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

2. What you need to know before you start using Lidocaine/Epinephrine Dermogen 20 mg/ml + 0.125 mg/ml Solution for Injection EFG

Do not use Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG:

• If you are allergic to the active substances, local anesthetics of the amide type, or to any of the other components of this medicine listed in section 6.
• If you have closed-angle glaucoma (increased intraocular pressure), paroxysmal tachycardia (rapid pulse), or absolute arrhythmia with high frequency (cardiac rhythm disorder).
• Do not administer intravenously.

Warnings and Precautions

Take into account before starting the administration of Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG:

• If you have any liver disorder. If the disorder is severe, special caution should be taken, as toxic concentrations 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 inhibitor drugs, tricyclic antidepressants, or phenothiazines, and if you are undergoing treatment with non-cardioselective beta-blockers.
• If you have cardiovascular dysfunction, as the depressive cardiac effects may be increased.
• If you are sensitive to drugs, especially anesthetics or other chemically related components.
• It may contribute to the development of malignant hyperthermia in case supplementary anesthesia is required.
• Oxygen, equipment, and resuscitation medications should be readily available.
• Avoid injection into an inflamed or infected area.

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

Other Medicines and Lidocaine/ Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG:

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

The following medicines are not recommended for administration:

• Tricyclic antidepressants or monoamine oxidase inhibitors (MAO): may increase the vasoconstrictor effect of epinephrine.
• Phenothiazine and butyrophenones: may reduce or reverse the vasoconstrictor effect of epinephrine.
• Non-cardioselective beta-blocker drugs (e.g., propranolol).
• Central nervous system depressants: may result in additive depressive effects.

• Disinfectant solutions containing heavy metal ions: lidocaine releases the ions from these solutions, which may cause significant local irritation and swelling.
• Beta-adrenergic blockers: may slow down the metabolism of lidocaine due to decreased hepatic blood flow, which may increase the risk of lidocaine toxicity.
• Cimetidine: may inhibit the hepatic metabolism of lidocaine, leading to an increased risk of lidocaine toxicity.
• Neuromuscular blockers: the anesthetic may prolong or potentiate the action of these types of drugs.

Intramuscular injection of lidocaine may produce an increase in phosphokinase levels.

Using Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG with Food:

After administration of Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG, do not ingest food until sensitivity has been restored.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:Consult your doctor or pharmacist before using a medicine. Caution should be exercised when prescribing to pregnant women.

No clinical data on lidocaine in pregnant women are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, birth, or postnatal development.

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

Driving and Using Machines

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

Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG contains Sodium Metabisulfite (E-223)

This medicine contains sodium metabisulfite (E-223) as an excipient. It can rarely cause severe allergic reactions and bronchospasm (sudden feeling of suffocation).

Athletes should be aware that lidocaine may produce a positive result in doping tests.

3. How to use Lidocaine/Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG

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

The recommended dose is:

• For infiltrations or terminal anesthesia, it is generally sufficient to administer 1 ml of Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG.
• For 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 take food until sensitivity has been restored.

If you use more Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG than you should

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(>1/100, <1/10):excitement, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, nausea, vomiting, tremors, and convulsions. Numbness of the tongue and perioral region. After excitement, depression with drowsiness, respiratory alterations that can 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(<1/10,000):Allergic reactions (urticaria, anaphylactoid reaction), blood disorders (methemoglobinemia).

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

If you notice any of these reactions or any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine/Epinephrine Dermogen 20 mg/ml + 0.125 mg/ml Solution for Injection EFG

Keep Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG out of the reach and sight of children.

Do not store above 30°C. Keep the blister in the outer packaging to protect it from light. Do not freeze.

Do not use this medicine after the expiration date stated on the packaging after Exp. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG

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

Appearance of the Product and Package Contents

Lidocaine / Epinephrine Dermogen 20 mg/ml + 0.0125 mg/ml Solution for Injection EFG is presented as a solution for injection in glass cartridges. Single-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 a blister support and a leaflet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, S.A.

C/La Granja, 1

28108-Alcobendas, Madrid

Spain

Manufacturer

PIERREL, S.P.A.

Via Nazzionale Appia (Capua, Caserta) I-81043

Italy

Date of the Last Revision of this Leaflet:04/2017.

Other Sources of Information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

……………………………………………………………………………………………………

This information is intended only for healthcare professionals

Method of Administration

By injection into the oral mucosa.

FOR USE ONLY IN DENTAL ANESTHESIA.

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

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

Major systemic reactions, such as those resulting from 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 passed.

Opened cartridges should not be used in other patients. Residues should be discarded.

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 (in particular, 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 state of consciousness should be controlled after each local anesthetic injection. Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of central nervous system toxicity.

Therapy in Cases of Overdose

Basic General Measures:

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

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

Hypotension: Horizontal position, if necessary, intravascular infusion of a complete electrolytic solution, vasopressor (e.g., ethylephrine i.v.).

Bradycardia: Atropine i.v.

Anaphylactic shock: Contact an emergency doctor, meanwhile, shock position, generous infusion of a complete electrolytic solution, if necessary, adrenaline i.v., cortisone i.v.

Cardiovascular arrest: Immediate cardiopulmonary resuscitation, contact the emergency doctor.