INIBSACAIN 5 mg/mL + 0.005 mg/mL Injectable Solution in Cartridge

2. What you need to know before you use Inibsacain

Do not useInibsacain 5 mg/ml + 0.005 mg/ml

• If you are allergic (hypersensitive) to bupivacaine hydrochloride, adrenaline, or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic (hypersensitive) to any other local anesthetic of the same group (e.g., articaine, lidocaine, mepivacaine, prilocaine)
• If you have narrow-angle glaucoma (a condition of the eyes characterized by increased intraocular pressure)
• If you have heart problems such as:
• • Paroxysmal tachycardia (rapid heart rate)
  • Atrial fibrillation (heart rhythm disturbances) with rapid heart rate
  • Impaired cardiac conduction
  • Uncompensated heart failure
  • Cardiogenic or hypovolemic shock (acute heart failure)
• If you have a degenerative nervous system 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 (excessive thyroid activity)
• Diabetes
• Asthma
• Advanced liver disease
• Severe kidney dysfunction
• Heart disease

Children and adolescents

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

Other medicines and Inibsacain

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 for treating depression)
• Oxytocic drugs of the ergotamine type (uterine stimulants)
• Phenothiazines and butyrophenones (medicines for treating psychotic disorders)
• Halothane (general anesthesia by inhalation)
• Non-cardioselective beta-blockers, such as propranolol (heart medicines)
• Medicines structurally similar to local anesthetics, such as those used for cardiac rhythm disorders (antiarrhythmics of class Ib)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine

Pregnancy

If you are pregnant, your doctor will prescribe Inibsacain, taking into account the benefit to you and the risk to your baby

Breastfeeding

If you are breastfeeding, your doctor will prescribe Inibsacain, taking into account the benefit to you and the risk to your baby

Driving and using machines

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

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

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling 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 doctor with experience in the use of this type of treatment

Inibsacain is administered by injection for dental use

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 you use more Inibsacain than you should

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

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 circulatory system:

Decreased heart contraction, 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. 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, 5-10 mg of ephedrine. If cardiac arrest occurs, cardiopulmonary resuscitation should be applied immediately, and 0.1-0.2 mg of adrenaline should be administered intravenously or intracardially as soon as possible. If cardiac arrest occurs, prolonged resuscitation efforts should be applied

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

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

• 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): decrease in heart rate, tingling sensation and loss of sensitivity (paresthesia), dizziness, vomiting, urinary retention, or increased blood pressure (hypertension)
• Uncommon (may affect up to 1 in 100 people): convulsions, tingling sensation and loss of sensitivity around the mouth, numbness of the tongue, increased auditory sensitivity (hyperacusis), visual disturbances, loss of consciousness, tremors, mild headache, ringing in the ears (tinnitus), and speech disorders
• Rare (may affect up to 1 in 1,000 people): cardiac arrest and alteration of heartbeats, nervous system damage (neuropathy), peripheral nerve damage, and inflammation of the arachnoid, double vision (diplopia), respiratory depression, allergic reactions, anaphylactic shock (severe allergic reaction)

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 side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Inibsacain

Keep this medicine out of the sight and reach of children

Store below 25°C

Do not use this medicine after the expiry date which is stated on the cartridge and on the outer packaging after EXP. The expiry date is the last day of the month shown

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

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 further information

Composition of Inibsacain

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

Appearance of the product and pack contents

Inibsacain is packaged in glass cartridges containing a clear, colorless, and particle-free solution for injection

The commercial presentation is packs containing 1 cartridge or 100 cartridges (clinical packaging) of 1.8 ml

Not all 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

Phone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

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This information is intended only for healthcare professionals

Before administering a local anesthetic, you should have a complete resuscitation equipment, including an oxygenation and ventilation system, and the necessary medications for the treatment of possible toxic reactions

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

Taking this into account, as well as the anesthetic technique and the situation of the patients to be treated, the administration of the medicine should be carried out according to the guidelines described and the recommendations included in the different sections of the Technical Data Sheet ("Posology and method of administration"; "Special warnings and precautions for use"), so it is necessary to refer to the text of the same to ensure the correct use of the product

The solutions should be used immediately after opening. Any remaining portion of the solution used 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 appears pink or darker than pale yellow 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 metal ions, mainly copper ions, can dissolve, causing 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 case alkaline solutions need to be added, e.g., carbonates, as precipitation may occur

Mixing with alkaline solutions results in rapid degradation of adrenaline

Last revision of the leaflet: September 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/