Product Information for the Patient

Mepivacaine B. Braun 20 mg/ml Injectable Solution

Mepivacaine Hydrochloride

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

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

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

Product Information Contents:

1. What is Mepivacaine B. Braun 20 mg/ml and for what it is used
2. What you need to know before using Mepivacaine B. Braun 20 mg/ml
3. How to use Mepivacaine B. Braun 20 mg/ml
4. Possible adverse effects
5. Storage of Mepivacaine B. Braun 20 mg/ml
6. Container contents and additional information

Mepivacaína is a medication that belongs to the group of local anesthetics of the amide type andis indicated for epidural and caudal anesthesia, peripheral nerve block, plexus nerve block, and eye surgery anesthesia.

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 be performed.

Do not administer Mepivacaine B. Braun 20 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 Mepivacaine B. Braun 20 mg/ml is administered:

?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 renal function impairment (kidneys).

?if you have vascular constriction disease, arteriosclerosis (artery hardening).

?if you are at risk of malignant hyperthermia (a complication including sudden high fever, muscle rigidity, and renal insufficiency).

?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 mepivacaine causing toxic reactions in your heart or nerves and brain.

• You will be closely monitored while you receive mepivacaine to detect as soon as possible any complications that may affect heart function, blood circulation, or nervous and brain functions, and receive any necessary treatment if such complications occur.

Other medications and Mepivacaine B. Braun 20 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 20 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;
• vasoconstrictors (reduction of blood vessel diameter);
• Heparin, anticoagulant medications (that prevent blood clotting), anti-inflammatory non-steroidal medications, 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 ulcers (such as cimetidine);
• Propranolol.

Mepivacaine is generally not combined with other local anesthetics.

Use in children and the elderly

Elderly patients require lower doses than young or middle-aged adults.

It should not be used in children and adolescents under 15 years old.

Pregnancy, lactation, and fertility

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

During pregnancy, Mepivacaine B. Braun 20 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 harming 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 20 mg/ml may temporarily affect your ability to move, attention, and coordination. Your doctor will inform you if you can drive or operate machinery.

Mepivacaine B.Braun 20 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 less than 23 mg of sodium (1 mmol) per 10 ml ampoule, which is essentially "sodium-free".

20 ml ampoules:

This medication contains 40 mg of sodium (main component of table salt/for cooking) per 20 ml ampoule. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.

Mepivacaína B. Braun 20 mg/ml is administered via epidural and perineural routes for nerve conduction blockade and administration routes for peri and retrobulbar blocks in ophthalmic surgery.

It will be administered by healthcare personnel only, and your doctor will determine the most appropriate 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 characteristics.

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 20 mg/ml than you should:

Overdose may cause signs and symptoms of intoxication. The severity of the signs and symptoms depends 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 first receive necessary treatment to normalize and stabilize heart, circulation, and respiratory 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 medications, this medication may produce 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).
• Hypotension.
• Hypertension.
• 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 extraocular muscles).
• Cardiac arrest.
• Angina pectoris.
• Problems with heart rhythm coordination(atrioventricular block).
• Cardiac arrhythmia.
• Dyspnea.

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

Extensive spinal anesthesia (total) 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 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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Mepivacaine B. Braun 20 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 ampule 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 drains or in the trash. Ask your pharmacist howto dispose of containers and medicines that you no longer need.This will help protect theenvironment.

Mepivacaine B. Braun 20 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 20 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.

Not all formats may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last Review Date of this Prospectus: August 2020

The detailed and updated information on 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 medical professionals or healthcare professionals:

Mepivacaine B. Braun 20 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 lowest effective dose should always be used. Dosage should be adjusted individually according to the patient's age and weight, as well as the specific case.

.

Regional anesthesia and nerve blocks:

The dose should not exceed 400 mg.

The maximum daily dose is 1g.

Mepivacaine B. Braun 20 mg/ml injectable solution can be administered continuously.

The following doses are recommended for different types of use:

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

The doses for adolescents aged 15 and over are the same as those for adults.

Not indicated for patients under 15 years.

Hepatic insufficiency

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

When using prolonged blocks, such as 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

• Perineural, epidural for nerve conduction blockade.
• Ophthalmic surgery: administration routes for peri and retrobulbar blocks.

Local anesthesia should not be injected into infected areas.

Before injection, ensure that the needle is not intravascular.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 continuous epidural administration, mepivacaine solutions should be more diluted.

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 quickly recognized due to increased heart rate. Heart rate should be measured repeatedly until 5 minutes after administration of the test dose.

Verbal contact with the patient should be maintained and heart rate should be measured repeatedly until 5 minutes after administration of the test dose. Aspiration should be repeated before administering the main dose. The main dose should be injected slowly, and especially when increasing the dose, constant contact with the patient should be maintained. 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.