Bupivacaine hyperbaric B. Braun 5 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bupivacaine Hyperbaric B. Braun 5 mg/ml Injection

bupivacaine 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Bupivacaine Hyperbaric B. Braun 5 mg/ml is and what it is used for
2. What you need to know before using Bupivacaine Hyperbaric B. Braun 5 mg/ml
3. How to use Bupivacaine Hyperbaric B. Braun 5 mg/ml
4. Possible side effects
5. How to store Bupivacaine Hyperbaric B. Braun 5 mg/ml
6. Contents of the pack and other information

1. What Bupivacaine Hyperbaric B. Braun 5 mg/ml is and what it is used for

Bupivacaine Hyperbaric B. Braun 5 mg/ml contains the active substance bupivacaine hydrochloride, which belongs to a group of medicines known as long-acting amide-type local anaesthetics. It produces marked blockade of nerve fibres.

Bupivacaine Hyperbaric B. Braun is used for spinal anaesthesia indicated in surgeries of the lower limbs and perineum, procedures on the lower abdomen, normal vaginal delivery and caesarean section, and reconstructive surgery of the lower limbs.

2. What you need to know before starting to use Bupivacaine Hyperbaric B. Braun 5 mg/ml

Do not use Bupivacaine Hyperbaric B. Braun 5 mg/ml

• If you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

• If you have:

• cardiovascular diseases, especially cardiac block or shock,

• chronic back pain,

• pre-existing central nervous system disorders due to infection, tumors, or other causes,

• blood coagulation disorders, or are undergoing anticoagulant therapy,

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

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

• sensitivity disturbances due to persistent central nervous system lesions (continuous tingling sensation, numbness, etc.),

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

• hemorrhagic cerebrospinal fluid (fluid surrounding the brain and spinal cord), or

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Bupivacaine Hyperbaric B. Braun.

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

Use of Bupivacaine Hyperbaric B. Braun 5 mg/ml with other medicines

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

It is important that you inform your doctor if you are taking any of the following medicines, as they may interact:

• Heparin (a medicine used to prevent blood clots).
• Steroidal anti-rheumatic drugs (NSAIDs) (prevent clot formation) oral (acenocoumarol, warfarin).
• Plasma substitutes (used to restore blood volume after hemorrhage).

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 medicine.

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

When anesthesia is administered during normal delivery or cesarean section, the recommended doses for these types of patients should be used.

It is not precisely known whether bupivacaine passes into breast milk; however, no risks to the infant have been reported. Nevertheless, caution is advised when using in breastfeeding mothers.

Driving and use of machines

Bupivacaine Hyperbaric B. Braun may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you can drive or operate machinery.

Bupivacaine Hyperbaric B. Braun 5 mg/ml contains sodium

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

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

This medicine will always be administered by healthcare professionals via injection into the cerebrospinal fluid through the lumbar space. Intrathecal route.

The dosage of bupivacaine hydrochloride varies depending on the type of surgical procedure and its duration, as well as the individual patient's response.

The most commonly used doses should be reduced in children, elderly or debilitated patients, and patients with hepatic and/or cardiac diseases.

The lowest dose required to achieve the desired effect will always be used.

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

As with other local anesthetics, excessive dosage, rapid absorption, or accidental intravascular injection may lead to symptoms of toxicity, which may manifest as:

• On the central nervous system:

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

• On the respiratory system:

Increased breathing rate, followed by respiratory difficulty or respiratory arrest.

• On the cardiovascular system:

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

Emergency treatment, antidotes

If toxic effects occur, the first measure is to stop administration of the local anesthetic and initiate symptomatic treatment, including assisted ventilation if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91.562 04 20, indicating the medicine and the amount used. Take this leaflet with you.

4. Possible adverse effects

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

In most cases, these are related to high doses, accidental injection into blood vessels, or allergic reactions or reduced tolerance on the part of the patient.

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

Unlike other anesthetics containing bupivacaine, cases of reduced hemoglobin in blood have not been reported, and allergic reactions are very rare.

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

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Bupivacaine Hiperbárica B. Braun 5 mg/ml

No special storage conditions are required.

Discard the solution if it becomes cloudy or shows sedimentation.

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

Keep out of the sight and reach of children.

Do not use Bupivacaine Hiperbárica B. Braun after the expiry date stated on the packaging 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 properly dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

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

• The active substance is bupivacaine hydrochloride. Each ml of solution contains 5 mg of bupivacaine hydrochloride.
• The other components are monohydrate glucose, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and contents of the container

Bupivacaine Hiperbárica 5 mg/ml is an injectable solution presented in 2 ml and 10 ml glass ampoules.

It is available in packages containing 1 and 100 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona),

Spain

Manufacturer:

• Braun Medical, S.A.

Ronda de los Olivares, Parcela 11,

Polígono Industrial Los Olivares,

23009 Jaén (Jaén),

Spain

The last revision of this summary was in: October 2025

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

This information is intended exclusively for physicians or healthcare professionals:

Single-use containers. Discard any unused residual content after completion of the infusion.

The solution should only be used if the container closure is undamaged and the solution is homogeneous.

Method of administration

The following points are essential to consider:

• Use the lowest possible dose.
• Use a needle of appropriate size.
• Inject slowly with multiple aspirations in two planes (rotate the needle 180º).
• Do not inject into infected areas.
• Monitor blood pressure when high doses are administered.
• Administer sedatives in moderate doses prior to anesthetic medication.
• Ensure resuscitation equipment is available to manage any potential complications.
• Perform a test injection of 5%-10% of the total dose.
• Maintain verbal contact with the patient and monitor cardiovascular signs. If signs of toxicity occur, discontinue administration immediately.

Use with caution in patients with underlying diseases (e.g., heart failure) or those concurrently receiving therapies that reduce hepatic blood flow.

Hepatic dysfunction, with reversible increases in alanine aminotransferase (ALT), alkaline phosphatase (FA), and bilirubin, has been observed after repeated injections or prolonged infusions of bupivacaine. In a small number of published reports, an association has been noted between bupivacaine use and drug-induced liver injury (DILI), particularly with prolonged use. Although the pathophysiology of this reaction is not yet fully understood, immediate withdrawal of bupivacaine has resulted in rapid clinical improvement. If signs of hepatic dysfunction occur during bupivacaine administration, the drug should be discontinued.

Exercise caution with dosing in cases of hypoxia, elevated serum potassium levels, or acidosis, as these conditions increase the risk of cardiac toxicity from bupivacaine, as well as in children under 12 years of age, elderly patients, and individuals with renal or hepatic impairment.

Dosing:

In general, a dose of 10 mg may be sufficient for a surgical procedure, although specific patients and procedures may require higher or lower doses.

The following are usual doses:

Type of anesthesia   mg  ml
Procedures on lower limbs and perineum  7.5–10  1.5–2
Lower abdominal procedures. Urology    12    2.4
Normal vaginal delivery            6    1.2
Caesarean section              7.5–10  1.5–2
Orthopedics and Traumatology        15    3

Emergency treatment, antidotes

If toxic effects occur, the first measure is to discontinue administration of the local anesthetic.

Subsequent treatment consists of controlling seizures and ensuring adequate ventilation with oxygen, assisted ventilation if necessary. Seizures may be treated with 5–10 mg of diazepam. If hypotension occurs, administer a vasopressor intravenously, for example, 15–30 mg of ephedrine.