Minims Fluorescein Sodium 1.0% – patient leaflet, side effects, dosage

1. What Minims^TM Fluorescein sodium eye

Minims^TM Fluorescein sodium contains a diagnostic agent. The active

• help your doctor or eye specialist to examine your eye,
• help your doctor or eye specialist to measure the pressure inside
• help in the fitting of hard contact lenses.

Scratches on the conjunctiva (the lining of the inside of the eyelids an Damages 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 the active substance (fluorescein).
• you wear soft contact lenses.

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

Your doctor will ask you to remove your soft contact lenses prior to th this product on soft contact lenses. Therefore, do not wear your soft co Driving and using machines

As with all eye drops, your vision may be blurred after putting the dro is clear before driving or using machines.

drops are and what they are used for substance, fluorescein sodium, is a temporary dye used to:

your eye by a test called tonometry, d part of the eye) are stained yellow or orange by fluorescein. ce of the eye) are stained green.

een ring.

ng s or to prescribe you an alternative.

e administration of the drops. There is no information on the effect of ntact lenses until the effects of the drops have completely worn off.

ps in. This will wear off within a few minutes. Wait until your vision

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 dose is 1 to 2 drops in one or both eyes.

Enough solution should be used to make sure that any damaged area 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.

e.

nits, to examine both eyes if necessary. Once opened, use s are stained.

P9UK01 77420

R&D

Bausch + Lomb ULOTKA PIL

Nazwa produktu

Product Name

Minims fluorescein sodium 1% and 2% DRP SOL

Kolor nadruku C

olours

Kraj

Country (ISO)

UK

Nr wykrojnika Spec No

5338 revision F

Opracowane przez Designed by

Shelby Fleskes

shelby.fleskes@bausch.com

Kod Wytwórcy Manufacturer co

de

77420

2

Data Date

19.03.2024

zny

-

Kod wersji

Internal version code

P9UK01

Inny kod Other code

77420 (Data Matrix)

minimum 8 pt

Wymiar ulotki PIL size

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G font family

Gramatura papie Paper weight

ru

60 g/m²

Komentarze Comments (Reason for the change)

-PMR_BNL_23_0219-A -Update B+L logo on carton and leaflet. Update Aubenas address from the carton. Removal of UK Only text on carton. Remove trademark sta TM. Editorial updates to leaflet.

-Packing Site: Laboratoire Chauvin Aubenas

of Aubenas address in the leaflet. Removal of Irish 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 Affair

s Dept. Approval

4. Possible side effects

The following side-effects have been reported very rarely:

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

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 or nurse. can also report side effects directly via:

Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHR

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 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 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.

around the eye, s of shock, attention. If you notice any side effects not listed in this leaflet,

This includes any possible side effects not listed in this leaflet. You

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

overwrap of each unit and on the carton after the letters “EXP”.

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

6. Further information

What do your eye drops contain

• The active ingredient is fluorescein sodium. Each unit contains ap

  (5 mg) or 2% w/v (10 mg).

• The other ingredient is purified water.

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:

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

DATE OF PREPARATION: November 2023

proximately 0.5 ml eye drops solution of fluorescein sodium 1% w/v se unit.

P9UK0

1 77420