Package Insert: Information for the User

Bupivacaine Physan 5 mg/ml Injectable Solution

Hydrochloride of Bupivacaine

Read this package insert carefully before starting to use the medication, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it 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 they are not listed in this package insert. See section 4.

This medication contains hydrochloride of bupivacaine, a local anesthetic(agent that reduces or eliminates sensations, affecting a particular region) thatbelongs to the subgroup of amides.

You have been prescribed to provide you with anesthetic effect.

Do not use Bupivacaína Physan 5 mg/ml:

• If you are allergic to hydrochloride of bupivacaine or to any of the other components of this medication (listed in section 6).
• If you are allergic to any other local anesthetic of the same group (for example, articaine, mepivacaine, lidocaine or prilocaine).
• If it is used as regional intravenous anesthesia (Bier block), since the accidental passage of bupivacaine into the bloodstream may lead to acute systemic toxicity reactions.
• If you have any of the following conditions, do not perform an epidural anesthesia:

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

Warnings and precautions

Consult your doctor before starting to use Bupivacaína Physan 5 mg/ml:

• If you have any type of heart block
• If you have heart rhythm disorders
• 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

Bupivacaine should be used with caution in children aged 1 to 12 years, as they have a higher probability of systemic toxicity

Other medications and Bupivacaína Physan 5 mg/ml

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

Bupivacaine should be used with caution in patients receiving treatment with structurally similar agents to local anesthetics of the amide type, as it may produce an increase in systemic toxic effects.

Inform your doctor if you are taking any of the following medications, as they may alter the effects of Bupivacaína Physan 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will prescribe Bupivacaína Physan 5 mg/ml taking into account the benefit it may have over the risk to your baby.

Breastfeeding

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

Driving and operating machinery

Bupivacaína Physan 5 mg/ml may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or operate machinery.

Bupivacaína Physan 5 mg/ml contains sodium

This medication contains 31.5 mg of sodium (main component of table salt/for cooking) per 10 ml ampoule. This is equivalent to 1.58% of the maximum daily sodium intake recommended for an adult.

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

This medication is administered in the form of an injection through infiltration, subcutaneous, intramuscular, epidural, intraarticular, perineural, periosteal, and retrobulbar routes.

The dose, administration speed, and treatment duration 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 Bupivacaína Physan 5 mg/ml is administered than necessary

Similar to 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 tingling, tongue numbness, mild drowsiness, ear ringing, blurred vision, and muscle tremors. Convulsions and loss of consciousness may follow, followed by respiratory 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 administering the local anesthetic. The subsequent treatment consists of stopping the convulsions and ensuring adequate respiration with oxygen, if necessary through assisted respiration. If convulsions occur, they can be treated with100 -150 mg of thiopentali.vor 5 - 10 mg of diazepami.v. If hypotension occurs, a vasopressor should be administered intravenously, for example 5 - 10 mg of ephedrine. If cardiac arrest occurs, cardiopulmonary resuscitation should be applied immediately and a dose of 0.1 – 0.2 mg of adrenaline should be administered as soon as possible via intravenous or intracardiac route. If cardiac arrest occurs, prolonged resuscitation efforts should be applied.

In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Tel. 91 5620420, indicating the medication and the amount administered.

Like all medications, Bupivacaína Physan 5 mg/ml may cause adverse effects, although not everyone will experience them.

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

• Very frequent (may affect more than 1 in 10 people):hypotension and nausea.
• Frequent (may affect up to 1 in 10 people):tingling, dizziness, bradycardia, hypertension, vomiting, urinary retention.
• Infrequent (may affect up to 1 in 100 people):seizures, tingling around the mouth, tongue numbness, increased auditory sensitivity, visual disturbances, loss of consciousness, tremors, mild headache, tinnitus, difficulty speaking correctly.
• Rare (may affect up to 1 in 1,000 people):allergic reactions, anaphylactic shock, nervous system alterations, double vision, cardiac arrest, arrhythmias, and breathing difficulties.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Do not freeze.

Do not use this medication after the expiration date that appears on the ampule and on the product packaging. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bupivacaína Physan 2.5 mg/ml

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

Appearance of the product and contents of the package

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

This medication is presented in clinical packaging containing 50 ampoules or 100 ampoules of glass of 10 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder

LAPHYSAN S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D,

28108 Alcobendas

MADRID. SPAIN

Responsible for manufacturing

LABORATORIOS BASI – PHARMACEUTICAL INDUSTRY, S.A.

Manuel Lourenço Ferreira Industrial Park,

No. 8, No. 15 and No. 16

3450-232 Mortágua - Portugal

This information is intended solely for doctors or healthcare professionals

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

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

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

In any case, and taking into account that the dosage must be calculated based on several factors, we recommend consulting the information provided in the Technical Data Sheet before using this medication.

Incompatibilities

Bupivacaína has limited solubility at a pH above 6.5. This must be taken into account in the case of adding alkaline solutions (e.g. carbonates), as precipitation may occur.

Last review of the prospectus: October 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/