DENTOCAINE (40 mg + 0.01 mg)/ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. PATIENT INFORMATION LEAFLET: USER INFORMATION
3. DENTOCAINE 40 mg/ml + 10 micrograms/ml, solution for injection
   1. You should read this leaflet carefully before using the medicine, as it contains important information for you.
4. What is DENTOCAINE 40 mg/ml + 10 micrograms/ml and what is it used for.
5. Important information before using DENTOCAINE 40 mg/ml + 10 micrograms/ml.
   1. Contraindications:
   2. Warnings and precautions
   3. DENTOCAINE 40 mg/ml + 10 micrograms/ml with other medicines
   4. DENTOCAINE 40 mg/ml + 10 micrograms/ml with food
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. DENTOCAINE 40 mg/ml + 10 micrograms/ml contains sodium and sodium metabisulfite.
6. How to use DENTOCAINE 40 mg/ml + 10 micrograms/ml.
   1. Overdose of DENTOCAINE 40 mg/ml + 10 micrograms/ml
7. Possible side effects.
   1. Tell your dentist, doctor, or pharmacist immediately if you experience any of the following serious side effects:
   2. Common side effects: may occur in up to 1 in 10 people:
   3. Uncommon side effects: may occur in up to 1 in 100 people:
   4. Rare side effects: may occur in up to 1 in 1,000 people:
   5. Very rare side effects: may occur in up to 1 in 10,000 people:
   6. Frequency not known: frequency cannot be estimated from the available data
   7. Reporting side effects
8. How to store DENTOCAINE 40 mg/ml + 10 micrograms/ml.
9. Contents of the pack and other information.
   1. What DENTOCAINE 40 mg/ml + 10 micrograms/ml contains
   2. What DENTOCAINE 40 mg/ml + 10 micrograms/ml looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of revision of the leaflet
   6. Dosage
   7. Method of administration
   8. Special warnings
   9. Precautions for use
   10. Treatment of overdose
   11. Special precautions for disposal and preparation of the medicinal product for administration

PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

Articaine hydrochloride/adrenaline

You should read this leaflet carefully before using the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your dentist, doctor, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your dentist, doctor, or pharmacist. See section 4.

Table of contents of the leaflet:

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

What it is used for.
DENTOCAINE 40 mg/ml + 10 micrograms/ml is used to numb the mouth during dental procedures.
This medicine contains two active substances:

• Articaine, a local anesthetic that prevents pain and
• Adrenaline, a vasoconstrictor that narrows blood vessels at the injection site, prolonging the effect of articaine and reducing 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 old (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure, 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 take longer or may involve more significant bleeding.

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

Do not use DENTOCAINE 40 mg/ml + 10 micrograms/ml if you have any of the following conditions:

Contraindications:

• You are allergic to articaine or adrenaline or any of the other ingredients of this medicine (listed in section 6);
• You are allergic to other local anesthetics;
• You have uncontrolled epilepsy.

Warnings and precautions

Before using DENTOCAINE 40 mg/ml + 10 micrograms/ml, discuss with your dentist if you have any of the following conditions:

• Severe heart rhythm disorders (e.g., atrioventricular block grade II and III);
• Acute heart failure (sudden weakening of the heart, e.g., unexpected chest pain at rest or after a heart attack);
• Low blood pressure;
• Abnormally fast heart rate;
• Heart attack within the last 3-6 months;
• You have undergone coronary artery bypass grafting within the last 3 months;
• You are taking beta-blocker medications, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe bradycardia (slow heart rate) (see section Interactions with other medicines);
• Very high blood pressure;
• You are taking certain medications for depression and Parkinson's disease (tricyclic antidepressants). These medications enhance the effects of adrenaline;
• Epilepsy;
• Your blood lacks a natural chemical called cholinesterase (cholinesterase deficiency);
• Kidney problems;
• Severe liver disease;
• A condition called myasthenia, which causes muscle weakness;
• Porphyria, which causes neurological complications or skin problems;
• You are using other local anesthetics, medications that cause temporary loss of sensation (including inhalation anesthetics, such as halothane);
• You are taking antiplatelet or anticoagulant medications to prevent narrowing or hardening of blood vessels in the hands and feet;
• You are over 70 years old.
• You have had or currently have heart disease
• Uncontrolled diabetes;
• Severe hyperthyroidism (thyrotoxicosis);
• A tumor called pheochromocytoma;
• A condition called glaucoma, which is an eye disease;
• Inflammation or infection at the injection site;
• Low oxygen levels in body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disorders due to excessive acidic components in the blood (metabolic acidosis).

DENTOCAINE 40 mg/ml + 10 micrograms/ml with other medicines

Tell your dentist about all the medicines you are taking, have recently taken, or plan to take.
It is especially important to inform your dentist if you are taking any of the following medicines:

• Other local anesthetics, medications that cause reversible loss of sensation (including inhalation anesthetics, such as halothane);
• Sedatives (such as benzodiazepines, opioids), e.g., to reduce anxiety before a dental procedure;
• Medications that affect the heart and lower blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• Tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used to treat Parkinson's disease (such as entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• Medications used to treat irregular heartbeat (such as digitalis, quinidine);
• Medications used to treat migraine attacks (such as methysergide or ergotamine);
• Sympathomimetic vasoconstrictor medications (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the last 24 hours, planned dental treatment should be postponed;
• Neuroleptic medications (such as 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 your lip, cheek, or tongue, especially in children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your dentist or doctor before using this medicine.
Your dentist or doctor will decide whether you can use DENTOCAINE 40 mg/ml + 10 micrograms/ml during pregnancy.
Breastfeeding can be resumed 5 hours after administration of the anesthetic.
No effect on fertility is expected with doses used in dental procedures.

Driving and using machines

If you experience side effects, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until you feel normal (usually within 30 minutes after the dental procedure).

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

• Sodium: less than 23 mg of sodium per cartridge, which means the medicine is essentially sodium-free.
• Sodium metabisulfite: in rare cases, may cause severe allergic reactions and respiratory disorders (bronchospasm).

If there is a risk of an allergic reaction, the dentist will choose a different anesthetic.

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

Only doctors or dentists with proper training should use 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 determine the appropriate dose, considering the patient's age, body weight, overall health, and dental procedure.
Use the smallest dose that allows for effective anesthesia.
This medicine is administered by slow injection into the mouth.

Overdose of DENTOCAINE 40 mg/ml + 10 micrograms/ml

It is unlikely that you will receive too much of this medicine, but if you feel unwell, tell your dentist. Symptoms of overdose include severe weakness, paleness, headache, feeling of excitement or overexcitement, feeling of disorientation, loss of balance, involuntary trembling or convulsions, pupil dilation, blurred vision, problems with focusing, speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or fast breathing, which can lead to temporary cessation of breathing, and ineffective heart contractions (cardiac arrest).
If you have any further questions about using this medicine, ask your dentist.

4. Possible side effects.

Like all medicines, DENTOCAINE 40 mg/ml + 10 micrograms/ml can cause side effects, although not everybody gets them.
While you are in the dentist's office, you will be closely monitored by the dentist for the effects of DENTOCAINE 40 mg/ml + 10 micrograms/ml.

Tell your dentist, doctor, or pharmacist immediately if you experience any of the following serious side effects:

• Swelling of the face, tongue, or throat, difficulty swallowing, hives, or breathing problems (angioedema)
• Rash, itching, swelling of the throat, and breathing problems: these may be symptoms of an allergic reaction (hypersensitivity).
• Combination of drooping eyelid and constricted pupil (Horner's syndrome)

These side effects may occur rarely (may affect up to 1 in 1,000 people).
Other side effects, not listed above, may also occur in some patients.

Common side effects: may occur in up to 1 in 10 people:

• Gingivitis
• Neuropathic pain - caused by nerve damage
• Numbness or weakness of sensation in the mouth and around the mouth
• Metallic taste, taste disturbances, or loss of taste
• Increased, unpleasant, or abnormal sensation of touch
• Increased sensitivity to heat
• Headache
• Abnormally fast heart rate
• Abnormally slow heart rate
• Low blood pressure
• Swelling of the tongue, lips, and gums

Uncommon side effects: may occur in up to 1 in 100 people:

• Burning sensation
• High blood pressure
• Glossitis and stomatitis
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

Rare side effects: may occur in up to 1 in 1,000 people:

• Anxiety, fear
• Facial nerve disorders (facial nerve palsy)
• Sleepiness
• Involuntary eye movements
• Double vision, temporary blindness
• Drooping eyelid and constricted pupil (Horner's syndrome)
• Displacement with lowering of the eyeball into the orbit (enophthalmia)
• Ringing in the ears, increased sensitivity to sound
• Palpitations
• Hot flashes
• Wheezing (bronchospasm), asthma
• Breathing problems
• Scaling and ulceration of the gums
• Scaling at the injection site
• Hives
• Minor muscle spasms, involuntary muscle spasms,
• Fatigue, weakness
• Chills.

Very rare side effects: may occur in up to 1 in 10,000 people:

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

Frequency not known: frequency cannot be estimated from the available data

• Extremely good mood (euphoria)
• Disorders of heart rhythm conduction (conduction disorders, atrioventricular block)
• Increased blood flow to a part of the body, leading to congestion in blood vessels
• Vasodilation or vasoconstriction
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Redness of the skin (flushing)
• Abnormally increased sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Feeling of heat or cold
• Bruxism.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store DENTOCAINE 40 mg/ml + 10 micrograms/ml.

Keep this 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 month.
Cartridges should be stored in the original packaging to protect from light.
Store in a temperature below 30°C.
Do not use this medicine if you notice that the solution is cloudy or discolored.
Cartridges are for single use. Use immediately after opening the cartridge.
Dispose of any unused solution.
Medicines should not be disposed of via wastewater or household waste. Your dentist knows how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information.

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

• The active substances are articaine hydrochloride and adrenaline tartrate. Each 1.8 ml cartridge of DENTOCAINE 40 mg/ml + 10 micrograms/ml solution for injection contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as adrenaline tartrate). 1 ml of DENTOCAINE 40 mg/ml + 10 micrograms/ml contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
• The other ingredients are sodium chloride, citric acid monohydrate, sodium metabisulfite (E223), hydrochloric acid (pH adjuster), sodium hydroxide solution (pH adjuster), 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 colorless and clear solution for injection.
Packaging containing 50 cartridges of 1.8 ml for self-aspirating syringes with a flat plunger
Packaging containing 50 cartridges of 1.8 ml for syringes with a retractable plunger for manual aspiration
Packaging containing 100 cartridges of 1.8 ml for self-aspirating syringes with a flat plunger
Packaging containing 100 cartridges of 1.8 ml for syringes with a retractable plunger for manual aspiration
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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of revision of the leaflet

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Information intended for healthcare professionals only:

Dosage

In all populations, use the smallest dose that will provide effective anesthesia. The required dose should be determined individually.
For routine procedures in adults, one cartridge is usually sufficient, but less than the contents of one cartridge may be sufficient to achieve effective anesthesia. For more extensive procedures, more than one cartridge may be necessary without exceeding the maximum recommended dose; the dentist will decide.
For most routine dental procedures, DENTOCAINE 40 mg/ml + 5 micrograms/ml is preferred.
In more complex dental procedures, such as those requiring intensive hemostasis, DENTOCAINE 40 mg/ml + 10 micrograms/ml is preferred.
Concomitant use of sedatives to reduce patient anxiety:
In patients who have received a sedative, the maximum safe dose of local anesthetic may be reduced due to the additive effects of these medications causing central nervous system depression.
Children and adolescents (12 to 18 years old)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, with a maximum dose of 500 mg of articaine. The maximum dose of 500 mg of articaine corresponds to a dose for a healthy adult with a body weight of over 70 kg.
Children (4 to 11 years old)
The safety of DENTOCAINE 40 mg/ml + 10 micrograms/ml in children under 4 years old has not been established. There are no available data.
The amount of medicine to be injected should be determined based on the child's age and body weight and the extent of the procedure.
The average effective dose of articaine is 2 mg/kg body weight and 4 mg/kg body weight for simple and complex procedures, respectively. Use the smallest dose that will provide effective dental anesthesia. In children over 4 years old (or over 20 kg body weight), the maximum dose of articaine is 7 mg/kg body weight, with a maximum dose of 385 mg of articaine for a healthy child with a body weight of 55 kg.
Special patient groups
Elderly patients and patients with kidney problems:
Due to the lack of clinical data, use with caution and administer the smallest dose that will provide effective anesthesia in elderly patients and patients with kidney problems.
In the serum of these patients, increased levels of the product may occur, especially after repeated administration. If it is necessary to repeat the administration of the medicinal product, the patient should be closely monitored to recognize any signs of relative overdose of the product.
Patients with liver function disorders
Use with caution and administer the smallest dose that will provide effective anesthesia in patients with liver function disorders, especially after repeated administration, although 90% of articaine undergoes first-pass inactivation by non-specific esterases in tissues and blood.
Patients with cholinesterase deficiency
In patients with cholinesterase deficiency or those treated with acetylcholinesterase inhibitors, increased levels of the product may occur in the serum, as the product is inactivated by 90% by serum esterases. Therefore, use the smallest dose that will provide effective anesthesia.

Method of administration

Infiltration injection and peripheral nerve block in the mouth.
Local anesthetics should be injected carefully in the presence of inflammation and/or infection at the injection site. The rate of injection should be very slow (1 ml/min).
Precautions to be taken before using or administering the medicinal product
This medicinal product should only be used by doctors or dentists with sufficient training and familiarization with the recognition and treatment of systemic toxic effects, or under their supervision.
Before inducing local anesthesia with a local anesthetic, ensure that appropriate resuscitation equipment and medications are available to treat any emergency situations related to the airways and circulation.
After each injection of a local anesthetic, monitor the patient's level of consciousness.

Special warnings

Adrenaline can disrupt blood flow to the gums, leading to local tissue necrosis.
After nerve block anesthesia of the mandible, very rare cases of prolonged or irreversible nerve damage and loss of taste have been reported.

Precautions for use

Risks associated with accidental intravascular injection:
Accidental intravascular injection can cause sudden high levels of adrenaline and articaine in the systemic circulation. This may be associated with severe side effects, such as convulsions, followed by central nervous system and cardiovascular depression, and coma, progressing to respiratory and cardiac arrest.
To ensure that the needle does not penetrate a blood vessel during injection, aspirate before administering the local anesthetic. However, the absence of blood in the syringe does not guarantee that the injection will not be intravascular.
Risks associated with injection into a nerve:
Accidental injection into a nerve can cause the medicine to spread back along the nerve.
To avoid injecting into a nerve and prevent nerve damage associated with nerve block, always gently withdraw the needle if the patient experiences a sensation similar to an electric shock during insertion or if the insertion is particularly painful. If nerve damage occurs, the neurotoxic effect may be enhanced due to the potential neurotoxicity of articaine and the presence of adrenaline, which may impair peri-neural blood flow and prevent local washing out of articaine.

Treatment of overdose

Before inducing local anesthesia with a local anesthetic, ensure that resuscitation equipment and medications are available to treat any emergency situations related to the airways and circulation.
The severity of overdose symptoms should prompt doctors/dentists to implement protocols that ensure the airways are secured and respiratory support is provided in a timely manner.
After each injection of a local anesthetic, monitor the patient's level of consciousness.
In case of acute systemic toxic effects, stop injecting the local anesthetic immediately. If necessary, change the patient's position to a supine position.
Treat symptoms from the central nervous system (convulsions, central nervous system depression) immediately with appropriate airway management and respiratory support, as well as anticonvulsant medications.
Ensuring optimal oxygen supply and supporting respiration and circulation, as well as treating acidosis, may prevent cardiac arrest.
In case of cardiovascular depression (hypotension, bradycardia), consider using appropriate treatment with intravenous fluids, vasoconstrictors, and/or inotropic agents. Administer doses suitable for the age and body weight of children.
In case of cardiac arrest, start cardiopulmonary resuscitation immediately.

Special precautions for disposal and preparation of the medicinal product for administration

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 draw up the solution must always be new and sterile.
Cartridges are for single use. If only part of the contents has been used, discard the remainder.
Dispose of any unused medicinal product or waste material in accordance with local requirements.
AUTO-ASPIRATION
For auto-aspiration, a syringe with an automatic aspiration function is required. Auto-aspiration is performed by gently pressing the plunger and then immediately releasing the pressure. The elastic diaphragm in the cartridge membrane, which is initially pressed against the base of the syringe, creates a vacuum inside the cartridge, allowing aspiration.
MANUAL ASPIRATION
For manual aspiration, a syringe with a hook or harpoon is required. Manual aspiration is performed by attaching the harpoon to the anesthetic cartridge and pulling back the plunger.