Lidocain-egis

Package Leaflet: Information for the User

Warning! Keep the Leaflet! 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 medicine.

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 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 medicine 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
• Read the leaflet carefully before taking 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, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

(listed in section 6).

• In dentistry and maxillofacial 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 a doctor or pharmacist

• in case of application to the throat mucosa (the cough reflex is also inhibited, which can lead to aspiration pneumonia);

if the patient has 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 the doctor may decide to use smaller doses of the medicine.

• Also, consider the following notes.
  It is essential to prevent the entry of lidocaine into the airways.
  When applying the Lidocain-EGIS spray, hold the bottle upright.
  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 brushing (applying with a swab soaked in the medicine).
  Application to the cheek mucosa poses a risk of swallowing disorders and, consequently, aspiration (inhalation) into the airways, especially in children. Due to the numbness of the tongue and cheek mucosa, there is a risk of their injury due to biting.
  Caution should be exercised 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

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

  Pregnancy and breastfeeding

  If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  Before taking any medicine, 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 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 your doctor. If you are unsure, 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, this medicine 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 cases of allergic reactions may occur. A severe allergic reaction to lidocaine may require immediate medical attention. If you experience any symptoms during and after using the medicine, tell 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

  • Weakening of the heart muscle, 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.

  Injuries, poisoning, and procedural complications

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

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

  Reporting side effects

  If you experience any side effects, including any possible side effects not listed in this leaflet, tell 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 49 21 309, website: https://smz.ezdrowie.gov.pl.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Lidocain-EGIS

  Store in a temperature below 25°C in the original packaging.
  Keep the medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the packaging. 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 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 contents of the pack

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

  Marketing authorization holder in Romania, the country of export:

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

  Manufacturer:

  Egis Pharmaceuticals PLC
  Mátiás király u. 65
  9900 Körmend
  Hungary

  Parallel importer:

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

  Repackaged by:

  InPharm Sp. z o.o. Services sp. k.
  ul. Chełmżyńska 249
  04-458 Warsaw
  Marketing authorization number in Romania, the country of export: 12783/2019/01

  Parallel import authorization number: 87/22 Date of approval of the leaflet: 16.02.2022