Lidocaine B. Braun 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lidocaine B. Braun 10 mg/ml solution for injection

Lidocaine hydrochloride

Read all of this 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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 side 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 local anaesthetics of the amide type, 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).

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
• 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 disorder 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, lidocaine should be used with caution, as efficacy and safety data are limited.

Using 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)
• medicines that inhibit the metabolism of lidocaine (e.g. cimetidine)

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 using 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 28 mg of sodium (the main component of table/cooking salt) per 10 ml ampoule. This corresponds to 1.4% of the maximum daily sodium intake recommended for an adult.

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 need. It will also depend on your height, age, and physical condition, as well as on the part 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.

Use in children

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

If you use more Lidocaine B. Braun than you should

The doctor supervising you is prepared 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 usually 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 signs or 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91.562 04 20, stating the medication 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 experiences them.

Inform your doctor or nurse immediately 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,
• decrease in blood pressure.

These adverse effects are rare (may affect up to 1 in 1,000 people).

The possible adverse effects after 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

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

• Transient neurological symptoms (pain in legs and buttocks)

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

• Tingling sensation in the legs, loss of sphincter control (cauda equina syndrome)
• "Ringing" in the ears or sensitivity to noise
• Hearing loss
• Visual disturbances
• Headache
• Dizziness
• Hypertension (high blood pressure)
• Bradycardia (slow heart rate)

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 site on the body)
• Spinal cord compression
• Cardiac arrest
• Respiratory depression (slow or interrupted breathing)
• Double vision
• Hypotension (low blood pressure)

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 it is a possible adverse effect 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 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 the container, discard any unused portion of the solution.

The solution should only be used if it is clear and colourless and 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. Contents of the pack and other information

Composition of Lidocaine B. Braun

The active substance is lidocaine hydrochloride.

One ml of the injectable solution contains 10 mg of lidocaine hydrochloride.

The other components are: sodium chloride, 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 10 ml polyethylene ampoules (Mini-Plasco), in packs of 1, 20 and 100 ampoules.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

This leaflet was approved in: June 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios): 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 available whenever local anesthetics are administered. The lowest effective dose producing the desired effect should be administered. The dose must be individually adjusted according to the specific characteristics of each case.

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 the patient's age, weight, and clinical condition:

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 should be carefully selected, and techniques causing pain should be avoided. The child's behavior should be closely monitored during treatment. The average dose to be administered lies within the range of 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 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 is limited data available 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). 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).

Administration method

The administration route of lidocaine varies depending on the type of anesthetic procedure used (infiltration anesthesia, intravenous regional anesthesia, nerve block, or epidural anesthesia).

Lidocaine B. Braun can be administered by intramuscular, subcutaneous, intradermal, perineural, epidural, or intravenous route (for intravenous local anesthesia or Bier block).

Interaction with other medicines 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 of time. 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, since toxic effects are cumulative.

Specific interaction studies between lidocaine and class III antiarrhythmic drugs (such as amiodarone) have not been conducted, but caution is recommended (see section 4.4).

Warnings and special precautions for use

In general, prior to lidocaine injection, 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 anesthetic. Like all local anesthetic 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 when treating the following categories of patients:

• Elderly patients and those generally debilitated.
• Patients with second- or third-degree AV block, as local anesthetics may reduce myocardial conduction.
• Patients with congestive heart failure, bradycardia, or impaired respiratory function.
• Patients with severe hepatic disease or renal insufficiency.
• Patients with epilepsy. These patients should be closely monitored for the onset of central nervous system symptoms. An increased susceptibility 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.
• Children under 4 years of age, as safety and efficacy data are limited.
• Newborns, in whom special caution is required (see section 5.2).

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

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).

Epidural anesthesia may cause serious adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolemia. Particular 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 promptly with, for example, 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).

Traumatic nerve injuries and/or local toxic effects on muscles and nerves are primarily caused by the injection of local anesthetics. The extent of these tissue injuries 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 efficacy 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 eliminated in several fractions.

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

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

Retrobulbar 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).

Lidocaine has been shown to be porphyrogenic 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.