Lignox Sprai

Package Leaflet: Information for the Patient

LIGNOX SPRAY, 100 mg/g, spray, solution

Lidocaine

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lignox Spray and what is it used for

Lignox Spray contains lidocaine. This substance is a local anesthetic from the group of amide derivatives with a short duration of action.
These drugs cause local, surface anesthesia of the mucous membranes (e.g. oral cavity) and skin.

Indications for Use

Lignox Spray can be used in adults and children over 4 years of age in all cases where skin or mucous membrane anesthesia is required, and in particular:

• In dentistry:
• before injections, opening superficial abscesses, removing loose primary teeth, bone fragments, dental stones,
• as gum anesthesia before fitting dental crowns and bridges,
• before taking dental impressions or X-rays to suppress the gag reflex,

In otolaryngology:

• before electrocautery procedures (cauterization with electric current),
• before procedures for cutting the septum and removing nasal polyps,
• before procedures for cutting tonsils to suppress the gag reflex, as well as anesthesia of the injection site of the anesthetic,
• as supplementary anesthesia before opening a peritonsillar abscess,
• before puncture (puncture) of the maxillary sinus,
• before rinsing the sinuses,

In obstetrics:

• during the last stage of labor,
• before incision and suturing of the perineum as a supplementary pain reliever,
• during suture removal,

In endoscopy and instrument examinations:

• as surface anesthesia of the throat and trachea, as well as to weaken reflexes and reduce hemodynamic response during the introduction of various instruments in the respiratory and digestive tracts.

2. Important Information Before Using Lignox Spray

When Not to Use Lignox Spray:

• if the patient is allergic to lidocaine, as well as to other local anesthetics with an amide structure or to any of the other ingredients of this medicine (listed in section 6);
• when the impression material used is plaster; due to the risk of aspiration, flexible materials should be used for impressions;
• in local anesthesia before tonsillectomy and adenoidectomy in children under 8 years of age, due to the more frequent occurrence of swallowing reflex in children;
• in children under 4 years of age;
• on the surface of instruments made of plastic. Relative contraindications include: hypovolemia, shock, atrioventricular block II and III, myasthenia, severe liver damage.

Warnings and Precautions

Particular attention should be paid to the expiration date of the medicine. Do not use the medicine after the expiration date.
Particular caution should be exercised:

• when using in the throat and cheek area (especially in children), due to the possibility of suppressing the cough reflex, difficulty swallowing, numbness of the tongue and cheek mucosa;
• when using on large surfaces in children;
• in patients with wounds or inflammation of the mucous membrane and (or) infected areas;
• in patients treated with tricyclic antidepressants and MAO inhibitors;
• when using the medicine in patients with epilepsy, cardiovascular diseases and heart failure, with conduction disorders or bradycardia, with severe renal failure, with liver function disorders, in a state of severe shock, in old age, seriously ill and in poor general health, with nephrotic syndrome, with decreased serum protein levels.

In patients with acute porphyria, Lignox Spray can only be used in emergency situations and with appropriate precautions.
Patients treated with antiarrhythmic drugs of class III (e.g. amiodarone) should be under close supervision combined with electrocardiographic monitoring (ECG), as the action of both drugs on heart function may be additive.
In patients under general anesthesia, higher concentrations of lidocaine may occur in the blood than in patients breathing freely.
The absorption of lidocaine depends on the site of administration. Lidocaine is easily and quickly absorbed through the mucous membranes. Absorption of particularly large amounts of lidocaine has been observed after its use in the bronchial tree, which increases the risk of toxic symptoms (e.g. convulsions).
If, due to the site of administration, the dose used, and the size of the anesthetized area, an increase in lidocaine concentration in the blood can be expected, smaller doses of the medicine should be used. The method of dosing should be determined individually, depending on the patient's age and general condition.
When using Lignox Spray, equipment and medicines necessary for the treatment of toxic symptoms should be available. In case of toxic symptoms from the nervous, respiratory, or circulatory system, immediate resuscitation measures must be taken: the doctor will ensure proper ventilation using oxygen, administer anticonvulsant drugs and blood pressure-increasing drugs.
Using Lignox Spray in a dose higher than recommended or too frequent administration of the medicine may cause an increase in lidocaine concentration in the blood and the occurrence of serious side effects.
Treatment in case of serious side effects may require the use of resuscitation equipment, oxygen, and resuscitation drugs.
NOTE! Lidocaine may give a positive result in doping tests.

Lignox Spray and Other Medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
Particular caution should be exercised in patients receiving other local anesthetics and medicines that are analogs of lidocaine. Lidocaine should be used with caution in patients receiving antiarrhythmic drugs (e.g. tocainide, mexiletine, amiodarone). The toxic effects of these drugs may be additive.
Use with caution in patients treated with tricyclic antidepressants and MAO inhibitors.
Drugs that reduce lidocaine clearance (e.g. cimetidine or beta-blockers) may cause potentially toxic concentrations of lidocaine in the blood, especially with repeated large doses over a long period.
Lidocaine enhances the effect of muscle relaxants.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
There is insufficient evidence regarding the safety of lidocaine use in pregnant women, so the medicine can only be used in pregnant women when necessary, in the absence of a safer treatment alternative.
Breastfeeding
There is insufficient data on the use of Lignox Spray in breastfeeding women.

Driving and Operating Machines

Local anesthetics, depending on the dose, may have a slight effect on mental functions, as well as temporarily disrupt motor functions and coordination.
The medicine contains propylene glycol and ethanol.May cause skin and mucous membrane irritation.

3. How to Use Lignox Spray

Lignox Spray is administered to the patient by a doctor. However, if the medicine has been prescribed for self-administration by the patient, it should always be used in accordance with the doctor's recommendations. In case of doubts, consult a doctor.
It should be used in adult patients and children over 4 years of age. The smallest effective dose of the medicine should always be used.
In weakened, seriously ill, and elderly patients, the method of dosing should be selected according to the patient's age and general condition.
Do not inhale the vapors. Do not swallow the medicine.
Lignox Spray should not get into the eyes. Protect your eyes from contact with the medicine.
Before the first use, press the spray pump several times to fill it with liquid.
Whenever possible, during the use of Lignox Spray, hold the bottle vertically.
A detailed description of the use of Lignox Spray is provided in the further part of the leaflet (see the section "Information intended exclusively for medical personnel").

Use in Children Over 4 Years of Age

The method of dosing the medicine differs depending on the age and weight of the child, the patient's general condition, the size of the anesthetized area, and the type of procedure performed.

Using a Higher Than Recommended Dose of Lignox Spray

In case of use in children or when using large amounts, it is recommended to calculate the dose based on the patient's body weight (see the section "Information intended exclusively for medical personnel").
In case of symptoms of acute systemic toxicity, in particular atrial flutter and cardiac arrest, immediate resuscitation measures should be taken.
In case of any further doubts related to the use of this medicine, consult a doctor.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of severe side effects, including allergic reactions, consult your doctor immediately.
Very rare(occur in less than 1 in 10,000 patients):
allergic reactions (symptoms: swelling of the face, lips, tongue, or throat (difficulty swallowing), swelling of hands, feet, and ankles, difficulty breathing, severe skin itching), in extreme cases anaphylactic shock (symptoms: blood pressure drop, weakness, fainting).
Frequency not known(frequency cannot be estimated from the available data):
local irritation at the site of application, sore throat, hoarseness, loss of voice (after administration to the laryngeal mucosa before intubation), nervousness, drowsiness, dizziness, convulsions, loss of consciousness, respiratory arrest, hypotension, myocardial hypoxia, bradycardia (too slow heart rate), cardiac arrest.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax +48 22 49 21 309, website: 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 Lignox Spray

Store in a temperature below 25°C.
Store the bottle tightly closed.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
After opening the packaging, store for no more than 12 months.
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 Pack and Other Information

What Lignox Spray Contains

• The active substance of the medicine is lidocaine.
• The other ingredients are: ethanol, propylene glycol, peppermint oil, saccharin.

What Lignox Spray Looks Like and What the Pack Contains

Lignox Spray is a colorless, clear alcoholic solution with a characteristic minty smell.
The immediate packaging consists of a type III brown glass bottle, closed with a spray pump made of HDPE/POM/LDPE/stainless steel/EVA/IIR/ LDPE and HDPE mixture, with an applicator made of PP/HDPE, containing 38 g of liquid. The bottle, together with the patient 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: [email protected]

Date of Last Update of the Leaflet: -------------------------------------------------------------------------------------------------------------------------------------------

Information Intended Exclusively for Medical Personnel:

Read the Summary of Product Characteristics (SmPC) of Lignox Spray.
The Summary of Product Characteristics is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Also, read section 3 of the leaflet.
One dose (one spray) of Lignox Spray contains 8.7 mg of lidocaine.
From one package (38 g of medicine), about 430 sprays can be performed.
It is not necessary to dry the treatment area before using Lignox Spray.
Lignox Spray should not be used on the surface of instruments made of plastic (see section 4.4 of the SmPC).
Always use the smallest effective dose of Lignox Spray.
Dosing
Adults
In weakened, seriously ill, and elderly patients, the method of dosing should be selected according to the patient's age and general condition.
Do not administer a maximum daily dose of more than 200 mg of lidocaine to adult patients, which corresponds to 2.2 ml of medicine (about 22 sprays).
The method of dosing the medicine differs depending on the indication and the size of the anesthetized area.
Guidelines for dosing in different indications:
Indications
Lidocaine dose (number of sprays)
Dentistry
8.7-26.1 mg (1-3 sprays)
Otolaryngology
8.7-26.1 mg (1-3 sprays)
Obstetrics
87-130.5 mg (10-15 sprays)
up to about 200 mg
(22 sprays)
Endoscopy
and instrument examinations
8.7-26.1 mg (1-3 sprays)
Children over 4 years of age
The method of dosing the medicine differs depending on the age and weight of the child, the patient's general condition, the size of the anesthetized area, and the type of procedure performed.
The average dose used is 16.2 mg to 24.3 mg of lidocaine per session.
The recommended dose of lidocaine in mg, which can be used in children, is calculated using the formula: child's weight (in kg) x 1.33. Do not administer a dose of lidocaine greater than 2.2 mg/kg body weight.
Treatment of Toxicity After Overdose
In case of symptoms of toxicity from the nervous, respiratory, or circulatory system, immediate resuscitation measures should be taken. Necessary medicines and equipment should be available immediately. Ensure proper ventilation using oxygen and apply artificial respiration. In case of seizures that do not stop spontaneously within 15-30 seconds, administer anticonvulsant drugs. Thiopental sodium administered intravenously in a dose of 1-3 mg/kg stops seizures immediately. Alternatively, diazepam can be used in a dose of 0.1 mg/kg body weight, although its action will be slow. Prolonged seizures can threaten the patient with hypoxia. In such cases, a muscle relaxant, e.g. 1 mg/kg body weight of succinylcholine, is administered intravenously. Succinylcholine may cause respiratory arrest, so it should only be administered by specialists with experience in tracheal intubation and treatment of patients with respiratory paralysis.
In case of cardiovascular symptoms (hypotension, bradycardia), intravenous administration of ephedrine in a dose of 5-10 mg/kg is recommended, and the dose can be repeated after 2-3 minutes if necessary.
In case of atrial flutter and cardiac arrest, immediate resuscitation measures should be taken.