Lidocaine Normon 20 mg/ml solution for injection EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lidocaine Normon 20 mg/ml injection solution EFG
Lidocaine hydrochloride
Read the entire leaflet carefully before you start using 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, 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
- What Lidocaine Normon is and what it is used for
- What you need to know before using Lidocaine Normon
- How to use Lidocaine Normon
- Possible adverse effects
- How to store Lidocaine Normon
- Contents of the pack and other information
1. What Lidocaine 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 transmission of nerve impulses near its site of action.
Lidocaine 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 anesthetics, or to any of the other ingredients of this medicine (listed in section 6).
- For epidural anesthesia in patients with marked hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemic shock (severe loss of blood or body fluids).
Epidural anesthesia must not be used during childbirth.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using 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 have any lung or respiratory disorders,
- if you have liver disease or kidney problems,
- if you suffer from 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 coagulation disorders,
- if you are in the last trimester of pregnancy,
- if you have a specific facial nerve disorder (MELKERSSON-ROSENTHAL syndrome),
- if you have low blood pressure or low blood volume,
- if you have severe muscle weakness (myasthenia gravis).
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
Tell 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 anesthetics.
- medicines used to treat gastroduodenal ulcers (e.g. cimetidine).
- medicines used to treat irregular heartbeat (e.g. amiodarone).
Pregnancy, breast-feeding 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 movement, attention, and coordination. Your doctor will advise you whether you can drive or operate machinery.
Important information about some of the ingredients of Lidocaine Normon
Athletes should be aware that lidocaine may produce a positive result in doping tests.
Lidocaine Normon contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; 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 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 attending you is prepared to manage serious adverse effects related to an overdose of Lidocaine Normon.
The first signs that you are receiving more lidocaine than you should include:
- seizures,
- restlessness,
- feeling tired or dizzy,
- nausea,
- numbness or tingling sensation of the lips and around the mouth,
- visual disturbances.
If you experience any of these symptoms, or if you think you have received more lidocaine than you should, 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, stating the name of the medicine and the amount taken. Take this leaflet with you.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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; this 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 caused by other amide-type local anesthetics.
Very common adverse effects (may affect more than 1 in 10 patients):
- Nausea and vomiting.
- Difficulty swallowing.
- Depressed mood.
Common adverse effects (may affect between 1 and 10 in 100 patients):
- Transient neurological symptoms (pain in 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 patients):
- Seizures.
- Numbness of the tongue or tingling sensation around the mouth.
- "Ringing" in the ears or sensitivity to noise.
- Loss of consciousness.
- Tinnitus.
- Speech difficulties.
- Hypertension (high blood pressure).
Rare adverse effects (may affect between 1 and 10 in 10,000 patients):
- 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 patients):
- Ventricular tachycardia.
Adverse effects with unknown frequency (cannot be estimated from 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 System for Pharmacovigilance of Human Medicines 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 packaging after EXP. The expiry date is the last day of the month indicated.
Single-use product. Any remaining solution should 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 medicines and of all materials that have come into contact with them 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 20 mg of lidocaine hydrochloride monohydrate.
- The other components are: sodium chloride and water for injections.
Appearance of the medicinal product and contents of the pack
Lidocaine Normon 20 mg/ml is presented as an injectable solution in glass ampoules containing 200 mg of lidocaine hydrochloride monohydrate in 10 ml or 100 mg of lidocaine hydrochloride monohydrate in 5 ml. Each pack contains 1 ampoule or 100 ampoules of 10 ml or 5 ml.
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 solution for injection EFG
Lidocaine Normon 50 mg/ml solution for injection EFG
Date of the most recent review of this leaflet: March 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
This information is intended for healthcare professionals only:
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 local anesthetics are administered. The lowest effective dose producing the desired effect should be used. The dose should be individually adjusted according to the specific circumstances of each patient.
Dosage
Adults
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 patient condition:
Route of administration or procedure | Recommended doses of lidocaine hydrochloride | ||
Concentration (mg/ml) | Volume (ml) | Total dose (mg) | |
Infiltration anesthesia | |||
Minor procedures | 10 mg/ml | 2–10 ml | 20–100 mg |
Major procedures | 10 mg/ml 20 mg/ml | 10–20 ml 5–10 ml | 100–200 mg 100–200 mg |
Intravenous regional anesthesia: | |||
Arm | 10 mg/ml 20 mg/ml | 10–20 ml 5–10 ml | 100–200 mg 100–200 mg |
Leg | 10 mg/ml 20 mg/ml | 20 ml 10 ml | 200 mg 200 mg |
Nerve blocks | 10 mg/ml 20 mg/ml | 2–20 ml 1–10 ml | 20–200 mg 20–200 mg |
Epidural anesthesia: | |||
Lumbar analgesia | 10 mg/ml 20 mg/ml | 25–40 ml 12.5–20 ml | 250–400 mg 250–400 mg |
Thoracic anesthesia | 10 mg/ml 20 mg/ml | 20–30 ml 10–15 ml | 200–300 mg 200–300 mg |
Sacral surgical analgesia | 10 mg/ml 20 mg/ml | 40 ml 20 ml | 400 mg 400 mg |
Obstetric sacral analgesia | 10 mg/ml 20 mg/ml | 20–30 ml 10–15 ml | 200–300 mg 200–300 mg |
To prolong anesthesia, lidocaine may be combined with a vasoconstrictor such as adrenaline. The 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 anesthetic technique must be carefully selected, and techniques causing pain should be avoided. The child's behavior must 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 of lidocaine hydrochloride that may be administered to children can also be calculated using the following expression: 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 are limited data to support 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 impairment 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 anesthetic procedure used (infiltration anesthesia, intravenous regional anesthesia, nerve block, or epidural anesthesia).
Lidocaína Normon may be administered by intramuscular, subcutaneous, intradermal, perineural, epidural, or intravenous routes (in intravenous local anesthesia 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 at 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 anesthetics or class Ib antiarrhythmic drugs, as toxic effects are cumulative.
No specific interaction studies have been conducted between lidocaine and class III antiarrhythmic drugs (e.g., amiodarone), but caution is advised (see section 4.4 of the Summary of Product Characteristics).
Class I antiarrhythmic agents
Concomitant administration of lidocaine with other class I antiarrhythmic agents should be avoided due to the risk of serious cardiac adverse effects.
Other antiarrhythmic agents
If lidocaine is used in combination with other antiarrhythmic agents such as beta-blockers or calcium channel blockers, the inhibitory effects on atrioventricular and intraventricular conduction and on contractility may be increased.
Medicinal products that may decrease the seizure threshold
Since lidocaine itself lowers the seizure threshold, co-administration with other medicinal products that lower the seizure threshold (e.g., tramadol or bupropion) may increase the risk of seizures.
Warnings and special precautions for use
In general, before injecting lidocaine, it must be ensured that emergency resuscitation equipment and medications for treating toxic reactions are immediately available. For major blocks, an intravenous cannula should be inserted before injecting the local anesthetic. Like all local anesthetic 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 anesthetics may reduce myocardial conductivity.
- 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 closely monitored for the emergence of central nervous system symptoms. 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 tendency to bleeding. Accidental injury to blood vessels may result in severe hemorrhage. 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, as safety and efficacy data are limited
- 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 antiarrhythmic drugs may be additive (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 anesthetics. 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 anesthesia may cause serious adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolemia. Caution should always be exercised in patients with reduced cardiovascular function.
Epidural anesthesia 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 ephedrine 5–10 mg intravenously; 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 nerve injuries and/or local toxic effects on muscles and nerves are primarily caused by the injection of local anesthetics. The extent of such tissue damage depends on the degree of trauma, the concentration of the local anesthetic, and the duration of tissue exposure to the local anesthetic. Therefore, the lowest effective dose should be used.
Special caution should also be exercised when injecting local anesthetic into inflamed (infected) tissue due to increased systemic absorption caused by higher blood flow and reduced effect due to the lower pH of infected tissue.
After release of the tourniquet following intravenous regional anesthesia, there is an increased risk of adverse reactions. Therefore, the local anesthetic should be removed in several fractions.
During anesthetic procedures in the neck and head region, patients are at increased risk of central nervous system toxic effects, 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, apnea, seizures, and transient blindness.
Retro- and peribulbar injections of local anesthetics carry a low risk of persistent ocular motor dysfunction. The 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.