USE SODIUM
CROMOGLICATE DROPS

Do not use Sodium Cromoglicate
Drops if you:
• are allergic (hypersensitive) to
sodium cromoglicate or any of
the other ingredients of Sodium
Cromoglicate Drops (see list of
ingredients in Section 6). An
allergic reaction may include
rash, itching, difficulty breathing
or swelling of the face, lips,
throat or tongue.

You must be confident that you or
your child’s eye symptoms are
caused by hay fever, or have been
previously diagnosed by your
doctor to suffer from hay fever: You
can be sure allergic eyes are caused
by hay fever if:
• both eyes are affected
WHAT IS IN THIS LEAFLET:
• you also have a runny or blocked
1. What Sodium Cromoglicate Drops
nose
are and what they are used for
• your eyesight is not affected
2. What you need to know before
• you know you suffer from hay
you use Sodium Cromoglicate
fever and your symptoms
Drops
coincide with the times of year
3. How to use Sodium Cromoglicate
when grass or tree pollen is high.
Drops
But if you or your child have:
4. Possible side effects
• no nose symptoms
5. How to store Sodium
• only one eye is affected
Cromoglicate Drops
• your sight is affected
6. Contents of the pack and other
Or if the eye symptoms:
information
• occur at the wrong time of year
for hay fever
SODIUM
• are likely to be caused by
1 WHAT
CROMOGLICATE DROPS
another allergy, e.g. a pet or dust
ARE AND WHAT THEY ARE
mite allergy
USED FOR
then you cannot be sure that the
condition is due to hay fever and
Sodium Cromoglicate Drops contain you should see your doctor or
the active ingredient sodium
pharmacist before you use these
cromoglicate.
drops.

Sodium cromoglicate belongs to a
group of medicines called
anti-allergics.

Warnings and precautions:
• Your eye drops also contain
benzalkonium chloride, which
may cause eye irritation in a few
Sodium Cromoglicate Eye Drops are
people.
used for the relief and treatment of
• Avoid contact with soft contact
the eye symptoms of hay fever. They
lenses. Remove contact lenses
work by reducing the body’s response
prior to application and wait at
to the allergy when used regularly
least 15 minutes before
during the course of treatment.
reinsertion. Benzalkonium
chloride is known to discolour
These symptoms occur usually in
soft contact lenses.
the late spring or early summer
when pollen from grasses or trees
Pregnancy and breast-feeding
comes into contact with the eyes of If you are pregnant or breast-feeding,
people who are sensitive to them.
think you may be pregnant or are
This condition is sometimes
planning to have a baby, ask your
called ‘hay fever eyes’ or by its
doctor or pharmacist for advice
medical term, seasonal allergic
before taking this medicine.
conjunctivitis.

Driving and using machines
This medicine can cause blurred
vision for a few minutes after use. If
this happens, do not drive or
operate machinery until you can see
normally again.

3

HOW TO USE SODIUM
CROMOGLICATE DROPS

Dosage
Adults (including the elderly) and
children:
• Place one or two drops into each
eye four times daily.
• Wash your hands before using
the drops.
• Tilt your head back and carefully
pull down your lower eyelid.

sudden wheeziness, difficulty in
breathing, swelling of the eyelids,
face or lips, rash or itching (especially
affecting your whole body).
The following side effects have
been reported:
• temporary stinging and blurring
of vision
• other symptoms of eye irritation
(rare).
If you get any side effects, talk to
your pharmacist. This includes any
side effects not listed in this leaflet.

5

HOW TO STORE SODIUM
CROMOGLICATE DROPS

Keep out of the reach and sight of
children.
Store below 25°C. Keep the bottle in
the outer carton to protect from light.

Do not use Sodium Cromoglicate
Drops after the expiry date which is
stated on the carton. The expiry date
• Without touching the eyelid with refers to the last day of that month.
the tip of the dropper, put one or Do not use your eye drops more
two drops into your lower lid and than 28 days after first opening the
bottle. Discard any unused medicine
then blink a few times to make
after this time.
sure your whole eye is covered
by the liquid.
Do not throw away any medicines
• Replace the cap securely on the
via wastewater or household waste.
bottle.
Ask your pharmacist how to throw
away medicines you no longer use.
If you have any questions
These measures will help protect
concerning the use of these drops
the environment.
in a child, or are unsure if the child
has eye symptoms of hay fever, you
OF THE PACK
should seek advice from your
6 CONTENTS
AND OTHER INFORMATION
doctor or pharmacist.
If you use more Sodium Cromoglicate
Drops than you should
Talk to your doctor or a pharmacist
if you use more of the eye drops
than you should, or if anyone
accidentally swallows any of the
medicine.

What Sodium Cromoglicate Drops
contain:
The active substance is sodium
cromoglicate 2% w/v.
The other ingredients are: disodium
edetate, benzalkonium chloride and
water.

If you forget to use Sodium
Cromoglicate Drops
If you miss a dose, use the drops as
directed, and then continue your
normal course of treatment. Do not
use a double dose to make up for a
forgotten dose.

What Sodium Cromoglicate Drops
look like and contents of the pack:
The medicine is a clear liquid in
white plastic tamper-evident bottles
fitted with a dropper and closed
with a screw cap. The bottle
contains 5 ml or 10 ml of Eye Drops
Solution.
If you have any further questions on Not all pack sizes may be marketed.
the use of this product, ask your
doctor or pharmacist.
Marketing Authorisation Holder:
PLIVA Pharma Ltd, Ridings Point,
Whistler Drive, Castleford,
4 POSSIBLE SIDE EFFECTS
WF10 5HX, UK.
Like all medicines, Sodium
Cromoglicate Drops can cause side Manufacturer:
effects, although not everybody
Alcon Cusi SA, C/Camil Fabra,
gets them.
58 El Masnou, Barcelona, Spain.
All medicines can cause allergic
reactions, although serious allergic
reactions are very rare. Tell your
doctor straight away if you get any

This leaflet was last revised in:
November 2011
PL 10622/0016

87477-B

BLACK

SODIUM CROMOGLICATE
EYE DROPS 2% W/V

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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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