BY Egis Pharmaceuticals PLC 1106 Budapest, Kereszturi ut 30-38.
What is Lidocaine-EGIS and what is it used for
Lidocaine, the active substance in the spray, is from the topical anesthetic group.
These anesthetics are compounds that temporarily inhibit conductivity in nerve tissue elements at the site of drug administration. After topical administration, these anesthetics first suppress the sensation of pain and then suppress the sensation of warmth and touch.
Lidocaine-EGIS spray can be used in all cases where skin and mucosal pain relief is required.
For example, with small surgical procedures to anesthetize the area of surgery or the injection site before local anesthesia.
It can be used in dentistry or oral surgery, otolaryngology, obstetrics, dermatology, endoscopy or instrumental examinations.
The recommended dose is:
Usually 1-3 sprays are sufficient, but 15-20 or more sprays are applied in gynecological procedures (no more than 40 sprays / 70 kg body weight).
The action of the local anesthetic occurs within 1 minute and lasts 5-6 minutes. The tingling may take 15 minutes. The spray should not come into contact with the eyes.
Use in children and adolescents
Lidocaine-EGIS 10% skin spray is indicated for use in children and adolescents aged 4 to 18 years.
Based on medical literature, surgery for the mouth and teeth, Lidocaine-EGIS can also be used in children, preferably with a wet cotton swab, to eliminate the fear of splashing and the tingling sensation appears as a side effect.
The dosage of lidocaine hydrochloride in mg for use in children can be calculated by the following formula: child weight (in kilograms) x 1.33.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When using a larger amount of spray or if you have hypersensitivity to the active substance, allergic or side-effects may occur throughout the body:
Very rare (can affect up to 1 in 10,000 people):
• Urticaria, swelling of the lips, mouth or throat, causing difficulty in swallowing or breathing; bronchial spasms, hypersensitivity reactions in the most serious cases.
• Dizziness, drowsiness, seizures, loss of consciousness
Unknown frequency (frequency cannot be determined from available data)
• Low blood pressure
• Delayed heartbeat, cardiac arrest (heart stops pumping blood)
• Myocardial damage
If you experience any of the above side effects, tell your doctor immediately.
The side effects are usually mild and occur at the site of administration:
Unknown frequency (frequency cannot be determined from available data):
• Slight pinching sensation at the time of spraying. It disappears after the analgesic effect occurs (within 1 minute).
• Temporary redness, swelling and sensory disturbances may occur at the site of administration.
• Temporary sore throat, excessive voice or loss of voice after throat application.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at the Drug Enforcement Agency, 8, Damyan Gruev Str., 1303 Sofia, tel .: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Lidocaine
Store below 25 ° C.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Lidocaine-EGIS contains
Each bottle contains 38 g of lidocaine solution (at least 650 doses).
Each dose contains 4.6 mg lidocaine.
The other ingredients are: ethanol 96%, propylene glycol, peppermint.
What Lidocaine-EGIS looks like and contents of the pack
Colorless solution with a characteristic menthol scent – A bottle fitted with a plastic mechanical dispenser and a protective cap are placed in a carton with the package leaflet: user information.
1×38 g (650 doses / bottle)
Marketing Authorization Holder
Egis Pharmaceuticals PLC 1106 Budapest,