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Bausch&Lomb

Minims® Lidocaine Hydrochloride 4% w/v and Fluorescein Sodium 0.25% w/v

Eye Drops, solution

Lidocaine 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® Lidocaine 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® Lidocaine Hydrochloride and Fluorescein Sodium eye drops are and what they are used for

Minims® Lidocaine Hydrochloride and Fluorescein Sodium contains a local anaesthetic (lidocaine) and a diagnostic agent (fluorescein). Lidocaine Hydrochloride 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, fora short time only, to help the doctor or eye specialist to examine your eye .

•    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. Damage to the cornea (the transparent membrane covering the surface of the eye) is 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 your eye drops

Do not use these drops if

•    you are allergic to one of the active substances (lidocaine or fluorescein) or any of the other ingredients (refer to the end of this leaflet).

•    you are allergic to other similar types of local anaesthetic.

Take special care

You should tell your doctor if:

•    your eyes are red or inflamed

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 for single use only and provided in single use Minims units, to examine both eyes if necessary. Once opened, use immediately. Discard any unused portion.

Dosage

•    The normal adult dose is 1 or more drops in one or both eyes.

•    The dose for children will be decided by the doctor or eye specialist.

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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 eve until the anaesthetic has worn off. Your doctor or eye specialist will make sure that your eye is properly protected.

If you use more Minims^{1 2} Lidocaine Hydrochloride and Fluorescein Sodium than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately.

4. Possible side effects

The following side-effects have been reported very rarely (can occur in less than 1 in 10.000 patients treated):

•    allergic reactions with redness and irritation of the eye, swelling around the eye,

•    severe allergic reaction with difficulty in breathing and symptoms of shock,

•    itchy skin rash with raised red blotches.

If you do experience any effects after using these drops, which appear to be an allergic reaction, seek immediate medical attention. 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. Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. The drops are for single use only and provided in 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

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What do your eye drops contain

•    The active ingredients are lidocaine hydrochloride and fluorescein sodium. Each unit contains approximately 0.5 ml eye drops solution of lidocaine hydrochloride 4% w/v (20 mg) and fluorescein sodium 0.25% w/v (1.25 mg).

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   The other ingredients are povidone, hydrochloric acid (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:

Bausch & Lomb UK 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:

Minims® Lidocaine Hydrochloride 4% w/v and Fluorescein Sodium 0.25% w/v:

PL 03468/0075 (UK); PA 555/12/1 (Ireland)

DATE OF PREPARATION: April 2015 Art.76862