LIDOCAINE/EPINEPHRINE NORMON 20 mg/mL + 0.0125 mg/mL INJECTABLE SOLUTION

Introduction

LEAFLET: INFORMATION FOR THE USER

Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

Lidocaine hydrochloride monohydrate/Epinephrine (bitartrate)

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• If you experience side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG and what is it used for
2. What you need to know before starting to use Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG
3. How to use Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG
4. Possible side effects
5. Storage of Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG
6. Package contents and additional information

1. What is Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG and what is it used for

Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml is indicated for local dental anesthesia, by infiltration or trunk block.

2. What you need to know before starting to use Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

Do not use Lidocaine/Epinephrine Normon:

• If you are allergic to lidocaine, epinephrine, local anesthetics of the amide type, or any other component of the formulation.
• If you have narrow-angle glaucoma (increased intraocular pressure), paroxysmal tachycardia (rapid pulse), or complete high-frequency arrhythmia (alteration of heart rhythm).

Warnings and precautions

• If you have any liver disorder. If the disorder is severe, special caution should be exercised, as toxic levels of lidocaine may be reached.
• If you have kidney disease, as the anesthetic or its derivatives may accumulate.

• If you are being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines, and if you are being treated with non-cardioselective beta-blockers.

• If you have heart dysfunction, as the cardiac depressive effects may be increased.
• If you are sensitive to drugs, especially anesthetics or other chemically related components.

Avoid injection into an inflamed or infected area.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

• Other medicines and Lidocaine/Epinephrine Normon:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including those obtained without a prescription. Some medicines may influence the action of others.

It is not recommended to administer Lidocaine/Epinephrine Normon with the following medicines:

• Tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs): may increase the vasodepressive effect of epinephrine.
• Phenothiazines and butyrophenones: may reduce or reverse the vasodepressive effect of epinephrine.
• Non-cardioselective beta-blockers (e.g., propranolol).
• Central nervous system depressants: may cause additive depressive effects.
• Disinfectant solutions containing heavy metal ions: lidocaine releases ions from these solutions, which can cause significant local irritation and swelling.
• Neuromuscular blockers: the anesthetic may prolong or potentiate the action of this type of drug.

Intramuscular injection of lidocaine may increase phosphokinase levels.

• Use of Lidocaine/Epinephrine Normon with food, drinks, and alcohol

After administration of Lidocaine/Epinephrine Normon, do not eat until sensitivity has been restored.

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine. Special caution should be exercised when prescribing to pregnant women.

Lidocaine is excreted in small amounts in breast milk. No problems have been described during breastfeeding.

Driving and using machines:Although no effects on the ability to drive are expected, the dentist will decide when you are able to drive and operate machinery.

• Lidocaine/Epinephrine Normon contains sodium metabisulfite and sodium:

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite (E-223).

For doses below 3.91 ml, this medicine contains less than 23 mg of sodium per dose; i.e., it is essentially "sodium-free".

For doses equal to or greater than 3.91 ml, this medicine contains 23 or more mg of sodium (main component of table/cooking salt) in each dose equivalent to 1.1-7.3% of the maximum recommended daily sodium intake for an adult.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to use Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

Your dentist will determine the dose and method of administration of Lidocaine/Epinephrine Normon.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

In infiltrations or terminal anesthesia, it is generally sufficient to administer 1 ml of Lidocaine/Epinephrine Normon. In trunk anesthesia, the dose will be 1.5 to 2 ml. The maximum dose in 24 hours is 500 mg of lidocaine, and it should not exceed 7 mg/kg of body weight in adults.

Do not eat until sensitivity has been restored.

Pediatric population and special populations

In children, elderly patients, debilitated patients, and patients with cardiac and/or hepatic diseases, the doses should be reduced, according to age and physical condition.

Method of administration

Administration should be done slowly.

Do not administer intravenously.

• If you receive more Lidocaine/Epinephrine Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or nurse immediately, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount used.

Respiratory, circulatory, and convulsive complications may occur. If they occur, administration will be interrupted, and appropriate treatment will be initiated.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lidocaine/Epinephrine Normon can have side effects, although not everyone will experience them.

The frequencies of adverse reactions are defined as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and frequency not known (cannot be estimated from available data).

Very common (at least 1 in 10 patients):excitement, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, nausea, vomiting, tremors, and convulsions. After excitement, respiratory depression and coma may appear, even with myocardial depression (decreased heart muscle activity), hypotension (decreased blood pressure), bradycardia (slow heart rate), arrhythmia (alterations in heart rhythm and frequency), and cardiac arrest.

Very rare(less than 1 in 10,000 patients):Allergic reactions.

Other adverse reactions:Epinephrine may cause tachycardia (rapid heart rate), cardiac rhythm disorders, increased blood pressure, although it is extremely rare.

If you think any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

Keep out of sight and reach of children.

Do not store above 30°C and keep in the original packaging to protect from light. Do not freeze.

Expiry date:Do not use Lidocaine/Epinephrine Normon after the expiry date stated on the packaging, after the expiry date. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

The active ingredients are Lidocaine hydrochloride monohydrate and Epinephrine (bitartrate). Each ml of the solution contains: Lidocaine hydrochloride monohydrate and Epinephrine (bitartrate).

The other ingredients are: Sodium metabisulfite (E-223), sodium chloride, water for injectable preparations.

Appearance of the product and package contents

Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml:clear, colorless or slightly yellowish solution.

Lidocaine/Epinephrine Normon 20 mg/ml + 0.0125 mg/ml is an injectable solution. It is presented in cartridges, in packages containing 1 cartridge of 1.7 ml and a leaflet.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in February 2020

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

For injection into the oral mucosa.

FOR USE ONLY IN DENTAL ANESTHESIA.

To avoid intravenous injection, aspiration should always be performed before injection.

The use of the appropriate injection syringe for infiltration anesthesia ensures perfect functioning, as well as maximum safety against cartridge breakage. Only the contents of intact cartridges should be injected.

In order to avoid any risk of infection (e.g., prevention of hepatitis transmission), it is essential to use newly sterilized syringes and needles. The remaining contents of partially used cartridges should not be administered to other patients.

For external disinfection of the cartridges, 91% isopropyl alcohol or 70% ethanol without denaturants is recommended. Solutions containing heavy metals are not recommended, as they release ions (mercury, zinc, copper, etc.), which can cause edema in local dental anesthetics.

When using any local anesthetic, oxygen, equipment, and resuscitation medications should be available.

Like other local anesthetics, due to excessive dosing, rapid absorption, or unnoticed intravascular injection, symptoms of intoxication may occur in the form of respiratory, circulatory, and convulsive complications.

In these cases, for respiratory disorders, ensure and maintain an open airway, administer oxygen, and initiate controlled or assisted breathing if necessary. In some patients, endotracheal intubation may be necessary.

For circulatory depression, it is recommended to administer a vasoconstrictor (preferably ephedrine) and intravenous fluids.

For convulsive crises, if the convulsions do not respond to assisted breathing, it is recommended to administer a benzodiazepine such as diazepam (in increments of 2.5 mg) or an ultrashort-acting barbiturate, such as thiopental or thiamylal (in increments of 50 to 100 mg) intravenously every 2 or 3 minutes. It should be kept in mind that in these circumstances, especially barbiturates, may cause circulatory depression when administered intravenously. It is also recommended to administer a neuromuscular blocker to reduce the muscular manifestations of persistent convulsive crises. When these drugs are administered, artificial respiration is mandatory.

Injection into an inflamed area should be avoided.