Mepivacaine Normon 20 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mepivacaine Normon 20 mg/ml injectable solution EFG

Mepivacaine hydrochloride

Read all of this 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 adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Mepivacaine Normon 20 mg/ml is and what it is used for
2. What you need to know before you are given Mepivacaine Normon 20 mg/ml
3. How to use Mepivacaine Normon 20 mg/ml
4. Possible adverse effects
5. How to store Mepivacaine Normon 20 mg/ml
6. Contents of the pack and other information

1. What Mepivacaína Normon 20 mg/ml is and what it is used for

Mepivacaína Normon 20 mg/ml solution for injection is a medicine that belongs to a group of medicines called amide-type local and regional anesthetics.

It is indicated for:

• Blockade of peripheral nerves and nerve plexuses
• Epidural and caudal anesthesia
• Anesthesia for ophthalmic surgery

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 examinations to prevent or relieve pain in the area of your body where the procedure will be performed.

2. What you need to know before Mepivacaine Normon 20 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 (e.g., bupivacaine or lidocaine);
• if you have severe defects in blood coagulation;
• if you have degenerative nerve disease;
• if you have serious problems with heart impulse conduction or other cardiac problems;
• 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 to you:

• if you have serious problems with your heart rhythm or any heart disease;
• if you have degenerative nerve disease;
• if you are elderly;
• if you are in poor general condition;
• 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 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.

Your dose 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 should such complications occur.

Other medicines and Mepivacaine Normon

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

Administration of mepivacaine together with the following medicines may require adjustment of the dose or discontinuation 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 blood vessel diameter);
• heparin, anticoagulant medicines (which prevent blood clotting), non-steroidal anti-inflammatory drugs, and plasma substitutes (products used in cases 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 burning or ulcers (such as cimetidine);
• propranolol.

Mepivacaine is generally not combined with other local anaesthetics.

Use in children and elderly

Elderly patients require lower doses than younger 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 this medicine is administered to you.

During pregnancy, mepivacaine will only be administered after strict evaluation of the indication and 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 completion of treatment.

Driving and use of machines

Mepivacaine may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you may drive or operate machinery.

Mepivacaine Normon contains sodium

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

Use in athletes

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

3. How to use Mepivacaine Normon 20 mg/ml

Mepivacaine Normon is intended for epidural and perineural administration for nerve conduction block, and for peri- and retrobulbar blocks in ophthalmic surgery.

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 and weight, as well as the specific characteristics of each case.

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

If you are given more Mepivacaine Normon 20 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 occur:

• 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 the 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 number: 91 562 04 20, indicating the product and the amount received.

4. Possible adverse effects

Like all medicines, this medicine can 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 heart rate (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.
• Coordination problems in heart rhythm (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 incorrect use

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 20 mg/ml

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

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mepivacaína Normon 20 mg/ml solution for injection EFG

• The active substance is mepivacaine hydrochloride. Each 10 ml vial contains 200 mg of mepivacaine hydrochloride and each 2 ml vial contains 40 mg of mepivacaine hydrochloride.
• The other components are: sodium chloride and water for injections.

Appearance of the medicinal product and contents of the pack

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

The commercial presentation is a box containing 1 vial or 100 vials of 10 ml or 2 ml of solution for injection.

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 leaflet: April 2023.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69203/P_69203.html

This information is intended for healthcare professionals only.

Mepivacaína Normon 20 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 required to achieve the desired effect should always be used. The dose should be individually adjusted according to the specific circumstances of each case.

Dosage and administration

Always use the smallest dose required to achieve the desired anaesthesia. The dosage should be individually adjusted according to the patient's age, weight, and the specific circumstances of each case.

Caudal and epidural anaesthesia, peripheral nerve blocks

The dose should not exceed 400 mg.

The maximum daily dose is 1 g.

Mepivacaína Normon 20 mg/ml solution for injection may be administered continuously.

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

For further details on doses to be used for anesthetizing 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

Doses for adolescents from 15 years of age are those indicated above for adults.

Not indicated for patients under 15 years of age.

Hepatic impairment

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

When prolonged blocks are used, for example, 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 necessary for surgical anesthesia within 24 hours in patients with renal dysfunction.

Administration

• Perineural, epidural administration for nerve conduction block.
• Ophthalmic surgery: routes of administration for peribulbar and retrobulbar blocks.

Local anesthetics must not be injected into infected areas.

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 dose.
2. Use a needle of appropriate size.
3. Inject slowly with repeated aspirations at two levels (rotate the needle 180º). Great care must be taken to avoid accidental intravascular injection. Careful aspiration is essential.
4. Monitor blood pressure.
5. Consider premedication. Premedication should include prophylactic administration of atropine and, depending on the amount 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 various methods of local or regional anesthesia.

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

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

Verbal contact with the patient must be maintained, and heart rate must be repeatedly monitored for up to 5 minutes after administration of the test dose. Aspiration must be repeated before administering the main dose. The main dose must 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 devices, and emergency medications for treatment of toxic reactions, is immediately available.