Prospecto: information for the patient

Lidocaína B. Braun 20 mg/ml injectable solution

Lidocaína hydrochloride

Read the entire prospect carefully before starting to use the medication, because it contains important information for you.

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

1. What isLidocaína B. Braunand for what it is used

2. What you need to know before starting to useLidocaína B. Braun

3. How to useLidocaína B. Braun

4. Possible adverse effects

5. Conservation ofLidocaína B. Braun

6. Contents of the package and additional information

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

Lidocaine also belongs to a group of medications called antiarrhythmics, so it can also be used to control a fast or severely abnormal heart rhythm (severe ventricular arrhythmias).

No useLidocaína B. Braun:

- If you are allergic to lidocaine, other amide-type local anesthetics, or any of the other components of this medication (listed in section 6).

- For epidural anesthesia in patients with pronounced hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemia.

Epidural anesthesia should not be used during childbirth.

This medication should not be used to control rapid or abnormal heartbeats if:

• You have severe heart problems, particularly if your heart beats irregularly or slowly,
• You have had a heart attack in the last 3 months or if your heart's ability to pump blood throughout the body is significantly impaired, unless your condition is potentially life-threatening.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Lidocaína B. Braun.

• If you are an elderly person or in a weakened state,
• If you suffer from heart problems such as slow or irregular heartbeat or heart failure,
• If you have any respiratory or pulmonary disorders,
• If you have liver disease or kidney problems,
• If you suffer from seizures,
• If you have 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 problems,
• If you are in the last trimester of pregnancy.
• Facial nerve disorder (Melkerssohn-Rosenthal syndrome),
• If you have low blood pressure or low blood volume,
• If you have severe muscle weakness (myasthenia gravis).

Control of rapid or abnormal heartbeats

Your doctor will administer this medication with special caution for heart problems only if you have elevated blood acidity (acidosis).

If you receive this medication, your:

- electrocardiogram,

- blood pressure,

- level of consciousness, and

- breathing will be monitored.

If one of the mentioned parameters worsens, your doctor may need to review your therapy. Additionally, they will ensure that emergency equipment is available during therapy.

If you receive this medication for a prolonged period, your doctor will ensure that:

- your fluid balance,

- blood electrolyte levels, and

- acid-base balance are controlled.

If you receive large amounts of this medication, your doctor will correct:

- any existing low potassium levels in your blood,

- oxygen deficiency, and

- acid-base balance disorders before starting infusion/injection.

Nota:

If you are under anesthesia, your doctor will examine your condition with great care. This will be done because the side effects affecting your nervous system and heart may go unnoticed and can occur without prior warning symptoms.

Children

Lidocaine is not recommended for use in children under 1 year of age. In children under 4 years, use with caution, as efficacy and safety data are limited.

Use of Lidocaína B. Braun with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Especially, inform your doctor if you are taking any of the following medications:

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

Pregnancy, breastfeeding, and fertility

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

Your doctor will only administer this medication during pregnancy or breastfeeding if they consider it necessary.

Driving and operating machinery

Lidocaína B. Braun may temporarily affect your ability to move, attention, and coordination. Your doctor will indicate if you can drive or operate machinery.

Lidocaína B. Braun contains sodium

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

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Anesthetic Therapy

Lidocaína B. Braun will be administered by a doctor. It will be administered as an injection into a vein, into a muscle, under the skin, around the nerves, or in the epidural space near the spinal cord.

Lidocaína B. Braun will be administered normally near the part of the body that is going to be operated on.

The dose administered by the doctor will depend on the type of pain relief needed. It will also depend on your height, age, and physical condition, as well as the part of the body where the medication is injected. You will receive the lowest dose possible to produce the desired effect. The lidocaína dose should be reduced in special populations and in patients with poor general health.

Control of rapid or abnormal heartbeats

This medication will be administered only by healthcare personnel, and your doctor will determine the most suitable dose for you.

The usual loading dose for adults is 50 to 100 mg, or 1 to 1.5 mg/kg of body weight as a direct intravenous injection, at a rate that should not exceed 25-50 mg per minute.

To maintain therapeutic plasma concentrations (1.5-5 µg/ml), lidocaína should be infused at a rate of 20 to 50 µg/kg/min (over 1-4 mg per minute).

The dose should be adjusted according to individual needs and therapeutic effect.

This applies especially when heart, liver, or kidney problems are present.

During pregnancy, the dose should be as low as possible.

Use in children

Anesthetic Therapy

The dose should be reduced in children. Lidocaína should be used with caution in children under four years old.

The usual maximum dose is 400 mg or approximately 20 ml of Lidocaína B. Braun.

Control of rapid or abnormal heartbeats

Lidocaína is not recommended for use in newborns. The initial lidocaína dose in children is 0.5 to 1 mg/kg. This dose may be repeated according to the patient's response, but the total dose should not exceed 3-5 mg/kg of body weight. If maintenance is necessary, an i.v. infusion of 10 to 50 µg/kg/min using a perfusion pump may be administered.

If you use more Lidocaína B. Braun than you should

The doctor attending you is prepared to treat severe adverse effects related to excessive use of Lidocaína B. Braun.

The first signs that you are using more lidocaína than you should are normally the following:

-convulsions,

-restlessness,

-feeling of fatigue 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 believe you have received more lidocaína than you should, inform your doctor or nurse immediately.

More severe adverse effects related to excessive use of lidocaína may include balance and coordination disorders, hearing changes, euphoria, confusion, speech problems, pallor, sweating, tremors, convulsions, effects on the heart and blood vessels, loss of consciousness, coma, and brief interruption of breathing (apnea).

If you have any other doubts 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 Toxicological Information Service phone: 91.562 04 20, indicating the medication and the amount used. Bring this leaflet with you.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you experience a severe allergic reaction (angioedema or anaphylactic shock). The signs may include the sudden appearance of:

• Swelling of the face, lips, tongue, or throat; it may cause difficulty swallowing.

-Intense or sudden swelling of the hands, feet, and ankles.

-Difficulty breathing.

-Intense itching of the skin (with rashes).

-Fever.

-Decreased 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.

- Depressive 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.

- Drowsiness.

- Sensation of dizziness.

- Blurred vision.

- Tremors.

- Dizziness.

- Sensation of tingling.

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

- Seizures.

- Numbness of the tongue or sensation of tingling around the mouth.

- "Sounds" in the ears or sensitivity to noise.

- Loss of consciousness.

- Tinnitus.

- Difficulty speaking.

- 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 a body area).

- 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 1 in 10,000 patients)

- Ventricular tachycardia.

Rare side 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).

Control of rapid or abnormal heartbeats

The following side effects may be serious. If any of the following side effects occur, inform your doctor immediately. Immediate treatment may be necessary.

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

• Allergic reactions ranging from hives and swelling to severe allergic reactions such as low blood pressure, difficulty breathing, airway constriction, and anaphylactic shock.
• Muscle contractions to generalized seizures and convulsions.
• Depression of consciousness to coma.
• Slow heartbeats, heart block, and even cardiac arrest.
• Low blood pressure.
• Difficulty breathing to interrupted breathing.

Very rare (may affect 1 in 10,000 patients):

• Rapid heartbeats.

Other side effects include:

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

• Feeling unwell, vomiting.
• Anxiety, difficulty swallowing.

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

• Confusion, restlessness, irritability, euphoria, hallucinations, depression.
• Drowsiness, dizziness, sensation of spinning, difficulty speaking, tinnitus, blurred vision.
• Sensation of tingling, numbness, burning, pinching, or numbness of the skin.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Human Medicines Pharmacovigilance Systemwww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Single use. The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Lidocaína B. Braun

The active ingredient is lidocaine hydrochloride.

One ml of the injectable solution contains 20 mg of lidocaine hydrochloride.

Each ampoule of 5 ml of solution contains 100 mg of lidocaine hydrochloride.

Each ampoule of 10 ml of solution contains 200 mg of lidocaine hydrochloride.

The other components are: sodium chloride, sodium hydroxide (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Lidocaína B. Braun is a transparent and colorless injectable solution.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

B. Braun Melsungen AG

Carl-Braun-Strasse 1Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

Last review date of thisleaflet:June 2021.

More detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices. http//www.aemps.gob.es/

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This information is intended solely for medical professionals or healthcare professionals:

Dosage and administration

Lidocaína B. Braun should only be used by experienced anesthesiologists or under their supervision. Equipment for resuscitation should be available when administering local anesthetics. The lowest effective dose should be administered. The dose should be adjusted individually according to the specific case.

Anesthetic treatment

Adults

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

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

Special populations

In patients with renal insufficiency or hepatic insufficiency and in elderly patients, the dose should be reduced according to age and physical condition of the patient (see section 4.4 and section 5.2 of the product information).

Pediatric population

Doses are calculated individually according to age and body weight of the patients and the nature of the procedure. The anesthetic technique should be carefully selected and those techniques that are painful should be avoided. The child's behavior should be closely monitored during treatment. The average dose that should 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 dose should not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

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 caution in children under four years old, as there are limited data to support the safety and efficacy of this product in this population at this time.

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

Treatment of severe ventricular arrhythmias

Lidocaine is generally administered in cases of severe ventricular arrhythmias that do not respond to other antiarrhythmics such as beta blockers or amiodarone or in cases of contraindications to amiodarone.

The dose should be adjusted individually according to the needs of each patient and the clinical response obtained.

Adults

Initial dose (bolus intravenous):

The usual initial dose is 50 to 100 mg or 1 to 1.5 mg/kg of body weight as a direct intravenous injection, corresponding to 2.5 – 5 ml or 0.05 – 0.075 ml/kg of Lidocaína B. Braun 20 mg/ml.

The injection rate should not exceed 25-50 mg/min, corresponding to 1.25 – 2.5 ml/min of Lidocaína B. Braun 20 mg/ml.

If the therapeutic effect after the first dose is insufficient during the first 5-10 minutes, a second dose of 0.5 to 0.75 mg/kg should be administered once or twice until a maximum of 200-300 mg in 1 hour.

Maintenance dose (intravenous infusion):

To maintain therapeutic plasma concentrations (1.5 - 5 µg/ml), lidocaine should be infused at a rate of 20 - 50 µg/kg/min (over 1-4 mg/min), corresponding to 0.001 – 0.0025 ml /kg /min of Lidocaína B. Braun 20 mg/ml.

The infusion should be stopped as soon as the patient's heart rate appears to be stable or at the first signs of toxicity. Rarely is it necessary to continue the infusion after 24 hours. It may be necessary to reduce the dose in prolonged intravenous infusions (over 24 hours) due to the risk of accumulation. As soon as possible, patients should be switched to an oral antiarrhythmic maintenance treatment.

Special populations

Use in elderly patients

In elderly patients, the dose should be calculated individually according to the patient's age and body weight. It may be necessary to reduce the dose in this population, as cardiac output and hepatic blood flow decrease with age, resulting in a decrease in lidocaine elimination (see section 5.2 of the product information).

Heart failure and liver insufficiency

The dose should be reduced in patients with heart failure and liver insufficiency, due to a reduction in lidocaine clearance (see section 5.2 of the product information).

Renal insufficiency

Renal insufficiency generally does not require special dose adjustment. However, these patients should be monitored for toxic effects caused by the accumulation of metabolites. In cases of severe renal insufficiency, it may be necessary to adjust the dose (see section 5.2 of the product information).

Pediatric population

The safety and efficacy of the use of lidocaine in children have not been fully established. Lidocaine injectable is not recommended for use in newborns (see section 5.2 of the product information).

The initial dose of lidocaine in children is 0.5- 1 mg/kg. This dose may be repeated according to the patient's response, but the total dose should not exceed 3-5 mg/kg of body weight. If maintenance is necessary, a continuous intravenous infusion of 10 - 50 µg/kg/min using a syringe pump may be administered.

For advanced cardiovascular life support in children, it is recommended to administer an initial rapid intravenous dose or an intraosseous injection (bolus) of 1 mg/kg of body weight until a maximum dose of 100 mg.

If ventricular tachycardia or ventricular fibrillation are not corrected by defibrillation (or cardioversion) and the recommended initial dose of lidocaine, a continuous intravenous or intraosseous infusion at a rate of 20-50 µg/kg/min should be administered.

Administration

Anesthetic treatment

The administration of lidocaine varies according to the anesthetic procedure used (local anesthesia by infiltration, regional intravenous anesthesia, nerve block or epidural anesthesia).

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

Treatment of severe ventricular arrhythmias

Intravenous. Intraosseous. Administer as a slow intravenous injection or as an intravenous infusion after dilution with an appropriate solution (see sections 6.2 and 6.6 of the product information).

Due to the relatively short duration of action of lidocaine, the injection should be followed by a continuous infusion, if possible, using a syringe pump. Continuous ECG monitoring, blood pressure, level of consciousness and respiration (see section 4.4 of the product information) should be performed during lidocaine administration.

The infusion solution can be prepared by adding 1000 mg of lidocaine hydrochloride, corresponding to 50 ml of Lidocaína B. Braun 20 mg/ml, to a volume of 500 ml of glucose solution or a physiological saline solution, resulting in a concentration of 2 mg/ml.

Interaction with other drugs and other forms of interaction

Drugs that inhibit lidocaine metabolism (e.g. cimetidine) may cause potentially toxic plasma concentrations when lidocaine is administered repeatedly at high doses for prolonged periods. Such interactions are of no clinical relevance during short-term lidocaine treatment at recommended doses.

Lidocaine should be used with caution in patients receiving other local anesthetics or class I 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 product information).

If lidocaine is administered as an antiarrhythmic agent, additional medication with epinephrine or norepinephrine may potentiate cardiac adverse effects.

Class I antiarrhythmic agents

The simultaneous administration of lidocaine with other class I antiarrhythmic agents should be avoided, as there is a risk of severe 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 effect on atrioventricular and intraventricular conduction and contractility may be increased.

Medications that may decrease the seizure threshold

Since lidocaine itself decreases the seizure threshold, coadministration with other medications that decrease the seizure threshold (e.g. tramadol or bupropion) may increase the risk of seizures.

Special precautions for use

Generally, before injecting lidocaine, it should be ensured that all emergency resuscitation equipment and medications for treating toxic reactions are immediately available. In cases of major blocks, an intravenous cannula should be inserted before injecting the local anesthetic. As with all local anesthetics, lidocaine may cause acute toxic effects on the cardiovascular system and central nervous system when high concentrations are achieved in the blood, especially after extensive intravascular administration.

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

• Elderly patients and generally debilitated patients.
• Patients with AV block II or III, as the local anesthetic may 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 closely monitored to detect the onset of central nervous system symptoms. An increase in the tendency to seizures may occur even at doses below the maximum.
• Patients with coagulopathy. The treatment with anticoagulants (e.g. heparin), NSAIDs or plasma substitutes increases the tendency to bleeding. Accidental vascular lesions may cause severe bleeding. If necessary, the bleeding time and activated partial thromboplastin time (TTPa), rapid test and platelet count should be checked.
• Third trimester of pregnancy
• Children under 4 years old, as safety and efficacy data are limited
• Newborns, special caution should be exercised (see section 5.2 of the product information)

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 product information).

There have been reports of post-marketing cases of chondrolysis in patients who received continuous postoperative intra-articular infusion of local anesthetics. In most cases of chondrolysis reported, 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 product information).

Epidural anesthesia may cause severe adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolemia. Always exercise caution in patients with reduced cardiovascular function.

Epidural anesthesia may cause hypotension and bradycardia. This risk can be reduced by administering intravenous crystalloid or colloid solutions. Hypotension should be treated immediately with, for example, 5-10 mg of efedrine 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 product information).

Nerve injuries and/or local toxic effects on muscles and nerves are caused mainly by the injection of local anesthetics. The extent of these tissue injuries 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. Therefore, the minimum effective dose should be used.

Special caution should be exercised when injecting the local anesthetic into inflamed (infected) tissue, as systemic absorption is increased due to increased blood flow and lower tissue pH.

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

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

Rarely, retro-ocular injections may reach the cranial subarachnoid space, causing intense/severe reactions that include cardiovascular collapse, apnea, seizures 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 may increase creatine phosphokinase concentrations, which may interfere with the diagnosis of acute myocardial infarction.

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

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

Antiarrhythmic therapy

In acidosis, the binding of lidocaine to plasma proteins is reduced, and therefore the free lidocaine concentration is increased. Therefore, the effect of lidocaine may be intensified in cases of acidosis.

Hypokalemia, hypoxia, and acid-base balance disorders should be corrected before using lidocaine in patients who require large doses of antiarrhythmic agents.

During prolonged parenteral lidocaine therapy, fluid balance, serum electrolytes and acid-base balance should be regularly monitored.

Lidocaine administration should be accompanied by continuous ECG monitoring, blood pressure, level of consciousness and respiration. Particular attention should be paid to adjusting the dose of antiarrhythmic drugs, and emergency cardiac equipment should be available. If one or more of the parameters indicate a worsening of cardiac function, a therapeutic review should be performed, which may include discontinuation of lidocaine if necessary.

Note: In narcotized patients, CNS disorders may be overlooked, and cardiac adverse effects may occur without prior warning symptoms.