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MINIMS PROXYMETACAINE & FLUORESCEIN

Active substance(s): FLUORESCEIN SODIUM / PROXYMETACAINE HYDROCHLORIDE

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Minims® Proxymetacaine Hydrochloride 0.5% w/v
and Fluorescein Sodium 0.25% w/v
Eye Drops, solution
Proxymetacaine Hydrochloride and Fluorescein
Sodium
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 Minims® Proxymetacaine Hydrochloride and
Fluorescein Sodium eye drops are and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1. What Minims® Proxymetacaine Hydrochloride and
Fluorescein Sodium eye drops are and what they are used
for
Minims® Proxymetacaine Hydrochloride and Fluorescein
Sodium contains a diagnostic agent (fluorescein) and a local
anaesthetic (proxymetacaine).
Proxymetacaine is a local anaesthetic which temporarily numbs
the surface of the eye.
Fluorescein sodium is a temporary dye which helps the doctor
or eye specialist to examine your eye.
Your eye drops are used to:
ƒ numb and stain the surface of the eye, for a short time only, to
help the doctor or eye specialist to examine your eye or to
perform minor operations such as the removal of foreign
bodies.
ƒ help your doctor or eye specialist to measure the pressure
inside your eye by a test called tonometry.
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 should be avoided in premature babies.
2. Before you use your eye drops
Do not use these drops:
ƒ if you are allergic to one of the active substances
(proxymetacaine or fluorescein) or any of the other ingredients
(refer to the end of this leaflet).
ƒ if you are allergic to other similar types of local anaesthetic.
ƒ in premature babies.
Take special care
You should tell your doctor if:
ƒ you have a heart disease
ƒ you have an over active thyroid gland (hyperthyroidism)
Your eye drops are not intended for long term use. Frequent
use of local anaesthetic in the eye over long periods of time
may severely affect your eyesight.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use
these drops or to prescribe you an alternative.
Contact lenses
The doctor will ask you to remove your contact lenses prior to
the administration of the drops. There is no information on the
effect of this product on contact lenses. Therefore, do not wear
your contact lenses until the effects of the drops have
completely worn off.
Driving and using machines
As with all eye drops, your vision may be blurred after putting
the drops in. Wait until your vision is clear before driving or
using machines.
3. How to use your eye drops
A doctor or eye specialist will use these eye drops to examine
your eye.
The drops are in special single use “Minims” units, to examine
both eyes if necessary. Once opened, use immediately. Discard
any unused portion.
Dosage
The normal dose is 1 to 2 drops in one or both eyes.

Method of administration
The doctor or eye specialist will put the drops in your eye for
you.
A sterile eyewash may be used to wash away any excess
solution.
Your eye will remain numb for up to 30 minutes. Avoid touching
the eye until the anaesthetic has worn off. Your doctor or eye
specialist will make sure that your eye is properly protected.
4. Possible side effects
ƒ Minims® Proxymetacaine Hydrochloride and Fluorescein
Sodium may sting after instillation and your vision may
become blurred. This will gradually wear off.
ƒ Some vision problems (caused by dilatation of the pupil or
relaxing eye muscles) have been sometimes observed.
ƒ The following side-effects have been reported very rarely :
o allergic reactions with redness and irritation of the eye,
swelling around the eye,
o severe allergic reaction with difficulty in breathing and
symptoms of shock (a shock is a medical emergency in
which the organs and tissues of the body are not receiving
an adequate flow of blood which deprives the organs and
tissues of oxygen. Signs such as weak rapid pulse, faster
heart beats, disorientation, chest pain, fainting and/or cold
moist skin may be experienced),
o itchy skin rash with raised red blotches.
o toxic reaction (giving signs such as intense discomfort,
pain, loss of visual acuity, sensitivity to light, whitish
cornea, redness) affecting the cornea (the transparent
membrane covering the front of the eye).
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 your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated
on the overwrap of each unit and on the carton after the letters
“EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator at 2-8°C. Do not freeze.
If necessary, the product may be stored at temperatures not
exceeding 25°C for up to 1 month only and then thrown away.
In that case, affix a label bearing the relevant expiry date to the
carton label.
The drops are in special single use “Minims” units, to examine
both eyes if necessary. Once opened, use immediately. Discard
any unused portion.
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 do your eye drops contain
ƒ The active ingredients are Proxymetacaine Hydrochloride and
Fluorescein Sodium. Each unit contains approximately 0.5 ml
eye drops solution of Proxymetacaine Hydrochloride 0.5% w/v
(2.5 mg) and Fluorescein Sodium 0.25% w/v (1.25 mg).
ƒ The other ingredients are povidone, hydrochloric acid, sodium
hydroxide (for pH adjustment) and purified water.
This medicine does not contain a preservative as it is a sterile
single use unit.
Contents of the pack
Each carton contains 20 units.
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 Number:
Minims® Proxymetacaine Hydrochloride 0.5% w/v and
Fluorescein Sodium 0.25% w/v: PL 0033/0152 (UK)
DATE OF PREPARATION: August 2008
Art.76439 GB256E01-05.07

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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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