Package Insert:Patient Information

Mepivacaína Normon 10 mg/ml Injectable Solution EFG

Mepivacaína Hydrochloride

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

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

Mepivacaína Normon 10 mg/ml injectable solution is a medication that belongs to the group of medications known as local and regional anesthetics of the amide type.

It is indicated for:

• Local anesthesia by infiltration.
• Blockage of peripheral nerves, nerve plexuses, and paravertebral nerves.
• Epidural and caudal 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 alleviate pain in the area of your body where the procedure will take place.

Noshould be administeredMepivacaína Normon

• if you are allergic to mepivacaína orany of the other components of this medication (listed in section 6);

• if you are allergic to other local anesthetics in the same group(for example, bupivacaína or lidocaína);
• if you have severe blood clotting disorders;
• if you have degenerative nervous system 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 Mepivacaína Normon is administered:

• if you have severe heart rhythm problems or any heart disease;
• if you have degenerative nervous system 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 narrowing disease, arteriosclerosis (artery hardening);
• if you may be at risk of malignant hyperthermia (a complication including sudden high fever, muscle rigidity and renal insufficiency);
• if you suffer from 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 mepivacaína causing toxic reactions in your heart or nerves and brain.

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

Other medications and Mepivacaína Normon 10 mg/ml

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

The administration of mepivacaína 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, anticoagulants (that prevent blood clotting), anti-inflammatory non-steroids and plasma substitutes (products used in case of blood loss). Your blood clotting function will be carefully controlled if you are receiving any of these medications;
• citochrome PYP 1A2 inhibitors (such as ciprofloxacino enoxacino or fluvoxamina);
• medications used to treat heartburn and stomach and intestinal ulcers (such as cimetidina);
• propranolol.

Mepivacaína is generally not combined with other local anesthetics.

Use in children and 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, think you may be pregnant or intend to become pregnant, consult your doctor before this medication is administered.

During pregnancy, mepivacaína 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 child.

Mepivacaína 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 treatment completion.

Driving and operating machinery

Mepivacaína may temporarily alter your ability to move, attention and coordination. Your doctor will indicate if you can drive or operate machinery.

Mepivacaína Normon 10 mg/ml contains sodium

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

Use in athletes

It is informed to athletes that this medication contains a component that may produce a positive analytical result in doping control.

Mepivacaína Normonis intended for intradermal, subcutaneous, intramuscular, periarticular, epidural or perineural administration.

It will be administered by healthcare personnel only, and your doctor will determine the most suitable 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 remain conscious.

Your blood pressure may be measured from time to time.

If you are administered more than the recommended dose of Mepivacaína Normon 10 mg/ml

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

a) Central nervous system symptoms

Mild intoxication:

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

Moderate intoxication:

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

Severe intoxication:

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

b) 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 breathing functions, and then to control severe convulsions and other nervous symptoms. 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: 91 562 04 20, indicating the product and amount received.

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.
• Tremors.
• 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.
• Depressed myocardial contraction (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 and drowsiness that may lead to loss of consciousness and respiratory arrest.

Reporting 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: http://www.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.

This medicationdoes not require special conditions for conservation.

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. In this way, you will help protect the environment.

Composition ofMepivacaína Normon10 mg/ml injectable solution EFG

• The active ingredient is hydrochloride of mepivacaína. Each ampoule of 10 ml contains 100 mg of hydrochloride of mepivacaína.
• The other components are: sodium chloride and water for injectable preparations.

Aspect of the product and content of the package

This medicine is a transparent, colorless or almost colorless solution.

The commercial presentation is a box with 1 ampoule or with 100 ampoules of 10 ml of injectable solution.

Holder of the marketing authorization and responsible for the manufacture

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: April 2023.

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

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This information is intended solely for healthcare professionals.

Mepivacaína Normon 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 characteristics of each case.

Dosage

Always use the smallest dose required to produce the desired anesthesia. The dosage should be adjusted individually according to the age and weight of the patient as well as the characteristics of each case.

Maximum dose for adults:

Local anesthesia by infiltration

The dose should not exceed 200 mg. Only 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.

Mepivacaína Normon 10 mg/ml injectable solution can 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.

Older patients

It may be necessary to apply lower doses for older 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.
• Injections in tissues with marked systemic absorption: up to 3 mg/Kg of body weight.
• Caudal anesthesia: 5 mg/Kg of body weight.

Liver insufficiency

In patients with liver insufficiency, no dose reduction is necessary for surgical anesthesia.

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

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:

1. Choose the smallest possible dose.
2. Use a needle of the appropriate size.
3. Inject slowly with multiple aspirations in two planes (rotate the needle 180°). Care must be taken to avoid accidental intravascular injection. It is essential to perform careful aspiration.
4. Monitor blood pressure.
5. Consider premedication. Premedication should include the prophylactic administration of atropine and, depending on the convenient amounts of local anesthetic to be injected, a short-acting barbiturate.
6. If necessary, suspend the administration of anticoagulants before administering the local anesthetic.
7. Observe general and specific contraindications for various local or regional anesthesia methods.

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 the increase in 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 available immediately.