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FLUORETS

Active substance(s): FLUORESCEIN SODIUM

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Fluorets® 1mg

Fluorescein sodium
Paper strips for ophthalmic use
Read all this leaflet carefully before you start using your
medicine. It contains a summary of the information available
on your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone
else.
In this leaflet:
1. What Fluorets® is and what it is used for
2. Before you use Fluorets®
3. How to use Fluorets®
4. Possible side effects
5. How to store Fluorets®
6. Further information
1. What Fluorets® is and what it is used for
Fluorets® contains a diagnostic agent. The active substance,
fluorescein sodium, is a temporary dye used to:
ƒ help your doctor or eye specialist to examine your eye
ƒ help your doctor or eye specialist to measure the pressure
inside your eye by a test called tonometry
ƒ help in the fitting of hard contact lenses
Scratches on the conjunctiva (the lining of the inside of the
eyelids and part of the eye) are stained yellow or orange by
fluorescein.
Damages to the cornea (the transparent membrane covering
the surface of the eye) are stained green.
Any foreign bodies which are stuck in your eye are surrounded
by a green ring.
This medicine is indicated for children, adults and the elderly.
2. Before you use Fluorets®
Do not use these paper strips if
ƒ you are allergic to the active substance (fluorescein).
ƒ you wear soft contact lenses.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use
these paper strips or to prescribe you an alternative.
Contact lenses
Your doctor will ask you to remove your soft contact lenses prior
to the application of the paper strip. There is no information on
the effect of this product on soft contact lenses. Therefore, do
not wear your soft contact lenses until the effects of the
medicine have completely worn off.
Driving and using machines
Your vision may be blurred after the application of the paper
strip to the eye. This will wear off within a few minutes. Wait until
your vision is clear before driving or using machines.
3. How to use Fluorets®
The doctor or eye specialist will apply the paper strip on to your
eye.
Do not use Fluorets® if the envelope of the paper strip has been
damaged or opened.
Remove the strip from the envelope, holding the exposed
handle end.
Do not touch the orange fluorescein impregnated tip.
A paper strip is first dampened at its orange tip with an
appropriate sterile eyewash (water or saline).
The dampened paper strip stroked across the bulbar
conjunctiva will allow the doctor or eye specialist to inspect your
eye.
You may be asked to blink a few times to spread the dye evenly
across the eye.
The strip should be used once and discarded.
A sterile eyewash (water or saline) may be used to wash away
any excess fluorescein.

4. Possible side effects
The following side-effects have been reported very rarely:
ƒ allergic reactions with redness and irritation of the eye,
swelling around the eye,
ƒ severe allergic reaction with difficulty in breathing and
symptoms of shock,
ƒ itchy skin rash with raised red blotches.
If any of the side effects gets serious, please seek immediate
medical attention. If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store Fluorets®
Keep out of the reach and sight of children.
Do not use Fluorets® after the expiry date which is stated on
the envelope and on the carton after the letters “EXP”. The
expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Store in the original
package in order to protect from light.
Do not use Fluorets® if the envelope of the paper strip has been
damaged or opened.
The paper strips are in special single use sterile units. Once
opened, use immediately. Discard the used strip.
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 does a paper strip contain
ƒ The active ingredient is fluorescein sodium. Each paper strip
contains approximately 1 mg of the active ingredient.
ƒ There are no other ingredients.
Each Fluorets® paper strip is a sterile, individually wrapped
paper strip coated at one end with 1 mg of fluorescein sodium.
Contents of the pack
A pack of Fluorets® contains 100 sterile individually wrapped
paper strips.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Fluorets® 1mg :
PL 0033/5095R (UK); PA 118/26/1 (Ireland)
DATE OF PREPARATION: May 2008
Art.76550 GB262E01-05.07

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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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