MEPIVACAINE B. BRAUN 20 mg/mL INJECTABLE SOLUTION

Read the entire package leaflet carefully before starting to use this medication because it contains important information for you

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

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

Contents of the 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. Storage of Mepivacaine B. Braun 20 mg/ml
6. Package Contents and Additional Information

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

Mepivacaine is a medication that belongs to the group of local anesthetics of the amide type and is indicated for epidural and caudal anesthesia, peripheral nerve blockade, nerve plexus blockade, and anesthesia for ophthalmic surgery.

Depending on the amount used, it will either completely stop the pain or cause 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 be performed.

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

Mepivacaine B. Braun 20 mg/ml should not be administered to you:

• if you are allergic to mepivacaine hydrochloride or to any of the other components of this medication (listed in section 6).
• if you are allergic to other local anesthetics, e.g., bupivacaine, lidocaine.
• if you have severe blood coagulation disorders.
• if you have degenerative nerve disease.
• if you have serious 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 Mepivacaine B. Braun 20 mg/ml is administered to you:

• if you have degenerative nerve disease.

• 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 Mepivacaine B. Braun 20 mg/ml is administered to detect any complications that may affect heart function, blood circulation, or nervous and brain functions as soon as possible, and to provide any necessary treatment in case such complications occur.

Other Medications and Mepivacaine B. Braun 20 mg/ml

Tell your doctor if you are using, have recently used, or might use any other medication.

The administration of Mepivacaine B. Braun 20 mg/ml together with the following medications may make it necessary to modify the dose of any of them or interrupt treatment:

• strong painkillers;
• other local anesthetics;
• certain medications used to treat heart rhythm disorders;
• general anesthetics such as ether;
• medications that cause vasoconstriction (reduction of blood vessel diameter);
• heparin, anticoagulant medications (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 medications;
• cytochrome PYP 1A2 inhibitors (such as ciprofloxacin, enoxacin, or fluvoxamine);
• medications 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 patients 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 or pharmacist before using this medication.

During pregnancy, Mepivacaine B. Braun 20 mg/ml will only be administered 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 unborn child.

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

This medication will be administered 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 B. Braun 20 mg/ml may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or use machines.

Mepivacaine B.Braun 20 mg/ml contains sodium

Ampoules of 5 ml:

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

Ampoules of 10 ml:

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

Ampoules of 20 ml:

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

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

Mepivacaine B. Braun 20 mg/ml is administered via the epidural and perineural route for nerve conduction blockade 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 required dose should always be used to produce the desired anesthesia. The dosage must be adjusted individually according to the patient's age, weight, and specific case particulars.

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

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

Your blood pressure may be measured from time to time.

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

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

1. Central nervous system symptoms:

Mild intoxication:

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

Moderate intoxication:

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

Severe intoxication:

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

1. Cardiovascular system symptoms

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 your 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: 91 652 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Burning sensation, pinpricks, 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
• Tinnitus (ringing in the ears).

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.
• Angina pectoris.
• Heart rhythm coordination 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 positioning (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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

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

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Mepivacaine B. Braun 20 mg/ml after the expiration date stated on the package (after EXP). The expiration date is the last day of the month indicated.

The contents of the ampoule should be used immediately after opening. Once opened, discard the unused portion of the solution. For single use only. Do not use this medication if you observe particles.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mepivacaine B. Braun 20 mg/ml

The other excipients are: sodium chloride, sodium hydroxide (for pH adjustment), and water for injectable preparations in sufficient quantity.

Appearance of the Product and Package Contents

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

Not all formats may be marketed.

Marketing Authorization Holder and Manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet: August 2020

Detailed and updated informationon this medication 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 B. Braun 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 must be adjusted individually according to the specific particulars of each case.

Dosage

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

.

Caudal and epidural anesthesia, peripheral nerve blocks:

The dose should not exceed 400 mg.

The maximum daily dose is 1g.

Mepivacaine B. Braun 20 mg/ml solution for injection can be administered continuously.

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

For more details on the doses 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 condition.

Pediatric Population

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

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

Hepatic Insufficiency

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

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

Renal Insufficiency

No dose reduction is 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, it must be ensured that the needle is not situated intravascularly.The injection should be performed slowly and fractionally.

Basic guidelines to follow:

1. Choose the lowest possible dosage.
2. Use a needle of the appropriate dimension.
3. Inject slowly with several aspirations in two planes (rotate the needle 180º).

Great care must be taken to avoid accidental intravascular injection. It is essential to perform careful aspiration.

1. Monitor blood pressure.
2. 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.
3. If necessary, suspend the administration of anticoagulants before the administration of the local anesthetic.
4. 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 complete dose, because 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, it must be ensured that the necessary equipment for resuscitation, e.g.: oxygen source, material to keep the respiratory tract clear and emergency medication for the treatment of toxic reactions, is available immediately.