Mepivacaine Normon 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mepivacaíne Normon 10 mg/ml solution for injection EFG

Mepivacaine hydrochloride

Read the entire 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, ask your doctor, nurse or pharmacist.
• If you experience any adverse effects, consult your doctor, nurse or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Mepivacaíne Normon 10 mg/ml is and what it is used for
2. What you need to know before being administered Mepivacaíne Normon 10 mg/ml
3. How to use Mepivacaíne Normon 10 mg/ml
4. Possible adverse effects
5. Storage of Mepivacaíne Normon 10 mg/ml
6. Contents of the pack and other information

1. What Mepivacaína Normon 10 mg/ml is and what it is used for

Mepivacaína Normon 10 mg/ml injectable solution is a medicine that belongs to a group of medicines called amide-type local and regional anesthetics.

It is indicated for:

• Local infiltration anesthesia.
• Peripheral nerve, plexus, and paravertebral blocks.
• Epidural and caudal anesthesia.

Depending on the amount used, it will either completely block pain or cause a partial loss of sensation.

It is used before surgery or various medical procedures to prevent or relieve pain in the area of the body where the procedure will be performed.

2. What you need to know before Mepivacaine Normon 10 mg/ml is administered to you

Do not administer Mepivacaine Normon

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

Warnings and precautions

Talk to your doctor or nurse before Mepivacaine Normon is administered:

• if you have serious heart rhythm problems or any heart disease;
• if you have a degenerative nerve disease;
• if you are elderly;
• if you are in poor general health;
• if you have liver disease (liver);
• if you have impaired kidney function (kidneys);
• if you have vascular disease or arteriosclerosis (hardening of the arteries);
• if you may be at risk of malignant hyperthermia (a complication including sudden high fever, muscle rigidity, and kidney failure);
• 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 prevent mepivacaine from causing toxic reactions in your heart, nerves, or brain.

You will be closely monitored during administration of mepivacaine to detect as early as possible any complications that may affect cardiac function, blood circulation, or nervous and brain functions, and to provide any necessary treatment if such complications occur.

Other medicines and Mepivacaine Normon 10 mg/ml

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

The administration of mepivacaine together with the following medicines may require adjustment of the dose of one or more of these medicines or interruption of treatment:

• strong analgesics;
• other local anaesthetics;
• certain medicines used to treat heart rhythm disorders;
• general anaesthetics such as ether;
• medicines that cause vasoconstriction (reduction in the diameter of blood vessels);
• heparin, anticoagulant medicines (which prevent blood clotting), non-steroidal anti-inflammatory drugs (NSAIDs), and plasma substitutes (products used in cases of blood loss). Your blood clotting function will be carefully monitored if you are receiving any of these medicines;
• cytochrome P450 1A2 inhibitors (such as ciprofloxacin, enoxacin, or fluvoxamine);
• medicines used to treat stomach and intestinal burning sensations and ulcers (such as cimetidine);
• propranolol.

Mepivacaine is generally not combined with other local anaesthetics.

Use in children and elderly

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

It must not be used in children under 1 year 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 this medicine is administered.

During pregnancy, mepivacaine will only be administered after strict evaluation of the indications and only if your doctor considers it absolutely necessary. Your doctor will take all possible precautions to avoid harm to you or your baby.

Mepivacaine is not the drug of choice for epidural anaesthesia in obstetrics.

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

Driving and use of machines

Mepivacaine may temporarily affect your motor ability, attention, and coordination. Your doctor will advise you whether you may drive or operate machinery.

Mepivacaine Normon 10 mg/ml contains sodium

This medicine contains 28 mg of sodium (a main component of table/cooking salt) per ampoule. This corresponds to 1.4% of the maximum daily sodium intake recommended for an adult.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

3. How to use Mepivacaine Normon 10 mg/ml

Mepivacaine Normon is intended for intradermal, subcutaneous, intramuscular, periarticular, epidural, or perineural administration.

It will be administered only by healthcare professionals, and your doctor will determine the most appropriate dose for you. The smallest dose required to achieve the desired anesthesia should always be used. Dosage must be individually adjusted according to the patient's age, weight, and the specific characteristics of each case.

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

Your doctor will ask you to talk to them while administering the medication to ensure that you remain conscious.

Your blood pressure may be monitored from time to time.

If you are given more Mepivacaine Normon 10 mg/ml than you should

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

• Central nervous system symptoms

Mild toxicity:

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

Moderate toxicity:

Speech disturbances, drowsiness, nausea, vomiting, dizziness, confusion, tremor, choreiform movements, seizures, mydriasis, tachypnea.

Severe toxicity:

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

• Cardiovascular system symptoms

Mild toxicity:

Palpitations, hypertension, tachycardia, tachypnea.

Moderate toxicity:

Tachycardia, cardiac arrhythmias, hypoxia, pallor.

Severe toxicity:

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

In such cases, you will receive necessary treatment first to normalize and stabilize heart, circulation, and respiratory functions, followed by treatment to control seizures and other severe neurological symptoms. This includes administration of oxygen and additional medications, primarily aimed at restoring normal heart function and circulation.

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

4. Possible adverse effects

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

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

• Burning sensation, prickling, and tingling of the skin (paresthesia), and dizziness.
• Slow and irregular heartbeat (bradycardia).
• Hypotension.
• Hypertension.
• Nausea.
• Vomiting.

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

• Dizziness (mild lightheadedness).
• Tremor.
• Central Nervous System depression.
• Loss of consciousness.
• Seizures (including epileptic fits).
• Speech disorders such as difficulty articulating sounds and words (dysarthria) and excessive talkativeness (logorrhea).
• Visual disturbances.
• 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 ocular muscles).
• Cardiac arrest.
• Angina pectoris.
• Impaired coordination of heartbeat (atrioventricular block).
• Cardiac arrhythmia.
• Difficulty breathing.

Frequency not known (frequency cannot be estimated from available data):

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

Adverse effects due to misuse

Extensive (total) spinal anesthesia may occur due to inadvertent intrathecal injection during planned epidural anesthesia, resulting from the use of too large a volume or incorrect patient positioning (when non-isobaric solutions are used).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaine Normon 10 mg/ml

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to 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 medicines and packaging once they are no longer needed. This will help protect the environment.

6. Package contents and other information

Composition of Mepivacaína Normon 10 mg/ml injectable solution EFG

• The active substance is mepivacaine hydrochloride. Each 10 ml ampoule contains 100 mg of mepivacaine hydrochloride.
• The other components are: sodium chloride and water for injections.

Appearance of the medicinal product and contents of the container

This medicine is a clear, colourless or practically colourless solution.

The pack presentation consists of a box containing 1 ampoule or 100 ampoules of 10 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 most recent review of this summary: April 2023.

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69201/P_69201.html

This information is intended for healthcare professionals only.

Mepivacaína Normon 10 mg/ml should only be used by physicians experienced in regional anaesthesia and resuscitation techniques, or under their supervision. Resuscitation equipment must be readily available when local anaesthetics are administered. The lowest effective dose should always be administered. The dose must be individually adjusted according to the specific circumstances of each case.

Dosage and administration

The smallest dose required to achieve the desired anaesthesia should always be used. Dosage must be individually adjusted according to the patient's age, weight, and the specific circumstances of each case.

Maximum doses for adults:

Infiltration anaesthesia
The dose should not exceed 200 mg. Only in limited cases, in tissues with low vascularity, doses up to 400 mg may be used after careful consideration of the benefit/risks associated with such high doses.

Caudal and epidural anaesthesia, peripheral nerve blocks
The dose should not exceed 300 mg.

The maximum daily dose is 1 g.

Mepivacaína Normon 10 mg/ml injectable solution may be administered continuously.

The following doses are recommended for different types of use:

*When multiple segments are anesthetized, the total dose must not exceed the recommended maximum dose.

For further details on doses to be administered for the anesthesia of specific nerves or for specific anesthetic techniques, consult standard textbooks.

Elderly patients

Lower doses may be required for elderly patients or those in poor general condition.

Pediatric population

Maximum doses for children from one year of age:

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

Hepatic impairment

Dose reduction is not required for surgical anesthesia in patients with hepatic impairment.

When prolonged blocks are used, e.g., by repeated administration, repeated doses of mepivacaine should be reduced by 50% in patients with Child-Pugh class C liver disease, and the total dose within 24 hours must not exceed 750 mg of mepivacaine.

Renal impairment

Dose reduction is not required for surgical anesthesia within 24 hours in patients with renal dysfunction.

Administration

• Intradermal, subcutaneous, intramuscular, periarticular administration for infiltration anesthesia.
• Perineural or epidural administration for nerve conduction blockade.

Before injection, ensure that the needle is not intravascular. Injection must be performed slowly and in fractions.

Basic guidelines to follow:

1. Use the lowest possible dosage.
2. Use a needle of appropriate size.
3. Inject slowly with multiple aspirations in two planes (rotate the needle 180º). Great care must be taken to avoid accidental intravascular injection. Careful aspiration is essential.
4. Monitor blood pressure.
5. Take into account premedication. Premedication should include prophylactic administration of atropine and, depending on the amounts of local anesthetic to be injected, a short-acting barbiturate.
6. If necessary, discontinue anticoagulant therapy prior to administration of the local anesthetic.
7. Observe general and specific contraindications for the various methods of local or regional anesthesia.

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

Verbal contact with the patient must be maintained, and heart rate should be repeatedly monitored for up to 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 must be maintained. Administration must be immediately interrupted at the first signs of toxicity.

Before administering a local anesthetic, ensure that resuscitation equipment, e.g., oxygen source, airway maintenance materials, and emergency medications for treatment of toxic reactions, is immediately available.