Label: information for the patient

Mepivacaína B. Braun 10 mg/ml injectable solution

Mepivacaína Hydrochloride

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

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

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

Mepivacaína is a medication that belongs to the group of local and regional anesthetics of the amide type andis indicated for local anesthesia by infiltration, epidural anesthesia and caudal, peripheral nerve blocks, nerve plexus blocks, and paravertebral blocks.

Depending on the amount used, it will completely stop the pain or cause a partial loss of sensitivity.

It is used before surgery or various medical examinations to prevent or relieve pain in the area of your body where the procedure will take place.

Do not administer Mepivacaine B. Braun 10 mg/ml:

• if you are allergic to mepivacaine hydrochloride, or to any of the other components of this medication (listed in section 6);
• if you are allergic to other local anesthetics, e.g.: Bupivacaine, Lidocaine;
• if you have severe blood clotting disorders;
• if you have degenerative nerve disease;
• if you have severe heart conduction problems, or other heart problems;
• if you have uncontrolled epilepsy;
• if you have increased intracranial pressure;

Warnings and precautions

Consult your doctor or nurse before receiving Mepivacaine B. Braun 10 mg/ml:

• if you have severe heart rhythm problems or any heart disease;
• if you have degenerative nerve disease;
• if you are elderly;
• if you have a poor general condition;
• if you have liver disease (liver);
• if you have kidney function impairment;
• if you have vascular narrowing disease, arteriosclerosis (hardening of the arteries);
• if you are at risk of malignant hyperthermia (a complication that includes sudden high fever, muscle rigidity, and renal failure);
• if you have epilepsy;
• if you have inflammation and/or infection at the injection site;
• If you have a blood disorder called porphyria.

The dose you will receive will be carefully controlled to avoid toxic reactions in your heart, nerves, and brain.

You will be closely monitored while receiving mepivacaine to detect any complications that may affect your cardiac function, blood circulation, or nervous and brain functions, and receive any necessary treatment if such complications occur.

Other medications and Mepivacaine B. Braun 10 mg/ml

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

The administration of Mepivacaine B. Braun 10 mg/ml with the following medications may require modification of the dose of one of them or interruption of treatment:

• strong analgesics;
• other local anesthetics;
• some medications used to treat heart rhythm disorders;
• general anesthetics such as ether;
• medications that produce vasoconstriction (reduction of blood vessel diameter);
• heparin,anticoagulant medications (that prevent blood clotting),non-steroidal anti-inflammatory drugs, and plasma substitutes (products used in case of blood loss). Your blood clotting function will be carefully monitored if you are receiving any of these medications;
• inhibitors of cytochrome PYP 1A2 (such as ciprofloxacin, enoxacin, or fluvoxamine);
• medications used to treat heartburn and stomach and intestinal ulcers (such as cimetidine);
• Propanolol.

Mepivacaine is generally not combined with other local anesthetics.

Use in children and the elderly

Children and the elderly require lower doses than young or middle-aged adults.

It should not be used in children under 1 year of age.

Pregnancy, lactation, and fertility

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

During pregnancy, Mepivacaine B. Braun 10 mg/ml will only be administered after strict consideration of the indications and if your doctor considers it absolutely necessary. Your doctor will take any possible precautions to avoid harm to you or your unborn child.

Mepivacaine is not a preferred medication in obstetric epidural anesthesia.

This medication will be administered during breastfeeding only if your doctor considers it necessary.If such administration is necessary, breastfeeding should be interrupted for up to 24 hours after the end of treatment.

Driving and operating machinery:

Mepivacaine B. Braun 10 mg/ml may temporarily affect your ability to move, attention, and coordination. Your doctor will indicate if you can drive or operate machinery.

Mepivacaine B.Braun 10 mg/ ml contains sodium

5 ml ampoules:

This medication contains less than 23 mg of sodium (1 mmol) per 5 ml ampoule, which is essentially "sodium-free".

10 ml ampoules:

This medication contains 27.6 mg of sodium (main component of table salt/for cooking) per 10 ml ampoule, which is equivalent to 1.4% of the maximum daily sodium intake recommended for an adult.

20 ml ampoules:

This medication contains 55.1 mg of sodium (main component of table salt/for cooking) per 20 ml ampoule, which is equivalent to 2.8% of the maximum daily sodium intake recommended for an adult.

Mepivacaína B. Braun 10 mg/ml is administered viaintradermal, subcutaneous,intramuscular, periarticular, epiduralor perineural routes.

It will be administered by healthcare personnel only, and your doctor will determine the mostappropriate dose for you. The smallest dose required to produce the desired anesthesia should always be used. Dosage should be adjusted individually according to the patient's age, weight, and specific case.

Special caution and careful dose adjustment are necessary in patients with liver, kidney, heart disease, poor general condition, and the elderly.

Your doctor will ask you to speak with them while they administer the medication to ensure you are conscious.

Your blood pressure may be measured from time to time.

If you are administered more Mepivacaína B. Braun 10 mg/ml than you should:

Overdose may cause signs and symptoms of intoxication. The severity of the signs and symptomsdepends on the dose administered. The following may be observed:

1. Central nervous system symptoms:

Mild intoxication:

Tickling and numbness in the mouth area, metallic taste, hearing and vision disturbances, yawning, anxiety, restlessness, chills, muscle spasms, nausea, vomiting, disorientation.

Moderate intoxication:

Speech disturbances, drowsiness, nausea, vomiting, dizziness, somnolence, confusion, tremors, choreiform movements, convulsions, mydriasis, tachypnea.

Severe intoxication:

Vomiting (risk of asphyxiation), anal sphincter paralysis, muscle tone loss and reactivity, stupor, irregular breathing, respiratory paralysis, coma, death.

1. Cardiovascular system symptoms:

Mild intoxication:

Palpitations, hypertension, tachycardia, tachypnea.

Moderate intoxication:

Tachycardia, cardiac arrhythmias, hypoxia, pallor.

Severe intoxication:

Severe hypoxia and cyanosis, primary cardiac insufficiency, hypotension, cardiac arrhythmias (bradycardia, atrial fibrillation, asystole).

In such cases, you will receive necessary treatment first to normalize and stabilize heart, circulation, and breathing functions, and then to control severe nervous symptoms and convulsions. This includes administering oxygen and additional medication, primarily to normalize heart function and circulation.

In case of overdose or accidental ingestion, consult your doctor, nurse, or pharmacist immediately or call the Toxicological Information Service, phone: 91 652 04 20, indicating the medication and amount ingested.

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

Frequent(may affect up to 1 in 10 people):

• Burning, prickling, and tingling sensations in the skin (paresthesia) and dizziness.
• Abnormal and slow heart rate (bradycardia).
• Low blood pressure.
• High blood pressure.
• Nausea.
• Vomiting.

Less frequent (may affect up to 1 in 100 people):

• Mild dizziness.
• Tremor.
• Depression of the Central Nervous System.
• Loss of consciousness.
• Seizures (including epileptic seizures).
• Speech disorders such as difficulty articulating sounds and words (dysarthria) and excessive talking (logorrhea).
• Visual disturbances
• Tinnitus (ringing in the ears).

Rare (may affect up to 1 in 1,000 people):

• Anaphylactic/anaphylactoid reactions.
• Allergic reactions.
• Pain due to nerve damage (neuropathy).
• Peripheral nerve damage
• Arachnoiditis.
• Diplopia (paralysis of the eye muscles).
• Cardiac arrest.
• Angina pectoris.
• Problems with heart rhythm coordination(atrioventricular block).
• Cardiac arrhythmia.
• Dyspnea (difficulty breathing).

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

• Euphoria.
• Anxiety/nervousness.
• Inability of the heart to contract effectively(myocardial depression)

Side effects due to misuse

A total spinal anesthesia may be produced by accidental intrathecal injection during planned epidural anesthesia, as a result of using too large a volume or incorrect patient positioning (when non-isobaric solutions are used).

The first signs are restlessness, whispering, and drowsiness that may lead to loss of consciousness and respiratory arrest.

Reporting of side effects

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

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Mepivacaine B. Braun 10 mg/ml after the expiration date shown on thecontainer (after CAD). The expiration date is the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. Once opened, discard any unused portion of the solution. For single use only. Do not use this medication if you observe particles.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist howto dispose of the containers and medicines that you no longer need.This will help protect theenvironment.

Mepivacaine B. Braun 10 mg/ml Composition

The other excipients are: sodium chloride, sodium hydroxide (for pH adjustment) and water for injection in sufficient quantity.

Product Appearance and Packaging Contents

Mepivacaine B. Braun 10 mg/ml is an injectable solution that is presented in polyethylene (Mini-Plasco) ampoules of 5, 10 and 20 ml. It is presented in packs of 1 ampoule and 100 ampoules.

It may not be marketed in all formats.

Marketing Authorization Holder and Responsible Manufacturer

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last Review Date of this Leaflet: July 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Mepivacaine B. Braun 10 mg/ml should only be used by experienced anesthesiologists and 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.

Dosage

The smallest dose required to produce the desired anesthesia should always be used. The dosage should be adjusted individually according to the patient's age and weight, as well as the specific case.

Maximum dose for adults:

Local anesthesia by infiltration

The dose should not exceed 200 mg. In limited cases, in tissues with low vascularization, doses of up to 400 mg may be used after considering the benefit/risk of these high doses.

Caudal and epidural anesthesia, peripheral nerve blocks:

The dose should not exceed 300 mg.

The maximum daily dose is 1g.

Mepivacaine B. Braun 10 mg/ml injectable solution may be administered continuously.

For different types of use, the following doses are recommended:

*When anesthetizing multiple segments, the total dose should not exceed the recommended maximum dose.

For more details on the doses to be applied for anesthetizing specific nerves or for specific anesthetic techniques, consult standard textbooks.

Geriatric patients

Lower doses may be necessary for elderly patients or those in poor general health.

Pediatric population

Maximum doses for children over one year of age:

• Maximum dose: 5 mg/Kg of body weight.
• Injecting into tissues with marked systemic absorption: up to 3 mg/Kg of body weight.
• Caudal anesthesia: 5 mg/Kg of body weight.

Hepatic insufficiency

No dose reduction is necessary for surgical anesthesia in patients with hepatic insufficiency.

When using prolonged blocks, for example, by repeated administration, the repeated doses of mepivacaine should be reduced by 50% in patients with Child-Pugh grade C liver disease and the total dose in 24 hours should not exceed 750 mg of mepivacaine.

Renal insufficiency

No dose reduction is necessary for surgical anesthesia until 24 hours in patients with renal dysfunction.

Administration:

• Intradermal, subcutaneous, intramuscular, periarticular for local anesthesia by infiltration.
• Perineural or epidural for nerve conduction block.

Before injection, ensure that the needle is not intravascularly located.The injection should be made slowly and in fractions.

Basic guidelines to follow:

Care must be taken to avoid accidental intravascular injection.It is essential to perform careful aspiration.

For epidural anesthesia, a test dose should be administered, consisting of 3 - 4 ml of a local anesthetic with added adrenaline (1: 200,000) before the full dose, as intravascular injection of adrenaline is rapidly recognized due to increased heart rate. Heart rate should be measured repeatedly until 5 minutes after administration of the test dose.

Precautions should be taken to avoid accidental intravascular injection. Careful aspiration and a test dose are essential.

Maintain verbal contact with the patient and heart rate should be measured repeatedly until 5 minutes after administration of the test dose. Repeat aspiration before administering the main dose. The main dose should be injected slowly, and especially when increasing the dose, maintain constant contact with the patient. Administration should be interrupted immediately at the first signs of toxicity.

Before administering a local anesthetic, ensure that the necessary equipment for resuscitation, e.g. oxygen source, material for maintaining a free airway, and emergency medication for treating toxic reactions, is immediately available.