Leaflet: information for the user

Minims Sodium Fluorescein 20 mg/ml eye drops solution

Sodium Fluorescein

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How Minims Sodium Fluorescein is given to you

4. Possible side effects

5. Storage of Minims Sodium Fluorescein

6. Contents of the pack and additional information

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

• To help your doctor or ophthalmologist examine your eye,
• To help your doctor or ophthalmologist measure the pressure inside your eye, through a test called tonometry,
• To aid in the adaptation of rigid contact lenses.

The fluorescein dyes abrasions on the conjunctiva (the transparent membrane that covers the interior of the eyelids and the white part of the eye) yellow or orange.

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

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

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

This eye drop should 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 be able to decide whether you should use this eye drop or if they should prescribe an alternative.

Contact lenses

Your doctor will ask you to remove your soft contact lenses before the administration of this eye drop. 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 disappeared.

Driving and using machines

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

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, for examining both eyes if necessary. Once opened, use immediately. Discard any remaining solution.

Dose

The usual 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.

You may rinse your eye with a sterile solution to remove excess product.

The following adverse 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 symptoms of shock,
• Rash with itching on the skin with red patches.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on each unit dose and on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not store at temperatures above 25°C. Do not freeze. Store in the original container to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Minims Fluoresceína sódica 20 mg/ml eye drops in solution

• The active ingredient is fluoresceína sódica. Each unit contains approximately 0.5 ml of fluoresceína sódica eye drops in solution 20 mg/ml (10 mg).
• The other components are purified water.

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

Contents of the packaging

Each box contains 20 single-dose units.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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

Last review date of this leaflet: October 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/