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BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION

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About the medicine

How to use BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bupivacaine Hyperbaric Physan 5 mg/ml solution for injection

Bupivacaine, hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you

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

? If you have any further questions, ask your doctor, pharmacist, or nurse.

? If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

  1. What Bupivacaine Hyperbaric Physan is and what it is used for
  2. What you need to know before you use Bupivacaine Hyperbaric Physan
  3. How to use Bupivacaine Hyperbaric Physan
  4. Possible side effects
  5. Storage of Bupivacaine Hyperbaric Physan
  6. Contents of the pack and other information

1. What Bupivacaine Hyperbaric Physan is and what it is used for

Bupivacaine Hyperbaric Physan contains bupivacaine hydrochloride, a local anesthetic (an agent that reduces or eliminates sensations, affecting a particular region) that belongs to the amide subgroup.

Bupivacaine Hyperbaric Physan has been prescribed to you to provide an anesthetic effect during surgery.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION

Discuss questions about BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Pedro Alvarez Guerrero

Psychiatry 8 years exp.

Dr. Alvarez Guerrero graduated in Medicine from the San Pablo CEU University in Madrid. He subsequently completed his specialization in Psychiatry in the Department of Psychiatry at Hospital Sant Joan de Deu in Manresa (Barcelona), where over the course of four years he acquired solid training in the bio-psycho-social model, developing his expertise across the different areas of mental health.

During his residency, he undertook training placements at Hospital Clínic de Barcelona, where he trained for several months in the psychiatric consultation-liaison unit. He also completed another placement at Hospital de Cruces in Bilbao, in the first-episode psychosis unit.

Throughout his professional career, Dr. Alvarez Guerrero has sought to complement his medical training with psychotherapeutic tools that allow him to address mental health disorders from a comprehensive perspective. For this reason, he specialized in Brief Strategic Psychotherapy through the Spanish Society of Psychosomatic Medicine and Psychotherapy, an approach focused on targeted and effective interventions.

With the aim of deepening his knowledge and promoting the rational use of treatments, he also completed a Master’s Degree in Psychopharmacology at the University of Valencia, which has enabled him to rigorously integrate the most up-to-date scientific evidence into the clinical management of psychopharmacological treatments.

He has also shown a particular interest in the field of legal psychiatry, completing an Official Master’s Degree in Legal, Forensic and Criminological Psychopathology at the Universitat Internacional de Catalunya. This training has allowed him to acquire the necessary competencies for the preparation of psychiatric expert reports in judicial and medico-legal contexts, thereby broadening the scope of his professional activity.

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€130
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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (5)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80

Frequently Asked Questions

Is a prescription required for BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION?
BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION?
The active ingredient in BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION is bupivacaine. This information helps identify medicines with the same composition but different brand names.
Who manufactures BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION?
BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION is manufactured by Laphysan S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to BUPIVACAINE HYPERBARIC PHYSAN 5 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (bupivacaine) include BUPIVACAINE AUROVITAS 2.5 mg/ml INJECTABLE SOLUTION, BUPIVACAINE AUROVITAS 5 mg/ml INJECTABLE SOLUTION, BUPIVACAINE B. BRAUN 5 mg/ml INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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