Minims Lidocaine & Fluorescein – patient leaflet, side effects, dosage

1. What Minims^TM Lidocaine Hydrochloride and they are used for

Minims^TM Lidocaine Hydrochloride and Fluorescein Sodium contains a Lidocaine Hydrochloride is a local anaesthetic which temporarily num Fluorescein sodium is a temporary dye which helps the doctor or eye s Your eye drops are used to:

• numb and stain the surface of the eye, for a short time only, to hel
• help your doctor or eye specialist to measure the pressure inside y Scratches on the conjunctiva (the lining of the inside of the eyelids an Damage to the cornea (the transparent membrane covering the surfa Any foreign bodies which are stuck in your eye are surrounded by a gr 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 fluore
• 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.

  Fluorescein Sodium eye drops are and what local anaesthetic (lidocaine) and a diagnostic agent (fluorescein). bs the surface of the eye.

  pecialist to examine your eye.

  p the doctor or eye specialist to examine your eye.

  our eye by a test called tonometry.

  d part of the eye) are stained yellow or orange by fluorescein. ce of the eye) is stained green.

  een ring.

  scein) or any of the other ingredients (refer to the end of this leaflet).

Your eye drops are not intended for long term use. Frequent use of loc affect your eyesight.

If you are pregnant, may be pregnant, or are breastfeedi

Tell your doctor or eye specialist, he/she may decide to use these drop Contact lenses

The doctor will ask you to remove your contact lenses prior to the adm product on contact lenses. Therefore, do not wear your contact lenses Driving and using machines

As with all eye drops, your vision may be blurred after putting the dro

3. How to use your eye drops

A doctor or eye specialist will use these eye drops to examine your ey The drops are for single use only and provided in single use Minims u 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 specia

  al anaesthetic in the eye over long periods of time may severely ng s or to prescribe you an alternative.

  inistration of the drops. There is no information on the effect of this until the effects of the drops have completely worn off.

  ps in. Wait until your vision is clear before driving or using machines.

  e.

  nits, to examine both eyes if necessary. Once opened, use list.

77413 P1UK01

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.

R & D

Bausch + Lomb ULOTKA PIL

Nazwa produktu

Product Name

Minims Lidocaine hydrochloride 4% w/v and Fluorescein sodium 0.25%

DRP SOL

Kolor nadruku Col

ours

Nr wykrojnika Spec No

Kraj

Country (ISO)

United Kingdom (UK)

5338 revision F

Opracowane przez Designed by

Shelby Fleskes

shelby.fleskes@bausch.com

Kod Wytwórcy Manufacturer code

77413

2

Data Date

14.03.2024

ny

-

Kod wersji

Internal version code

P1UK01

Inny kod Other code

77413 (Data Matrix)

minimum 8 pt

Wymiar ulotki PIL size

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G font family

Gramatura papieru Paper weight

60 g/m²

Komentarze Comments (Reason for the change)

-PMR_BNL-23-0178-A -Update B+L logo on carton and leaflet. Remova Aubenas address in the leaflet. Removal of Irish ‘UK Only’ text on carton. Remove trademark sta TM. Editorial updates to leaflet.

-Packing Site: Bausch & Lomb Aubenas

l of Aubenas address from the carton. Update of MA holder details from carton and leaflet. Add tements on carton and leaflet and replace R with

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs

Dept. Approval

Method of administration

The doctor or eye specialist will put the drops in your eye for you. A st Your eye will remain numb for up to 30 minutes. Avoid touching the e specialist will make sure that your eye is properly protected. If you use more Minims^TM Lidocaine Hydrochloride and Fl unlikely to occur. If you suddenly feel unwell after receiving the drops department immediately.

4. Possible side effects

The following side-effects have been reported very rarely (can occur i

• allergic reactions with redness and irritation of the eye, swelling a
• severe allergic reaction with difficulty in breathing and symptoms
• itchy skin rash with raised red blotches.

If you do experience any effects after using these drops, which appea If any of the side effects gets serious, please seek immediate medical please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This incl side effects directly via:

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for M

erile eyewash may be used to wash away any excess solution. ye until the anaesthetic has worn off. Your doctor or eye uorescein Sodium than you should, an overdose is very , tell your doctor or eye specialist or contact your nearest emergency n less than 1 in 10.000 patients treated):

round the eye, of shock, r to be an allergic reaction, seek immediate medical attention. attention. If you notice any side effects not listed in this leaflet, udes any side effects not listed in this leaflet. You can also report

HRA Yellow Card in the Google Play or Apple App Store.

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 ov date refers to the last day of that month. Do not store above 25°C. Do n The drops are for single use only and provided in single use Minims u immediately. Discard any unused portion.

Medicines should not be disposed of via wastewater or household wa required. These measures will help to protect the environment.

6. Further information

What do your eye drops contain

• The active ingredients are lidocaine hydrochloride and fluorescein of lidocaine hydrochloride 4% w/v (20 mg) and fluorescein sodium
• The other ingredients are povidone, hydrochloric acid (for pH adju This medicine does not contain a preservative as it is a sterile single u 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

Manufacturer:

erwrap of each unit and on the carton after the letters “EXP”. The expiry ot freeze. Store in the original package in order to protect from light. nits, to examine both eyes if necessary. Once opened, use ste. Ask your pharmacist how to dispose of medicines no longer sodium. Each unit contains approximately 0.5 ml eye drops solution 0.25% w/v (1.25 mg).

stment) and purified water.

se unit.

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

DATE OF PREPARATION: November 2023

7741

3 P1UK01

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