Ophtesic

Italy
Brand name Ophtesic
Form ointment, ophthalmic
Active substance / Dosage
LIDOCAINE HYDROCHLORIDE
Prescription type Restricted prescription – for use by specialist only
ATC code
S01HA07
Registration number 050077
Manufacturer LDD PHARMA
Ophtesic ointment, ophthalmic

Table of Contents

Patient Information Leaflet

Ophtesic 20 mg/g, ophthalmic gel in single-dose container

lidocaine hydrochloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor has instructed you to.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor.
  • If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

  1. What Ophtesic is and what it is used for
  2. What you need to know before using Ophtesic
  3. How to use Ophtesic
  4. Possible side effects
  5. How to store Ophtesic
  6. 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.
Ophtesic is used to produce a temporary loss of sensitivity in the eye before and during certain types of procedures performed by a doctor.
Ophtesic should begin to take effect within 5 minutes after application by the doctor.

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
  • For ocular use only.
  • Prolonged use of this type of ophthalmic anaesthetic may lead to corneal clouding.
  • Ophtesic 20 mg/g, ophthalmic gel in single-dose container is intended for single use only and must be disposed of immediately after use. Other medicines and Ophtesic Inform your doctor if you are taking, have recently taken, or might take any other medicines. Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
Driving and use of machines
After using Ophtesic, you may experience blurred vision for a period of time. Do not drive or operate machinery until this effect has cleared.

3. How to use Ophtesic

Ophtesic will be applied to the eye(s) by the physician prior to the ophthalmic procedure.
Dosage
The physician should cover the surface of the eye(s) and the ocular adnexa with the gel 5 minutes before the procedure.
The recommended dose is 1 gram applied to the surface of the eye. This dose is generally sufficient to achieve initial anaesthesia. An additional amount may be used, depending on the size of the eye or the duration of the procedure.
1 gram corresponds approximately to one third of a tube.
The physician must not use more than one tube per eye or per single procedure.
The gel may be reapplied to maintain the anaesthetic effect.
Method of administration
The physician must proceed as follows:

  1. The paper lid of the blister must be peeled off, then the tube and the dispenser must be removed from the sterile blister. Their integrity must be checked.
White packaging of Ophtesic 20 mg/g ophthalmic gel with batch number, expiration date and manufacturer LDG Pharma on a light background
  1. The two parts must be assembled by screwing the dispenser onto the thread of the tube and rotating clockwise to pierce the sealed aluminium membrane.
  1. The tube should be held pointing downwards, then a gentle lateral pressure should be applied to extrude the gel and cover the surface of the eye and the ocular adnexa.
  2. The gel should be left in place for 3-5 minutes before being removed by irrigation. The eye or eyelid must not be touched with the tip of the dispenser.
  3. The tube and blister must be disposed of after use.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported with unknown frequency:

  • conjunctival hyperemia
  • corneal epithelial changes
  • ocular burning sensation
  • punctate keratitis
  • corneal swelling
  • headache

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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 Ophtesic

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 tube and the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25 °C.
The product is for single use only and must be disposed of immediately after use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ophtesic contains

  • The active substance is lidocaine: 1 gram of gel contains 20 mg of lidocaine hydrochloride (anhydrous).
  • The other components are: hypromellose (E464), sodium hydroxide (E524) (pH regulator), hydrochloric acid (E507) (pH regulator) and water for injections. Description of the appearance of Ophtesic and contents of the pack Ophtesic is a transparent, colourless gel supplied in a 3.5 g tube. Pack sizes: 1, 20 or 100 tubes. Marketing Authorisation Holder LDD Pharma 93, rue Jean Jaurès 92800 Puteaux France Manufacturer RECIPHARM KARLSKOGA AB Bjökbornsvägen 5 - Box 140 691 33 Karlskoga Sweden