MINIMS LIDOCAINE/FLUORESCEIN 40 mg/mL + 2.5 mg/mL EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Minims Lidocaine/Fluorescein40 mg/ml + 2.5mg/ml eye drops, solution in single-dose container

lidocaine hydrochloride/fluorescein sodium

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Minims Lidocaine/Fluorescein and what is it used for
2. What you need to know before you use Minims Lidocaine/Fluorescein
3. How to use Minims Lidocaine/Fluorescein
4. Possible side effects
   1. Storage of Minims Lidocaine/Fluorescein
   2. Contents of the pack and further information

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

Minims Lidocaine/Fluorescein eye drops, solution contains a local anesthetic (lidocaine) and a diagnostic agent (fluorescein).

Lidocaine hydrochloride is a local anesthetic that temporarily numbs the surface of the eye. Fluorescein sodium is a temporary dye that helps the doctor or ophthalmologist examine the eyes.

The eye drops are used to:

• numb and stain the surface of the eye for a short period of time to help the doctor or ophthalmologist examine the eye;
• as an aid for the doctor or ophthalmologist to measure the intraocular pressure using a test called tonometry.

Possible abrasions on the conjunctiva (the lining of the inside of the eyelids and part of the eye) are stained yellow or orange with fluorescein.

Damage to the cornea (the transparent membrane that covers the surface of the eye) is stained green.

Possible foreign bodies in the eye are surrounded by a green ring.

This medicine is indicated for use in children from 3 years, adolescents, adults, and the elderly.

2. What you need to know before you use Minims Lidocaine/Fluorescein

Do not use Minims Lidocaine/Fluorescein:

• if you are allergic to one of the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other types of local anesthetics similar to lidocaine.

Warnings and precautions

Consult your doctor or pharmacist before using this medicine, if:

• you have red or inflamed eyes;
• you wear contact lenses.

This eye drop is not intended for prolonged use. Frequent use of local anesthetics in the eye over long periods of time can seriously affect vision.

Anesthetized eyes must be protected from dust and contamination.

Children and adolescents

This medicine is indicated for use in adolescents and children from 3 years.

The product must not be used in children under 3 years.

Other medicines and Minims Lidocaine/Fluorescein

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or ophthalmologist, as they may decide to use this eye drop or prescribe an alternative.

Contact lenses

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

Driving and using machines

As with all eye drops, you may have blurred vision after administration of the drops. Do not drive or use machines until your vision is clear.

3. How to use Minims Lidocaine/Fluorescein

Your doctor or ophthalmologist will use this eye drop to examine your eyes.

The eye drop is for single use and is provided in single-dose containers that can be used in both eyes if necessary. Once opened, use immediately. Discard any unused contents.

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

Use in children and adolescents

The doctor or ophthalmologist will decide the suitable dose for adolescents and children over 3 years. Normally, the same dose as for adults is used.

The product must not be used in children under 3 years.

Method of administration

The doctor or ophthalmologist will administer the eye drop into your eye. After administration, a sterile eye drop may be used to remove excess solution. The eye will remain numb for up to 30 minutes. Avoid touching your eye until the anesthetic effect has passed. Your doctor or ophthalmologist will ensure that the eye is properly protected. It is not possible to check the sensitivity of the cornea.

If you use more Minims Lidocaine/Fluorescein than you should

If you use more Minims Lidocaine/Fluorescein eye drops, solution than you should, it is very unlikely that an overdose will occur. If you suddenly feel unwell after administration of the eye drops, inform your doctor or ophthalmologist, or contact the nearest emergency service immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount ingested.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this eye drop can cause side effects, although not everybody gets them.

The following side effects have been reported very rarely (may affect up to 1 in 10,000 patients):

• allergic reactions with redness and irritation of the eye (conjunctivitis), inflammation around the eye;
• severe allergic reaction with difficulty breathing and symptoms of shock;
• itchy skin rash with red elevated patches.

If after using this eye drop you experience any effect that suggests an allergic reaction, seek medical attention immediately.

In case of worsening of any of the side effects, seek medical attention immediately. If you experience any side effect not listed in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es/.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Minims Lidocaine/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 the packaging of 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. Store in the original packaging to protect from light and moisture loss. Do not freeze. The eye drop is for single use and is provided in single-dose containers that can be used in both eyes if necessary. Once opened, use immediately. Discard any unused contents.

Medicines should not be disposed of via wastewater or household waste. Place the containers and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Minims Lidocaine/Fluorescein

• The active substances are lidocaine hydrochloride and fluorescein sodium. Each single-dose container of 0.5 ml of eye drops, solution contains 20 mg of lidocaine hydrochloride (4% w/v) and 1.25 mg of fluorescein sodium (0.25% w/v). Each drop contains 1496 µg of lidocaine hydrochloride and 93.5 µg of fluorescein sodium.
• The other ingredients are povidone, hydrochloric acid (for pH adjustment), and purified water.

This medicine does not contain preservatives, as it is a sterile single-use unit.

Appearance and packaging

Sterile solution for single use, transparent, yellow in color, reasonably free from visible particles, in a conically-shaped polypropylene container with a twist-and-turn opening mechanism and wrapped in an individual polypropylene/paper bag. Each container holds 0.5 ml of solution. The nozzle of the container is elongated in a dropper shape.

Each carton contains 20 single-dose containers.

Marketing authorization holder and manufacturer

Marketing authorization 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

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder.

Local representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid, Spain

Tel: 91 – 657 63 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary: Lidocaine/Fluorescein Health-Med 40 mg/ml + 2.5 mg/ml oldatos szemcsepp egyadagos tartályban

Italy: Lidocaina e Fluoresceina Health-Med, 40 mg/ml + 2.5 mg/ml, collirio, soluzione

Malta: Minims Lidocaine & Fluorescein

Portugal: Lidocaína + Fluoresceína Health Med, colírio, solução em recipiente unidose

Spain: Minims Lidocaína/Fluoresceína 40 mg/ml + 2.5 mg/ml colirio en solución en envase unidosis

Greece: Lidocaine & Fluorescein/Health-Med

Cyprus: Lidocaine & Fluorescein Health-Med

Date of last revision of this package leaflet:April 2024

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