Mepivacaine B. Braun 20 mg/ml solution for injection

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Mepivacaine B. Braun 20 mg/ml Solution for Injection

Mepivacaine Hydrochloride

Read the entire leaflet carefully before you start using this medicine as it contains important information for you

• Keep this leaflet as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Package leaflet:

1. What Mepivacaine B. Braun 20 mg/ml is and what it is used for
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 side effects
5. How to store Mepivacaine B. Braun 20 mg/ml
6. Contents of the pack and other information

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

Mepivacaine is a medicine belonging to the group of amide-type local anesthetics, indicated for epidural and caudal anesthesia, peripheral nerve block, plexus nerve block, and 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 procedures to prevent or relieve pain in the area of your body where the procedure will be performed.

2. What you need to know before using Mepivacaine B. Braun 20 mg/ml

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

• you are allergic to mepivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to other local anesthetics, e.g., bupivacaine, lidocaine.
• you have severe disorders of blood coagulation.
• you have a degenerative nerve disease.
• you have serious heart conduction problems or other cardiac conditions.
• you have uncontrolled epilepsy.
• you have increased intracranial pressure.

Warnings and precautions

Consult your doctor or nurse before Mepivacaine B. Braun 20 mg/ml is administered to you:

? if you have serious problems with your heart rhythm or have any heart disease.

• if you have a degenerative nervous system disorder.

? if elderly.

? if a poor general condition is present.

? if you have liver diseases (liver).

? if you have impaired renal function (kidney function).

? if you suffer from disease due to narrowing of blood vessels, arteriosclerosis (hardening of the arteries).

? if you might be at risk of malignant hyperthermia (a complication involving sudden high fever, muscle rigidity, and kidney failure).

? if you suffer from epilepsy.

? if inflammation and/or infection at the injection site occurs.

? 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 should such complications occur.

Other medicines and Mepivacaine B. Braun 20 mg/ml

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

Administration of Mepivacaine B. Braun 20 mg/ml together with the following medicines may require adjustment of the dose of one or both medicines or discontinuation of treatment:

• strong analgesics;
• other local anesthetics;
• certain medicines used to treat heart rhythm disorders;
• general anesthetics 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, 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 anesthetics.

Use in children and elderly

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

It must 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

During pregnancy, Mepivacaine B. Braun 20 mg/ml will be administered to you only after strict assessment of the indications and only if your doctor considers it absolutely necessary. Your doctor will take any possible precautions to avoid harm to you or your unborn child.

Mepivacaine is not a drug of choice for epidural anesthesia in obstetrics.

You will be administered this medicine during breastfeeding only if your doctor considers it necessary. If administration is required, breastfeeding should be discontinued for 24 hours after completion of treatment.

Driving and use of machines:

Mepivacaine B. Braun 20 mg/ml may temporarily affect your motor skills, attention, and coordination. Your doctor will advise you whether you may drive or operate machinery.

Mepivacaine B. Braun 20 mg/ml contains sodium

5 ml vials:

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml vial, which is essentially "sodium-free".

10 ml vials:

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml vial, which is essentially "sodium-free".

20 ml vials:

This medicine contains 40 mg of sodium (the main component of table/cooking salt) in each 20 ml vial. This corresponds to 2% of the maximum daily recommended sodium intake for an adult.

3. How to use Mepivacaine B. Braun 20 mg/ml

Mepivacaine B. Braun 20 mg/ml is administered by epidural and perineural routes to block nerve conduction, and by peri- and retrobulbar routes 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 anaesthesia should always be used. Dosage must be individually adjusted according to the patient's age and weight, as well as the specific circumstances of each case.

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

Your doctor will ask you to talk with him/her while administering the medicine to ensure that you remain conscious.

Your blood pressure may be monitored from time to time.

If you are given more Mepivacaine B. Braun 20 mg/ml than you should:

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

1. Central nervous system symptoms:

Mild intoxication:

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

Moderate intoxication:

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

Severe intoxication:

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

2. Symptoms in the cardiovascular system

Mild intoxication:

Palpitations, hypertension, tachycardia, tachypnea.

Moderate intoxication:

Tachycardia, cardiac arrhythmias, hypoxia, pallor.

Severe intoxication:

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 the functions of your heart, circulation, and respiration, and subsequently to control seizures and other severe neurological symptoms. This includes administration of oxygen and additional medication, primarily aimed at normalizing heart function and circulation.

In case of overdose or accidental ingestion, consult your doctor, nurse, or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 652 04 20, indicating the medication and the amount ingested.

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 (paraesthesia) and dizziness.
• Slow and abnormal 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.
• Impaired coordination of the 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 use errors

Extensive (total) spinal anaesthesia may occur due to inadvertent intrathecal injection during planned epidural anaesthesia, 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaine B. Braun 20 mg/ml

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 expiry date stated on the packaging (after EXP). The expiry date refers to the last day of the month indicated.

The contents of the ampoule must be used immediately after opening. After opening, discard any unused portion of the solution. For single use only. Do not use this medicine if particles are observed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Mepivacaine B. Braun 20 mg/ml

Active Ingredient	Per 1 ml	Per 5 ml	Per 10 ml	Per 20 ml
Mepivacaine hydrochloride	20 mg	100 mg	200 mg	400 mg

The other excipients are: sodium chloride, sodium hydroxide (for pH adjustment), and water for injections to make up the sufficient quantity.

Appearance of the product and contents of the container

Mepivacaine B. Braun 20 mg/ml is an injectable solution presented in polyethylene ampoules (Mini-Plasco) of 5, 10 and 20 ml. It is available in packages containing 1 ampoule and 100 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the most recent review of this summary: August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.

This information is intended solely for doctors or healthcare professionals:

Mepivacaine B. Braun 20 mg/ml must only be used by physicians experienced in regional anesthesia and resuscitation techniques, or under their supervision. Resuscitation equipment must be readily available when administering local anesthetics. The lowest effective dose producing the desired effect should be administered. The dose must be individually adjusted according to the specific characteristics of each case.

Dosage

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

.

Caudal and epidural anesthesia, peripheral nerve blocks:

The dose should not exceed 400 mg.

The maximum daily dose is 1 g.

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

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

Sciatic nerve block	15 – 20 ml
Brachial plexus block	3 - 5 ml
Ophthalmic surgery
Retrobulbar block	3 ml
Peribulbar block (total dose)	5 - 7.5 ml
Epidural anesthesia for surgery	5 – 15 ml
Caudal anesthesia	10 – 20 ml

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 aged 15 years and older are those indicated above for adults.

It is 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 grade C liver disease (Child-Pugh classification), and the total dose within 24 hours should not exceed 750 mg of mepivacaine.

Renal impairment

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

Administration

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

Local anesthetic must not be injected into infected areas.

Before injection, it must be ensured that the needle is not positioned intravascularly. Injection should 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 at two levels (rotate the needle 180°).

Great care must be taken to avoid accidental intravascular injection. Careful aspiration is essential.

1. Monitor blood pressure.
2. Consider premedication. Premedication should include prophylactic administration of atropine and – depending on the appropriate amount of local anesthetic to be injected – a short-acting barbiturate.
3. If necessary, discontinue anticoagulant therapy prior to administration of the local anesthetic.
4. Observe general and specific contraindications for the various methods of local or regional anesthesia.

For continuous epidural administration, more diluted solutions of mepivacaine 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, because intravascular injection of adrenaline is rapidly recognized due to the increase in heart rate. Heart rate must be monitored repeatedly for up to 5 minutes after administration of the test dose.

Verbal contact with the patient must be maintained, and cardiac rhythm must be monitored repeatedly for up to 5 minutes after administration of the test dose. Aspiration must 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 stopped immediately at the first signs of toxicity.

Before administering a local anesthetic, it must be ensured that resuscitation equipment is immediately available, e.g., oxygen source, equipment to maintain a patent airway, and emergency medications for treatment of toxic reactions.