BUPIVACAINE B. BRAUN 7.5 MG/ML SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bupivacaine B. Braun 7.5 mg/ml solution for injection

bupivacaine hydrochloride

Read the entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, as 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.

Contents of the leaflet

1. What Bupivacaine B. Braun 7.5 mg/ml is and what it is used for
2. What you need to know before using Bupivacaine B. Braun 7.5 mg/ml
3. How to use Bupivacaine B. Braun 7.5 mg/ml
4. Possible adverse effects
5. How to store Bupivacaine B. Braun 7.5 mg/ml
6. Contents of the pack and other information

1. What Bupivacaine B. Braun 7.5 mg/ml is and what it is used for

Bupivacaine B. Braun 7.5 mg/ml contains the active substance bupivacaine hydrochloride, which belongs to a group of medicines called amide-type local anesthetics. It is indicated for local infiltration anesthesia, conduction anesthesia, epidural and spinal anesthesia, diagnostic and therapeutic nerve blocks for pain management, and epidural and caudal anesthesia for vaginal delivery.

2. What you need to know before using Bupivacaína B. Braun 7.5 mg/ml

Do not use Bupivacaína B. Braun 7.5 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 are allergic to any other amide-type local anesthetic.

Do not use if you have serious heart conduction problems or other cardiac conditions, in patients with degenerative neurological disease or severe blood coagulation disorders.

Local anesthetics must not be injected into infected areas.

General and specific contraindications for different methods of local and regional anesthesia must be taken into account.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Bupivacaína B. Braun 7.5 mg/ml.

Inform your doctor of any allergies or medical conditions you have or have had, especially:

• if your liver is not functioning properly, as your doctor may need to adjust the dose,
• if your kidneys are not functioning properly, as this may increase the risk of toxicity,
• if you suffer from vascular disease, arteriosclerosis (hardening of the arteries), or neurological disease due to diabetes (a condition characterized by excess glucose in the blood).

Use in children

Bupivacaína B. Braun 7.5 mg/ml should not be used in children.

Use in elderly

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

Use of Bupivacaína B. Braun 7.5 mg/ml with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Administration of Bupivacaína B. Braun together with the following medicines may require dose adjustments or discontinuation of treatment:

• Medicines that cause vasoconstriction (reduction in the diameter of blood vessels).
• Heparin, anticoagulant medicines (which prevent blood clotting), non-steroidal anti-inflammatory drugs (NSAIDs), and plasma substitutes (products used in case of blood loss).

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 stages of pregnancy, this medicine should only be administered after strict assessment of the indication.

When epidural anesthesia is performed during the last weeks of pregnancy, the dose should be reduced to approximately one-third.

Although fetal exposure to bupivacaine is lower than with other local anesthetics, the newborn should be closely monitored for possible effects of the anesthetic.

Bupivacaine passes into breast milk, but in such small amounts that it poses no risk to the breastfed infant.

Driving and use of machines

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

Bupivacaína B. Braun 7.5 mg/ml contains sodium

This medicine contains 29.9 mg of sodium (main component of table/cooking salt) in 10 ml. This corresponds to 1.5% of the maximum daily sodium intake recommended for an adult.

3. How to use Bupivacaine B. Braun 7.5 mg/ml

Bupivacaine B. Braun 7.5 mg/ml is administered via epidural and retrobulbar block.

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. The dosage must be individually adjusted according to the patient's age, weight, and the specific circumstances of each case.

Dosage adjustment is necessary in patients with liver, kidney, or heart disease, as well as in elderly patients.

If you use more Bupivacaine B. Braun 7.5 mg/ml than you should

Toxicity affects both the central nervous system (CNS) and the cardiovascular system (CVS). Two phases can be distinguished: mild to moderately severe toxicity is characterized by stimulation, while severe toxicity is characterized by sedation and paralysis. Symptoms are:

Symptoms of the stimulation phase:

Mild toxicity

CNS

Perioral tingling, tongue paresthesia, numbness of the mouth, tinnitus, metallic taste, anxiety, restlessness, tremors, muscle spasms, vomiting.

CVS

Palpitations, hypertension, tachycardia, tachypnea.

Moderately severe toxicity:

CNS

Speech disturbances, drowsiness, insomnia, tremors, choreiform movements, tonic-clonic seizures, mydriasis, nausea, vomiting, tachypnea.

CVS

Tachycardia, arrhythmia, pallor, cyanosis.

Symptoms of the paralysis phase:

Severe toxicity:

CNS

Somnolence, stupor, irregular breathing, respiratory arrest, loss of muscle tone, vomiting with aspiration, sphincter paralysis, death.

CVS

Severe cyanosis, hypotension, cardiac arrest, hypo-/asystole.

The appearance of one or more of these symptoms requires immediate action.

1. Stop the administration of the local anesthetic immediately.
2. Ensure and maintain an open airway. Administer oxygen, which must not be discontinued once symptoms subside but should continue for several additional minutes.
3. If seizures occur, administer an ultra-short-acting barbiturate such as thiopental (50–100 mg) or diazepam (5–10 mg) intravenously in small repeated doses, but only until seizures are controlled. It is also recommended to administer a short-acting muscle relaxant such as succinylcholine (1 mg/kg body weight), intubate, and provide artificial ventilation with 100% O2.
4. Immediately monitor blood pressure, pulse, and pupil size.
5. In case of hypotension, immediately lower the patient's head and administer a vasoconstrictor that preferentially stimulates the myocardium. Additionally, administer fluids (e.g., electrolyte solution).
6. Extensive (total) spinal anesthesia may occur due to accidental intrathecal injection during epidural anesthesia. Initial symptoms include restlessness and somnolence, which may progress to unconsciousness and respiratory arrest. Treatment of extensive (total) spinal anesthesia consists of ensuring and maintaining an open airway, administering oxygen, and, if necessary, initiating assisted and controlled ventilation.

It is assumed that procedures to manage suspected cardiac arrest are known. In the case of a serious incident, it is advisable to consult an anesthesiology and intensive care specialist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medication and the amount taken. Bring this leaflet with you.

4. Possible adverse effects

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

The possible side effects following administration of bupivacaine are essentially the same as those produced by other amide-type local anaesthetics.

Allergic reactions to amide-type local anaesthetics may very rarely occur (less than 1 in 10,000 people).

Mild systemic toxic reactions are expected at plasma concentrations above 1.6 – 2 mg/l, while the threshold concentration for seizures is 2 – 4 mg/l. Such plasma concentrations may occur with excessive doses (concentration too high or volume too large), following inadvertent intravascular injection, or after administration of standard doses in patients with poor general condition or with liver or kidney disease.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bupivacaine B. Braun 7.5 mg/ml

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Bupivacaine B. Braun after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. After opening, discard any unused portion of the solution.

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 Bupivacaine Injectable B. Braun 7.5 mg/ml

• The active substance is bupivacaine hydrochloride. Each 5 ml of solution contains 37.5 mg of bupivacaine hydrochloride. Each 10 ml ampoule contains 75 mg of bupivacaine hydrochloride.

• The other components are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Bupivacaine B. Braun 7.5 mg/ml is an injectable solution presented in polyethylene ampoules (Mini-Plasco) of 5 ml and 10 ml. It is supplied in packs containing 100 ampoules.

Marketing Authorization Holder and Manufacturer

• Braun Medical, S.A.
  Ctra. de Terrassa, 121
  08191 Rubí (Barcelona),
  Spain

Date of the most recent review of this summary: October 2025.

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

This information is intended for healthcare professionals only:

The smallest dose required to achieve the desired anesthesia should always be used:

• Epidural anesthesia:

The dosing instructions below refer to a single administration in a 70 kg adult. Repeated or intermittent administration may be possible.

Recommended maximum dose for single administration:

Up to 20 ml of bupivacaine hydrochloride 7.5 mg/ml or up to 2 mg of bupivacaine hydrochloride per kg of body weight, corresponding to a maximum dose of 150 mg.

In debilitated patients, the dose should be less than 2 mg/kg of body weight.

For epidural anesthesia, dosage depends on age; children and elderly patients require lower doses than young or middle-aged adults. The following is a dosage guideline for the lumbar region:

15 years: 1.3 ml/segment
20 years: 1.5 ml/segment
40 years: 1.3 ml/segment
60 years: 1.0 ml/segment
80 years: 0.7 ml/segment

Due to the prolonged effect of 0.75% bupivacaine, repeating the injection due to loss of analgesia is only required after at least 4 hours; this may be performed intermittently or continuously. In general, lower concentration solutions, e.g., bupivacaine 0.25%, are used for this purpose.

• Retrobulbar block:

15 to 30 mg (2 – 4 ml).

The following should be considered when administering Bupivacaine B. Braun:

1. Use the lowest possible dose.
2. Use a needle of appropriate size.
3. Inject slowly with multiple aspirations at two levels (rotate the needle 180º).
4. Do not inject into infected areas.
5. Monitor blood pressure.
6. Consider premedication. Premedication should include prophylactic administration of atropine and – especially if large amounts of local anesthetic are required – a short-acting barbiturate.
7. If necessary, discontinue anticoagulant therapy prior to administration of the local anesthetic.
8. Observe general and specific contraindications for various methods of local or regional anesthesia.

Handle under standard aseptic conditions used for injectable solutions.

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