Cartidont

Patient Information Leaflet: Information for the User

Cartidont 40 mg/ml + 5 micrograms/ml, solution for injection with adrenaline, 40 mg/ml + 10 micrograms/ml, solution for injection with adrenaline

Articaine hydrochloride/adrenaline
Please read this leaflet carefully before using this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your dentist, doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your dentist, doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What CARTIDONT is and what it is used for

CARTIDONT is used to numb (anesthetize) the oral cavity during dental procedures.
This medicinal product contains two active substances:

• articaine, a local anesthetic that prevents pain, and
• adrenaline, a vasoconstrictor that narrows the blood vessels at the injection site, thereby prolonging the effect of articaine. In addition, adrenaline reduces bleeding during surgical procedures.

CARTIDONT will be administered to you by a dentist.
CARTIDONT is indicated for children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure to be performed, the dentist will choose one of the two medicinal products:
CARTIDONT 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline is generally used for short-duration dental procedures,
CARTIDONT 40 mg/ml + 10 micrograms/ml injectable solution with adrenaline is more suitable for longer procedures or those that may involve significant bleeding.

2. What you should know before using CARTIDONT

Do not use CARTIDONT if you have any of the following conditions:

• allergy to articaine or adrenaline, or to any of the other components of this medicine (listed in section 6);
• allergy to other local anesthetics;
• epilepsy not adequately controlled with pharmacological treatment.

Warnings and precautions
Consult your dentist before using CARTIDONT if you have any of the following conditions:

• severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block);
• acute heart failure (acute weakness of the heart muscle, e.g., sudden chest pain at rest or following myocardial infarction (e.g., heart attack));
• low blood pressure;
• abnormally rapid heart rate;
• heart attack within the last 3–6 months;
• coronary artery bypass surgery within the last 3 months;
• taking blood pressure medications called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the heart rate (see section Other medicines);
• very high blood pressure;
• concurrent use of medications for depression and Parkinson’s disease (tricyclic antidepressants). These drugs may enhance the effects of adrenaline;
• epilepsy;
• deficiency of a naturally occurring chemical called cholinesterase in the blood (plasma cholinesterase deficiency);
• kidney problems;
• severe liver problems;
• a disease called myasthenia gravis, which causes muscle weakness;
• porphyria, which causes neurological complications and skin problems;
• use of other local anesthetics, or medicines causing reversible loss of sensation (including volatile anesthetics such as halothane);
• taking medications called antiplatelet agents or anticoagulants, to prevent narrowing or hardening of blood vessels in the arms and legs;
• age over 70 years;
• any current or past heart problems;
• uncontrolled diabetes;
• excessive thyroid activity (thyrotoxicosis);
• a tumor called pheochromocytoma;
• a disease called closed-angle glaucoma affecting the eyes;
• inflammation or infection at the site where the injection is to be administered;
• reduced oxygen levels in body tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disturbances due to excess acid in the blood (metabolic acidosis).

Other medicines and CARTIDONT
Inform your dentist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your dentist if you are taking any of the following medicines:

• other local anesthetics, or medicines causing reversible loss of sensation (including volatile anesthetics such as halothane);
• sedatives (e.g., benzodiazepines, opioids), for example to reduce anxiety before the dental procedure;
• medicines for heart and blood pressure (e.g., guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used to treat depression (e.g., amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used to treat Parkinson’s disease (e.g., entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (e.g., moclobemide, phenelzine, tranylcypromine, linezolid);
• medicines used to treat irregular heart rhythms (e.g., digitalis, quinidine);
• medicines used for migraine attacks (e.g., methysergide or ergotamine);
• sympathomimetic vasoconstrictors (e.g., cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the previous 24 hours, scheduled dental treatment should be postponed;
• neuroleptic drugs (e.g., phenothiazines).

CARTIDONT and food
Avoid eating or chewing gum until normal sensation returns, as there is a risk of biting your lips, cheeks, or tongue, especially in children.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your dentist or doctor before using this medicine.
Your dentist or doctor will decide whether you can use CARTIDONT during pregnancy.
Breastfeeding can be resumed 5 hours after anesthesia.
No adverse effects on fertility are expected at the doses used for dental procedures.

Driving and use of machines
If you experience side effects such as dizziness, blurred vision, or fatigue, you should not drive or operate machinery until you have fully recovered (usually within 30 minutes after the dental procedure).

CARTIDONT contains sodium and sodium metabisulfite

• Sodium: less than 23 mg per cartridge; this means it is practically “sodium-free”
• Sodium metabisulfite: may rarely cause severe allergic reactions and breathing difficulties (bronchospasm).

3. How to use CARTIDONT

Only physicians and dentists are qualified to use CARTIDONT.
The dentist will decide whether to use CARTIDONT 40 mg/ml + 5 micrograms/ml or
CARTIDONT 40 mg/ml + 10 micrograms/ml, and will determine the appropriate dose based
on your age, weight, general health status, and the dental procedure being performed. The
lowest effective dose capable of inducing anesthesia should be used.
This medicine is administered by slow injection into the oral cavity.
If you are given more CARTIDONT than you should
It is unlikely that you would be administered an excessive amount of the injection; however, if
you begin to feel unwell, inform your dentist immediately. Symptoms of overdose include severe
weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance,
involuntary tremor or chills, pupil dilation, blurred vision, difficulty focusing objects,
speech disturbances, dizziness, seizures, stupor, loss of consciousness, coma, yawning,
abnormal breathing (either slowed or accelerated) which may cause temporary respiratory
arrest, and inability of the heart to contract effectively (cardiac arrest).
If you have any doubts about the use of this medicine, consult your dentist.

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

While you are in the dental office, your dentist will carefully monitor the effects of CARTIDONT.
Inform your dentist, doctor, or pharmacist immediately if you experience any of the
following serious side effects:

• swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or breathing difficulties (angioedema);
• skin rash, itching, throat swelling, and breathing difficulties: these could be symptoms of an allergic reaction (hypersensitivity);
• a combination of drooping eyelid and pupil constriction (Horner’s syndrome).

These side effects occur rarely (they may affect 1 in 1,000 people).
Other side effects not listed above may also occur in some patients.
Common side effects (may affect up to 1 in 10 people):

• gingival inflammation
• neuropathic pain: pain due to nerve damage
• numbness or reduced sensation inside and around the mouth
• metallic taste, altered or loss of taste
• increased, unpleasant, or abnormal tactile sensitivity
• increased sensitivity to heat
• headache
• abnormally increased heart rate
• abnormally decreased heart rate
• low blood pressure
• swelling of the tongue, lips, and gums

Uncommon side effects (may affect up to 1 in 100 people):

• burning sensation
• high blood pressure
• inflammation of the tongue and mouth
• nausea, vomiting, diarrhea
• skin rash, itching
• neck pain or injection site pain

Rare side effects (may affect up to 1 in 1,000 people):

• nervousness, anxiety
• facial nerve disorders (facial paralysis)
• drowsiness
• breathing difficulties
• wheezing (bronchospasm), asthma
• palpitations
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and constricted pupil (Horner’s syndrome) – displacement with recession of the eyeball into the orbit due to changes in orbital volume (enophthalmos)
• ringing in the ears (tinnitus), hearing hypersensitivity
• hot flushes
• exfoliation and ulceration of the gums
• exfoliation at the injection site
• hives (urticaria)
• muscle spasms, involuntary muscle contractions
• fatigue, weakness
• chills

Very rare side effects (may affect up to 1 in 10,000 people):

• persistent loss of sensation, widespread numbness, and loss of taste

Not known: (frequency cannot be estimated from the available data)

• excessive well-being (euphoria)
• heart rhythm coordination problems (conduction disorders, atrioventricular block)
• increased blood flow to a body part, resulting in vascular congestion
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• cheek swelling and localized swelling
• burning mouth syndrome
• skin redness (erythema)
• abnormally increased sweating
• worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• sensation of heat or cold
• jaw locking

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your
dentist, doctor, or pharmacist. You can also report side effects directly via the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store CARTIDONT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze. Store in the original packaging to protect from light.
Do not use this medicine if you notice that the solution is cloudy or changes colour.
Cartridges are for single use only. Use immediately after opening the cartridge.
Discard any unused solution.
Do not dispose of medicines via wastewater or household waste. Ask your dentist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CARTIDONT contains

• The active substances are articaine hydrochloride and adrenaline tartrate.

  • Each 1.7 ml cartridge of injectable solution CARTIDONT 40 mg/ml + 5 micrograms/ml with adrenaline contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
  • 1 ml of CARTIDONT 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).

• Each 1.7 ml cartridge of injectable solution CARTIDONT 40 mg/ml + 10 micrograms/ml with adrenaline contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).

  • 1 ml of CARTIDONT 40 mg/ml + 10 micrograms/ml injectable solution with adrenaline contains 40 mg of articaine hydrochloride and 10 µg of adrenaline (as adrenaline tartrate).

• The other components are sodium chloride, sodium metabisulfite (E223), water for injections.

Description of the appearance of CARTIDONT and contents of the pack
CARTIDONT is a clear, colourless solution.
It is supplied in single-use glass cartridges, sealed at the base with a movable rubber plunger and at the top with a rubber seal held in place by an aluminium cap.
Pack: box containing 50 glass cartridges of 1.7 ml.

Marketing Authorisation Holder and Manufacturer
CURASEPT S.p.A. - Via G. Parini, 19 - CAP 21047, Saronno (VA), Italy
Manufacturer
Pierrel S.p.A. - Strada Statale Appia n. 46/48 - 81043 CAPUA (CE)

The following information is intended exclusively for physicians or healthcare professionals

Dosage:
For all populations, the lowest effective dose capable of inducing anesthesia should be used. The required dosage must be determined on an individual basis.
For routine procedures, the normal dose for adult patients is one cartridge; however, less than one cartridge may be sufficient to achieve effective anesthesia. At the dentist's discretion, more than one cartridge may be necessary for more complex procedures, without exceeding the recommended maximum dose.
For most routine dental procedures, CARTIDONT 40 mg/ml + 5 micrograms/ml is preferred.
For more complex procedures, such as those requiring pronounced hemostasis, CARTIDONT 40 mg/ml + 10 micrograms/ml is preferred.

Concomitant use of sedatives to reduce patient anxiety:
The safe maximum dose of local anesthetic may be reduced in sedated patients due to the additive central nervous system depressant effect.

Adults and adolescents (aged 12 to 18 years):
In adults and adolescents, the maximum dose of articaine is 7 mg/kg, with an absolute maximum dose of 500 mg. The maximum dose of 500 mg of articaine applies to a healthy adult with a body weight exceeding 70 kg.

Children (aged 4 to 11 years):
The safety of CARTIDONT in children under 4 years of age has not been established. No data are available.
The amount to be injected must be determined based on the child's age and body weight, as well as the extent of the procedure. The effective average dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest effective dose capable of inducing anesthesia should be used. In children aged 4 years (or at least 20 kg [44 lbs] body weight) and older, the maximum dose of articaine is 7 mg/kg, with an absolute maximum dose of 385 mg of articaine for a healthy child weighing 55 kg.

Special populations
Elderly patients and patients with renal disease
Due to the lack of clinical data, particular precautions should be taken to administer the lowest effective dose capable of inducing anesthesia in elderly patients and those with renal disease.
Elevated plasma levels of the product may occur in these patients, especially after repeated use. If repeated injections are necessary, the patient must be carefully monitored for signs of relative overdose.

Patients with hepatic impairment
Particular precautions should be taken to administer the lowest effective dose capable of inducing anesthesia in patients with hepatic impairment, especially after repeated use, despite the fact that 90% of articaine is inactivated by plasma and tissue nonspecific esterases.

Patients with plasma cholinesterase deficiency
Elevated plasma levels of the product may occur in patients with cholinesterase deficiency or those receiving acetylcholinesterase inhibitors, since the product is inactivated by plasma esterases by 90%. Therefore, the lowest effective dose capable of inducing anesthesia should be used.

Administration method
Infiltration and perineural use in the oral cavity.
Local anesthetics should be injected cautiously in the presence of inflammation and/or infection at the injection site. The injection must be performed very slowly (1 ml/min).

Precautions to be taken before handling or administering the medicinal product
This medicinal product must be used exclusively by physicians or dentists with adequate knowledge and experience in the diagnosis and treatment of systemic toxicity, or under their supervision. Before inducing regional anesthesia with local anesthetics, appropriate resuscitation equipment and medications must be available to ensure immediate management of any respiratory or cardiovascular emergencies. The patient’s level of consciousness must be monitored after each local anesthetic injection.
When using CARTIDONT for infiltration or locoregional anesthesia, the injection must always be performed slowly and preceded by aspiration.

Special warnings
Epinephrine reduces blood flow in the gums, which may cause local tissue necrosis.
Very rare cases of prolonged or irreversible nerve injury and loss of taste have been reported following mandibular block anesthesia.

Precautions for use
Risks associated with accidental intravascular injection
Accidental intravascular injection may cause a sudden increase in systemic levels of epinephrine and articaine. This may lead to serious adverse reactions, such as seizures, followed by cardiorespiratory and central nervous system depression and coma, potentially progressing to respiratory and circulatory arrest. Therefore, to ensure the needle does not enter a blood vessel during injection, aspiration must be performed before injecting the local anesthetic. However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.

Risks associated with intraneural injection
Accidental intraneural injection may cause the drug to travel up the nerve. To avoid intraneural injection and prevent nerve injury related to nerve blocks, the needle should be slightly withdrawn if the patient experiences an electric shock sensation during injection or if the injection is particularly painful. In cases of nerve injury, the neurotoxic effect may be exacerbated by the potential chemical neurotoxicity of articaine and the presence of epinephrine, which may reduce perineural blood supply and hinder local elimination of articaine.

Management of overdose
Before administering regional anesthesia with local anesthetics, appropriate resuscitation equipment and medications must be available to ensure immediate management of any respiratory or cardiovascular emergencies.
The severity of overdose symptoms requires the physician/dentist to implement protocols ensuring timely airway protection and assisted ventilation.
The patient’s level of consciousness must be monitored after each local anesthetic injection.
If signs of acute systemic toxicity occur, the injection of local anesthetic must be immediately discontinued. If necessary, place the patient in a supine position.
Symptoms of central nervous system toxicity (seizures, CNS depression) must be treated immediately with appropriate airway/respiratory support and administration of anticonvulsant drugs.
Optimal oxygenation, ventilation, circulatory support, and correction of acidosis may prevent cardiac arrest.
In cases of cardiovascular depression (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressors, and/or inotropes should be considered. In children, the administered dose must be adjusted according to age and body weight.
In case of cardiac arrest, immediate cardiopulmonary resuscitation must be initiated.

Special precautions for disposal and handling
This medicinal product must not be used if the solution is cloudy or changes color.
To avoid the risk of infection (e.g., transmission of hepatitis), syringes and needles used to withdraw the solution must always be new and sterile.
Cartridges are for single use only. If a cartridge is partially used, discard the remaining solution.
Unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.