Leaflet: information for the patient

Lidocaine B. Braun 10 mg/ml injectable solution

Lidocaine, 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 isLidocaine B. Braunand what it is used for

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

3. How to useLidocaine B. Braun

4. Possible side effects

5. Storage ofLidocaine B. Braun

6. Contents of the container and additional information

This medication contains lidocaine hydrochloride and belongs to a group of medications called amide 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).

Warnings and precautions

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

• if you are an elderly person or are in a weakened general state
• if you suffer from 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 epilepsy.
• if you have inflammation or infection at the injection site.
• if you have porphyria (a rare hereditary 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 use in 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)
• medications that inhibit lidocaine metabolism (e.g. cimetidine)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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, pay attention, and coordinate. Your doctor will indicate if you can drive or operate machinery.

Lidocaína B. Braun contains sodium

This medication contains 28 mg of sodium (main component of table salt/for cooking) in each 10 ml ampule. This is equivalent to 1.4% of the maximum daily sodium intake recommended for an adult.

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 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.

Use in children

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

If you use more Lidocaína B. Braun than you should

The doctor attending you is prepared to treat severe adverse 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 adverse effects related to excessive lidocaína may appear, such as balance and coordination disorders, auditory 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 at 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.

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

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

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

- Nausea and vomiting

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

- Transient neurological symptoms (pain in the legs and buttocks).

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

- Tingling sensation in the legs, loss of bladder control (cauda equina syndrome)

- "Noise" in the ears or sound sensitivity

- Hearing loss

- Visual disturbances

- Headache

- Dizziness

- Hypertension (high blood pressure)

- Bradycardia (slow heart rate)

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

- Cardiac arrest

- Respiratory depression (slow or interrupted breathing)

- Double vision

- Hypotension (low blood pressure)

Unknown frequency side effects (cannot be estimated from available data):

- Horner's syndrome (associated with epidural anesthesia or applications in the head and neck region)

Reporting 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 prospectus. 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 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. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lidocaína B. Braun

The active ingredient 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 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 10 ml polyethylene ampoules (Mini-Plasco) in packs 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 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

This leaflet was approved in: June 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

Lidocaína B. Braun should only be used by doctors with experience in regional anesthesia and resuscitation techniques or under their supervision. There should be emergency resuscitation equipment 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.

Dosage

Adults

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

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.

Children

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.

When administering lidocaine to children, the lowest effective concentration should always be used to prevent systemic toxicity.

Lidocaine is indicated for adults and children. However, it should be used with special caution in children under four years old, as there is limited safety and efficacy data available for this population at this time.

Lidocaine injectable 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 convulsions and cardiac arrhythmias is unknown.

Special populations

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

Administration

The administration of lidocaine varies depending on the anesthesia procedure used (local anesthesia by infiltration, 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

Medications 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 Ib antiarrhythmic drugs, as cumulative toxic effects are possible.

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).

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 immediately available. In the event of major blocks, an intravenous cannula should be inserted before injecting the local anesthetic. As with all local anesthetics, lidocaine can cause acute toxic effects on the cardiovascular and central nervous systems when high concentrations are achieved in the blood, especially after extensive intravascular administration.

Care should be taken 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 can reduce myocardial conductivity.
• Patients with congestive heart failure, bradycardia or respiratory function deterioration.
• 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. Consideration should be given to an increased tendency to seizures even at doses below the maximum.
• Patients with coagulopathy. Treatment with anticoagulants (e.g. heparin), NSAIDs or plasma substitutes increases the risk of bleeding. Accidental vascular lesions can cause severe bleeding. If necessary, the bleeding time and activated partial thromboplastin time (APTT) should be checked, as well as the rapid test and platelet count.
• Third trimester of pregnancy
• Children under 4 years old, as safety and efficacy data are limited
• Newborns (see section 5.2)

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).

There have been reports of condylar fractures in patients who received continuous postoperative intra-articular perfusion of local anesthetics. In most cases of condylar fractures 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).

Epidural anesthesia can cause severe adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolemia. Always be cautious 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, efedrine 5-10 mg intravenously; repeat as necessary.

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

Nerve damage and/or local toxic effects on 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 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 regional intravenous anesthesia, there is a higher 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 higher risk of toxic effects of the drug on the central nervous system even at low doses (see section 4.8).

Rarely, retro- and periocular injections of local anesthetics can reach the cranial subarachnoid space, causing intense/severe reactions that include 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 concentrations, which can interfere with the diagnosis of acute myocardial infarction.

Lidocaine injectable is not recommended for use in newborns (see section 5.2).

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.