Dentocaine

DENTOCAINE 40 mg/ml + 10 micrograms/ml, solution for injection
Articaine hydrochloride / adrenaline

Please read the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your dentist, doctor, or pharmacist.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your dentist, doctor, or pharmacist. See section 4.

Table of contents of the leaflet:

1. What DENTOCAINE 40 mg/ml + 10 micrograms/ml is and what it is used for
2. Important information before using DENTOCAINE 40 mg/ml + 10 micrograms/ml
3. How to use DENTOCAINE 40 mg/ml + 10 micrograms/ml
4. Possible side effects
5. How to store DENTOCAINE 40 mg/ml + 10 micrograms/ml
6. Contents of the pack and other information

1. What DENTOCAINE 40 mg/ml + 10 micrograms/ml is and what it is used for

DENTOCAINE 40 mg/ml + 10 micrograms/ml is used to anaesthetize the oral cavity during dental procedures.

This medicine contains two active substances:

• Articaine, a local anaesthetic which prevents the sensation of pain, and
• Adrenaline, a vasoconstrictor which constricts blood vessels at the site of injection, thereby prolonging the effect of articaine. It also helps reduce bleeding during the procedure.

DENTOCAINE 40 mg/ml + 10 micrograms/ml or DENTOCAINE 40 mg/ml + 5 micrograms/ml is administered to the patient by a dentist.

DENTOCAINE 40 mg/ml + 10 micrograms/ml is intended for children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.

Depending on the type of dental procedure being performed, the dentist will decide which of the two medicines to use:

• DENTOCAINE 40 mg/ml + 5 micrograms/ml is usually used for simple and short dental procedures
• DENTOCAINE 40 mg/ml + 10 micrograms/ml is more suitable for procedures that are longer or associated with potentially heavier bleeding.

2. Important information before using DENTOCAINE 40 mg/ml + 10 micrograms/ml

When not to use DENTOCAINE 40 mg/ml + 10 micrograms/ml if the patient suffers from any of the following conditions:

• The patient is allergic to articaine or adrenaline, or to any of the other components of this medicine (listed in section 6);
• The patient is allergic to other locally acting anaesthetic agents;
• The patient has epilepsy that is not adequately controlled by medication.

Warnings and precautions
Before starting treatment with DENTOCAINE 40 mg/ml + 10 micrograms/ml, discuss with the dentist if the patient has any of the following conditions:

• Severe heart rhythm disorders (e.g. second- or third-degree atrioventricular block);
• Acute heart failure (acute weakening of the heart, e.g. sudden chest pain at rest or after myocardial infarction (i.e. heart attack));
• Low blood pressure;
• Abnormally rapid heartbeat;
• Myocardial infarction within the last 3–6 months;
• Coronary artery bypass grafting (CABG) performed within the last 3 months;
• The patient is taking antihypertensive medicines called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of heart function (see section DENTOCAINE 40 mg/ml + 10 micrograms/ml and other medicines);
• Very high blood pressure;
• The patient is concurrently taking certain medicines used to treat depression and Parkinson’s disease (tricyclic antidepressants). These medicines enhance the effect of adrenaline;
• Epilepsy;
• The patient’s blood lacks a natural chemical substance called cholinesterase (plasma cholinesterase deficiency);
• Kidney problems;
• Severe liver disease;
• Myasthenia gravis, a condition causing muscle weakness;
• Porphyria, which causes neurological complications or skin problems;
• The patient is using other locally acting anaesthetic agents, medicines causing temporary loss of sensation (including inhaled anaesthetics such as halothane);
• The patient is taking antiplatelet or anticoagulant medicines to prevent narrowing or hardening of blood vessels in the arms and legs;
• The patient is over 70 years of age;
• The patient has had or currently has heart disease;
• Uncontrolled diabetes;
• Severe hyperthyroidism (thyrotoxicosis);
• A tumour called phaeochromocytoma;
• A condition called closed-angle glaucoma, which is an eye disease;
• Inflammation or infection at the site of injection;
• Reduced oxygen supply to body tissues (hypoxia), high potassium levels (hyperkalaemia), and metabolic disturbances due to excessive levels of acidic components in the blood (metabolic acidosis).

DENTOCAINE 40 mg/ml + 10 micrograms/ml and other medicines
Inform the dentist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the dentist if the patient is taking any of the following medicines:

• Other locally acting anaesthetic agents, medicines causing reversible loss of sensation (including inhaled anaesthetics such as halothane);
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• Medicines acting on the heart and lowering blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• Tricyclic antidepressants used in the treatment of depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline);
• COMT inhibitors used in the treatment of Parkinson’s disease (such as entacapone or tolcapone);
• MAO inhibitors used in the treatment of depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• Medicines used to treat irregular heartbeat (e.g. digoxin, quinidine);
• Medicines used to treat migraine attacks (such as methysergide or ergotamine);
• Sympathomimetic vasoconstrictor medicines (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to raise blood pressure: if used within the last 24 hours, planned dental treatment should be postponed;
• Neuroleptic medicines (e.g. phenothiazines).

DENTOCAINE 40 mg/ml + 10 micrograms/ml with food
Avoid eating, including chewing gum, until normal sensation returns, due to the risk of biting the lip, cheek or tongue, especially in children.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient may use DENTOCAINE 40 mg/ml + 10 micrograms/ml during pregnancy.
Breastfeeding may be resumed 5 hours after administration of anaesthesia.
No effect on fertility is expected with doses used during dental procedures.

Driving and operating machinery
If adverse effects occur, such as dizziness, blurred vision or fatigue, the patient should not drive or operate machinery until feeling normal again (usually within 30 minutes after the dental procedure).

DENTOCAINE 40 mg/ml + 10 micrograms/ml contains sodium and sodium metabisulphite.

• Sodium: less than 23 mg of sodium per cartridge, meaning the medicine is practically sodium-free.
• Sodium metabisulphite: in rare cases, may cause severe allergic reactions and breathing problems (bronchospasm).

If there is a risk of allergic reaction, the dentist will choose another anaesthetic medicine.

3. How to use DENTOCAINE 40 mg/ml + 10 micrograms/ml

Only doctors or dentists who have appropriate training are qualified to administer DENTOCAINE 40 mg/ml + 10 micrograms/ml.
The dentist will decide whether to use DENTOCAINE 40 mg/ml + 10 micrograms/ml or DENTOCAINE 40 mg/ml + 5 micrograms/ml, and will determine the appropriate dose, taking into account the patient’s age, body weight, general health status, and the dental procedure.
The lowest effective dose required to achieve adequate anaesthesia should be used.
This medicine is administered by slow injection into the oral cavity.

Use of a higher than recommended dose of DENTOCAINE 40 mg/ml + 10 micrograms/ml
It is unlikely that the patient would receive an excessive dose of this medicine, but if the patient feels unwell, they should inform the dentist. Symptoms of overdose include severe weakness, pale skin, headache, feeling of excitation or hyperactivity, confusion, loss of balance, involuntary trembling or convulsions, dilated pupils, blurred vision, difficulty focusing clearly on an object, speech disturbances, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which may lead to temporary cessation of breathing, and ineffective heart contractions (known as cardiac arrest).

If you have any further questions about the use of this medicine, consult your dentist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
While the patient is in the dental office, they will be closely monitored by the dentist for the effects of DENTOCAINE 40 mg/ml + 10 micrograms/ml.
Immediately inform the dentist, doctor, or pharmacist if any of the following serious adverse reactions occur in the patient:

• swelling of the face, tongue or larynx, difficulty swallowing, hives or breathing problems (angioedema)
• rash, itching, throat swelling and breathing difficulties: these may be symptoms of an allergic reaction (hypersensitivity)
• combination of drooping eyelid and pupil constriction ( Horner's syndrome )

These adverse reactions may occur rarely (affecting up to 1 in 1,000 patients).
Other adverse reactions not listed above may also occur in some patients.

Common adverse reactions: may occur in up to 1 in 10 patients:

• gingivitis
• neuropathic pain – caused by nerve damage
• numbness or reduced sensation to touch in the mouth and around the lips
• metallic taste, taste disturbances or loss of taste sensation
• increased sensitivity to touch, unpleasant or abnormal sensation to touch
• increased sensitivity to heat
• headache
• abnormally fast heartbeat
• abnormally slow heartbeat
• low blood pressure
• swelling of the tongue, lips and gums

Uncommon adverse reactions: may occur in up to 1 in 100 patients:

• burning sensation
• high blood pressure
• inflammation of the tongue and oral cavity
• nausea, vomiting, diarrhoea
• rash, itching
• neck pain or pain at injection site

Rare adverse reactions: may occur in up to 1 in 1,000 patients:

• nervousness, anxiety
• facial nerve disorders (facial nerve paralysis)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and pupil constriction (Horner's syndrome)
• backward displacement with sinking of the eyeball into the orbit ( enophthalmos )
• ringing in the ears, hearing hypersensitivity
• palpitations
• hot flushes
• wheezing (bronchospasm), asthma
• breathing difficulties
• peeling and ulceration of the gums
• peeling at the injection site
• hives
• minor muscle twitching, involuntary muscle contractions
• fatigue, weakness
• chills

Very rare adverse reactions: may occur in up to 1 in 10,000 patients:

• permanent loss of sensation, prolonged numbness or loss of taste

Frequency not known: frequency cannot be estimated from available data

• extremely good mood (euphoria)
• disturbances in heart coordination (conduction disturbances, atrioventricular block)
• increased blood flow to a body part, leading to congestion in blood vessels
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• cheek swelling and local swelling
• burning mouth syndrome
• skin redness (flushing)
• excessive sweating
• exacerbation of neuromuscular symptoms in Kearns-Sayre syndrome
• sensation of heat or cold
• bruxism (teeth grinding)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store DENTOCAINE 40 mg/ml + 10 micrograms/ml
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
Store cartridges in their original packaging to protect from light.
Store below 30°C.
Do not use this medicine if the solution appears cloudy or discoloured.
Cartridges are for single use only. Use immediately after opening.
Any unused solution should be discarded.
Do not dispose of medicines via wastewater or household waste. Dentists know how to properly dispose of unused medicines. This helps protect the environment.

6. Contents of the package and other information

What DENTOCAINE 40 mg/ml + 10 micrograms/ml contains

• The active substances are articaine hydrochloride and adrenaline bitartrate.
  o Each 1.8 ml cartridge of injectable solution of DENTOCAINE 40 mg/ml + 10 micrograms/ml contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as adrenaline bitartrate).
  o 1 ml of DENTOCAINE 40 mg/ml + 10 micrograms/ml contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline bitartrate).
• The other components are sodium chloride, citric acid monohydrate, sodium metabisulphite (E223), hydrochloric acid (pH regulator), sodium hydroxide solution (pH regulator) and water for injections.

What DENTOCAINE 40 mg/ml + 10 micrograms/ml looks like and contents of the pack
DENTOCAINE 40 mg/ml + 10 micrograms/ml is a clear, colourless injectable solution.
Pack sizes containing 50 cartridges of 1.8 ml for self-aspirating syringes with flat plunger
Pack sizes containing 50 cartridges of 1.8 ml for syringes with retractable plunger for manual aspiration
Pack sizes containing 100 cartridges of 1.8 ml for self-aspirating syringes with flat plunger
Pack sizes containing 100 cartridges of 1.8 ml for syringes with retractable plunger for manual aspiration
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratorios INIBSA, S.A.
Ctra. Sabadell a Granollers, km 14,5
08185 Lliçà de Vall (Barcelona)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

Information intended exclusively for medical professionals:

Dosage
For all patient populations, the smallest dose that provides effective anesthesia should be used. The required dose must be determined individually.
For routine procedures in adults, 1 cartridge is usually administered, but effective anesthesia may be achieved with less than the content of one cartridge. For more extensive procedures, administration of multiple cartridges may be necessary, without exceeding the maximum recommended dose; the decision is made by the dentist.
For most routine dental procedures, DENTOCAINE 40 mg/ml + 5 micrograms/ml is preferred.
For more complex dental procedures, such as those requiring intense hemostasis, DENTOCAINE 40 mg/ml + 10 micrograms/ml is preferred.

Concomitant use of sedative drugs to reduce patient anxiety:
In patients who have received sedative medication, the maximum safe dose of local anesthetic may be reduced due to the additive central nervous system depressant effects of these drugs.

Children and adolescents (aged 12 to 18 years)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, and the absolute maximum dose of articaine must not exceed 500 mg. A maximum dose of 500 mg of articaine corresponds to the dose for a healthy adult weighing over 70 kg.

Children (aged 4 to 11 years)
The safety of DENTOCAINE 40 mg/ml + 10 micrograms/ml has not been established in children under 4 years of age. No data are available.
The amount of drug to be injected should be determined based on the child's age, body weight, and the extent of the procedure.
The average effective dose of articaine is 2 mg/kg body weight for simple procedures and 4 mg/kg body weight for complex procedures. The smallest dose providing effective dental anesthesia should be used. In children aged 4 years and older (or weighing at least 20 kg), the maximum dose of articaine is 7 mg/kg body weight, and the absolute maximum dose of articaine must not exceed 385 mg in a healthy child weighing 55 kg.

Special patient groups
Elderly patients and patients with renal impairment:
Due to lack of clinical data, special caution should be exercised to administer the smallest dose that provides effective anesthesia in elderly patients and those with renal impairment.
Increased plasma concentrations of the product may occur in these patients, especially after repeated administration. If repeat injection of the medicinal product is necessary, the patient should be carefully monitored for signs of relative overdose.

Patients with hepatic impairment:
Special caution should be exercised to administer the smallest dose that provides effective anesthesia in patients with hepatic impairment, particularly after repeated administration, even though 90% of articaine undergoes initial inactivation by nonspecific plasma esterases in tissues and blood.

Patients with plasma cholinesterase deficiency:
Elevated plasma concentrations of the product may occur in patients with plasma cholinesterase deficiency or those receiving treatment with acetylcholinesterase inhibitors, as the product is inactivated by plasma esterases in 90%. Therefore, the smallest effective dose providing adequate anesthesia should be used.

Administration method
Infiltration injection and peripheral nerve block in the oral cavity.
Local anesthetics should be injected cautiously in the presence of inflammation and/or infection at the injection site. The injection rate should be very slow (1 ml/min).

Precautions to be taken prior to use or administration of the medicinal product
This medicinal product should be used only by physicians or dentists who are adequately trained and familiar with the recognition and management of systemic toxic reactions, or under the supervision of such physicians. Prior to inducing local anesthesia with a local anesthetic agent, appropriate resuscitation equipment and medications must be available to allow immediate treatment of any emergency involving the respiratory or cardiovascular systems. After each injection of a local anesthetic agent, the patient's level of consciousness should be monitored.
When using DENTOCAINE 40 mg/ml + 10 micrograms/ml for infiltration or conduction anesthesia, the injection must always be performed slowly and with prior aspiration.

Special warnings
Adrenaline may disrupt blood flow in the gingiva, potentially leading to local tissue necrosis.
Very rare cases of prolonged or irreversible nerve damage and loss of taste have been reported following mandibular conduction anesthesia.

Precautions for use
Risks associated with accidental intravascular injection:
Accidental intravascular injection may result in sudden high systemic concentrations of adrenaline and articaine. This may lead to severe adverse effects such as seizures, followed by central nervous system and cardiovascular and respiratory depression, coma, and progression to respiratory and circulatory arrest.
Therefore, prior to injecting the local anesthetic agent, aspiration should be performed to ensure the needle has not entered a blood vessel. However, the absence of blood in the syringe does not guarantee avoidance of intravascular injection.

Risks associated with intraneural injection:
Accidental injection into a nerve may cause retrograde spread of the drug along the nerve.
To avoid intraneural injection and prevent nerve injury related to nerve block, the needle should always be gently withdrawn if the patient experiences an electric shock-like sensation during needle insertion or if the injection is particularly painful. If nerve injury occurs, neurotoxic effects may be exacerbated due to the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may impair perineural blood flow and prevent local washout of articaine.

Management of overdose
Prior to inducing local anesthesia with a local anesthetic agent, appropriate resuscitation equipment and medications must be available to allow immediate treatment of any respiratory or cardiovascular emergencies.
The severity of overdose symptoms should prompt physicians/dentists to initiate protocols ensuring timely airway protection and respiratory support.
After each injection of a local anesthetic agent, the patient's level of consciousness should be monitored.
If acute systemic toxic reaction occurs, injection of the local anesthetic agent should be immediately discontinued. If necessary, the patient's position should be changed to supine.
Central nervous system symptoms (seizures, CNS depression) should be promptly treated with appropriate airway management, respiratory support, and administration of anticonvulsant drugs.
Ensuring optimal oxygen delivery, respiratory and circulatory support, and treatment of acidosis may prevent cardiac arrest.
In case of circulatory depression (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasoconstrictors, and/or inotropic agents should be considered. Age- and body weight-appropriate doses should be administered to children.
In case of circulatory arrest, cardiopulmonary resuscitation should be initiated immediately.

Special precautions for removal and preparation of the medicinal product for use
Do not use this medicinal product if the solution is cloudy or discolored.
To avoid the risk of infection (e.g., transmission of hepatitis), syringes and needles used to withdraw the solution must always be fresh and sterile.
Cartridges are intended for single use only. If only part of the cartridge content is used, the remainder must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

SELF-ASPIRATION
Self-aspiration requires a syringe with automatic aspiration function. Self-aspiration is performed by gently depressing the plunger and then immediately releasing pressure. The flexible diaphragm in the cartridge membrane, initially pressed against the axis of the syringe base, creates negative pressure within the cartridge, enabling aspiration.

MANUAL ASPIRATION
For manual aspiration, a syringe with a hook or harpoon is required. Manual aspiration is performed after attaching the harpoon to the anesthetic cartridge and pulling back the plunger.