OPHTESIC 20 mg/g OPHTHALMIC GEL SINGLE-DOSE CONTAINER

Introduction

Patient Information Leaflet

Ophtesic20 mg/g, ophthalmic gel in single-dose container

Lidocaine hydrochloride

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor.

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

Contents of the leaflet

1. What is Ophtesic and what is it used for
2. What you need to know before using Ophtesic
3. How to use Ophtesic
4. Possible side effects
5. Storage of Ophtesic
6. Contents of the pack and further information

1. What is Ophtesic and what is it used for

Ophtesic is an ophthalmic anaesthetic gel used during ophthalmic procedures.

This medicine is used to induce a temporary feeling of numbness in the eye before and during certain types of procedures performed by your doctor.

This medicine should start to take effect within 5 minutes of your doctor applying it.

2. What you need to know before using Ophtesic

Do not use Ophtesic:

• If you are allergic to lidocaine, to any other local anaesthetic or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• For ophthalmic use only.
• Prolonged use of this type of ophthalmic anaesthetic may cause corneal opacification.
• This medicine is for single use and should be discarded immediately after use.

Other medicines and Ophtesic

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Children

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor before using this medicine.

Driving and using machines

You may have blurred vision for a while after using this medicine. Do not drive or use machines until the effects have worn off.

3. How to use Ophtesic

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

Dosage

Your doctor should cover the surface of your eye(s) and the surrounding 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 anaesthesia. 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.

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

The gel can be reapplied to maintain the anaesthetic effect.

Method of administration

Your doctor should proceed as follows:

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

1. The two parts should be assembled by screwing the nozzle onto the thread of the tube and turning it clockwise to pierce the sealed aluminium membrane.

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

1. The gel should be left in place for 3 to 5 minutes before being rinsed off. 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.

4. Possible side effects

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

The following side effects have been reported with an unknown frequency:

• conjunctival redness
• changes in the corneal epithelium
• eye burning sensation
• punctate corneal inflammation
• corneal inflammation
• headache

Reporting of side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ophtesic

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

Do not use this medicine after the expiry date stated on the tube and carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ophtesic

• The active substance 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 injections.

Appearance and packaging of the product

This medicine is a colourless and transparent gel supplied in a 3.5 gram tube.

Carton of 1, 20 or 100 tubes.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratoires Doliage Development (LDD)

93, rue Jean-Jaurès

92800 Puteaux

France

Local representative

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6º

08028 Barcelona – Spain

Manufacturer

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 medicine is authorised in the Member States of the European Economic Area under 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

Date of last revision of this leaflet: June/2023

Other sources of information

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