PATIENT INFORMATION LEAFLET

Lidocaína/Epinefrina Normon 20 mg/ml + 0,0125 mg/ml injectable solution EFG

Lidocaína hydrochloride monohydrate/Epinephrine (bitartrate)

Lidocaína/Epinefrina Normon 20 mg/ml + 0,0125 mg/mlis indicated for local dental anesthesia, by infiltration or peripheral nerve block.

? No use Lidocaína/Epinefrina Normon:

• Si usted presenta alergia a lidocaína, epinefrina, anestésicos locales tipo amida o a cualquiera de los demás componentes de la formulación.
• Si usted presenta glaucoma de ángulo cerrado (aumento de la presión intraocular), taquicardia paroxística (pulso rápido) o arritmia completa de frecuencia elevada (alteración del ritmo cardíaco).

? Advertencias y precauciones

• Si tiene algún trastorno del hígado. Si el trastorno es severo se debe tener especial precaución ya que se pueden alcanzar concentraciones tóxicas de lidocaína.
• Si usted presenta enfermedad del riñón, ya que pueden acumularse el anestésico o sus derivados.

• Si usted está siendo tratado con fármacos inhibidores de la monoaminooxidasa, antidepresivos tricíclicos o fenotiacinas y si usted está en tratamiento con beta-bloqueantes no cardioselectivos.

• Si usted padece disfunción del corazón ya que se pueden aumentar los efectos depresores cardíacos.
• Si usted presenta sensibilidad a fármacos, especialmente a anestésicos u otros componentes químicamente relacionados.

Evitar la inyección en una zona inflamada o infectada.

Consulte a su médico, incluso si cualquiera de las circunstancias anteriormente mencionadas le hubiera ocurrido alguna vez.

• Otros medicamentos y Lidocaina/Epinefrina Normon:

Informe a su médico o farmacéutico si está tomando o ha tomado recientemente cualquier otro medicamento, incluso los adquiridos sin receta médica. Algunos fármacos pueden influir en la acción de otros.

No se recomienda la administración de Lidocaína/ Epinefrina Normon con los siguientes medicamentos:

• Antidepresivos tricíclicos o inhibidores de la MAO (monoaminooxidasa): pueden aumentar el efecto vasodepresor de epinefrina.
• Fenotiacina y butirofenonas: pueden reducir o revertir el efecto vasodepresor de epinefrina.
• Fármacos beta-bloqueantes no cardioselectivos (p. ej., propranolol).
• Depresores del sistema nervioso central: puede dar lugar a efectos depresores aditivos.
• Soluciones desinfectantes que contengan iones de metales pesados: lidocaína libera los iones de estas soluciones pudiendo producir gran irritación local e hinchazón.
• Bloqueantes neuromusculares: el anestésico puede prolongar o potenciar la acción de este tipo de fármacos.

La inyección intramuscular de lidocaína puede producir aumento en los niveles de fosfoquinasa.

• Uso de Lidocaina/Epinefrina Normon con alimento, bebidas y alcohol

Después de la administración de Lidocaína /Epinefrina Normon, no se ingerirán alimentos hasta que no se haya restablecido la sensibilidad.

• Embarazo y lactancia:

Consulte a su médico o farmacéutico antes de utilizar cualquier medicamento. Se deberá tener especial precaución cuando se prescriba a mujeres embarazadas.

Lidocaína se excreta, en pequeñas cantidades, en leche materna. No se han descrito problemas durante la lactancia

? Conducción y uso de máquinas: Aunque no son de prever efectos sobre la capacidad para conducir, el odontólogo decidirá en que momento es capaz de conducir y manejar maquinaria.

• Lidocaína/Epinefrina Normon contiene metabisulfito sódico y sodio:

Este medicamento puede producir reacciones alergicas graves y broncoespasmo (sensación repentina de ahogo) porque contiene metabisulfito de sodio (E-223).

Para las dosis por debajo de 3,91 ml, este medicamento contiene menos de 23 mg de sodio por dosis; esto es, esencialmente “exento de sodio”.

Para las dosis iguales o superiores a 3,91 ml, este medicamento contiene 23 o más mg de sodio (componente principal de la sal de mesa/para cocinar) en cada dosis equivalente a 1,1-7,3% de la ingesta diaria máxima de sodio recomendada para un adulto.

Se informa a los deportistas que este medicamento contiene un componente que puede establecer un resultado analítico de control de dopaje como positivo.

Your dentist will determine the dosage and method of administration of Lidocaína/Epinefrina Normon.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

In infiltrations or terminal anesthesia, it is generally sufficient to administer 1 ml of Lidocaína/Epinefrina Normon. In regional anesthesia, the dose will be 1.5 to 2 ml. The maximum dose in 24 hours is 500 mg of lidocaína, not exceeding in any case 7 mg/kg of body weight in adults.

Do not eat until you have regained your sensitivity.

Pediatric population and special populations

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

Method of administration

Administration should be carried out slowly.

Do not administer by intravenous route.

• If you receive more Lidocaína/Epinefrina Normon than you should

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

Respiratory, circulatory, and convulsive complications may occur. In case of occurrence, administration will be interrupted and appropriate treatment will be established.

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

Like all medications, Lidocaína/Epinefrina Normon may have adverse effects, although not everyone will experience them.

The frequencies of adverse reactions are defined as: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (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 unknown frequency (cannot be estimated from available data).

Very frequent (in at least 1 in 10 patients):excitement, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, nausea, vomiting, tremors, and seizures. After excitement, depression of respiration and coma may appear, even with myocardial depression (decrease in heart muscle activity), hypotension (decrease in 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:The epinephrine may cause tachycardia (acceleration of heartbeats), cardiac rhythm disturbances, increase in blood pressure, although this is extremely rare.

If you consider that some of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

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

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not store at a temperature above30°Cand store in the original packaging to protect it from light. Do not freeze.

Expiration Date:Do not use Lidocaína/Epinefrina Normon after the expiration date that appears on the packaging, after expiration. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Lidocaína/Epinefrina Normon 20 mg/ml + 0.0125 mg/ml injectable solution EFG

The active ingredients areLidocaína hydrochloride monohydrate and epinephrine (bitartrate).Each ml of the solution contains:Lidocaína hydrochloride monohydrateandEpinephrine (bitartrate).

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

Appearance of the product and contents of the package

Lidocaína/Epinefrina Normon 20 mg/ml + 0.0125 mg/ml:Transparent, colorless or slightly yellowish solution.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

The last review of this leaflet was in February 2020

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

For injection into the oral mucosa.

ONLY FOR USE IN DENTAL ANESTHESIA.

To avoid a venous injection, a prior 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 the external disinfection of cartridges, isopropyl alcohol 91% or ethanol 70% without denaturants is recommended. Solutions containing heavy metals should not be recommended, as they release ions (mercury, zinc, copper, etc.), which cause edema in local dental anesthetic injections.

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

Like other local anesthetics, due to excessive dosing, rapid absorption, or accidental 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 establish controlled or assisted ventilation if necessary. In some patients, endotracheal intubation may be necessary.

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

For convulsive crises, if convulsions do not respond to assisted ventilation, administering a benzodiazepine such as diazepam (in increments of 2.5 mg) or an ultra-short-acting barbiturate such as thiopental or thiamylal (in increments of 50 to 100 mg) intravenously every 2 to 3 minutes is recommended. It should be noted 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 administering these medications, artificial respiration is obligatory.

It should be avoided to inject into an inflamed area.