Leaflet: information for the user

Lidocaína B. Braun 50 mg/ml injectable solution

Lidocaína, hydrochloride

Read 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, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Lidocaína B.Braun and what it is used for

2. What you need to know before starting to use Lidocaína B.Braun

3. How to use Lidocaína B.Braun

4. Possible side effects

5. Storage of Lidocaína B. Braun

6. Contents of the pack and additional information

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

Lidocaína B. Braun is used to provide local anesthesia by injection around nerves or areas where surgical procedures will be performed.

No useLidocaína B. Braun:

- If you are allergic to lidocaine, other local anesthetics of the amide type, 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 hypovolemic shock (severe loss of blood or body fluids).

Epidural anesthesia should not be used during childbirth.

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 general 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 epilepsy
• 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.

Children

Lidocaine is not recommended for newborns. 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, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

Lidocaína B. Braun contains sodium

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

Lidocaína B. Braun will be administered by a doctor. It will be given 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 in poor general health.

Use in children

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.

If you use more Lidocaína B. Braun than you should

The doctor treating you is prepared to treat severe side effects related to excessive 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 think you have received more lidocaína than you should, inform your doctor or nurse immediately.

More severe side effects related to excessive lidocaína may appear, such as 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 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 phone: 91.562 04 20, indicating the medication and the amount used. Bring this leaflet with you.

Like all medicines, this medicine may 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

- Vertigo

- Sensation of tingling

Uncommon 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, respiratory difficulty, 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)

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.

No special storage conditions are required.

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.

Single use. The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard any 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. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

The active ingredient is lidocaine hydrochloride.

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

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

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

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

Appearance of the product and contents of the package

Lidocaine 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 marketed.

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

This leaflet was approved in July 2021.

The 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 only for doctors or healthcare professionals:

Dosage and administration

Lidocaine B. Braun should only be used by doctors with experience in regional anesthesia and resuscitation techniques or under their supervision. Equipment for emergency resuscitation should be available when local anesthetics are administered. The lowest effective dose should be administered. The dose should be adjusted individually according to the characteristics of each case.

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 kg. The dose should be adjusted according to age, weight and patient condition:

It is preferable to use a low dose (10 mg/ml or less) of lidocaine for continuous local anesthesia.

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.

Paediatric population

Doses are calculated individually according to the age and body weight of the patients and the nature of the procedure. The anesthesia technique should be selected carefully 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.

Systemic toxicity should always be prevented in children by using the lowest effective concentration.

Lidocaine is indicated in adults and children. However, it should be used with special caution in children under four years old, as there is limited data to support the safety and efficacy of this product in this population of patients at this time.

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

Special populations

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

Administration

The administration of lidocaine varies according to 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 medicines and other forms of interaction

Medicines 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 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 with lidocaine and class III antiarrhythmic drugs (e.g. amiodarone), but caution is recommended (see section 4.4 of the SmPC).

Special warnings and precautions for use

In general, before injecting lidocaine, it should be ensured that all emergency resuscitation equipment and medications for treating toxic reactions are available immediately. In case 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 and central nervous systems when high concentrations are reached in the blood, especially after extensive intravascular administration.

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

• Older patients and those who are generally debilitated.
• 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 for the appearance of central nervous system symptoms. An increase in the 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 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 there is limited data to support the safety and efficacy of this product in this population of patients at this time.
• Newborns. Special caution should be exercised (see section 5.2 of the SmPC)

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 SmPC).

There have been reports of chondrolysis in patients who received continuous postoperative intra-articular perfusion 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 perfusion is not an approved indication for lidocaine (see section 4.8 of the SmPC).

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, efedrine 5-10 mg intravenously; repeat as necessary.

Paracervical block may cause bradycardia or fetal tachycardia in some cases and close monitoring of fetal heart rate is necessary (see section 4.6 of the SmPC).

Nerve damage and/or local toxic effects in muscles and nerves are caused mainly 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. Therefore, the minimum effective dose should be used.

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

Once the tourniquet is removed after intravenous regional 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 SmPC).

Rarely, retro-ocular injections may reach the cranial subarachnoid 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 in 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 SmPC).

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.