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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:

■    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.

■    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:

■    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).

■    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 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

■    Minims® Proxymetacaine Hydrochloride and Fluorescein Sodium may sting after instillation and your vision may become blurred. This will gradually wear off.

■    Some vision problems (caused by dilatation of the pupil or relaxing eye muscles) have been sometimes observed.

■    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

■    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).

■    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