Package Insert: Information for the Patient

Ophtesic20 mg/g, eye gel in single-dose packaging

Lidocaine hydrochloride

Read this entire package insert carefully before starting to use this medication,because it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects,consult your doctor,even if they are not listed in this package insert. See section 4.

1.What is Ophtesic and what it is used for

2.What you need to know before starting to use Ophtesic

3.How to use Ophtesic

4.Possible adverse effects

5.Storage of Ophtesic

6.Contents of the package and additional information

Ophtesicis an ophthalmic anesthetic gel used during ophthalmic procedures.

This medicationis used to cause a temporary sensation of numbness in the eye before and during certain types of procedures performed by the doctor.

This medicationshould start to take effect within 5 minutes after your doctor applies it.

Do not use Ophtesic:

• If you are allergic to lidocaine, any other local anesthetic, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

• For ophthalmic use only.
• The prolonged use of this type of ophthalmic anesthetic may cause corneal opacification.
• This medication is for single administration and should be discarded immediately after use.

Other medications and Ophtesic

Inform your doctor if you are taking, have taken recently, or may take any other medication.

Children

If necessary, your doctor may consider using Ophtesic in your children.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

You may experience blurred vision for a short time after using this medication. Do not drive or operate machinery until the effect has worn off.

Before the ophthalmic procedure, the doctor will apply this medication to your eye(s).

Dosage

The doctor must cover the surface of your eye(s) and the adjacent area with the gel 5 minutes before the procedure.

The recommended dose is 1 gram spread over the surface of the eye. This dose is usually sufficient to achieve initial anesthesia. Additional amounts may be used depending on the size of the eye and the duration of the procedure.

1 gram corresponds to approximately one-third of the tube.

The doctor should not use more than one tube per eye or per procedure.

The gel can be reapplied to maintain the anesthetic effect.

Method of Administration

Your doctor should proceed as follows:

1. The paper cover of the blister pack should be removed, and then the tube and nozzle should be taken out of the sterile blister pack. The integrity should be checked.

1. The two parts should be assembled by screwing the nozzle onto the tube, and turning clockwise to pierce the sealed aluminum membrane.

1. The tube should be held upside down, and then gently pressed on the edge to release the gel and cover the surface of the eye and the adjacent area.

1. The gel should be left in place for 3 to 5 minutes before rinsing. The eye or eyelid should not be touched with the tip of the nozzle.

1. The tube and blister pack should be discarded after use.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been described with an unknown frequency:

-conjunctival redness

-changes in the corneal epithelium

-ocular burning sensation

-corneal punctate inflammation

-corneal inflammation

-headache

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, 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 for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the tube and on the boxafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25?°C.

The product is for single use and must be discarded immediately after use.

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

Composition of Ophtesic

• The active ingredient is lidocaine: 1 gram of gel contains 20 mg of lidocaine hydrochloride (anhydrous).
• The other ingredients are: Hypromellose (E464), sodium hydroxide (E524) (for pH adjustment), hydrochloric acid (E507) (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the package

This medication is an incolored and transparent gel supplied in a 3.5-gram tube.

Box of 1, 20, or 100 tubes.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Doliage Development (LDD)

93, rue Jean-Jaurès

92800 Puteaux

France

Local representative

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6th floor

08028 Barcelona – Spain

Responsible for manufacturing

RECIPHARM KARLSKOGA AB

Bjökbornsvägen 5- Box 140

691 33 Karlskoga

Sweden

Ar2i S.A. Analyses recherches et innovation instrumentale

Immeuble le carnot

20 avenue Edouard Herriot

92350 Le Plessis-Robinson

France

This medication is authorized in the member states of the European Economic Area with the following names

Germany: Ophtesic 20 mg/g Augengel im Einzeldosisbehältnis

Austria: Ophtesic 20 mg/g Augengel im Einzeldosisbehältnis

Belgium: Ophtesic 20 mg/g, ooggel in verpakking voor éénmalig gebruik/ Ophtesic 20 mg/g Augengel im Einzeldosisbehältnis/ Ophtesic 20 mg/g gel ophtalmique en récipient unidose

Denmark: Ophtesic, øjengel i enkeltdosisbeholder

Spain: Ophtesic 20 mg/g, gel oftálmico en envase unidosis

Finland: Ophtesic 20 mg/g, silmägeeli, kerta-annospakkaus/ Ophtesic 20 mg/g ögongel i endosbehållare.

France: OPHTESIC 20 mg/g, gel ophtalmique en récipient unidose

Italy: Ophtesic 20 mg/g, gel oftalmico in contenitore monodose.

Luxembourg: Ophtesic 20 mg/g gel ophtalmique en récipient unidose

Norway: Ophtesic 20 mg/g øyegel i endosebeholder

Netherlands: OPHTESIC 20 mg/g ooggel in verpakking voor éénmalig gebruik

Poland: OPHTESIC 20mg/g zel do oczu w pojemniku jednodawkowym

Sweden: Ophtesic 20 mg/g ögongel i endosbehållare

Last review date of this leaflet: June/2023

Other sources of information

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