LIDOCAINE B. BRAUN 50 mg/ml injectable solution

2. What you need to know before you use Lidocaine B. Braun

Do not useLidocaine B. Braunif:

• You are allergic to lidocaine, other local anesthetics of the amide type, or any of the other ingredients of this medicine (listed in section 6).

• For epidural anesthesia in patients with severe hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemic shock (severe blood or fluid loss).

Epidural anesthesia should not be used during labor.

Warnings and precautions:

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

• If you are elderly or in a weakened general state.
• If you have heart problems such as slow or irregular heartbeat or heart failure.
• If you have any lung or respiratory disorder.
• If you have liver or kidney disease.
• If you have a history of seizures.
• If you have inflammation or infection at the injection site.
• If you have porphyria (a rare inherited disorder that affects the skin and nervous system).
• If you have blood coagulation problems.
• If you are in the third trimester of pregnancy.

Children

Lidocaine is not recommended for use in newborns. In children under 4 years of age, it should be used with caution since efficacy and safety data are limited.

Using Lidocaine B. Braun with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Other local anesthetics.
• Medicines used to treat stomach ulcers (e.g., cimetidine).
• Medicines used to treat irregular heartbeat (e.g., amiodarone).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctor will only give you this medicine during pregnancy or breastfeeding if it is necessary.

Driving and using machines

Lidocaine B. Braun may temporarily affect your ability to move, pay attention, and coordinate. Your doctor will tell you if you can drive or use machines.

Lidocaine B. Braun contains sodium

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

3. How to use Lidocaine B. Braun

Lidocaine B. Braun will be given to you by a doctor. It will be administered 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 will usually be administered near the part of the body that will be operated on.

The dose that 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 the part of the body where the medicine is injected. You will receive the lowest possible dose to produce the desired effect. The dose of lidocaine should be reduced in special populations and in patients in poor general health.

Use in children

The dose should be reduced in children. Lidocaine should be used with caution in children under 4 years of age.

The maximum recommended dose is 400 mg or approximately 20 ml of Lidocaine B. Braun.

If you use more Lidocaine B. Braun than you should

The doctor treating you is prepared to treat serious side effects related to an overdose of Lidocaine B. Braun.

The first signs that you are using more lidocaine than you should are usually the following:

• Seizures,
• Restlessness,
• Feeling of tiredness or dizziness,
• Nausea,
• Numbness or tingling sensation of the lips and around the mouth,
• Vision problems.

If you experience any of these signs or if you think you have received more lidocaine than you should, tell your doctor or nurse immediately.

More serious side effects related to an overdose of lidocaine may occur, such as balance and coordination disorders, hearing changes, euphoria, confusion, speech problems, paleness, sweating, tremors, seizures, effects on the heart and blood vessels, loss of consciousness, coma, and short-term interruption of breathing (apnea).

If you have any further questions on 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 phone: 91.562 04 20, indicating the medicine and the amount used. Bring this leaflet with you.

4. Possible side effects

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

Tell your doctor or nurse immediately if you experience a severe allergic reaction (angioedema or anaphylactic shock). The signs may include:

• Sudden swelling of the face, lips, tongue, or throat; may cause difficulty swallowing,
• Severe or sudden swelling of the hands, feet, and ankles,
• Difficulty breathing,
• Intense itching of the skin (with hives).
• Fever,
• Decrease in blood pressure.

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

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

• Nausea and vomiting
• Difficulty swallowing
• Depressed mood

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

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

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

• Hypersensitivity reactions, such as urticaria, skin rash, angioedema, bronchospasm, difficulty breathing, 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 side effects (may affect up to 1 in 10,000 patients)

• Ventricular tachycardia

Side 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Human Medicines Pharmacovigilance System www.notificaRAM.es. By reporting side 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 which is stated on the pack. The expiry date is the last day of the month stated.

For single use only. The contents of the ampoules should be used immediately after opening. Once the pack is opened, discard the unused portion of the solution.

The solution should only be used if it is transparent and colorless and the pack is not damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

The active substance is lidocaine hydrochloride.

1 ml of the solution for injection contains 50 mg of lidocaine hydrochloride.

Each 5 ml ampoule contains 250 mg of lidocaine hydrochloride.

Each 10 ml ampoule contains 500 mg of lidocaine hydrochloride.

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

Appearance and pack contents

Lidocaine B. Braun is a clear and colorless solution for injection.

It is available in polyethylene (Mini-Plasco) ampoules of 5 and 10 ml. It is available in packs of 1, 20, and 100 ampoules.

Not all 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 for Medicines and Health Products. http//www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Dosage and Administration

Lidocaína B. Braun should only be used by physicians with experience in regional anesthesia and resuscitation techniques or under their supervision. Resuscitation equipment should be available when administering local anesthetics. The lowest possible dose that produces the desired effect should be administered. The dose must be adjusted individually according to the particularities 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 can serve as a guide for adults with a body weight of approximately 70 kilograms. The dose should be adjusted based on age, weight, and patient condition:

A low dose (10 mg/ml or lower) of lidocaine is preferred for continuous local anesthesia.

To prolong anesthesia, lidocaine can be combined with a vasoconstrictor, such as adrenaline. The addition of adrenaline to a concentration of 1/100,000 to 1/200,000 has been effective.

Pediatric population

Doses are calculated individually according to the patient's age and body weight and the nature of the procedure. The anesthesia technique should be carefully selected, and techniques that are painful should be avoided. The child's behavior should be closely monitored during treatment. The average dose to be administered is in the range of 20 mg to 30 mg of lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride that can be administered to children can also be calculated using the expression: child's weight (in kilograms) x 1.33.

The equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight should 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 this time.

Lidocaine injectable is not recommended for use in newborns (see section 5.2 of the Technical Sheet). In this age group, the optimal concentration of lidocaine in serum necessary to avoid toxic effects such as convulsions and cardiac arrhythmias is unknown.

Special populations

In patients with renal or hepatic insufficiency 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 Technical Sheet).

Administration method

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

Lidocaine B. Braun can be administered intramuscularly, subcutaneously, intradermally, perineurally, epidurally, or intravenously (in local intravenous anesthesia or Bier block).

Interaction with other medications and other forms of interaction

Drugs that inhibit the metabolism of lidocaine (e.g., cimetidine) can cause potentially toxic plasma concentrations when lidocaine is administered repeatedly in high doses over prolonged periods. Such interactions are of no clinical relevance during short-term treatment with lidocaine at the 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 with lidocaine and class III antiarrhythmic drugs (e.g., amiodarone), but caution is recommended (see section 4.4 of the Technical Sheet).

Special warnings and precautions for use

In general, before injecting lidocaine, it should be ensured that all emergency resuscitation equipment and medications for the treatment of toxic reactions are available immediately. In the case of major blocks, an intravenous cannula should be inserted before injecting the local anesthetic. Like all local anesthetic agents, lidocaine can cause acute toxic effects on the cardiovascular and central nervous systems when high blood concentrations occur, especially after extensive intravascular administration.

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

• Elderly and debilitated patients in general.
• Patients with AV block II or III, as the local anesthetic can reduce myocardial conductivity.
• Patients with congestive heart failure, bradycardia, or impaired respiratory function.
• Patients with severe liver disease or renal insufficiency.
• Patients with epilepsy. These patients should be carefully monitored for the appearance of central nervous system symptoms. An increase in the tendency to convulsions should be considered 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 can cause severe bleeding. If necessary, the bleeding time and activated partial thromboplastin time (APTT) should be checked, as well as the platelet count.
• Third trimester of pregnancy
• In children under 4 years of age, as safety and efficacy data are limited
• In newborns, special caution should be exercised (see section 5.2 of the Technical Sheet)

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 can be cumulative (see section 4.5 of the Technical Sheet).

There have been post-marketing reports of cases of chondrolysis in patients who received continuous postoperative intra-articular infusion of local anesthetics. In most of the reported cases of chondrolysis, the shoulder joint was involved. Due to the multiple contributing factors and the inconsistency in the scientific literature regarding the mechanism of action, causality has not been established. Continuous intra-articular infusion is not an approved indication for lidocaine (see section 4.8 of the Technical Sheet).

Epidural anesthesia can 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 can cause hypotension and bradycardia. This risk can be reduced by administering intravenous crystalloid or colloid solutions. Hypotension should be treated immediately with, for example, ephedrine 5-10 mg intravenously; repeat as necessary.

Paracervical block can occasionally cause fetal bradycardia or tachycardia, and close monitoring of fetal heart rate is necessary (see section 4.6 of the Technical Sheet).

Nerve trauma and/or local toxic effects on muscles and nerves are mainly caused by the injection of local anesthetics. The extent of these tissue lesions depends on the magnitude of the trauma, the concentration of the local anesthetic, and the duration of exposure of the tissue to the local anesthetic. For this reason, the minimum effective dose should be used.

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

After removing the tourniquet after regional intravenous anesthesia, there is a higher risk of adverse reactions. Therefore, the local anesthetic should be eliminated in several fractions.

During anesthetic procedures in the neck and head region, patients are exposed to a higher risk of toxic effects of the drug on the central nervous system even at low doses (see section 4.8 of the Technical Sheet).

Rarely, retro-ocular injections can reach the subarachnoid cranial space, causing intense/severe reactions, including cardiovascular collapse, apnea, convulsions, and transient blindness.

Retro- and periocular 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 can increase creatine phosphokinase levels, which can interfere with the diagnosis of acute myocardial infarction.

Lidocaine injectable is not recommended for use in newborns (see section 5.2 of the Technical Sheet).

It has been shown that lidocaine is porphyrogenic in animals and should not be administered to patients with acute porphyria unless it is absolutely unavoidable. Extreme caution should be exercised in all patients with porphyria.