PROSPECTO: INFORMATION FOR THE USER

Bupivacaine Hiperbárica Physan 5 mg/ml injectable solution

Bupivacaine, hydrochloride

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

?Keep this prospectus, as you may need to read it again.

?If you have any doubts, consult your doctor, pharmacist, or nurse.

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

1. What is Bupivacaine Hiperbárica Physan and how it is used

2. What you need to know before starting to use Bupivacaine Hiperbárica Physan

3. How to use Bupivacaine Hiperbárica Physan

4. Possible adverse effects

5. Storage of Bupivacaine Hiperbárica Physan

6. Contents of the package and additional information

Bupivacaína Hiperbárica Physan contains hydrochloride of bupivacaína, a local anesthetic (agent that reduces or eliminates sensations, affecting a particular region) that belongs to the subgroup of

amides.

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

No use Bupivacaína Hiperbárica Physan:

?If you are allergic (hypersensitive) to hydrochloride of bupivacaine or to any of the other

components of Bupivacaína 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 used as regional intravenous anesthesia (Bier block), since the accidental passage of bupivacaine to the bloodstream may lead to acute systemic toxicity reactions.

?If you have any of the following conditions:

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

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

?Septicemia (passage of infectious germs to the blood).

?Skin infection at the injection site or in a nearby position.

?Cardiovascular disease, especially heart block or hypovolemic shock.

?Bleeding disorders, ongoing anticoagulant treatment, or blood abnormalities.

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

?Chronic back pain.

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

?Cerebrospinal fluid hemorrhage.

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

?Persistent tingling sensation.

Warnings and precautions

Consult your doctor before starting to use Bupivacaína Hiperbárica Physan:

?If you have any type of heart block

?If you have arrhythmias

?If you have low blood pressure

?If you have bleeding

?If you have any type of infection

?If you have liver or kidney abnormalities.

Children

Bupivacaine should be used with caution in children under 12 years old, due to a higher probability of systemic toxicity.

Other medications and Bupivacaína Hiperbárica Physan

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.

The concomitant administration of heparin, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and plasma substitutes (dextrans) may increase the tendency to bleeding by the injection of the local anesthetic.

Similarly, it may be necessary to control the coagulation state of patients after concomitant medication with non-steroidal anti-inflammatory drugs.

Pregnancy and lactation

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

Pregnancy

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

Lactation

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

Driving and operating machinery

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

Bupivacaína Hiperbárica Physan should only be administered under the supervision of a doctor with experience in the use of this type of treatment.

Bupivacaína Hiperbárica Physan is administered in the form of an injection via the intrathecal route.

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

If more Bupivacaína Hiperbárica Physan is administered than is necessary

Like 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 tongue anesthesia, mild loss of consciousness, fainting, blurred vision, headache, tremors followed by drowsiness, convulsions, and unconsciousness.

? On the respiratory system :

Accelerated breathing, followed by respiratory difficulty or arrest.

? On the cardiovascular system :

Decreased heart contraction ability, low blood pressure (hypotension).

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

If toxic effects occur, the first measure is to stop administering the local anesthetic. The subsequent treatment consists of stopping convulsions and ensuring adequate respiration with oxygen, if necessary by assisted respiration. If convulsions occur, they can be treated with 5-10 mg of diazepam. If hypotension exists, a vasopressor should be administered intravenously, for example, 15-30 mg of ephedrine.

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

Like all medications, Bupivacaína Hiperbárica Physan may produce adverse effects, although not all people will experience them.

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

?Very frequent (may affect more than 1 in 10 patients):hypotension, bradycardia, and nausea

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

?Infrequent (may affect up to 1 in 100 patients):tingling, alterations 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 alterations, 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

at www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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.

Due to the specialty containing glucose, caramelization may appear during autoclave sterilization. Therefore, it should not be re-sterilized.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medications that you no longer need. This will help protect the environment.

Bupivacaine Hiperbárica Physan Composition

?The active ingredient is hydrochloride of bupivacaine. Each ml contains 5 mg of hydrochloride of bupivacaine. Each ampoule of 4 ml contains 20 mg of hydrochloride of bupivacaine.

?The other components are: dextrose anhydrous, sodium hydroxide (E-524)/hydrochloric acid

(for pH adjustment) and water for injectable preparations.

Product appearance and packaging contents

Bupivacaine Hiperbárica Physan is packaged in glass ampoules.

This medicine, is presented in boxes that contain 50 or 100 ampoules (clinical containers) of glass of 4 ml.

Marketing Authorization Holder

LAPHYSAN S.A.U.

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

28108 Alcobendas

MADRID SPAIN

Responsible for manufacturing

Laboratorios Inibsa, S.A.

Ctra. Sabadell to 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 solely for doctors or healthcare professionalsThe solutions must be used immediately after opening. Any remaining solution must be discarded.

Due to the specialty containing glucose, caramelization may appear during autoclave sterilization. For this reason, it should not be re-sterilized.

Regional anesthesia procedures must always be carried out by properly trained professionals and in suitable areas. The necessary equipment and medications for emergency monitoring and resuscitation must be available. Intravenous access, e.g. i.v. infusion, must be establishedbeforeinitiating spinal anesthesia. Doctors must take necessary precautions to avoid intravascular injection and must receive adequate training and be familiar with the diagnosis and treatment of side effects, systemic toxicity, and other complications. If signs of acute systemic toxicity or a total spinal block appear, the injection of local anesthetic must be stopped immediately.

Patients with a general condition of weakness due to age or other compromised factors such as partial or total cardiac conduction block, advanced hepatic or renal dysfunction, require special attention, although regional anesthesia may be an optimal choice for surgery.

Like other local anesthetics, bupivacaine can cause acute toxic effects on the central nervous system and cardiovascular system if used in local anesthesia procedures that result in high blood concentrations of the drug. This is especially true after an unintended intravascular injection.

In any case, and taking into account that the dosage must be calculated based on several factors, it is recommended to consult the information provided in the Technical Data Sheet before using this medication.

Incompatibilities

Generally, it is recommended not to mix spinal solutions with any product.

Last prospectus revision: October 2018

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/