Bupivacaine Physan 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bupivacaína Physan 5 mg/ml solution for injection

Bupivacaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Bupivacaína Physan 5 mg/ml is and what it is used for

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

It has been prescribed to provide you with an anaesthetic effect.

2. What Bupivacaína Physan 5 mg/ml is and what it is used for

Do not use Bupivacaína Physan 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).

• If used for intravenous regional anaesthesia (Bier block), since accidental entry of bupivacaine into the bloodstream may lead to acute systemic toxic reactions.

• 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

Talk to your doctor before starting to use Bupivacaína Physan 5 mg/ml:

• If you have any type of heart block.
• If you have heart rhythm disorders.
• If you have low blood pressure.
• If you are experiencing bleeding.
• If you have any type of infection.
• If you have liver or kidney problems.

Children

Bupivacaine should be used with caution in children aged 1 to 12 years, as they have a higher risk of systemic toxicity.

Other medicines and Bupivacaína Physan 5 mg/ml

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

Bupivacaine should be used with caution in patients receiving treatment with agents structurally similar to amide-type local anaesthetics, as this may increase the risk of systemic toxic effects.

Tell your doctor if you are taking any of the following medicines, as they may alter the effects of Bupivacaína Physan 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 5 mg/ml after carefully weighing the potential benefits against the possible risks to your baby.

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

Bupivacaína Physan 5 mg/ml contains sodium

This medicine contains 31.5 mg of sodium (main component of table/cooking salt) per 10 ml ampoule. This corresponds to 1.58% of the maximum daily recommended sodium intake for an adult.

3. How to use Bupivacaine Physan 5 mg/ml

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

This medicine is administered by injection via infiltration, subcutaneous, intramuscular, epidural, intra-articular, perineural, periosteal, and retrobulbar routes.

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 5 mg/ml is administered than intended

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

• Central nervous system effects:

Tingling, numbness of the tongue, lightheadedness, tinnitus, blurred vision, and muscle tremors. This may be followed by seizures and unconsciousness, followed by 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 discontinue administration of the local anesthetic. Subsequent treatment includes controlling seizures and ensuring adequate respiration with oxygen, 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 Tel. 91 5620420, indicating the medicine and the amount administered.

4. Possible adverse effects

As with all medicines, Bupivacaína Physan 5 mg/ml may 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 sensitivity to sound, visual disturbances, loss of consciousness, tremors, mild headache, 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, and 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 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 contain no preservatives and must be used immediately after opening. Any remaining solution should be discarded.

Medicines should not be disposed of via sewage systems or in household waste. Ask your pharmacist how to properly 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 vial 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 pack

Bupivacaine Physan 2.5 mg/ml is supplied in glass vials.

This medicinal product is available in clinical packs containing 50 or 100 glass vials 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.

Manuel Lourenço Ferreira Industrial Park,

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 appropriately trained professionals and in areas with immediate access to resuscitation equipment and medications. When performing major blocks, an intravascular catheter should be inserted prior to the injection site of the local anesthetic. Physicians must receive adequate training according to the procedure they are performing and must be familiar with the diagnosis and management 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 medicinal product.

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/