BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Bupivacaine Hyperbaric Physan

Do not use Bupivacaine Hyperbaric Physan:

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

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

? If it is used as regional intravenous anesthesia (Bier block), as the unintended passage of bupivacaine into the bloodstream can lead to acute systemic toxicity 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 spinal column.

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

? Skin infection at the injection site or nearby.

? Cardiovascular disease, especially heart block or hypovolemic shock.

? Coagulation disorders, ongoing anticoagulant treatment, 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 Hyperbaric Physan:

? 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 under 12 years of age, as they have a higher probability of systemic toxicity.

Other medicines and Bupivacaine Hyperbaric Physan

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, even those obtained 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 increase the risk of systemic toxic effects.

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

Similarly, coagulation status monitoring may be necessary in patients after concomitant medication with non-steroidal anti-inflammatory drugs.

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 Hyperbaric Physan, taking into account the benefits and risks to your baby.

Breastfeeding

If you are breastfeeding, your doctor will prescribe Bupivacaine Hyperbaric Physan, taking into account the benefits and risks to your baby.

Driving and using machines

Bupivacaine Hyperbaric Physan may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or use machines.

3. How to use Bupivacaine Hyperbaric Physan

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

Bupivacaine Hyperbaric Physan is administered by intrathecal injection.

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 Hyperbaric Physan is administered than it should be

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

? On the respiratory system:

Acceleration of breathing, followed by difficulty or respiratory arrest.

? On the cardiovascular system:

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

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

If toxic effects occur, the first measure is to stop the administration of the local anesthetic. The subsequent treatment consists of stopping the convulsions and ensuring adequate breathing with oxygen, if necessary by assisted breathing. 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 medicine and the amount administered.

4. Possible side effects

Like all medicines, Bupivacaine Hyperbaric Physan can cause side effects, although not everyone gets them.

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

? 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, 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 disorders, and breathing difficulties

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bupivacaine Hyperbaric 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 carton. The expiry 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.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupivacaine Hyperbaric 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 injectable preparations.

Appearance of the product and pack contents

Bupivacaine Hyperbaric Physan is packaged in glass ampoules.

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

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 y Nº16.

3450-232 Mortágua, Portugal

Spain

Phone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

This information is intended only for healthcare professionalsThe solutions should be used immediately after opening. Any remaining solution should be discarded.

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

Regional anesthesia procedures should always be performed by properly trained professionals and in suitable areas. The necessary equipment and medications for monitoring and emergency resuscitation should be available. Intravenous access, e.g., i.v. perfusion, should be performed before starting intrathecal anesthesia. Doctors should take the necessary precautions to avoid intravascular injection and should 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 total spinal block appear, the injection of the local anesthetic should be stopped immediately.

Patients with a general condition of weakness due to age or other compromised factors, such as partial or total heart conduction block, advanced liver or kidney 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 unintended intravascular injection.

In any case, and considering that the dosage should be calculated based on several factors, it is recommended to consult the information provided in the Technical Sheet before using this medicine.

Incompatibilities

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

Last revision of the leaflet: October 2018

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