MINIMS PROXYMETACAINE HYDROCHLORIDE 0.5% W/V EYE DROPS

Active substance: PROXYMETACAINE HYDROCHLORIDE

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Minims® Proxymetacaine Hydrochloride 0.5%w/v
Eye Drops, solution
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 eye drops is
and what it is 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 eye drops
is and what it is used for
Minims® Proxymetacaine Hydrochloride contains a local
anaesthetic. It is used to numb the surface of the eye
temporarily.
Your doctor or eye specialist will use it:
to examine your eye without it being painful,
to measure the pressure inside your eye,
to perform minor operations such as the removal of
stitches and foreign bodies,
for the fitting of contact lenses.
This medicine should be avoided in premature babies.
2. Before you use your eye drops
Do not use these drops
if you are allergic to the active substance
(proxymetacaine) or any of the other ingredients (refer to
the end of this leaflet).
if you are allergic to other similar types of local
anaesthetic.
in premature babies.
Take special care
You should tell your doctor if:
you have a heart disease
you have an over active thyroid gland (hyperthyroidism)
your eyes are red and inflamed
Minims should not be used in patients with known allergies.
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.
Using other medicines
Staining solution containing fluorescein should be used with
care when Minims® Proxymetacaine Hydrochloride is applied.
Your doctor or eye specialist will be aware of this and will make
sure that a long enough time interval is allowed between these
medicines.
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
Your 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
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 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 used, they should be thrown
away.
Dosage
The amount of anaesthetic used will vary, depending on the
procedure decided by your doctor or eye specialist:
To measure the pressure inside your eye or to remove
foreign bodies: 1 or 2 drops just before the medical act.
To remove stitches: 1 or 2 drops are applied 2 to 3
minutes before operating.
To perform deep or prolonged anaesthesia: 1 drop applied
every 5 to 10 minutes. This can be repeated up to 7 times.

Method of administration
The doctor or eye specialist will put the drops in your eye for
you.
You may be asked to press on the inner corners of your eyes
for 3 minutes. This will help stop the solution draining into your
nose and throat. This is especially advisable in children, the
elderly and population at risk.
Your eye will remain numb for about one hour, depending on
how many drops you received. Avoid touching the eye until the
anaesthetic has worn off.
A period of at least one minute should be allowed after
administration of Minims Proxymetacaine hydrochloride 0.5%
w/v, before subsequent administration of other topical agents.
4. Possible side effects
Allergic reactions can occasionally occur that affect the cornea
(a transparent membrane covering the iris and pupil of the eye)
and the iris. Your doctor or eye specialist will be able to tell if an
allergic reaction occurs.
The following reactions have been reported very rarely and
usually wear off quickly:
widening of the pupil (center of the iris)
transient loss of lens movement (inability to read)
irritation of the conjunctiva (a membrane which lines the
inside of the eyelid)
In rare circumstances, a defect or inflammation of the cornea
(whitening of the deep cornea, immunology-mediated disorder)
and/or inflammation of the iris may occur.
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 used, they should be thrown
away.
6. Further information
What do your eye drops contain
The active ingredient is Proxymetacaine Hydrochloride.
Each unit contains approximately 0.5 ml eye drops
solution of proxymetacaine hydrochloride 0.5% (2.5 mg).
The other ingredients are hydrochloric acid, sodium
hydroxide 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
A copy of this Patient Information Leaflet is available in large
print and audio format at www.xpil.medicines.org.uk
DATE OF PREPARATION: March 2009
Art.76559 GB255E01-05.07

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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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