PROSPECTO: INFORMATION FOR THE USER

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

Bupivacaine, hydrochloride / Epinephrine

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

No useInibsacain 5 mg/ml + 0.005 mg/ml

• If you are allergic (hypersensitive) to hydrochloride of bupivacaine, adrenaline, or to any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to any other local anesthetic of the same group (for example: articaine, lidocaine, mepivacaine, prilocaine)
• If you have narrow-angle glaucoma (eye condition characterized by increased intraocular pressure)
• If you have heart problems such as:
• • Paroxysmal tachycardia (rapid heart rhythm)
  • Atrial fibrillation (heart rhythm alterations) with rapid heart rate
  • Conduction impairment of the cardiac impulse
  • Decompensated heart failure
  • Cardiogenic or hypovolemic shock
• If you have degenerative nervous disease
• If you have coagulation disorders
• If the injection area is infected

Warnings and precautions

Consult your doctor before starting to use Inibsacain if you have:

• Severe or untreated hypertension (high blood pressure)
• Hyperthyroidism (excessive thyroid activity)
• Diabetes
• Asthma
• Advanced liver disease
• Severe renal dysfunction
• Heart disease

Children and adolescents

The safety and efficacy of Inibsacain have not been established in children and adolescents under 18 years, so it is not recommended for use in this population.

Other medications and Inibsacain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication

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

• Tricyclic antidepressants (medications for depression treatment)
• Oxytocic ergotamine-type drugs (uterine stimulants)
• Phenothiazines and butyrophenones (medications for psychotic disorders)
• Halothane (general anesthesia by inhalation)
• Non-cardioselective beta-blockers, such as propranolol (heart medications)
• Medications structurally similar to local anesthetics, such as those used for arrhythmia (class Ib antiarrhythmics)

Pregnancy and lactation

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

Pregnancy

Your doctor will prescribe Inibsacain taking into account the benefit it may have over the risk to your baby.

Lactation

Your doctor will prescribe Inibsacain taking into account the benefit it may have over the risk to your baby.

Driving and using machines

Inibsacain may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or use machines.

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

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) due to the presence of sodium metabisulfite.

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

Inibsacain should only be administered under the supervision of a doctor with experience in the use of this type of treatment.

Inibsacain is administered in the form of an injection for dental use.

The dose, rate of administration, and duration of treatment will be variable 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 is necessary

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

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

• On the circulatory system:

Decreased heart contraction ability, 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 administering the local anesthetic. The subsequent treatment consists of stopping convulsions and ensuring adequate respiration with oxygen, if necessary by assisted respiration. If convulsions occur, they can 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 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 route. If cardiac arrest occurs, prolonged resuscitation efforts should be applied.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Very frequent (may affect more than 1 in 10 people):low blood pressure and nausea
• Frequent (may affect up to 1 in 10 people):slow heart rate, tingling sensation and numbness (paresthesia), dizziness, vomiting, urinary retention or high blood pressure (hypertension).
• Uncommon (may affect up to 1 in 100 people):seizures, tingling sensation and numbness around the mouth, tongue numbness, increased auditory sensitivity (hyperacusis), visual disturbances, loss of consciousness, tremors, mild headache, ear buzzing (tinnitus) and speech articulation disorders.
• Rare (may affect up to 1 in 1,000 people):cardiac arrest and heart rhythm alteration, nervous system alteration (neuropathy), peripheral nerve injury and arachnoiditis, double vision (diplopia), respiratory depression, allergic reactions, anaphylactic shock (extreme allergic reaction).

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.

Store below 25°C.

Do not use this medication after the expiration date that appears on the cartridge and on the product packaging after CAD. 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.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, 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 Inibsacain

• The active principles are hydrochloride of bupivacaine and epinephrine (adrenaline). Each ml contains 5 mg of hydrochloride of bupivacaine and 0.005 mg of epinephrine (adrenaline) (in the form of bitartrate). Each cartridge of 1.8 ml contains 9 mg ofhydrochloride of bupivacaine and 0.009 mg of epinephrine (adrenaline) (in the form of bitartrate).
• The other components are sodium chloride, sodium metabisulphite (E-223), hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Inibsacain is packaged inglass cartridges containing acolorless and particle-free injectable solution.

The commercial presentation are packagesthat contain 1 cartridge or 100 cartridges (clinical package) of 1.8 ml.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and Responsible for the manufacture

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]

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

This information is intended solely for medical professionals or healthcare professionals

Before administering a local anesthetic, a complete resuscitation team should be available, equipped with an oxygenation and assisted ventilation system, and with the appropriate medications for the treatment of possible toxic reactions.

Inject the solution slowly and with prior aspiration, to avoid accidental intravascular injection, which could cause toxic effects.

Considering this, in addition to the anesthetic technique and the situation of the patients who will receive the treatment, the administration of the medication should be carried out in accordance with the guidelines described and the recommendations included in the different sections of the Technical Data Sheet(“Posology and administration method”; “Warnings and special precautions for use”), so it is necessary to refer to the text of the same to ensure correct use of the product.

The solutions should be used immediately after opening. Any remaining portion of the used solution should be discarded.

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

The solution is colorless, transparent and free of particles, so it should not be used if it presents a pinkish or darker yellow color or if it contains a precipitate or any foreign particles inside.

Appropriate precautions should 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 the metal ions dissolve, mainly copper ions, which can cause local irritation (swelling, edema) at the injection site and accelerated degradation of adrenaline).

Incompatibilities

The solubility of bupivacaine is limited to pH > 6.5. This should be taken into account in the case of adding alkaline solutions, e.g. carbonates, as a precipitation may occur.

Mixing with alkaline solutions leads to a rapid degradation of adrenaline.

Last review of the leaflet: September 2020

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