Lidocaine egis

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Lidocain-EGIS (Lidocain)
10%, cutaneous spray, solution
Lidocainum
Lidocain-EGIS and Lidocain are different trade names of the same medicinal product.
Please read the entire 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 you experience any adverse reactions, 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 use of 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 situation requiring anaesthesia of the skin and mucous membranes, e.g. minor surgical procedures to anaesthetize the surgical field, anaesthetizing 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 to use 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 preferable to apply lidocaine by painting (using a swab soaked in the medicine).
Application to the buccal mucosa (inside of the cheek) may pose a risk of swallowing difficulties and subsequent aspiration (inhalation) into the respiratory tract, especially in children. Due to numbness of the tongue and buccal 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 through 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.
Caution is advised when using Lidocain-EGIS concurrently with antiarrhythmic medicines (medicines used for heart rhythm disorders).
Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if pregnancy is suspected or being planned, consult a doctor or pharmacist before using this medicine.
Consult a doctor before using any medicine. In the absence of a safer treatment option, lidocaine may 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 ethanol (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 directed by a physician. 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, this procedure may need to be repeated to re-prime.

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

• Allergic reactions may occur very rarely. 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: central nervous system depression, dizziness, drowsiness, convulsions, 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 sensation disappears as soon as the medicine starts to work (within 1 minute). At the site of application, transient erythema, 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) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Lidocain-EGIS

Store below 25°C, in the original packaging.
Keep Lidocain-EGIS out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. 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 colourless alcoholic solution with a mint odour in a brown glass bottle equipped with a metering pump and spray nozzle, in a cardboard box.
The pack contains 38 g of solution.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, 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
Poland

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

Marketing authorisation number in Romania, country of export: 12783/2019/01
Parallel import authorisation number: 41/13