BUPIVACAINE PHYSAN 7.5 mg/mL INJECTABLE SOLUTION

2. What you need to know before using Bupivacaine Physan 7.5 mg/ml

Do not use Bupivacaine Physan 7.5 mg/ml:

• If you are allergic to bupivacaine hydrochloride or any other component of this medicine (listed in section 6).
• If you are allergic to any other local anesthetic of the same group (e.g., articaine, mepivacaine, lidocaine, or prilocaine).
• If it is used as intravenous regional anesthesia (Bier block), as the unintended passage of bupivacaine into the bloodstream can lead to acute toxicity systemic reactions.
• In epidural anesthesia during childbirth.
• If you have any of the following conditions, epidural anesthesia should not be performed:

• Pre-existing central nervous system disease due to infection, tumors, or other causes.
• Spinal deformity and active disease (e.g., spondylitis, tumor, tuberculosis) or recent injury (e.g., fracture) of the spine.
• Skin infection at the injection site or nearby.
• Cardiovascular disease, especially heart block or hypovolemic shock.
• Coagulation disorders or ongoing anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to use Bupivacaine Physan 7.5 mg/ml:

• If you have any type of heart block
• If you have heart rhythm disturbances
• If you have low blood pressure
• If you have bleeding
• If you have any type of infection
• If you have liver or kidney disorders.

Children

The safety and efficacy of this medicine have not been established in children under 12 years of age. Therefore, its use is not recommended in this population.

Other medicines and Bupivacaine Physan 7.5 mg/ml

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, 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 an increase in systemic toxic effects may occur.

Tell your doctor if you are taking any of the following medicines, as they may alter the effects of Bupivacaine Physan 7.5 mg/ml:

• Anticoagulants such as heparin
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, to combat inflammation, pain, or fever
• Plasma substitutes (dextran)

Pregnancy and breastfeeding

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.

Pregnancy

If you are pregnant, your doctor will prescribe Bupivacaine Physan 7.5 mg/ml, taking into account the benefit to you and the risk to your baby.

Bupivacaine Physan 7.5 mg/ml should not be used during childbirth.

Breastfeeding

Bupivacaine is excreted in breast milk, but at therapeutic doses of this medicine, no effects are expected in breastfed children.

Driving and using machines

Bupivacaine Physan 7.5 mg/ml may temporarily affect your ability to move, attention, and coordination. Your doctor will indicate if you can drive or use machines.

Bupivacaine Physan 7.5 mg/ml contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 2 ml ampoule; it is essentially "sodium-free".

This medicine contains 27.6 mg of sodium (main component of table/cooking salt) per 10 ml ampoule. This is equivalent to 1.38% of the maximum recommended daily sodium intake for an adult.

3. How to use Bupivacaine Physan 7.5 mg/ml

This medicine should only be administered under the supervision of a doctor with experience in the use of this type of medicine.

This medicine is administered by injection, infiltration, epidurally, and retrobulbarly.

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

If more Bupivacaine Physan 7.5 mg/ml is administered than necessary

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

• On the central nervous system:

Characterized by tingling, numbness of the tongue, mild fainting, ringing in the ears, blurred vision, and muscle tremors. Then, convulsions and loss of consciousness may appear, followed by breathing problems.

• On the cardiovascular system:

Low blood pressure (hypotension), decreased heart rate, arrhythmia, and cardiac arrest.

If toxic effects occur, the first measure is to stop the administration of the local anesthetic. The subsequent treatment consists of stopping convulsions and ensuring adequate breathing with oxygen, if necessary by assisted breathing. If convulsions occur, they can be treated with 100-150 mg of thiopental i.v. or 5-10 mg of diazepam i.v. If hypotension exists, a vasopressor should be administered intravenously, for example, 5-10 mg of ephedrine. If cardiac arrest occurs, cardiopulmonary resuscitation should be applied immediately, and 0.1-0.2 mg of adrenaline should be administered intravenously or intracardially as soon as possible. If cardiac arrest appears, prolonged resuscitation efforts should be applied.

In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount administered.

4. Possible side effects

Like all medicines, Bupivacaine Physan 7.5 mg/ml can cause side effects, although not everyone will experience them.

The side effects you may experience can be classified according to their frequency as:

• Very common (may affect more than 1 in 10 people): low blood pressure and nausea.
• Common (may affect up to 1 in 10 people): tingling, dizziness, decreased heart rate, increased blood pressure, vomiting, urinary retention.
• Uncommon (may affect up to 1 in 100 people): convulsions, tingling around the mouth, numbness of the tongue, increased hearing sensitivity, visual disturbances, loss of consciousness, tremors, mild headache, ringing in the ears, difficulty speaking correctly.
• Rare (may affect up to 1 in 1,000 people): allergic reactions, anaphylactic shock, nervous system disorders, double vision, cardiac arrest, arrhythmias, breathing difficulties.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Bupivacaine Physan 7.5 mg/ml

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 expiration date stated on the ampoule and carton. The expiration date is the last day of the month indicated.

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

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

6. Package contents and additional information

Composition of Bupivacaine Physan 2.5 mg/ml

• The active ingredient is bupivacaine hydrochloride. One ml contains 2.5 mg of bupivacaine hydrochloride. Each 10 ml ampoule contains 25 mg of bupivacaine hydrochloride.
• The other ingredients are: sodium chloride, sodium hydroxide (E-524), and/or hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and package contents

Bupivacaine Physan 2.5 mg/ml is packaged in glass ampoules.

This medicine is presented in clinical packages containing 50 or 100 glass ampoules of 10 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

LAPHYSAN S.A.U.

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

28108 Alcobendas

MADRID. SPAIN

Manufacturer

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nº 8, Nº 15 y Nº 16

3450-232 Mortágua - Portugal

This information is intended only for healthcare professionals

The solutions should be used immediately after opening. Any remaining solution should be discarded.

Precautions should be taken to prevent acute toxicity reactions, avoiding intravascular injection. Aspiration is recommended before and during administration. Accidental intravascular injection can be detected by a temporary increase in heart rate. The maximum dose should be administered very slowly, at a rate of 25-50 mg/min, or in dose increments, maintaining constant verbal contact with the patient. If symptoms of toxicity appear, administration should be stopped immediately.

Regional or local anesthesia procedures, except for those of a trivial nature, should always be performed by properly trained professionals and in areas with immediate access to resuscitation equipment and medicines. When performing major blocks, a venous catheter should be inserted beforehand at the injection site of the local anesthetic. Doctors should receive adequate training according to the procedure they will perform and be familiar with the diagnosis and treatment of side effects, systemic toxicity, and other complications.

In any case, and considering that the dosage should be calculated based on several factors, we recommend consulting the information provided in the Technical Sheet before using this medicine.

Incompatibilities

Bupivacaine has limited solubility at pH above 6.5. This should be taken into account in case alkaline solutions (e.g., carbonates) need to be added, as precipitation may occur.

Last revision of the leaflet: October 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/