Leaflet: information for the user

Bupivacaine/Adrenaline Physan 5 mg/ml + 0.005 mg/ml injectable solution

Hydrochloride of bupivacaine / Adrenaline

Read this leaflet carefully before starting to use the medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this leaflet. See section 4.

This medication contains hydrochloride of bupivacaína, a local anesthetic(agent that reduces or eliminates sensations, affecting a particular region) thatbelongs to the subgroup of amides, and adrenaline, a vasoconstrictor agent that narrows blood vessels,reducing blood flow in the area where the doctor injects the needle (local anesthesia), prolonging the effect of the anesthesia in the injection site.

You have been prescribed to provide you with anesthetic effect.

No use Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml:

• If you are allergic to hydrochloride of bupivacaína, to adrenaline or to any of the other components of Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml (listed in section 6).
• If you are allergic to any other local anesthetic of the same group (for example, articaína, mepivacaína, lidocaína or prilocaína).
• If it is used as intravenous regional anesthesia (Bier block), since the accidental passage of bupivacaína 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/Adrenalina Physan 5 mg/ml + 0,005 mg/ml:

• If you have any type of heart block
• If you have arrhythmias
• If you have low blood pressure
• If you have hemorrhage
• If you have any type of infection
• If you have liver or kidney disorders
• If you have severe or untreated high blood pressure
• If you have uncontrolled thyroid disease
• If you have cerebral circulation disorders
• If you have advanced diabetes

Children

Bupivacaína 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/Adrenalina Physan 5 mg/ml + 0,005 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.

Bupivacaína 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/Adrenalina Physan 5 mg/ml + 0,005 mg/ml:

• Anticoagulants, such as heparin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, to combat inflammation, pain or fever
• Plasma substitutes (dextran).
• Tricyclic antidepressants.
• Ergotamine-type oxytocics (medications used to induce labor).
• Phenothiazines and butyrophenones for the treatment of psychotic disorders.
• Non-selective beta-blockers such as propranolol for the treatment of high blood pressure.
• Inhalation general anesthetics, such as halothane.

Pregnancy and lactation

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

Pregnancy

Your doctor will prescribe Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml, taking into account the benefit that may be obtained against the risk to your baby.

Lactation

Bupivacaína is excreted in breast milk, but at therapeutic doses of this medication, no effects are expected in breastfed infants.No sufficient information is available regarding the excretion of adrenaline in breast milk, but it is unlikely to affect the infant.

Driving and operating machinery

Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml may temporarily alter your ability to move, attention and coordination. Your doctor will indicate if you can drive or operate machinery.

Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml contains metabisulfito de sodio and sodium

This medication may produce severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains metabisulfito.

This medication contains 32.8 mg of sodium (main component of table salt/for cooking) per ampoule. This is equivalent to 1.64% 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, subcutaneously, intramuscularly, epidurally, intraarticularly, perineurally, periosteally, and retrobulbarly.

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

If more Bupivacaína/Adrenalina Physan 5 mg/ml + 0,005 mg/ml is administered than is 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. This may be followed by seizures and loss of consciousness, leading to breathing difficulties.

• 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 seizures and ensuring adequate oxygenation, if necessary through assisted ventilation. If seizures occur, they can be treated with100 -150 mg of thiopental i.v or 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 injection. 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, phone 91 562 04 20, indicating the medication and the amount administered.

Like all medications, Bupivacaína/Adrenalina Physan 5 mg/ml + 0.005 mg/ml may cause adverse effects, although not everyone will experience them.

The adverse effects you may experience can be classified based on their frequency as follows:

• 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, paresthesia 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 disorders, double vision, cardiac arrest, arrhythmias, 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 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. Protect from light.

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 Bupivacaine/Adrenaline Physan 5 mg/ml + 0.005 mg/ml

• The active principles are hydrochloride of bupivacaine and epinephrine (adrenaline). One ml contains 5 mg of hydrochloride of bupivacaine and 0.005 mg of epinephrine (adrenaline) (in the form of bitartrate). Each ampoule of 10 ml contains 50 mg ofhydrochloride of bupivacaine and 0.05 mg of epinephrine (adrenaline) (in the form of bitartrate).
• The other components are: sodium chloride, sodium metabisulphite (E-223), sodium hydroxide (E-524) and/or hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Bupivacaine/Adrenaline Physan 5 mg/ml + 0.005 mg/ml is packaged in glass ampoules.

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

Only some package sizes may be marketed.

Holder of the marketing authorization

LAPHYSAN S.A.U.

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

28108 Alcobendas

MADRID. SPAIN

Responsible for manufacturing

Laboratórios Basi - Indústria Farmacéutica S.A.

Parque Industrial Lourenço Ferreira, Nº8, Nº15 and Nº16.

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.

Due to the instability of adrenaline, products containing it should not be sterilized.

Appropriate precautions must be taken to avoid prolonged contact between anesthetic solutions containing adrenaline (low pH) and metal surfaces (e.g. needles and metal parts of syringes), as metal ions dissolve, mainly copper ions, which can causelocal irritation (swelling, edema) at the injection site and accelerated degradation of adrenaline).

Precautions must be taken to prevent acute toxicity reactions, avoiding intravascular injection. It is recommended to perform aspiration before and during administration. When administering high doses, for example in the case of epidural block, it is advisable to perform a test dose with 3-5 ml of bupivacaine with epinephrine. An 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 increments of dose, maintaining constant verbal contact with the patient. If symptoms of toxicity appear, administration should be stopped immediately.

Regional or local anesthesia processes, except for trivial ones, 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 should be inserted at the injection site of the local anesthetic. Doctors should receive adequate training according to the process they are to 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 should be calculated based on several factors, we recommend consulting the information provided in the Technical Dossier before using this medicine.

Incompatibilities

Bupivacaine has limited solubility at a pH above 6.5. This should be taken into account in the case of adding alkaline solutions, for example carbonates, as precipitation may occur. Containing adrenaline, the mixture with alkaline solutions leads to rapid degradation of the same.

Last review of the leaflet: October 2020

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