Lidocaine B. Braun 50 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lidocaine B. Braun 50 mg/ml solution for injection

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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lidocaine B. Braun 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 B. Braun 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 B. Braun

Do not use Lidocaine B. Braun:

• 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 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 anaesthesia must not be used during childbirth.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before using Lidocaine B. Braun if:

• you are elderly or in a generally weakened condition
• you have heart problems such as slow or irregular heartbeat or heart failure
• you have any lung or respiratory disorders
• you have liver disease or kidney problems
• you have epileptic seizures
• you have inflammation or infection at the injection site
• you have porphyria (a rare inherited disorder affecting the skin and nervous system)
• you have blood clotting disorders
• 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, lidocaine should be used with caution, as efficacy and safety data are limited.

Use of Lidocaine B. Braun 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 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 or breastfeeding, think you may be pregnant, or are planning 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

Lidocaine B. Braun may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you may drive or operate machinery.

Lidocaine B. Braun contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ampoule; therefore, it is essentially “sodium-free”.

3. How to use Lidocaine B. Braun

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

The dose your doctor gives you will depend on the type of pain relief you require, as well as your height, age, physical condition, and the body area 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.

Use in children

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

The maximum dose should not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

If you use more Lidocaine B. Braun than you should

The doctor supervising you is trained to manage serious adverse effects related to an overdose of Lidocaine B. Braun.

The first signs that you are receiving more lidocaine than you should are usually:

• seizures,
• restlessness,
• feeling tired or dizzy,
• nausea,
• numbness or tingling sensation 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 lidocaine overdose 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 or pharmacist immediately or call the Toxicology Information Service at 91.562 04 20, stating the medication and amount taken. Bring this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine may 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; which may lead to difficulty swallowing,
• severe or sudden swelling of the hands, feet, and ankles,
• difficulty breathing,
• intense skin itching (with hives),
• fever,
• decrease in blood pressure.

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

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

• Nausea and vomiting
• Discomfort when 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 noise sensitivity
• 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 difficulties, and, in severe cases, anaphylactic shock
• Trauma
• Chills
• Irritation (reaction at a body site)
• 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 frequency not known (cannot be estimated from available data):

• Horner's syndrome (associated with epidural anaesthesia 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 of 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 B. Braun

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

No special storage conditions are required.

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

For single use only. The contents of the ampoules must be used immediately after opening. After opening, any unused portion of the solution must be discarded.

The solution should only be used if it is clear and colourless, and if the container is undamaged.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

The active substance is lidocaine hydrochloride.

One ml of the injectable solution contains 50 mg of lidocaine hydrochloride.

Each 5 ml vial of solution contains 250 mg of lidocaine hydrochloride.

Each 10 ml vial of solution contains 500 mg of lidocaine hydrochloride.

The other components are: sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Lidocaine B. Braun is a clear, colourless injectable solution.

It is supplied in polyethylene vials (Mini-Plasco) of 5 ml and 10 ml. Pack sizes of 1, 20 and 100 vials are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

• Braun Melsungen AG

Carl-Braun-Strasse 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

This leaflet was approved in July 2021.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Dosage and administration

Lidocaine B. Braun 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 required to achieve the desired effect should be administered. The dose must be individually adjusted according to the specific circumstances of each case.

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 that are painful 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 can be administered to children may also be calculated using the following formula: child's weight (in kilograms) x 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 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 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 anaesthetic procedure used (infiltration anaesthesia, intravenous regional anaesthesia, nerve block, or epidural anaesthesia).

Lidocaine B. Braun may be administered intramuscularly, subcutaneously, intradermally, perineurally, epidurally, or intravenously (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).

Special warnings and 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 occur, particularly after extensive intravascular administration.

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

• Elderly and generally debilitated patients.
• Patients with second- or third-degree AV block, as the local anaesthetic 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 carefully monitored for the onset 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 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 should be exercised (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 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 hypovolemia. 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 5–10 mg ephedrine intravenously; repeat as necessary.

Paracervical block may occasionally cause fetal bradycardia or tachycardia, and close monitoring of fetal heart rate is necessary (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 anaesthetics. The extent of these tissue injuries depends on the magnitude 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 head and neck 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, 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.