MEPIVACAINE NORMON 20 mg/ml INJECTABLE SOLUTION

2. What you need to know before you are given Mepivacaine Normon 20 mg/ml

You should not be given Mepivacaine Normon

• if you are allergic to mepivacaine or any of the other components of this medicine (listed in section 6);
• if you are allergic to other local anesthetics of the same group (e.g., bupivacaine or lidocaine);
• if you have severe blood coagulation disorders;
• if you have degenerative nerve disease;
• if you have serious problems with heart impulse conduction or other heart problems;
• if you have uncontrolled epilepsy;
• if you have increased intracranial pressure.

Warnings and precautions

Consult your doctor or nurse before you are given Mepivacaine Normon:

• if you have serious heart rhythm problems or any heart disease;
• if you have degenerative nerve disease;
• if you are elderly;
• if you are in poor general health;
• if you have liver disease;
• if you have impaired kidney function;
• if you have a disease that causes narrowing of the blood vessels, arteriosclerosis (hardening of the arteries);
• if you may be at risk of malignant hyperthermia (a complication that includes sudden high fever, muscle stiffness, and kidney failure);
• if you have epilepsy;
• if you have inflammation and/or infection at the injection site;
• if you have a blood disease 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 are given mepivacaine to detect any complications that may affect heart function, blood circulation, or nervous and brain functions as soon as possible, and to give you any necessary treatment in case such complications occur.

Other medicines and Mepivacaine Normon

Tell your doctor or nurse if you are using, have recently used, or may need to use any other medicine.

The administration of mepivacaine with the following medicines may make it necessary to modify the dose of one of them or interrupt treatment:

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

Mepivacaine is generally not combined with other local anesthetics.

Use in children and elderly

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

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

Pregnancy, breastfeeding, and fertility

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

During pregnancy, mepivacaine will only be given after careful 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 child.

Mepivacaine is not a preferred drug for epidural anesthesia in obstetrics.

This medicine will be given to you during breastfeeding only if your doctor considers it necessary. If such administration is necessary, breastfeeding should be interrupted until 24 hours after the end of treatment.

Driving and using machines

Mepivacaine may temporarily affect your ability to move, pay attention, and coordinate. Your doctor will tell you if you can drive or use machines.

Mepivacaine Normon contains sodium

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

Use in athletes

Athletes are informed that this medicine contains a component that may produce a positive doping test result.

3. How to use Mepivacaine Normon 20 mg/ml

Mepivacaine Normon is intended for epidural and perineural administration for nerve conduction block 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 suitable dose for you. The smallest dose required to produce the desired anesthesia should always be used. The dosage must be adjusted individually according to the patient's age and weight, as well as the specific characteristics of each case.

In patients with liver, kidney, or heart disease, poor general health, or elderly patients, special caution and careful dose adjustment are necessary.

Your doctor will ask you to talk to them while they administer the medicine to ensure you are conscious.

Your blood pressure may be measured from time to time.

If you are given more Mepivacaine Normon 20 mg/ml than you should

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

• Symptoms in the central nervous system:

Mild poisoning:

Numbness and tingling in the mouth area, metallic taste, changes in hearing and vision, yawning, anxiety, restlessness, chills, muscle spasms, nausea, vomiting, disorientation.

Moderate poisoning:

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

Severe poisoning:

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

• Symptoms in the cardiovascular system

Mild poisoning:

Palpitations, hypertension, tachycardia, tachypnea.

Moderate poisoning:

Tachycardia, cardiac arrhythmias, hypoxia, pallor.

Severe poisoning:

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

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

In case of overdose or accidental ingestion, consult your doctor, nurse, or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the product and the amount received.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Sensation of burning, pinching, and tingling in the skin (paresthesia) and dizziness.
• Slow and abnormal heart rate (bradycardia).
• Hypotension.
• Hypertension.
• Nausea.
• Vomiting.

Uncommon (may affect up to 1 in 100 people):

• Dizziness (mild dizziness).
• Tremors.
• Central nervous system depression.
• Loss of consciousness.
• Convulsions (including epileptic seizures).
• Speech disorders such as difficulty articulating sounds and words (dysarthria) and excessive talkativeness (logorrhea).
• Visual impairment
• Ringing in the ears (tinnitus).

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

• Anaphylactic/anaphylactoid reactions.
• Allergic reactions.
• Pain due to nerve injury (neuropathy).
• Peripheral neural damage.
• Arachnoiditis.
• Diplopia (paralysis of the eye muscles).
• Cardiac arrest.
• Chest pain.
• Heart rhythm problems (atrioventricular block).
• Cardiac arrhythmia.
• Breathing difficulties.

Frequency not known (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) can occur through accidental intrathecal injection during planned epidural anesthesia, as a result of using too large a volume or incorrect patient placement (when non-isobaric solutions are used).

The first signs are restlessness and drowsiness, which can lead to loss of consciousness and respiratory arrest.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaine Normon 20 mg/ml

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the box after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofMepivacaine Normon20 mg/ml injectable solution EFG

• The active ingredient is mepivacaine hydrochloride. Each 10 ml ampoule contains 200 mg of mepivacaine hydrochloride, and each 2 ml ampoule contains 40 mg of mepivacaine hydrochloride.
• The other ingredients are: sodium chloride and water for injectable preparations.

Appearance of the product and package contents

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

The commercial presentation is a box with 1 ampoule or 100 ampoules of 10 ml or 2 ml of injectable solution.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

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

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.

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This information is intended only for healthcare professionals.

Mepivacaine Normon 20 mg/ml should only be used by doctors with experience in regional anesthesia and resuscitation techniques or under their supervision. Resuscitation equipment should be available when local anesthetics are administered. The lowest possible dose that produces the desired effect should be administered. The dose should be adjusted individually according to the specific characteristics of each case.

Dosage

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

Caudal and epidural anesthesia, peripheral nerve blocks

The dose should not exceed 400 mg.

The maximum daily dose is 1g.

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

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

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

Elderly patients

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

Pediatric population

The doses for adolescents from 15 years of age are the same as those indicated for adults.

It is not indicated for children under 15 years of age.

Hepatic impairment

In patients with hepatic impairment, dose reduction is not necessary for surgical anesthesia.

When prolonged blocks are used, for example, through repeated administration, repeated doses of mepivacaine 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 mepivacaine.

Renal impairment

Dose reduction is not necessary for surgical anesthesia in patients with renal dysfunction up to 24 hours.

Administration

• Perineural, epidural route for nerve conduction block.
• 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 placed intravascularly.The injection should be performed slowly and fractionally.

Basic rules to follow:

1. Choose the smallest possible dose.
2. Use a needle of the appropriate size.
3. Inject slowly with several aspirations in two planes (rotate the needle 180°). Great care should be taken to avoid accidental intravascular injection. Careful aspiration is essential.
4. Monitor blood pressure.
5. Take into account 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 the administration of the local anesthetic.
7. Observe the general and specific contraindications for the various methods of local or regional anesthesia.

For continuous epidural administration, more diluted mepivacaine solutions should be used.

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

Verbal contact with the patient should be maintained, and the heart rate should be measured repeatedly until 5 minutes after the 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 symptoms of toxicity.

Before administering a local anesthetic, ensure that the necessary equipment for resuscitation, such as an oxygen source, material to keep the airway clear, and emergency medication for the treatment of toxic reactions, is available immediately.