Label: Information for the User

Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml Injectable Solution EFG

Lidocaína, Epinefrina

Read this label carefully before starting to use this medication, as it contains important information for you

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Lidocaína / Epinefrina Dermogen is an injectable solution. It is presented in a cartridge, in a single unit package, a package of 50 cartridges and a package of 100 cartridges.

Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG is indicated for local dental anesthesia, by infiltration or peripheral nerve block.

Do not use Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG:

• If you are allergic to the active principles, amide-type local anesthetics, or any of the other components of this medication included in section 6.
• If you have closed-angle glaucoma (increased intraocular pressure), paroxysmal tachycardia (rapid pulse), or absolute arrhythmia with high frequency (cardiac rhythm alteration).
• Do not administer by intravenous route.

Warnings and precautions

Consider before starting the administration of Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG:

• If you have any liver disorder. If the disorder is severe, you should have special caution since toxic concentrations of lidocaína may be reached.
• If you have kidney disease, since 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-selective beta-blockers.
• If you have cardiovascular dysfunction since the depressor effects on the heart may be increased.
• If you are sensitive to drugs, especially to anesthetics or other chemically related components.
• It may contribute to the development of malignant hyperthermia in the case of supplementary anesthesia being required.
• Oxygen, equipment, and resuscitation medications should be readily available.
• Avoid injecting into an inflamed or infected area.

Consult if any of the circumstances mentioned above have occurred to the patient at any time.

Other medications and Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Even those acquired without a prescription. Some medications may influence the action of others.

Do not administer with the following medications:

• Tricyclic antidepressants or monoamine oxidase inhibitors (MAO): may increase the vasopressor effect of epinephrine.
• Phenothiazine and butyrophenone: may reduce or reverse the vasopressor effect of epinephrine.
• Non-selective beta-blockers (e.g., propanolol).
• Central nervous system depressants: may lead to additive depressor effects.

• Disinfectant solutions containing heavy metal ions: lidocaína releases the ions of these solutions, which may cause severe local irritation and swelling.
• Non-selective beta-blockers: may slow down the metabolism of lidocaína due to reduced hepatic blood flow, leading to an increased risk of lidocaína toxicity.
• Cimetidine: may inhibit the hepatic metabolism of lidocaína, leading to an increased risk of lidocaína toxicity.
• Neuromuscular blockers: the anesthetic may prolong or potentiate the action of this type of medication.

The intramuscular injection of lidocaína may produce an increase in phosphokinase levels.

Use of Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG with food:

After administration of Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG, do not ingest food until sensitivity has been restored.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:Consult your doctor or pharmacist before using a medication. You should exercise caution when prescribing to pregnant women.

No clinical data on lidocaína are available for pregnant women. Animal studies do not directly or indirectly indicate harmful effects with respect to pregnancy, embryonic/fetal development, delivery, or postnatal development.

Lactation:Consult your doctor or pharmacist before using a medication. Lidocaína is excreted in small amounts in breast milk. Although the possible consequences for the infant are unknown, the potential for adverse effects appears to be low.

Driving and operating machinery

Although no effects on the ability to drive vehicles are anticipated, the dentist will decide when you are able to drive and operate machinery.

Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG contains sodium metabisulfite (E-223)

This medication contains sodium metabisulfite (E-223) as an excipient. Rarely, it may cause severe allergic reactions and bronchospasm (sudden feeling of choking).

Competitors should be aware that lidocaína may produce a positive result in doping tests.

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

The recommended dose is:

• In infiltrations or terminal anesthesia, administration of 1 ml of Lidocaína / Epinefrina Dermogen 20 mg/ml + 0,0125 mg/ml injectable solution EFG is generally sufficient.
• 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 sensitivity is restored.

If you use more Lidocaína / Epinefrina Dermogen 20 mg/ml + 0,0125 mg/ml injectable solution EFG than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount received.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Common(>1/100, <1>:excitement, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, nausea, vomiting, tremors, and seizures. Tongue numbness and perioral numbness. After excitement, depression with drowsiness, respiratory alterations that may lead to respiratory arrest and coma, even with cardiac alterations (myocardial depression), low blood pressure (hypotension), decreased heart rate (bradycardia), arrhythmia, and cardiac arrest.

Very Rare(<1>:allergic reactions (urticaria, anaphylactoid reaction), blood disorder (methemoglobinemia).

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

If any of these reactions or any other reaction not described in this prospectus are observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep Lidocaína / Epinefrina Dermogen 20 mg/ml + 0.125 mg/ml injectable solution EFG out of the reach and sight of children.

Do not store at a temperature above 30°C. Store the blister in the outer packaging to protect it from light. Do not freeze.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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

• The active principles are lidocaine and epinephrine
• The other excipients are: Sodium metabisulphite (E-223), sodium chloride, injection water.

Appearance of the product and contents of the package

Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG is presented as an injectable solution in glass cartridges. Unit package containing one cartridge and a leaflet. Package containing 50 cartridges of 1.8 ml and a leaflet. Clinical package containing 100 cartridges in blister support and a leaflet.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER, S.A.

C/La Granja, 1

28108-Alcobendas, Madrid

Spain

Responsible for manufacturing

PIERREL, S.P.A.

Via Nazzionale Appia (Capua, Caserta) I-81043

Italy

Date of the last review of this leaflet:04/2017.

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.

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This information is intended solely for healthcare professionals

Administration method

By injection into the oral mucosa.

ONLY FOR USE IN DENTAL ANESTHESIA.

To avoid intravascular injection, a control aspiration should always be carried out in at least two planes (rotation of the needle in 180°), although a negative aspiration result does not rule out the possibility of an involuntary and unnoticed intravascular injection.

The injection speed should not exceed 0.5 ml in 15 seconds, i.e., 1 cartridge per minute.

Major systemic reactions, resulting from an accidental intravascular injection, can be avoided in most cases by a technical injection (after aspiration, slow injection of 0.1-0.2 ml and slow application of the rest), not before 20-30 seconds have elapsed).

Used cartridges should not be used in other patients. Residues should be disposed of.

Precautions for use.

Each time a local anesthetic is used, the following medications/therapies should be available:

• -Anticonvulsant medications (benzodiazepines or barbiturates), muscle relaxants, atropine, and vasopressors or epinephrine for severe allergic or anaphylactic reactions.

• -Resuscitation equipment (particularly an oxygen source) capable of artificial ventilation if necessary.

• -Careful and constant monitoring of cardiovascular and respiratory vital signs (adequate ventilation) and the patient's level of consciousness after each local anesthetic injection. Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or somnolence may be early warning signs of central nervous system toxicity.

Treatment in cases of overdose

General basic measures:

Hypertension:Elevation of the upper body, if necessary, nifedipine sublingual will be administered.

Convulsions:Protect the patient from simultaneous damage, if necessary, benzodiazepines (e.g., diazepam i.v.) will be administered.

Hypotension:Horizontal position, if necessary, intravenous infusion of a complete electrolyte solution, vasopressor (e.g., etilefrine i.v.)

Bradycardia:Atropine i.v.

Anaphylactic shock:Get in touch with an emergency doctor, meanwhile,

Shock position, generous infusion of a complete electrolyte solution, if necessary, adrenaline i.v., cortisone i.v.

Cardiovascular arrest:Immediate cardiopulmonary resuscitation, get in touch with the emergency doctor.