Ophtesic 20 mg/g ophthalmic gel in single-dose container
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Ophtesic 20 mg/g, ophthalmic gel in single-dose container
Hydrochloride lidocaine
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ophtesic is and what it is used for
- What you need to know before using Ophtesic
- How to use Ophtesic
- Possible adverse effects
- Storage of Ophtesic
- Contents of the pack and other information
1. What Ophtesic is and what it is used for
Ophtesic is an ophthalmic anesthetic gel used during ophthalmic procedures.
This medicine is used to cause a temporary sensation of numbness in the eye before and during certain types of procedures performed by a doctor.
This medicine should begin to take effect within 5 minutes after your doctor applies it.
2. What you need to know before starting to use 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
Talk to 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 only and must 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 your children.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and using machines
You may experience blurred vision for a short time after using this medicine. Do not drive or operate machinery until this effect has 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 applied to the surface of the eye. This dose is usually sufficient to achieve initial anesthesia. An additional amount 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 may be reapplied to maintain the anesthetic effect.
Method of administration
Your doctor should proceed as follows:
- Remove the paper cover of the blister, then take out the tube and the nozzle from the sterile blister. Check their integrity.
- Assemble both parts by screwing the nozzle onto the thread of the tube, turning clockwise to pierce the sealed aluminum membrane.
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Hold the tube upside down, then gently press at the edge to release the gel and cover the surface of the eye and the surrounding area.
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Leave the gel in place for 3 to 5 minutes before rinsing it off. Do not touch the eye or eyelid with the tip of the nozzle.
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The tube and blister must be discarded after use.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported with unknown frequency:
- conjunctival redness
- changes in the corneal epithelium
- sensation of eye burning
- punctate corneal inflammation
- corneal inflammation
- headache
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.
Do not store above 25°C.
This product is for single use only and must be discarded immediately after use.
Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This helps protect the environment.
6. Contents of the pack and other 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 of the medicine and contents of the pack
This medicine is a colourless and transparent gel supplied in a 3.5-gram tube.
Pack: 1, 20 or 100 tubes.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Doliage Développement (LDD)
34, rue Jean-Jaurès
92800 Puteaux
France
Local Representative
Horus Pharma Ibérica, S.L.U.
Gran Vía Carlos III, 98, 6º
08028 Barcelona – Spain
Manufacturer
MERIBEL PHARMA 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 20 mg/g zel do oczu w pojemniku jednodawkowym
Sweden: Ophtesic 20 mg/g ögongel i endosbehållare
Date of the most recent review of this leaflet: June 2023
Other sources of information
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)