Lidocaine Normon 50 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lidocaine Normon 50 mg/ml injection solution EFG

Lidocaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Lidocaine Normon is and what it is used for
2. What you need to know before using Lidocaine Normon
3. How to use Lidocaine Normon
4. Possible adverse effects
5. How to store Lidocaine Normon
6. Contents of the pack and other information

1. What Lidocaína Normon is and what it is used for

This medicine contains lidocaine hydrochloride and belongs to a group of medicines called amide-type local anesthetics. It is used to block pain by reducing the conduction of nerve impulses near its site of action.

Lidocaína Normon is used to provide anesthesia by local injection around nerves or at sites where surgical procedures will be performed.

2. What you need to know before using Lidocaine Normon

Do not use Lidocaine Normon

• If you are allergic to lidocaine, to other amide-type local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).
• For epidural anaesthesia in patients with severe hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemic shock (severe loss of blood or body fluids).

Epidural anaesthesia must not be used during childbirth.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Lidocaine Normon:

• if you are elderly or in a generally weakened condition
• if you have heart problems such as slow or irregular heartbeat or heart failure
• if you suffer from any lung or respiratory disorder
• if you have liver disease or kidney problems
• if you have epileptic seizures
• if there is inflammation or infection at the injection site
• if you have porphyria (a rare inherited disease affecting the skin and nervous system)
• if you have blood clotting disorders
• if you are in the last trimester of pregnancy

Children

The use of lidocaine is not recommended in newborns. In children under 4 years of age, it should be used with caution, as data on efficacy and safety are limited.

Interaction of Lidocaine Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines:

• other local anaesthetics
• medicines used to treat gastroduodenal ulcers (e.g. cimetidine)
• medicines used to treat irregular heartbeat (e.g. amiodarone)

Pregnancy, breastfeeding and fertility

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

Your doctor will only administer this medicine during pregnancy or breastfeeding if considered necessary.

Driving and use of machines

This medicine may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you can drive or operate machinery.

Lidocaine Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; i.e., essentially "sodium-free".

3. How to use Lidocaine Normon

Lidocaine Normon will be administered to you by a doctor. It will be given as an injection into a vein, into a muscle, under the skin, around nerves, or into the epidural space near the spinal cord.

Lidocaine Normon is usually administered near the part of the body to be operated on.

The dose your doctor administers will depend on the type of pain relief you require, as well as on your height, age, physical condition, and the site of the body where the medicine is injected. You will receive the lowest possible dose needed to achieve the desired effect. The dose of lidocaine should be reduced in special populations and in patients with poor general health.

When injected into tissues with high systemic absorption, the single dose of lidocaine hydrochloride should not exceed 400 mg.

Use in children

The dose should be reduced in children. Lidocaine should be used with caution in children under four years of age.

If you are given more Lidocaine Normon than you should

The doctor supervising you is prepared to manage serious adverse effects related to an overdose of Lidocaine Normon.

The first signs that you have received more lidocaine than you should include:

• seizures,
• restlessness,
• feeling tired or dizzy,
• nausea,
• numbness or tingling of the lips and around the mouth,
• vision problems.

If you experience any of these symptoms, or if you think you have received too much lidocaine, inform your doctor or nurse immediately.

More serious adverse effects related to an overdose of lidocaine may occur, such as disturbances in balance and coordination, hearing changes, euphoria, confusion, speech difficulties, pallor, sweating, tremors, seizures, effects on the heart and blood vessels, loss of consciousness, coma, and brief interruption of breathing (apnea).

If you have any further questions about the use of this product, ask your doctor. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service (Tel. 915 620 420) immediately, indicating the medication and the amount used. Take this leaflet with you.

4. Possible adverse effects

Like all medicines, Lidocaína Normon may cause adverse effects, although not everyone experiences them.

Immediately inform your doctor or nurse if you experience a severe allergic reaction (angioedema or anaphylactic shock). Signs may include sudden onset of:

• swelling of the face, lips, tongue, or throat; which may lead to difficulty swallowing,
• severe or sudden swelling of the hands, feet, and ankles,
• difficulty breathing,
• intense skin itching (with hives),
• fever,
• decreased blood pressure.

The possible adverse effects after administration are essentially the same as those produced by other amide-type local anesthetics.

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea and vomiting
• Difficulty swallowing
• Depressed mood

Common adverse effects (may affect between 1 and 10 in 100 people):

• Transient neurological symptoms (pain in the legs and buttocks)
• Confusion, restlessness, irritability, euphoria, hallucinations, and depression
• Drowsiness
• Dizziness
• Blurred vision
• Tremors
• Vertigo
• Tingling sensation

Uncommon adverse effects (may affect between 1 and 10 in 1,000 people):

• Seizures
• Numbness of the tongue or tingling sensation around the mouth
• "Ringing" in the ears or noise sensitivity
• Loss of consciousness
• Tinnitus
• Speech difficulties
• Hypertension (high blood pressure)

Rare adverse effects (may affect between 1 and 10 in 10,000 people):

• Hypersensitivity reactions such as urticaria, skin rash, angioedema, bronchospasm, breathing difficulty, and, in severe cases, anaphylactic shock
• Trauma
• Chills
• Irritation (reaction in an area of the body)
• Spinal cord compression
• Muscle spasms
• Hypotension (low blood pressure)
• Respiratory depression (slow or interrupted breathing)
• Bradycardia (slow heart rate)

Very rare adverse effects (may affect 1 in 10,000 people):

• Ventricular tachycardia

Adverse effects with unknown frequency (cannot be estimated from the available data):

• Horner's syndrome (associated with epidural anesthesia or applications in the head and neck region)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Human Medicines Pharmacovigilance System at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine Normon

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Single-use product. Any remaining solution must be discarded. Visually inspect before use. Use only if the solution is clear and free from visible particles.

Medicines must not be disposed of via wastewater or household waste. The disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Lidocaine Normon

• The active substance is lidocaine. Each ml of solution contains 50 mg of lidocaine hydrochloride monohydrate.
• The other component is: water for injections.

Appearance of the product and contents of the pack

Lidocaine Normon 50 mg/ml is presented as an injectable solution in glass ampoules containing 500 mg of lidocaine hydrochloride monohydrate in 10 ml. Each pack contains 1 ampoule or 100 ampoules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Lidocaine Normon 10 mg/ml injectable solution EFG
Lidocaine Normon 20 mg/ml injectable solution EFG

Date of the most recent review of this leaflet: March 2026

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

This information is intended exclusively for healthcare professionals:

To prepare a 1.5% solution of lidocaine hydrochloride monohydrate, dilute 2% lidocaine hydrochloride monohydrate in a syringe with 0.9% sodium chloride: 3 units (ml) of 2% lidocaine hydrochloride monohydrate with 1 unit (ml) of 0.9% sodium chloride. The diluted solution must be prepared immediately before use.

To prepare a 0.5% solution of lidocaine hydrochloride monohydrate, dilute 1% lidocaine hydrochloride monohydrate in a syringe with 0.9% sodium chloride: 1 unit (ml) of 1% lidocaine hydrochloride monohydrate with 1 unit (ml) of 0.9% sodium chloride. The diluted solution must be prepared immediately before use.

Dosage and method of administration

Lidocaine Normon should only be used by physicians experienced in regional anesthesia and resuscitation techniques, or under their supervision. Resuscitation equipment must be readily available when administering local anesthetics. The lowest effective dose producing the desired effect should be administered. The dose must be individually adjusted according to the specific characteristics of each patient.

When injected into tissues with high systemic absorption, the single dose of lidocaine hydrochloride should not exceed 400 mg. The table described below may serve as a guide for adults with a body weight of approximately 70 kilograms. The dose should be adjusted according to age, weight, and the patient's condition:

A lower dose (10 mg/ml or less) of lidocaine is preferred for prolonged local anaesthesia.

To prolong anaesthesia, lidocaine may be combined with a vasoconstrictor such as adrenaline. Addition of adrenaline at a concentration of 1/100,000 to 1/200,000 has proven effective.

Paediatric population

Doses should be individually calculated according to the patient's age, body weight, and the nature of the procedure. The anaesthetic technique should be carefully selected, and techniques causing pain should be avoided. The child's behaviour should be closely monitored during treatment. The average dose to be administered ranges from 20 mg to 30 mg of lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride that may be administered to children can also be calculated using the formula: child's weight (in kilograms) × 1.33.

The equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight must not be exceeded.

To prevent systemic toxicity in children, the lowest effective concentration should always be used.

Lidocaine is indicated in adults and children. However, it should be used with special caution in children under four years of age, as there is limited data supporting the safety and efficacy of this product in this patient population at present.

Injectable lidocaine is not recommended for use in newborns (see section 5.2 of the Summary of Product Characteristics). In this age group, the optimal serum concentration of lidocaine required to avoid toxic effects such as seizures and cardiac arrhythmias is unknown.

Special populations

In patients with renal or hepatic impairment and in elderly patients, the dose should be reduced according to the patient's age and physical condition (see section 4.4 and section 5.2 of the Summary of Product Characteristics).

Method of administration

The method of administration of lidocaine varies depending on the type of anaesthetic procedure used (infiltration anaesthesia, intravenous regional anaesthesia, nerve block, or epidural anaesthesia).

Lidocaine Normon may be administered by intramuscular, subcutaneous, intradermal, perineural, epidural, or intravenous routes (for intravenous local anaesthesia or Bier block).

Interaction with other medicinal products and other forms of interaction

Drugs that inhibit the metabolism of lidocaine (e.g. cimetidine) may lead to potentially toxic plasma concentrations when lidocaine is administered repeatedly in high doses over prolonged periods. Such interactions are not clinically relevant during short-term treatment with lidocaine at recommended doses.

Lidocaine should be used with caution in patients receiving other local anaesthetics or class Ib antiarrhythmic drugs, as toxic effects are cumulative.

Specific interaction studies between lidocaine and class III antiarrhythmic drugs (e.g. amiodarone) have not been conducted, but caution is recommended (see section 4.4 of the Summary of Product Characteristics).

Warnings and special precautions for use

In general, prior to injection of lidocaine, it must be ensured that emergency resuscitation equipment and medications for the treatment of toxic reactions are immediately available. For major blocks, an intravenous cannula should be inserted before injecting the local anaesthetic. Like all local anaesthetic agents, lidocaine may cause acute toxic effects on the cardiovascular system and central nervous system when high blood concentrations are achieved, particularly after extensive intravascular administration.

Caution should be exercised when treating the following categories of patients:

• Elderly and generally debilitated patients.
• Patients with second- or third-degree AV block, as local anaesthetics may reduce myocardial conduction.
• Patients with congestive heart failure, bradycardia, or impaired respiratory function.
• Patients with severe hepatic disease or renal impairment.
• Patients with epilepsy. These patients should be carefully monitored for signs of central nervous system toxicity. An increased tendency to seizures may occur even with doses below the maximum.
• Patients with coagulopathy. Treatment with anticoagulants (e.g. heparin), NSAIDs, or plasma substitutes increases the risk of bleeding. Accidental injury to blood vessels may lead to severe haemorrhage. If necessary, bleeding time, activated partial thromboplastin time (aPTT), prothrombin time, and platelet count should be checked.
• Third trimester of pregnancy.
• In children under 4 years of age, due to limited safety and efficacy data.
• In newborns, special caution is required (see section 5.2 of the Summary of Product Characteristics).

Patients treated with class III antiarrhythmic drugs (e.g. amiodarone) should be closely monitored, and ECG monitoring should be considered, as the cardiac effects of lidocaine and class III antiarrhythmics may be cumulative (see section 4.5 of the Summary of Product Characteristics).

Post-marketing reports have described cases of chondrolysis in patients who received continuous postoperative intra-articular infusion of local anaesthetics. In most reported cases of chondrolysis, the shoulder joint was involved. Due to multiple contributing factors and inconsistencies in the scientific literature regarding the mechanism of action, a causal relationship has not been established. Continuous intra-articular infusion is not an approved indication for lidocaine (see section 4.8 of the Summary of Product Characteristics).

Epidural anaesthesia may cause serious adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolaemia. Caution should always be exercised in patients with reduced cardiovascular function.

Epidural anaesthesia may cause hypotension and bradycardia. This risk can be reduced by intravenous administration of crystalloid or colloid solutions. Hypotension should be treated immediately, for example, with intravenous ephedrine 5–10 mg; repeat as necessary.

Paracervical block may occasionally cause fetal bradycardia or tachycardia, and close monitoring of fetal heart rate is required (see section 4.6 of the Summary of Product Characteristics).

Traumatic and/or local toxic effects on nerves and muscles are mainly caused by the injection of local anaesthetics. The extent of these tissue injuries depends on the degree of trauma, the concentration of the local anaesthetic, and the duration of tissue exposure to the local anaesthetic. Therefore, the lowest effective dose should be used.

Special caution should also be exercised when injecting local anaesthetic into inflamed (infected) tissue due to increased systemic absorption caused by higher blood flow and reduced efficacy due to the lower pH of infected tissue.

After release of the tourniquet following intravenous regional anaesthesia, there is an increased risk of adverse reactions. Therefore, the local anaesthetic should be removed in several fractions.

During anaesthetic procedures in the neck and head region, patients are at increased risk of central nervous system toxic effects from the drug, even at low doses (see section 4.8 of the Summary of Product Characteristics).

Rarely, retrobulbar injections may reach the cranial subarachnoid space, causing severe reactions including cardiovascular collapse, apnoea, seizures, and transient blindness.

Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular motor dysfunction. Main causes include trauma and/or local toxic effects on muscles and/or nerves.

Intramuscular lidocaine may increase creatine phosphokinase concentrations, which may interfere with the diagnosis of acute myocardial infarction.

Injectable lidocaine is not recommended for use in newborns (see section 5.2 of the Summary of Product Characteristics).

Lidocaine has been shown to be porphyrinogenic in animals and should not be administered to patients with acute porphyria unless absolutely necessary. Extreme caution should be exercised in all patients with porphyria.