Lignox

Package Leaflet: Information for the User

LIGNOX, 50 mg/g, gel

(Lidocaine hydrochloride)

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

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

What is Lignox and what is it used for

Lignox gel is used for surface anesthesia of mucous membranes and skin:

• surface anesthesia of mucous membranes before injection (in order to reduce the pain associated with needle insertion); especially in patients sensitive to pain;
• surface anesthesia in dental procedures, e.g. scaling (removal of dental tartar), superficial incisions of abscesses;
• in the extraction of heavily mobile milk teeth and permanent teeth (in periodontal diseases);
• in prosthetics: as a preventive measure to eliminate the patient's gag reflex when taking impressions in the oral cavity. Lidocaine, the active substance of the medicine, is a local anesthetic of amide structure, with a short duration of action. Local anesthetics penetrate the epithelium and reach the pain receptors located in the submucosal membrane. They cause local, surface anesthesia of the mucous membrane (e.g. oral cavity), wound surfaces, and skin. When applied in small amounts to the skin or mucous membranes, they have only local anesthetic effects, without systemic effects.

Important information before using Lignox

When not to use Lignox:

if the patient is allergic to lidocaine hydrochloride and other local anesthetics of amide structure or any of the other ingredients of this medicine (listed in section 6);

• in children under 4 years of age.

Relative contraindications are: shock, atrioventricular block II and III, myasthenia, severe liver damage. Use with caution in patients treated with tricyclic antidepressants and MAO inhibitors.

Warnings and precautions

The gel must not be swallowed, excess should be spat out.
NOTE: The preparation contains an active substance that may give a positive result in doping tests.

Lignox and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as medicines you plan to take.
Lidocaine enhances the effect of muscle relaxants. It weakens the effect of sulfonamides.

Overdose

Lidocaine is easily and quickly absorbed from mucous membranes; in the case of use in children, in patients with low body weight, or in the case of using large amounts, it is recommended to calculate the dose based on the patient's body weight.
In children and patients in poor general condition, the maximum daily dose is 2.9 mg/kg body weight and should be calculated individually for each case.
Do not exceed the dose of 3 mg/kg body weight. The maximum daily dose for adults, which should not be exceeded, is 200 mg of lidocaine, which corresponds to 4.5 g of gel (approximately 8.5 cm of squeezed gel).
In the event of symptoms of toxicity from the nervous, respiratory, or circulatory system, immediate resuscitative measures should be taken: ensure proper ventilation using oxygen, administer anticonvulsant drugs and drugs that increase blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
There is insufficient evidence regarding the safety of using Lignox gel in pregnant women. The medicine should not be used in pregnant women.
The safety of use in breastfeeding women has not been established.

Driving and using machines

Lignox causes mild, transient impairment of psychophysical fitness, ability to drive vehicles, and operate machinery.
Your doctor will inform you when you can resume activities that require increased attention after the procedure.
Lignox contains cochineal red (E 124).It may cause allergic reactions.
Due to the presence of aspartame (E 951), the medicine may be harmful to patients with phenylketonuria.

How to use Lignox

Apply 0.1 to 0.2 g of gel (i.e. approximately 2 to 3 mm of squeezed gel) to the dried mucous membrane using a swab, which corresponds to 4 to 8 mg of lidocaine.
Do not exceed the dose of 3 mg/kg body weight.
Lidocaine is easily and quickly absorbed from mucous membranes – in the case of use in children, in adults with low body weight, or in the case of using large amounts, it is recommended to calculate the dose based on the patient's body weight.
In children and patients in poor general condition, the maximum daily dose is 2.9 mg/kg body weight and should be calculated individually for each case.
The maximum daily dose for adults, which should not be exceeded, is 200 mg of lidocaine, which corresponds to 4.5 g of Lignox gel (i.e. approximately 8.5 cm of squeezed gel).
Lidocaine administered in gel starts working after 2-5 minutes; its effect lasts for 10 to 15 minutes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, the product may cause an allergic reaction, rarely anaphylactic shock.
Side effects (taste disorders, tongue numbness, headaches, dizziness, feeling of anxiety, rapid breathing) may occur in the case of overdose, i.e. when too large a dose is administered in relation to body weight.
Side effects related to systemic action depend on the concentration of lidocaine in serum, which depends on the administered dose, site of administration, local blood flow, body weight, and the patient's general condition.
The likelihood of side effects from the cardiovascular or central nervous system after proper use of the gel is negligible.
An undesirable effect that may occur after using lidocaine is drowsiness of varying severity .

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
e-mail: ndl@urpl.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.

How to store Lignox

Store below 25°C. Do not freeze.
Store the tube tightly closed.
Medicines should be kept out of the sight and reach of children.
Check the expiry date on the packaging.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the month stated.
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.

Contents of the pack and other information

What Lignox contains

The active substance is lidocaine hydrochloride.
1 g of gel contains 50 mg of lidocaine hydrochloride.
The other ingredients are: macrogol 400, macrogol 4000, cetylpyridinium chloride, aspartame (E

• 951), cochineal red (E 124), strawberry flavor, purified water.

What Lignox looks like and contents of the pack

Lignox is a uniform, soft, opaque gel of a color from light pink to red, with a strawberry flavor.
The packaging of the medicine is a tube containing 20 g of gel. The tube, along with the leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: chema@chema.rzeszow.pl

Date of last revision of the leaflet: