Lidocain-egis

Package Leaflet: Information for the User

Lidocain-EGIS, 10%, Skin Spray, Solution

Lidocaine
Read the package leaflet carefully before taking 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, pharmacist, or nurse.
• 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 experience any side effects, including any not listed in this leaflet, please tell your 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 pack and other information

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

Lidocaine, the active substance of Lidocain-EGIS, belongs to a group of local anesthetics.
Local anesthetics temporarily block nerve conduction in the area 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 or mucous membrane anesthesia is required, e.g., in minor surgical procedures for anesthesia of the surgical field, anesthesia of the injection site before local anesthesia. The medicine can be used in dentistry and oral 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 oral surgery, the use of lidocaine spray is contraindicated before taking dental impressions, due to the risk of the medicine entering the airways.

Warnings and precautions

Before starting treatment with Lidocain-EGIS, consult your doctor or pharmacist

• in case of application to the throat mucosa (the cough reflex is also suppressed, 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 effect of the active substance and therefore the doctor may decide to use smaller doses of the medicine.

It is also important to consider the following notes.
It is essential to prevent the entry of lidocaine into the airways.
During the application of Lidocain-EGIS spray, the bottle should be held vertically.
The spray should not get into the eyes.
Children
In children under 2 years of age, it is best to use lidocaine in the form of brushing (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.
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 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

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Caution should be exercised when using Lidocain-EGIS in case of concomitant use of antiarrhythmic medicines (medicines used in heart rhythm disorders).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In the absence of a safer treatment method, lidocaine may also be used during pregnancy. Lidocaine passes into breast milk, but at the doses normally used, 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 ethanol (alcohol), propylene glycol, and peppermint oil (containing d-limonene as an ingredient).

Ethanol (alcohol)

This medicine contains 34.61 mg of ethanol (alcohol) in each dose (spray).
In case of application to the skin:
May cause burning of damaged skin.
In case of application to mucous membranes:
The amount of ethanol in one dose of this medicine (spray) is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Propylene glycol

This medicine contains 9.08 mg of propylene glycol in each dose (spray).
In case of application to the skin:
Propylene glycol may cause skin irritation.
In case of application to mucous membranes:
Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Fragrance (peppermint oil)

This medicine contains a fragrance with d-limonene. D-limonene may cause allergic reactions.

3. How to use Lidocain-EGIS

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Local anesthetic effect occurs within one minute and lasts from 5 to 6 minutes.
Numbness may last for 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.

4. Possible side effects

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

• Very rare: allergic reactions. Severe allergic reaction to lidocaine may require immediate medical attention. If you experience any symptoms during and after application of the medicine, tell your doctor immediately.

Pychiatric disorders

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

Nervous system disorders

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

Cardiac disorders

• Myocardial weakness, 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 edema (angioedema) and urticaria.

Injury, poisoning, and procedural complications

• At the time of 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 sensation disorders may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Lidocain-EGIS

Store the medicine at a temperature below 25°C.
Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP. The expiry date refers to the last day of the month.
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 Lidocain-EGIS contains

The active substance of Lidocain-EGIS is lidocaine. 38 g of alcoholic solution contains 3.8 g of lidocaine.
One dose (spray) contains 4.6 mg of lidocaine.
The other ingredients are: ethanol 96%, propylene glycol, peppermint oil (contains d-limonene as an ingredient).

What Lidocain-EGIS looks like and contents of the pack

Colorless or slightly yellowish alcoholic solution with a characteristic peppermint smell in a type III orange glass bottle with a dosing pump and spray nozzle, protected by a LDPE cap, in a cardboard box.
The pack contains 38 g of solution.

Marketing authorization holder

EGIS Pharmaceuticals PLC
1106 Budapest
Keresztúri út 30-38
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: