Bupivacaine Physan 7.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bupivacaine Physan 7.5 mg/ml injectable solution

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Bupivacaine Physan 7.5 mg/ml is and what it is used for
2. What you need to know before using Bupivacaine Physan 7.5 mg/ml
3. How to use Bupivacaine Physan 7.5 mg/ml
4. Possible adverse effects
5. How to store Bupivacaine Physan 7.5 mg/ml
6. Contents of the pack and other information

1. What Bupivacaína Physan 7.5 mg/ml is and what it is used for

This medicine contains bupivacaine hydrochloride, a local anaesthetic (an agent that reduces or eliminates sensations by affecting a particular region) belonging to the amide subgroup.

It has been prescribed to provide you with anaesthetic effect.

2. What you need to know before using Bupivacaína Physan 7.5 mg/ml

Do not use Bupivacaína Physan 7.5 mg/ml:

• If you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

• If you are allergic to any other local anaesthetic of the same group (e.g., articaine, mepivacaine, lidocaine, or prilocaine).

• When used for intravenous regional anaesthesia (Bier block), as inadvertent leakage of bupivacaine into the bloodstream may lead to acute systemic toxic reactions.

• For epidural anaesthesia during childbirth.

• If you have any of the following conditions, epidural anaesthesia should not be performed:

• Pre-existing central nervous system disease due to infection, tumours, or other causes.

• Spinal deformity and active disease (e.g., spondylitis, tumour, tuberculosis) or recent injury (e.g., fracture) of the spine.

• Skin infection at or near the injection site.

• Cardiovascular disease, especially cardiac block or hypovolemic shock.

• Coagulation disorders or ongoing anticoagulant therapy.

Warnings and precautions

Consult your doctor before using Bupivacaína Physan 7.5 mg/ml if:

• You have any type of heart block
• You suffer from heart rhythm disorders
• You have low blood pressure
• You are experiencing bleeding
• You have any type of infection
• You have liver or kidney impairment.

Children

The safety and efficacy of this medicine have not been established in children under 12 years of age. Therefore, its use is not recommended in this population.

Other medicines and Bupivacaína Physan 7.5 mg/ml

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

Bupivacaine should be used with caution in patients receiving treatment with agents structurally related to amide-type local anaesthetics, as this may lead to increased systemic toxic effects.

Inform your doctor if you are taking any of the following medicines, as they may alter the effects of Bupivacaína Physan 7.5 mg/ml:

• Anticoagulants such as heparin
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, used to treat inflammation, pain, or fever
• Plasma substitutes (dextran)

Pregnancy and breastfeeding

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

Pregnancy

If you are pregnant, your doctor will prescribe Bupivacaína Physan 7.5 mg/ml only after considering the benefit to you versus the potential risk to your baby.

Bupivacaína Physan 7.5 mg/ml must not be used during labour.

Breastfeeding

Bupivacaine is excreted in breast milk, but at therapeutic doses of this medicine, effects on breastfed infants are not expected.

Driving and using machines

Bupivacaína Physan 7.5 mg/ml may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you may drive or operate machinery.

Bupivacaína Physan 7.5 mg/ml contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 2 ml ampoule; therefore, it is essentially “sodium-free”.

This medicine contains 27.6 mg of sodium (main component of table/cooking salt) per 10 ml ampoule. This corresponds to 1.38% of the maximum daily recommended sodium intake for an adult.

3. How to use Bupivacaine Physan 7.5 mg/ml

This medicine must be administered only under the supervision of a physician experienced in the use of this type of medication.

This medicine is administered by injection via infiltration, epidural route, or retrobulbar use.

The dose, rate of administration, and duration of treatment 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 Bupivacaine Physan 7.5 mg/ml is administered than intended

As with other local anesthetics, excessive dosage, rapid absorption, or accidental intravascular injection may lead to symptoms of toxicity, which may manifest as:

• Central nervous system effects:

Tingling, numbness of the tongue, mild dizziness, tinnitus, blurred vision, and muscle tremors. These may be followed by seizures and loss of consciousness, leading to respiratory difficulties.

• Cardiovascular system effects:

Low blood pressure (hypotension), decreased heart rate, arrhythmia, and cardiac arrest.

If toxic effects occur, the first step is to stop administration of the local anesthetic. Subsequent treatment includes controlling seizures and ensuring adequate respiration with oxygen, using assisted ventilation if necessary. Seizures may be treated with 100–150 mg of thiopental i.v. or 5–10 mg of diazepam i.v. If hypotension occurs, a vasopressor should be administered intravenously, for example, 5–10 mg of ephedrine. If circulatory arrest occurs, immediate cardiopulmonary resuscitation must be initiated, and a dose of 0.1–0.2 mg of adrenaline should be administered intravenously or intracardially as soon as possible. In the event of cardiac arrest, prolonged resuscitation efforts should be undertaken.

In case of overdose or accidental administration, consult your physician or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount administered.

4. Possible adverse effects

Like all medicines, Bupivacaine Physan 7.5 mg/ml can cause adverse effects, although not everyone will experience them.

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

• Very common (may affect more than 1 in 10 people): decreased blood pressure and nausea.
• Common (may affect up to 1 in 10 people): tingling, dizziness, slowed heart rate, increased blood pressure, vomiting, urinary retention.
• Uncommon (may affect up to 1 in 100 people): seizures, tingling around the mouth, tongue numbness, increased hearing sensitivity, visual disturbances, loss of consciousness, tremors, mild headache, tinnitus (ringing in the ears), difficulty speaking properly.
• Rare (may affect up to 1 in 1,000 people): allergic reactions, anaphylactic shock, nervous system disturbances, double vision, cardiac arrest, arrhythmias, breathing difficulties.

Reporting of adverse effects

If you experience any type of adverse reaction, consult your doctor, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines at www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bupivacaine Physan 7.5 mg/ml

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 on the product carton. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or in household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupivacaine Physan 2.5 mg/ml

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

Appearance of the product and contents of the container

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

This medicinal product is available in clinical packs containing 50 glass ampoules or 100 glass ampoules of 10 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

LAPHYSAN S.A.U.

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

28108 Alcobendas

MADRID. SPAIN

Manufacturer

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nos. 8, 15 and 16

3450-232 Mortágua - Portugal

This information is intended for medical or healthcare professionals only

Solutions should be used immediately after opening. Any remaining solution must be discarded.

Precautions must be taken to prevent acute toxic reactions by avoiding intravascular injection. Aspiration is recommended before and during administration. Accidental intravascular injection may 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 incremental doses, maintaining constant verbal contact with the patient. If symptoms of toxicity occur, administration must be stopped immediately.

Regional or local anesthesia procedures, except those of a trivial nature, should always be performed by properly trained professionals and in settings with immediate access to resuscitation equipment and medications. When performing major blocks, an intravascular catheter should be inserted at the local anesthetic injection site beforehand. Physicians must receive appropriate training for the specific procedure they are performing and must be familiar with the diagnosis and treatment of adverse effects, systemic toxicity, and other complications.

In any case, and considering that dosage must be calculated based on several factors, we recommend consulting the information provided in the Summary of Product Characteristics before using this medication.

Incompatibilities

Bupivacaine has limited solubility at pH above 6.5. This should be taken into account when adding alkaline solutions (e.g. carbonates), as precipitation may occur.

Last revision of the summary: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/