Minims diagnostic with anesthetic

Package leaflet: Information for the user

Minims Diagnostic with Anaesthetic, 40 mg/mL + 2.5 mg/mL eye drops, solution in single-dose container

lidocaine hydrochloride/sodium fluorescein

Please 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 questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Minims Diagnostic with Anaesthetic eye drops, solution is and what it is used for
2. What you need to know before using Minims Diagnostic with Anaesthetic eye drops, solution
3. How to use Minims Diagnostic with Anaesthetic eye drops, solution
4. Possible side effects
5. How to store Minims Diagnostic with Anaesthetic eye drops, solution
6. Contents of the pack and other information

1. What Minims Diagnostico con Anestetico eye drops, solution is and what it is used for

Minims Diagnostico con Anestetico eye drops, solution contains a local anaesthetic (lidocaine) and a diagnostic agent (fluorescein).
Lidocaine hydrochloride is a local anaesthetic that temporarily numbs the surface of the eye.
Sodium fluorescein is a temporary dye that helps the doctor or ophthalmologist to examine the eye.
The eye drops are used to:

• anaesthetize and stain the surface of the eye, only for a short period of time, allowing the doctor or ophthalmologist to examine the eye;
• assist the doctor or ophthalmologist in measuring intraocular pressure using a test called tonometry. Abrasions on the conjunctiva (the inner lining of the eyelids and part of the eye) are stained yellow or orange by fluorescein. Corneal lesions (the transparent membrane covering the surface of the eye) appear green. Any foreign bodies present in the eye are highlighted by a green ring. This medicine is indicated for use in children from 3 years of age, adolescents, adults and the elderly.

2. What you need to know before using Minims Diagnostic with Anaesthetic eye drops, solution

Do not use Minims Diagnostic with Anaesthetic eye drops, solution:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Minims Diagnostic with Anaesthetic eye drops, solution if:

• your eyes are red or inflamed;
• you wear contact lenses. The eye drops are not intended for prolonged use. Frequent use of local anaesthetics in the eye over long periods of time may seriously damage vision.

Protect the anaesthetised eye(s) from dust and contamination.
Children and adolescents
Minims Diagnostic with Anaesthetic is indicated for use in adolescents and children from the age of 3 years.
This product must not be used in children under 3 years of age.
Other medicines and Minims Diagnostic with Anaesthetic eye drops, solution
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, inform your doctor or ophthalmologist, who will decide whether to use this eye drop or prescribe another medicine.
Contact lenses
Your doctor will ask you to remove contact lenses before instilling the drops. There is no information available on the effect of this product on contact lenses. Therefore, do not wear contact lenses until the effects of the drops have completely worn off.
Driving and using machines
As with all eye drops, your vision may become blurred after administration. Wait until your vision is clear again before driving or operating machinery.

3. How to use Minims Diagnostico with Anaesthetic eye drops, solution

The doctor or ophthalmologist will administer these eye drops to examine the eye.
The eye drops are for single use and are supplied in individual single-dose containers to examine both eyes, if necessary. Once opened, use immediately. Discard any unused contents.
The recommended dose in adults is 1 or 2 drops in one or both eyes.
Use in children and adolescents
The dose in children from the age of 3 years and in adolescents will be decided by the doctor or ophthalmologist. The dose is usually the same as that used in adults.
This product must not be used in children under 3 years of age.
Method of administration
The doctor or ophthalmologist will instil the drops into the eye. A sterile eye wash may be used to rinse away excess solution. The eye will remain anaesthetised for up to 30 minutes. Avoid touching the eye until the anaesthesia has worn off. The doctor or ophthalmologist will ensure that your eye is adequately protected. Corneal sensitivity cannot be tested.
If you use more Minims Diagnostico with Anaesthetic eye drops, solution than you should
If you use more Minims Diagnostico with Anaesthetic eye drops, solution than you should, it is very unlikely that an overdose will occur. However, if you experience sudden discomfort after instillation of the drops, inform your doctor or ophthalmologist immediately or contact the nearest emergency department.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported very rarely (may occur in less than 1 in 10,000 patients):

• allergic reactions with eye redness and irritation (conjunctivitis), swelling around the eye,
• severe allergic reaction with breathing difficulties and symptoms of shock,
• itchy skin rash with raised red spots.

If, after using these drops, you experience effects that appear to be an allergic reaction, consult a doctor immediately.

If any of the side effects worsen, inform your doctor immediately. If you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Minims Diagnostico con Anestetico eye drops, solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging of each single-dose container and on the box after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging to protect the medicine from light and moisture loss. Do not freeze. The drops are for single use and are supplied in single-dose containers, allowing examination of both eyes if necessary. Use immediately after opening.
Dispose of any unused product.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Minims Diagnostico con Anestetico eye drops, solution contains

• 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 1,496 micrograms of lidocaine hydrochloride and 93.5 micrograms of fluorescein sodium.
• The other components are povidone, hydrochloric acid (for pH adjustment) and purified water.

This medicinal product does not contain preservatives as it is a single-use sterile solution.
Description of the appearance of Minims Diagnostico con Anestetico eye drops, solution and contents of the
package
Single-use sterile solution, clear, yellow in colour, free from visible foreign particles, in a sealed conical container made of polypropylene, fitted with a twist-off cap, individually wrapped in a single pouch made of polypropylene/paper. Each container holds 0.5 mL of solution. The container's nozzle is elongated to form a dropper.
Each package 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
D24 PPT3
Ireland
Manufacturer
Laboratoire Chauvin S.A.S.
Zone Industrielle de Ripotier
50 Avenue Jean Monnet
Aubenas
07200 France
This medicinal product is authorised in the EEA Member States under the following names:
Hungary: Lidocaine/Fluorescein Minims 40 mg/ml + 2,5 mg/ml oldatos szemcsepp egyadagos tartályban
Italy: Minims Diagnostico con Anestetico
Malta: Minims Lidocaine & Fluorescein
Portugal: Lidocaína+Fluoresceína Minims 40 mg/ml + 2,5 mg/ml 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/Bausch+Lomb
Cyprus: Lidocaine & Fluorescein/Bausch+Lomb
Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco) (https://www.aifa.gov.it/trova-farmaco).