Leaflet: information for the user

Bupivacaine Hiperbárica B. Braun 5 mg / ml injectable solution in Mini-Plasco

Bupivacaine hydrochloride

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco and what is it used for

2. What you need to know before starting to use Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco

3. How to use Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco

4. Possible side effects

5. Storage of Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco

6. Contents of the pack and additional information

Bupivacaine is a long-acting local anesthetic. It produces a pronounced block of nerve fibers.

Bupivacaína Hiperbárica B. Braun is used for spinal anesthesia indicated in lower limb and perineal interventions, lower abdominal interventions, normal vaginal delivery and cesarean section, and reconstructive surgery of the lower limbs.

No use Bupivacaína Hiperbárica B. Braun 5 mg/ml Mini-Plasco

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of Bupivacaína Hiperbárica B. Braun.

• If you have:

•cardiovascular diseases, especially heart block or shock,

•chronic back pain,

•pre-existing central nervous system disease attributable to infection, tumors, or other causes,

•blood clotting disorders, anticoagulant treatment,

•headache, especially if there is a history of migraines,

•low or high blood pressure (hypertension or hypotension),

•alterations in sensitivity as a result of persistent central nervous system damage (continuous tingling, numbness, etc.),

•spinal deformities or characteristics that may interfere with the administration and/or effectiveness of the anesthetic,

•hemorrhagic cerebrospinal fluid (fluid that surrounds the brain and spinal cord) or

•history of malignant hyperthermia (elevated body temperature and intense muscle contractions).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useBupivacaína Hiperbárica B. Braun.

Use with caution if the patient has any disease (e.g. heart failure) or is receiving therapy that reduces blood flow to the liver at the same time.

Use ofBupivacaína Hiperbárica B. Braun 5 mg/ml Mini-Plascowith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is essential to inform your doctor if you use any of the following medications, as they may interact:

• Heparin (medication used to prevent blood clot formation).
• Oral anti-inflammatory steroids (AINES) (prevent blood clot formation) such as acenocoumarol or warfarin.
• Plasma substitutes (used to recover blood volume after bleeding).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

During the early stages of pregnancy, it should only be administered after strict consideration of the indications.

When anesthesia is performed during normal delivery or cesarean section, the indicated doses for this type of patient should be administered.

The exact passage of bupivacaine into breast milk is not known, although no risks have been described for the infant; it is recommended to use with caution in lactating mothers.

Driving and operating machines

Bupivacaína Hiperbárica B. Braun may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or operate machines.

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Bupivacaína Hiperbárica B. Braun 5 mg/ml Mini-Plasco contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 1 milliliter; it is essentially “sodium-free”.

This medication will always be administered by healthcare personnelvia injection into the cerebrospinal fluid through the lumbar space. Intrathecal route.

The dosage of hydrochloride of bupivacaine varies depending on the type of surgical intervention and its duration and the individual response of each patient.

The most commonly used doses should be reduced when treating children, elderly or debilitated patients, and patients with liver and/or heart diseases.

Always use the lowest dose required to produce the desired effect.

If you use more Bupivacaína Hiperbárica B. Braun 5 mg/ml Mini-Plasco than you should

Like other local anesthetics, due to excessive dosing, rapid absorption, or accidental injection into blood vessels, symptoms of intoxication may occur, which may manifest as:

- On the central nervous system:

Characterized by tongue anesthesia, mild loss of consciousness, fainting, blurred vision, headache, tremors followed by drowsiness, convulsions, and unconsciousness.

- On the respiratory system:

Acceleration of breathing, followed by respiratory difficulty or arrest.

- On the circulatory system:

Peripheral vasodilation, hypotension, myocardial depression, delayed atrioventricular conduction, and arrhythmias, including cardiac arrest.

Emergency treatment, antidotes

If toxic effects occur, the first measure is to stop administering the local anesthetic, and to treat the present symptoms, including, if necessary, assisted respiration.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service phone: 91.562 04 20, indicating the medication and the amount used. Bring this leaflet with you.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Most cases are related to high doses, accidental injection into blood vessels, or allergic reactions or decreased tolerance by the patient.

At recommended doses and with proper anesthetic procedures, no significant side effects have been observed.

Differently from other anesthetics with bupivacaine, cases of decreased hemoglobin in the blood have not been described, and allergic reactions are very rare.

Side effects from overdose or difficulties in anesthetic technique may cause back pain or headache, fecal and/or urinary incontinence, hypotension, altered sensitivity, and paralysis of the lower limbs, respiratory problems, and slow heart rate.

If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required.

Discard the solution if it presents turbidity or sedimentation.

Do not use if the container shows visible signs of deterioration.

Keep out of the sight and reach of children.

Do not use Bupivacaína Hiperbárica B. Braun after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed ofthrough drains or in the trash. Ask your pharmacist how to dispose of the medicines that are no longer needed. This will help protect the environment.

Composition of Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco:

Composition in 1 ml:

Bupivacaine hydrochloride5.0 mg

The other components are: glucose monohydrate, sodium hydroxide, andwater for injection preparations.

Appearance of the product and contents of the package

Bupivacaine Hiperbárica 5 mg/mlMini-Plasco is an injectable solution that is presented in polyethylene ampoules (Mini-Plasco®) of 4 ml.

It is presented in packages containing 20 and 100 ampoules. It may not be marketed in all formats

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last review of thisleaflet was in:April 2021

Detailed and updated informationof this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices(AEMPS):http//www.aemps.gob.es

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This information is intended solely for doctors or healthcare professionals

Single-use containers. Dispose of any remaining unused content after completing the infusion.

Only use the solution if the container closure is not damaged and the solution is homogeneous

Administration form

It is essential to take into account:

•Choose the lowest possible dose.

•Use an appropriately sized needle.

•Inject slowly with multiple aspirations in two planes (rotate the needle 180°).

•Do not inject into infected areas.

•Monitor blood pressure if high doses are administered.

•Administer tranquilizers at moderate doses before anesthetic medication.

•Have the necessary equipment for resuscitation available to treat any complications that may occur.

•Perform a 5-10% test injection of the dose.

•Maintain verbal contact with the patient and monitor cardiovascular signs. If symptoms of toxicity occur, stop administration.

Use with caution if the patient has any disease (heart failure) or is receiving therapy that reduces blood flow to the liver at the same time.

Exercise caution with doses in cases of hypoxia, increased hematocrit potassium levels, or acidosis, as these situations increase the risk of cardiac toxicity of bupivacaine, as well as in children under 12 years old, the elderly, and individuals with renal or hepatic insufficiency.

Dosage:

In general, it can be said that a dose of 10 mg per surgical procedure is sufficient, but certain patients and special procedures may require more or less.

The following are the usual doses:

Interventions in lower extremities and perineum

7.5-101.5-2

Interventions in the lower abdomen. Urology

122.4

Normal vaginal delivery

61.2

Cesarean section

7.5-101.5-2

Orthopedics and Traumatology

153

Emergency treatment, antidotes

If toxic effects occur, the first measure is to stop administering the local anesthetic.

The subsequent treatment consists of stopping seizures and ensuring adequate respiration with oxygen, if necessary by assisted respiration. If seizures occur, they can be treated with 5-10 mg of diazepam. If hypotension occurs, administer intravenously a vasopressor, for example 15-30 mg of ephedrine.