Lidocain-egis

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Lidocain-EGIS (Lidocaine)

10%, spray for the skin, solution

Lidocainum
Lidocain-EGIS and Lidocaine are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Lidocain-EGIS and what is it 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 packaging and other information

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

Lidocaine, the active substance of Lidocain-EGIS, belongs to the group of local anesthetics.
Local anesthetics temporarily block nerve conduction at the site of application.
After local application, local anesthetics first block the sensation of pain, and then the sensation of heat and touch. Lidocaine can be used in any case where skin and mucous membrane anesthesia is required, e.g., in minor surgical procedures to anesthetize the operating field, anesthetize the injection site before local anesthesia. The drug can be used in dentistry and maxillofacial surgery, otolaryngology, gynecology and obstetrics, dermatology, endoscopy, and invasive examinations.

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 spray is contraindicated before taking dental impressions, due to the risk of the medicine entering the airways.

Warnings and precautions

Before starting to use Lidocain-EGIS, you should consult a doctor or pharmacist

• in case of application to the throat mucosa (the cough reflex is also inhibited, which may cause aspiration pneumonia);
• in case 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 effects of the active substance, and therefore the doctor may decide to use smaller doses of the medicine.

You should also consider the following notes.
It is essential to prevent lidocaine from entering the airways.
When applying Lidocain-EGIS spray, the bottle should be held vertically.
The spray should not get into the eyes.
Children
For children under 2 years of age, it is best to use lidocaine in the form of swabbing (applying with a swab soaked in the medicine).
Application to the mucous membrane of the cheeks poses a risk of swallowing disorders and, consequently, aspiration (inhalation) into the airways, especially in children. Due to the numbness of the tongue and mucous membrane of the cheeks, there is a risk of their injury due to biting.
Care should be taken when using the medicine on 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 when the treated child is sensitive to lidocaine. In such a case, the doctor may decide to use smaller doses of the medicine.

Other medicines and Lidocain-EGIS

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Care should be taken when using Lidocain-EGIS if you are also taking anti-arrhythmic medicines (medicines used for heart rhythm disorders).

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you think you may be pregnant or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine. Before using any medicine, you should consult your doctor. In the absence of a safer treatment method, lidocaine may also be used during pregnancy. Lidocaine passes into breast milk, but when used in the usual therapeutic doses, the amount that passes into breast milk is so small that it does not pose a risk to the health of the breastfed child.

Driving and using machines

Depending on the dose, local anesthetics may have a slight effect on mental functions and motor coordination and may temporarily impair the ability to drive vehicles and operate machines.

Lidocain-EGIS contains a small amount of ethanol, 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 directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Local anesthetic effect occurs within one minute and lasts 5 to 6 minutes. Numbness may last 15 minutes. The spray should not get into the eyes.
After removing the cap and attaching the dosing tip, before the first use, the dosing pump should be primed (by pumping several times until the spray appears).
If the dosing pump has not been used for a long time, it may be necessary to repeat the priming process to refill it.

4. Possible side effects

Like all medicines, Lidocain-EGIS can cause side effects, although not everybody gets them.
In case of using higher doses or hypersensitivity to the active substance, the following systemic side effects may occur:
Immune system disorders

• Very rare cases of allergic reactions may occur. A severe allergic reaction to lidocaine may require immediate medical attention. If you experience any discomfort during or after using the medicine, you should inform your doctor immediately.

Psychiatric disorders

• Very rare: symptoms from the central nervous system, excitement, nervousness

Nervous system disorders

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

Cardiac disorders

• Myocardial weakness, slow heart rate, cardiac arrest

Vascular disorders

• Low blood pressure

Respiratory, thoracic, and mediastinal disorders

• Bronchospasm, respiratory failure

Skin and subcutaneous tissue disorders

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

Injury, poisoning, and procedural complications

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

If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Lidocain-EGIS

Store in a temperature below 25°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use Lidocain-EGIS after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste containers.
You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lidocain-EGIS contains

The active substance of the medicine is lidocaine. 38 g of the 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 what the pack contains

Colorless alcoholic solution with a peppermint smell in a brown glass bottle, equipped with a dosing pump and a spray nozzle, in a cardboard box.
The packaging contains 38 g of the solution.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
1106 Budapest
Keresztúri út. 30-38
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 12783/2019/01

Parallel import authorization number: 41/13 Date of approval of the leaflet: 23.01.2023

[Information about the trademark]