Minims fluorescein sodium 20 mg/ml ophthalmic solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Minims Fluorescein sodium 20 mg/ml eye drops solution

Sodium fluorescein

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

• Helping your doctor or ophthalmologist to examine your eye,
• Assisting your doctor or ophthalmologist in measuring the pressure inside the eye through a test called tonometry,
• Aiding in the fitting of rigid contact lenses.

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

Any abrasions or ulcers on the cornea (the transparent front surface of the eye) are stained green.

Any foreign body trapped in the eye will appear surrounded by a green ring.

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

2. What you need to know before Minims Fluorescein is administered to you

Do not use this eye drop 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 whether an alternative should be prescribed.

Contact lenses

Your doctor will ask you to remove soft contact lenses before this eye drop is administered. There is no information available 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 worn off.

Driving and using machines

You may notice that your vision becomes blurred for a short time immediately after using this medicine. Do not drive or operate machinery until this effect has disappeared.

3. How Minims Fluorescein is administered

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

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

Dosage

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

Method of administration

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

The eye may be irrigated with a sterile solution to remove any excess product.

4. Possible adverse effects

The following adverse effects have very rarely been observed:

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

Reporting of adverse effects

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

5. Storage of Minims Fluorescein

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

Do not use this medicine after the expiry date stated on each single-dose unit and on the outer carton after "EXP". The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other 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 drops solution 20 mg/ml (10 mg).
• The other component is purified water.

This medicinal product does not contain preservatives as it is supplied in single-dose units.

Contents of the pack

Each carton contains 20 single-dose units.

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 the most recent review of this leaflet: October 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/