Ophtesic

Leaflet attached to the packaging: Information for the patient

OPHTESIC, 20 mg/g, eye gel in a single-dose container

Lidocaine hydrochloride

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is OPHTESIC and what is it used for
• 2. Important information before using OPHTESIC
• 3. How to use OPHTESIC
• 4. Possible side effects
• 5. How to store OPHTESIC
• 6. Contents of the packaging and other information

1. What is OPHTESIC and what is it used for

OPHTESIC is an anesthetic eye gel used during ophthalmic procedures.
OPHTESIC is used to cause temporary loss of sensation in the eye before and during certain types of procedures performed by a doctor.
OPHTESIC should start working within 5 minutes of being applied by the doctor.

2. Important information before using OPHTESIC

When not to use OPHTESIC:

• If the patient is allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• For ophthalmic use only.
• Prolonged use of this type of anesthetic agent in the eyes may cause corneal clouding.
• OPHTESIC, 20 mg/g, eye gel in a single-dose container is intended for single use and should be discarded immediately after use. Before starting treatment with OPHTESIC, the patient should discuss this with their doctor.

OPHTESIC and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

Immediately after using OPHTESIC, the patient may experience blurred vision for some time. Until this symptom subsides, they should not drive or operate machinery.

3. How to use OPHTESIC

The doctor will apply OPHTESIC to the patient's eye(s) before the ophthalmic procedure.
Dosage
The doctor should cover the surface of the eye(s) and adnexa with the gel 5 minutes before the procedure.
The recommended dose is 1 gram spread over the surface of the eye. This dose usually provides sufficient initial anesthesia. Depending on the size of the eye or the duration of the procedure, additional amounts may be used.
1 gram is approximately one-third of a 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
The doctor should perform the following steps:

• 1. Remove the paper cover, then remove the tube and tip from the sterile blister pack. Check their integrity.

• 2. Assemble both parts by screwing the tip onto the tube, then twisting in the direction of the arrow to pierce the aluminum seal.

• 3. Holding the tube with the tip down, gently press the side of the tube to release the gel and cover the surface of the eye and adnexa.
• 4. The gel must remain in place for 3 to 5 minutes before being rinsed off. Do not touch the eye or eyelid with the tip of the tube.
• 5. After use, discard the tube and blister pack.

4. Possible side effects

Like all medicines, OPHTESIC can cause side effects, although not everybody gets them.
The following side effects have been reported with an unknown frequency:

• conjunctival redness
• corneal epithelial changes
• eye burning sensation
• punctate keratitis
• corneal edema
• headache

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OPHTESIC

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the tube and carton after "Expiry date". The expiry date refers to the last day of the month.
Do not store above 25°C.
The product is for single use and must be discarded immediately after use.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer needed. Taking this into account will help protect the environment.

6. Contents of the packaging and other information

What OPHTESIC contains

• The active substance is lidocaine: 1 gram of gel contains 20 mg of lidocaine hydrochloride (anhydrous).
• The other ingredients are: hypromellose type 2910, sodium hydroxide (E524) (for pH adjustment), hydrochloric acid (E507) (for pH adjustment), and water for injection.

What OPHTESIC looks like and contents of the pack

OPHTESIC is a clear, colorless gel supplied in a 3.5 g tube in a cardboard box.
The pack contains 1, 20, or 100 tubes.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoires Doliage Developpement (LDD)
93, rue Jean Jaurès
92800 Puteaux
France
Phone: +33 (0)1 42 91 39 19

Manufacturer

RECIPHARM KARLSKOGA AB
Bjökbornsvägen 5 – Box 140
691 33 Karlskoga
Sweden

Date of last revision of the leaflet: