MINIMS FLUORESCEIN SODIUM 20 mg/mL EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Minims Fluorescein Sodium 20 mg/ml Eye Drops Solution

Fluorescein Sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Minims Fluorescein and what is it used for
2. What you need to know before you are given Minims Fluorescein
3. How Minims Fluorescein is given
4. Possible side effects
5. Storing Minims Fluorescein
6. Contents of the pack and further information

1. What is Minims Fluorescein and what is it used for

Minims Fluorescein contains a diagnostic agent. The active substance, fluorescein sodium, is a temporary dye used to:

• Help your doctor or ophthalmologist examine your eye,
• Help your doctor or ophthalmologist measure the pressure inside the eye, through a test called tonometry,
• Help with the adaptation of rigid contact lenses.

Fluorescein stains abrasions on the conjunctiva (the transparent membrane that covers the inside of the eyelids and the white part of the eye) yellow or orange.

Abrasions or ulcers on the cornea (the transparent part of the eye's surface) are stained green.

Any foreign body trapped in your eye will be seen surrounded by a green ring.

This medicine is indicated for children, adults, and elderly patients.

2. What you need to know before you are given Minims Fluorescein

This eye drop must not be administered if:

• You are allergic to the active substance (fluorescein).
• You are wearing soft contact lenses.

If you are pregnant, think you may be pregnant, or are breastfeeding

Consult your doctor or ophthalmologist, who will decide whether you should use this eye drop or prescribe an alternative.

Contact Lenses

Your doctor will ask you to remove your soft contact lenses before administering this eye drop. There is no information on the effect of this product on soft contact lenses. Therefore, do not use soft contact lenses until the effects of this eye drop have completely disappeared.

Driving and Using Machines

You may notice that your vision becomes blurry for a moment immediately after applying this medicine. Do not drive or use machines until this effect has disappeared.

3. How Minims Fluorescein is given

An ophthalmologist or eye care specialist will use these drops to examine your eye.

This eye drop is for single use and is presented in Minims single-dose containers, to examine both eyes if necessary. Once opened, use immediately. Discard any remaining solution.

Dose

The normal dose is 1 or 2 drops in one eye or in both eyes.

Method of Administration

The ophthalmologist or eye care specialist will instill the drops into your eyes.

The eye can be rinsed with a sterile solution to remove excess product.

4. Possible Side Effects

The following side effects have been observed, very rarely:

• Allergic reactions with red eyes and eye irritation, swelling around the eye,
• Severe allergic reactions with difficulty breathing and shock symptoms,
• Itchy skin rash with red hives.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Minims Fluorescein

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on each single-dose container and on the carton after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C. Do not freeze. Store in the original package to protect from light.

This eye drop is for single use and is presented in Minims single-dose containers, to examine both eyes if necessary. Once opened, use immediately. Discard any remaining solution.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Minims Fluorescein Sodium 20 mg/ml Eye Drops Solution

• The active substance is fluorescein sodium. Each unit contains approximately 0.5 ml of fluorescein sodium eye drop solution 20 mg/ml (10 mg).
• The other ingredients are purified water.

This medicine does not contain preservatives since it is provided in single-dose containers.

Contents of the Pack

Each carton contains 20 single-dose containers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

Local Representative:

Bausch & Lomb S.A.

Avda. Valdelaparra, 4

28108 Alcobendas, Madrid

Spain

Date of Last Revision of this Leaflet: October 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/