Lignocainum Ielfa

Leaflet attached to the packaging: information for the user

LIGNOCAINUM JELFA, 20 mg/g, gel

Lidocaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Lignocainum Jelfa and what is it used for

The active substance of Lignocainum Jelfa is an amide derivative with local anesthetic effect.
The medicine containing lidocaine is used for local anesthesia of the mucous membrane or skin. It does not irritate tissues and does not dilate blood vessels. Due to its high viscosity and low surface tension, it reduces the friction coefficient between the mucous membrane and medical instruments touching it.
The effect of the medicine starts 2-3 minutes after application and lasts for about

• 30-60 minutes. The medicine is absorbed into the general circulation after local administration, most quickly from the mucous membranes.

Indications for use

Lignocainum Jelfa type A is used in anesthesiology and laryngology:

• for coating endotracheal tubes and tracheotomy tubes, gastric tubes, probes;
• for surface anesthesia of the nasal mucosa, nasopharynx before laryngoscopy, polyp removal from the nasal passages, removal of the enlarged palatine tonsil;
• as initial anesthesia for intubation of conscious patients.

Lignocainum Jelfa type U is used in urology:

• for anesthesia of the urethra before procedures (catheterization of the bladder, cystoscopy, crushing stones in the bladder, electrocoagulation of bladder papilloma, dilation of urethral stricture); a sterile cannula, placed on the tube, allows for the administration of the gel directly into the urethra;
• for coating the surface of instruments (catheters, cystoscopes).

2. Important information before using Lignocainum Jelfa

When not to use Lignocainum Jelfa:

• if the patient is allergic to lidocaine or other local anesthetics containing amide compounds, or to any of the other ingredients of this medicine (listed in section 6);
• for lubricating the metal tube stiffener.

Warnings and precautions

If the following warnings apply to the patient, they should consult a doctor, pharmacist, or nurse before starting to use Lignocainum Jelfa.
Use with caution:

• in patients treated with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs);
• on infected or damaged mucous membranes;
• in patients with heart diseases and circulatory disorders;
• be careful not to let lidocaine enter the lumen of the tracheotomy tube.

Use the lowest effective dose to avoid high lidocaine concentrations in the blood and severe side effects.

Lignocainum Jelfa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Lidocaine:

• enhances the effect of muscle relaxants;
• reduces the effect of sulfonamides.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if necessary.
Be cautious when using the gel in breastfeeding women.

Driving and using machines

Using the medicine may temporarily and slightly impair your ability to drive and use machines.
If in doubt about performing these activities, consult your doctor.

Lignocainum Jelfa contains:

methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.

3. How to use Lignocainum Jelfa

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Lignocainum Jelfa is used directly on the mucous membrane or on the surface of medical instruments.
Anesthesiology and laryngology
Before laryngological procedures, the gel is applied to the mucous membranes by brushing.
Urology
To anesthetize the urethra, the gel is administered using a sterile cannula into the urethra until the feeling of filling, usually in a volume of about 15-20 ml. In men, the urethral orifice is then closed for 5 minutes, after which the clamp is removed and the procedure is started.
After use, both the urological cannula and the gel in contact with it are no longer sterile and should not be used again.

Use in children and adolescents

Lidocaine is easily and quickly absorbed from the mucous membranes - when used in children, the dose should be calculated based on body weight.
Do not exceed the dose of 3 mg/kg body weight.
The same applies to patients with low body weight, weakened, elderly, and when using large amounts of the medicine.

Using a higher dose of Lignocainum Jelfa than recommended

May cause a drop in blood pressure, excitement, clonic-tonic convulsions, depression of the cardiovascular system. If these symptoms occur, immediate medical attention is required.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lignocainum Jelfa can cause side effects, although not everybody gets them.
Lidocaine may cause allergic reactions after local administration and, after absorption, systemic effects.
The occurrence and severity of systemic effects depend on the concentration of the medicine in the serum, the patient's general condition, liver function, age, body weight, heart disease, and hyperthyroidism.
Heart disorders:
bradycardia (rare rhythm), cardiovascular collapse leading to cardiac arrest.
Vascular disorders:
decreased blood pressure.
Nervous system disorders:
dizziness, paresthesia;
drowsiness after lidocaine administration is usually an early sign of its high concentration in the blood, e.g., due to very rapid absorption.
Psychiatric disorders:
excitement, anxiety, disorientation.
Skin and subcutaneous tissue disorders:
skin changes, urticaria, edema.
Immune system disorders:
anaphylactic reactions.
Some people may experience other side effects when using Lignocainum Jelfa gel.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lignocainum Jelfa

Store below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
Shelf life after first opening the tube - 7 days.
Do not use this medicine after the expiry date stated on the carton after: Expiry date.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Lignocainum Jelfa gel contains

• The active substance of the medicine is lidocaine hydrochloride. 1 g of gel contains 20 mg of lidocaine hydrochloride.
• The other ingredients of the medicine are: hydroxyethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), purified water.

What Lignocainum Jelfa gel looks like and what the pack contains

Lignocainum Jelfa is a clear or slightly opalescent, colorless, uniform gel.
Packaging available:

• - type Afor use in anesthesiology and laryngology - aluminum tube with a cannula and a plastic cap with HDPE containing 30 g of gel, in a cardboard box.
• - type Ufor use in urology - aluminum tube with a membrane and a plastic cap with HDPE containing 30 g of gel, in a cardboard box. A sterile urological cannula is attached to the packaging.

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA

• 58 – 500 Jelenia Góra, ul. Wincentego Pola 21 Date of last revision of the leaflet:10/2024