Inibsacain 5 mg/ml + 0.005 mg/ml solution for injection in cartridge

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Inibsacain 5 mg/ml + 0.005 mg/ml injectable solution in cartridge

Bupivacaine, hydrochloride / Adrenaline

Contents of the leaflet:

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

1. What Inibsacain is and what it is used for

Inibsacain 5 mg/ml + 0.005 mg/ml injection solution in cartridges is a local anesthetic (an agent that reduces or eliminates sensations, affecting a particular region). This medicine is used for local dental anesthesia in adults.

2. What you need to know before using Inibsacain

Do not use Inibsacain 5 mg/ml + 0.005 mg/ml

• If you are allergic (hypersensitive) to bupivacaine hydrochloride, adrenaline, or to any of the other components of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to any other local anaesthetic of the same group (e.g., articaine, lidocaine, mepivacaine, prilocaine).
• If you have narrow-angle glaucoma (an eye condition characterized by increased intraocular pressure).
• If you have heart problems such as:
  • Paroxysmal tachycardia (accelerated heart rate)
  • Atrial fibrillation (irregular heart rhythm) with rapid heart rate
  • Impaired conduction of cardiac impulses
  • Decompensated heart failure (impaired heart function)
  • Cardiogenic or hypovolemic shock (acute heart failure)
• If you have a degenerative nerve disease.
• If you have blood coagulation disorders.
• If the injection site is infected.

Warnings and precautions

Consult your doctor before using Inibsacain if you have:

• Severe or untreated hypertension (high blood pressure)
• Thyrotoxicosis (overactive thyroid)
• Diabetes
• Asthma
• Advanced liver disease
• Severe renal (kidney) dysfunction
• Heart diseases

Children and adolescents

The safety and efficacy of Inibsacain have not been established in children and adolescents under 18 years of age; therefore, its use is not recommended in this population.

Other medicines and Inibsacain

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking any of the following medicines, as they may alter the effect of Inibsacain:

• Tricyclic antidepressants (medicines used to treat depression)
• Ergot-type oxytocic drugs (uterine stimulants)
• Phenothiazines and butyrophenones (medicines used to treat psychotic disorders)
• Halothane (inhalational general anaesthetic)
• Non-cardioselective beta-blockers, such as propranolol (heart medications)
• Medicines structurally similar to local anaesthetics, such as antiarrhythmic drugs of class Ib (used for cardiac rhythm disorders)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 Inibsacain after weighing the potential benefit against the possible risk to your baby.

Breastfeeding

If you are breastfeeding, your doctor will prescribe Inibsacain after weighing the potential benefit against the possible risk to your baby.

Driving and use of machines

Inibsacain may temporarily affect your motor skills, attention, and coordination. Your doctor will advise you whether you can drive or operate machinery.

Inibsacain contains sodium metabisulfite (E-223) and sodium:

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

This medicine contains less than 1 mmol of sodium (23 mg) per 1.8 ml cartridge; i.e., it is essentially "sodium-free".

3. How to use Inibsacain

Inibsacain should only be administered under the supervision of a physician experienced in the use of this type of treatment.

Inibsacain is administered as an injection for dental 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 Inibsacain is administered than should be

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

As with other local anesthetics, symptoms of toxicity may occur due to excessive dosing, rapid absorption, or accidental intravascular injection, and may manifest as:

• On the central nervous system:

Characterized by tongue anesthesia, mild loss of consciousness, fainting, blurred vision, headache, tremors followed by drowsiness, seizures, and unconsciousness.

• On the cardiovascular system:

Reduced cardiac contractility, low blood pressure (hypotension).

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

If toxic effects occur, the first measure is to stop the administration of the local anesthetic. Subsequent treatment consists of stopping seizures and ensuring adequate respiration with oxygen, if necessary by assisted ventilation. If seizures occur, they may be treated with 5–10 mg of diazepam. If hypotension occurs, a vasopressor should be administered intravenously, for example, 5–10 mg of ephedrine. If circulatory arrest occurs, cardiopulmonary resuscitation must be initiated immediately and a dose of 0.1–0.2 mg of adrenaline administered intravenously or intracardially as soon as possible. In the event of cardiac arrest, prolonged resuscitation efforts should be applied.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects you may experience can be classified by frequency as follows:

• Very common (may affect more than 1 in 10 people): decrease in blood pressure and nausea
• Common (may affect up to 1 in 10 people): decreased heart rate, tingling sensation and loss of sensitivity (paraesthesia), dizziness, vomiting, urinary retention or increase in blood pressure (hypertension).
• Uncommon (may affect up to 1 in 100 people): seizures, tingling sensation and loss of sensitivity around the mouth, numbness of the tongue, increased sensitivity to sound (hyperacusis), visual disturbances, loss of consciousness, tremors, mild headache, ringing in the ears (tinnitus), and speech articulation disorders.
• Rare (may affect up to 1 in 1,000 people): cardiac arrest and heart rhythm disturbances, nerve disorder (neuropathy), peripheral nerve injury and arachnoid inflammation, double vision (diplopia), respiratory depression, allergic reactions, anaphylactic shock (extreme allergic reaction).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inibsacain

Keep this medicine out of sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton and on the container after EXP. 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 must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Inibsacain

• The active substances are bupivacaine hydrochloride and epinephrine (adrenaline). Each ml contains 5 mg of bupivacaine hydrochloride and 0.005 mg of epinephrine (adrenaline) (as bitartrate). Each 1.8 ml cartridge contains 9 mg of bupivacaine hydrochloride and 0.009 mg of epinephrine (adrenaline) (as bitartrate).
• The other components are sodium chloride, sodium metabisulfite (E-223), hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Inibsacain is packaged in glass cartridges containing a clear, particle-free, colorless injectable solution.

The commercial presentations are packages containing either 1 cartridge or 100 cartridges (clinical pack) of 1.8 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Inibsa, S.A.

Ctra. Sabadell a Granollers km 14.5

08185 Lliçà de Vall (Barcelona)

Spain

Telephone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

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This information is intended exclusively for physicians or healthcare professionals

Before administering a local anesthetic, a complete resuscitation equipment set must be available, including an oxygen delivery system and assisted ventilation, as well as appropriate drugs for treating potential toxic reactions.

Injections must always be administered slowly and with prior aspiration to avoid accidental intravascular injection, which could cause toxic effects.

In addition to the anesthetic technique and the patient's condition, administration of the medicinal product should follow the guidelines and recommendations described in the different sections of the Summary of Product Characteristics (“Posology and method of administration”; “Warnings and special precautions for use”). Therefore, reference must be made to the full text of the SmPC to ensure correct use of the product.

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

Due to adrenaline's instability, products containing adrenaline must not be re-sterilized.

The solution is colorless, transparent, and free of particles; therefore, it should not be used if it appears pinkish or darker than pale yellow, or if it contains a precipitate or any foreign particles.

Appropriate precautions should be taken to avoid prolonged contact between anesthetic solutions containing adrenaline (low pH) and metallic surfaces (e.g., needles and metal parts of syringes), as metal ions—primarily copper ions—may leach out, potentially causing local irritation (swelling, edema) at the injection site and accelerated degradation of adrenaline.

Incompatibilities

Bupivacaine solubility is limited at pH > 6.5. This should be considered when alkaline solutions (e.g., carbonates) are added, as precipitation may occur.

Mixing with alkaline solutions leads to rapid degradation of adrenaline.

Last revision of the package leaflet: September 2020

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