Bupivacaine hyperbaric Physan 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bupivacaine Hiperbaric Physan 5 mg/ml injectable solution

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, consult your doctor, pharmacist, or nurse.

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

Leaflet contents:

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

1. What Bupivacaína Hiperbárica Physan is and what it is used for

Bupivacaína Hiperbárica Physan contains bupivacaine hydrochloride, a local anaesthetic (an agent that reduces or eliminates sensation, affecting a particular region) belonging to the amide subgroup.

Bupivacaína Hiperbárica Physan has been prescribed for you to provide anaesthetic effect during surgery.

2. What you need to know before using Bupivacaine Hiperbárica Physan

Do not use Bupivacaine Hiperbárica Physan:

? If you are allergic (hypersensitive) to bupivacaine hydrochloride or to any of the other
components of Bupivacaine Hiperbárica Physan (listed in section 6).

? If you are allergic (hypersensitive) to any other local anesthetic of the same group (for
example, mepivacaine, lidocaine).

? If it is to be used for intravenous regional anesthesia (Bier block), as inadvertent leakage of bupivacaine into the bloodstream may lead to systemic acute toxic reactions.

? If you have any of the following conditions:

? Pre-existing central nervous system disease due to infection, tumors, or other causes.

? Spinal deformity and active disease (e.g., spondylitis, tumor) or recent injury (e.g., fracture) of the spine.

? Septicemia (infectious germs entering the bloodstream).

? Skin infection at or near the injection site.

? Cardiovascular disease, especially cardiac block or hypovolemic shock.

? Coagulation disorders, ongoing anticoagulant therapy, or blood disorders.

? History of malignant hyperthermia (pathological increase in body temperature).

? Chronic back pain.

? Pre-existing headache, especially if there is a history of migraine.

? Hemorrhagic cerebrospinal fluid.

? Hypertension (high blood pressure) or hypotension (low blood pressure).

? Persistent tingling sensation.

Warnings and precautions

Consult your doctor before starting to use Bupivacaine Hiperbárica Physan:

? If you have any type of heart block

? If you suffer from heart rhythm disorders

? If you have low blood pressure

? If you are experiencing bleeding

? If you have any type of infection

? If you suffer from liver or kidney disorders.

Children

Bupivacaine should be used with caution in children under 12 years of age, as they have a higher risk of systemic toxicity.

Other medicines and Bupivacaine Hiperbárica Physan

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

Bupivacaine should be used with caution in patients receiving treatment with agents structurally similar to amide-type local anesthetics, as this may lead to increased systemic toxic effects.

Concomitant administration of heparin, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), and plasma substitutes (dextran) may increase the risk of bleeding following injection of the local anesthetic.

In addition, monitoring of coagulation status may be required in patients receiving concomitant treatment with non-steroidal anti-inflammatory drugs.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this
medication.

Pregnancy

If you are pregnant, your doctor will prescribe Bupivacaine Hiperbárica Physan after weighing the potential benefit against the possible risk to your baby.

Breastfeeding

If you are breastfeeding, your doctor will prescribe Bupivacaine Hiperbárica Physan after weighing the potential benefit against the possible risk to your baby.

Driving and use of machines

Bupivacaine Hiperbárica Physan may temporarily affect your motor ability, attention, and
coordination. Your doctor will advise you whether you may drive or operate machinery.

3. How to use Bupivacaine Hiperbárica Physan

Bupivacaine Hiperbárica Physan must be administered only under the supervision of a physician experienced in the use of this type of treatment.

Bupivacaine Hiperbárica Physan is administered as an intrathecal injection.

The dose, rate of administration, and duration of treatment will vary depending on the anesthetic procedure being performed, the area to be anesthetized, and the patient's weight, clinical condition, and response.

If more Bupivacaine Hiperbárica Physan is administered than intended

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 somnolence, seizures, and unconsciousness.

? On the respiratory system:

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

? On the cardiovascular system:

Reduced myocardial contractility, low blood pressure (hypotension).

At high doses: vasodilation, circulatory collapse, conduction disturbances, decreased heart rate, atrioventricular block, arrhythmias, cardiac arrest.

If toxic effects occur, the first step is to stop administration of the local anesthetic. Subsequent treatment consists of controlling seizures and ensuring adequate respiration with oxygen, using assisted ventilation if necessary. If seizures occur, they may be treated with 5–10 mg of diazepam. If hypotension occurs, a vasopressor should be administered intravenously, for example, 15–30 mg of ephedrine.

In case of overdose or accidental administration, contact the Toxicology Information Service at Tel. 91 5620420, indicating the drug and the amount administered.

4. Possible adverse effects

Like all medicines, Bupivacaína Hiperbárica Physan may cause adverse effects, although not everyone experiences them.

The adverse effects you may experience can be classified by frequency as follows:

? Very common (may affect more than 1 in 10 patients): decrease in blood pressure, heart rate, and nausea

? Common (may affect up to 1 in 10 patients): headache, vomiting, urinary retention, or incontinence.

? Uncommon (may affect up to 1 in 100 patients): tingling, disturbances in touch, hearing, smell, vision, or taste, muscle weakness, or back pain.

? Rare (may affect up to 1 in 1,000 patients): cardiac arrest, allergic reactions, anaphylactic shock, nervous system disturbances, and breathing difficulties.

Reporting of adverse effects

If you experience any adverse effects, 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 at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bupivacaine Hiperbárica Physan

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date stated on the ampoule and on the product carton. The expiry date refers to the last day of the month indicated.

The solutions do not contain preservatives and must be used immediately after opening. Any remaining solution should be discarded.

Because this product contains glucose, caramelization may occur during autoclave sterilization. Therefore, re-sterilization must be avoided.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Bupivacaína Hiperbárica Physan

• The active substance is bupivacaine hydrochloride. Each ml contains 5 mg of bupivacaine hydrochloride. Each 4 ml ampoule contains 20 mg of bupivacaine hydrochloride.

• The other components are: anhydrous glucose, sodium hydroxide (E-524)/hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the pack

Bupivacaína Hiperbárica Physan is packaged in glass ampoules.

This medicine is available in packs containing 50 or 100 glass ampoules (clinical packs) of 4 ml.

Marketing Authorization Holder

LAPHYSAN S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D,

28108 Alcobendas

MADRID SPAIN

Manufacturer

Laboratorios Inibsa, S.A.

Ctra. Sabadell a Granollers, km. 14,5

08185 Lliçà de Vall (Barcelona)

Laboratórios Basi - Indústria Farmacéutica S.A.

Parque Industrial Lourenço Ferreira, Nº8, Nº15 and Nº16.

3450-232 Mortágua, Portugal

Spain

Telephone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

This information is intended for healthcare professionals only. Solutions should be used immediately after opening. Any unused portion must be discarded.

Due to the presence of glucose in this product, caramelization may occur during autoclave sterilization. Therefore, re-sterilization must not be performed.

Regional anaesthetic procedures must always be performed by appropriately trained professionals and in suitable settings. Equipment and drugs necessary for monitoring and emergency resuscitation must be readily available. Intravenous access, e.g. i.v. infusion, should be established before initiating intrathecal anaesthesia. Physicians must take necessary precautions to avoid intravascular injection and must be adequately trained and familiar with the diagnosis and treatment of adverse effects, systemic toxicity and other complications. If signs of acute systemic toxicity or total spinal block occur, injection of the local anaesthetic must be stopped immediately.

Patients with poor general condition due to age or other compromised factors such as partial or complete cardiac conduction block, advanced hepatic or renal dysfunction require special attention, although regional anaesthesia may still be an optimal choice for surgery.

Like other local anaesthetics, bupivacaine may cause acute toxic effects on the central nervous and cardiovascular systems if used in local anaesthetic procedures resulting in high blood concentrations of the drug. This is particularly likely following inadvertent intravascular injection.

In any case, and considering that dosage must be calculated according to several factors, it is recommended to consult the information provided in the Summary of Product Characteristics before using this medicine.

Incompatibilities

In general, it is recommended not to mix spinal solutions with any other product.

Last revision of the leaflet: October 2018

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.es/