Lidocaine-egis

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Lidocain-EGIS (Lidocain)
10%, cutaneous spray, solution
Lidocainum
Lidocain-EGIS and Lidocain are different brand names for the same medicine.

• Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Lidocain-EGIS is and what it is used for

Lidocaine, the active substance in Lidocain-EGIS, belongs to a group of medicines called local anaesthetics.
Local anaesthetics temporarily block nerve conduction at the site of application.
After local application, local anaesthetics first suppress the sensation of pain, followed by the sensation of heat and touch.
Lidocaine may be used in any case where anaesthesia of the skin and mucous membranes is required, e.g. during minor surgical procedures to anaesthetize the operative field, or to anaesthetize the injection site prior to local anaesthesia. The medicine may be used in dentistry and maxillofacial surgery, otorhinolaryngology, gynaecology and obstetrics, dermatology, endoscopy, and invasive diagnostic procedures.

2. Important information before using Lidocain-EGIS

When not to use Lidocain-EGIS

• If the patient is allergic to lidocaine or any of the other ingredients of this medicine

(listed in section 6).

• In dentistry and maxillofacial surgery, the use of lidocaine in aerosol form is contraindicated prior to taking prosthetic impressions due to the risk of the medicine entering the respiratory tract.

Warnings and precautions
Before starting treatment with Lidocain–EGIS, consult a doctor or
pharmacist

• when applying to the mucous membrane of the throat (the cough reflex may also be suppressed, which could lead to aspiration pneumonia);

• in cases of severe shock, cardiac arrhythmias (heart rhythm disorders), low blood pressure, impaired liver or kidney function, porphyria, or epilepsy, the patient may be more sensitive to the active substance, and therefore the doctor may decide to use lower doses of the medicine.

The following points should also be considered.
It is essential to prevent lidocaine from entering the respiratory tract.
When applying Lidocain-EGIS as an aerosol, the bottle should be held vertically.
The aerosol must not enter the eyes.
Children
In children under 2 years of age, it is best to use lidocaine by painting (applying with a medicated swab).
Application to the mucous membranes of the cheeks carries a risk of swallowing disorders and subsequent aspiration into the respiratory tract, especially in children. Due to numbness of the tongue and cheek mucosa, there is a risk of injury from biting.
Caution should be exercised when applying the medicine to damaged or infected skin or mucous membranes (oral cavity, gums), as lidocaine is well absorbed through mucous membranes and damaged skin. This is particularly important if the child being treated is sensitive to lidocaine.
In such cases, the doctor may decide to use lower doses of the medicine.
Other medicines and Lidocain-EGIS
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.
Exercise caution when using Lidocain-EGIS if taking antiarrhythmic medicines (medicines used for heart rhythm disorders) concomitantly.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if there is suspicion of pregnancy, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Consult a doctor before using any medicine. If no safer treatment method is available, lidocaine may also be used during pregnancy. Lidocaine passes into breast milk; however, when usual therapeutic doses are used, the amount transferred is so small that it does not pose a health risk to the breastfed infant.
Driving and operating machinery
Depending on the dose, local anaesthetics may have a slight effect on mental function and motor coordination, and may temporarily impair the ability to drive or operate machinery.
Lidocain-EGIS contains a small amount of alcohol, less than 100 mg per dose. The medicine contains
propylene glycol, which may cause skin irritation.

3. How to use Lidocain-EGIS

This medicine should always be used as recommended by a doctor. If in doubt, consult a doctor or pharmacist.
Local anaesthetic effect appears within one minute and lasts for 5 to 6 minutes. Numbness may persist for up to 15 minutes. The aerosol must not enter the eyes.
After removing the cap and attaching the dosing nozzle, the pump dispenser should be primed before first use (by pumping several times until the aerosol appears).
If the pump dispenser has not been used for a prolonged period, the priming procedure may need to be repeated to re-prime the pump.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When higher doses are used or in cases of hypersensitivity to the active substance, the following systemic adverse reactions may occur:

Immune system disorders

• In very rare cases, allergic reactions may occur. A severe allergic reaction to lidocaine may require immediate medical attention. If the patient experiences any discomfort during or after administration of the medicine, they should immediately inform their doctor.

Psychiatric disorders

• Very rare: central nervous system symptoms, restlessness, nervousness.

Nervous system disorders

• Very rare: symptoms of central nervous system depression, dizziness, drowsiness, seizures, loss of consciousness.

Cardiac disorders

• Weakening of the heart muscle, slow heart rate, cardiac arrest.

Vascular disorders

• Low blood pressure.

Respiratory, thoracic and mediastinal disorders

• Bronchospasm, respiratory paralysis.

Skin and subcutaneous tissue disorders

• Severe allergic reaction causing facial or throat swelling (angioedema) and urticaria.

Injury, poisoning and procedural complications

• At the moment of spraying, a mild stinging sensation may occur. This disappears when the medicine starts to work (within 1 minute). At the site of application, transient redness, swelling and sensory disturbances may occur.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Lidocain-EGIS

Store below 25°C in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Lidocain-EGIS contains
The active substance is lidocaine. 38 g of alcoholic solution contains 3.80 g of lidocaine.
One spray contains 4.6 mg of lidocaine.
The other ingredients are: ethanol 96%, propylene glycol, peppermint oil.

What Lidocain-EGIS looks like and contents of the pack
A clear alcoholic solution with a minty odour, in a brown glass bottle equipped with a metering pump and spray nozzle, protected by a protective cap, packed in a cardboard box.
The pack contains 38 g of solution.

For further information, please contact the responsible entity or the parallel importer.

Responsible entity in Romania, country of export:
Egis Pharmaceuticals PLC
Keresztúri út. 30-38
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorization number in Romania, country of export: 12783/2019/01
Parallel import authorization number: 87/22