Articaina OgnA

Package leaflet: Information for the patient

ARTICAINA OGNA

40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline
40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline
Articaine hydrochloride/adrenaline
Please read this leaflet carefully before you are given 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, inform your dentist, doctor, or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ARTICAINA OGNA is and what it is used for

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

• Articaine, a local anaesthetic that prevents pain;
• 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.

ARTICAINA OGNA will be administered by a dentist.
ARTICAINA OGNA 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:

• ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, solution for injection with adrenaline, is generally used for simple and short-duration dental procedures;
• ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, solution for injection with adrenaline, is more suitable for longer procedures or those likely to involve significant bleeding.

2. What you should know before using ARTICAINA OGNA

ARTICAINA OGNA must not be administered to you if you have any of the following conditions:

• allergy to articaine or adrenaline, or to any of the other ingredients 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 receiving ARTICAINA OGNA 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;
• concomitant use of medications for depression and Parkinson’s disease (tricyclic antidepressants). These medicines may enhance the effects of adrenaline;
• epilepsy;
• deficiency of a naturally occurring substance 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 or skin problems;
• use of other local anesthetics, 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 ARTICAINA OGNA
Inform your dentist if you are currently using, have recently used, or might use any other medicines.
It is particularly important to inform your dentist if you are taking any of the following medicines:

• other local anesthetics, medicines causing reversible loss of sensation (including volatile anesthetics such as halothane);
• sedatives (e.g., benzodiazepines, opioids), for example to reduce anxiety before a 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, the planned dental treatment must be postponed;
• neuroleptic drugs (e.g., phenothiazines).

ARTICAINA OGNA 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, planning to become pregnant, or breastfeeding, consult your dentist or doctor before receiving this medicine.
Your dentist or doctor will decide whether you can be given ARTICAINA OGNA 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, do not drive or operate machinery until you have fully recovered (usually within 30 minutes after the dental procedure).

ARTICAINA OGNA 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). If there is a risk of an allergic reaction, the dentist will choose a different medicine for anesthesia.

3. How to use ARTICAINA OGNA

Only physicians and dentists are qualified to use ARTICAINA OGNA.
The dentist will decide whether to use 40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline, or 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline, and will determine the appropriate dose based on your age, weight, general health status, and the dental procedure.
The lowest effective dose required to achieve anesthesia should be used.
This medicine is administered by slow injection into the oral cavity.
If you are given more ARTICAINA OGNA than you should
It is unlikely that you will be administered an excessive amount of injection; however, if you start to feel unwell, inform your dentist immediately. Symptoms of overdose include severe weakness, pallor, headache, agitation or restlessness, disorientation, loss of balance, involuntary tremor or shivering, dilated pupils, 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 at the dental clinic, your dentist will carefully monitor the effects of ARTICAINA OGNA.
Immediately inform your dentist, doctor or pharmacist 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, swelling of the throat 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 are rare (may occur in 1 out of 1,000 people). Other side effects not listed above may also occur in some patients.

Common side effects (may affect up to 1 out of 10 people):

• inflammation of the gums
• 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 out of 100 people):

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

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

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

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

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

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

• excessive sense of well-being (euphoria)
• heart rhythm coordination problems (conduction disorders, atrioventricular block)
• increased blood flow to a body area, resulting in vascular congestion
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• localized swelling of the cheeks
• 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 get any side effects, including those not listed in this leaflet, tell 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.
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARTICAINA OGNA

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.
Keep the cartridges in the outer box, tightly closed, to protect the medicine from light.
Do not use this medicine if you notice that the solution is cloudy or changes colour.
The cartridges are for single use only. Use immediately after opening the cartridge. Discard any unused solution.
Do not dispose of any medicine 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 ARTICAINA OGNA Contains
The active substances are articaine hydrochloride and adrenaline tartrate.

• Each 1.8 ml cartridge of ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, solution for injection with adrenaline, contains 72 mg of articaine hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).
• 1 ml of ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, solution for injection with adrenaline, contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
• Each 1.8 ml cartridge of ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, solution for injection with adrenaline, contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as adrenaline tartrate).
• 1 ml of ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, solution for injection with adrenaline, contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).

The other components are sodium chloride, sodium metabisulfite (E223), water for
injections.
Description of the Appearance of ARTICAINA OGNA and Contents of the Package
ARTICAINA OGNA is a clear, colourless solution.
It is packaged in single-use glass cartridges sealed at the base with a movable rubber plunger and at the
top with a rubber seal secured by an aluminium cap.
Box containing 50 glass cartridges of 1.8 ml.
Marketing Authorization Holder
GIOVANNI OGNA & Figli S.r.l.
Via Figini, 41 – 20835 Muggiò (MB)
Manufacturer
Pierrel S.p.A.
Strada Statale Appia, 46/48 – 81043 Capua (CE)

Package Leaflet: Information for the Physician
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 a routine procedure, the normal dose for adult patients is 1 cartridge, but 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, ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, solution for injection with adrenaline, is preferred.
For more complex procedures, such as those requiring pronounced hemostasis, ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, solution for injection with adrenaline, is preferred.
Concomitant use of sedatives to reduce patient anxiety:
The maximum safe 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 ARTICAINA OGNA 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, body weight, and 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 following repeated use. If repeated injections are necessary, the patient should be closely 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, particularly 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 90% via plasma esterases. Therefore, the lowest effective dose capable of inducing anesthesia should be used.
Method of Administration
Infiltration and perineural use in the oral cavity.
Local anesthetics should be injected with caution 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 equipment and drugs for resuscitation must be readily available to ensure immediate treatment of any respiratory and cardiovascular emergencies. The patient’s level of consciousness must be monitored after each injection of local anesthetic.
When using ARTICAINA OGNA for infiltration or locoregional anesthesia, the injection must always be performed slowly and preceded by aspiration.
Special Warnings
Adrenaline reduces blood flow in the gingiva, 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 adrenaline and articaine. This may be associated with serious adverse reactions, such as seizures, followed by cardiorespiratory and central nervous system depression and coma, progressing to respiratory and circulatory arrest.
Therefore, to ensure that 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 injuries 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 the event of nerve injury, the neurotoxic effect may be exacerbated by the potential chemical neurotoxicity of articaine and the presence of adrenaline, as adrenaline may reduce perineural blood supply and hinder local elimination of articaine.
Treatment of Overdose
Before administering regional anesthesia with local anesthetics, appropriate resuscitation equipment and drugs must be available to ensure immediate treatment of any respiratory and cardiovascular emergencies.
The severity of overdose symptoms should prompt the physician/dentist to implement protocols ensuring timely airway protection and assisted ventilation.
The patient’s level of consciousness must be monitored after each injection of local anesthetic.
If signs of acute systemic toxicity occur, the injection of local anesthetic must be immediately stopped. If necessary, place the patient in a supine position.
Symptoms of CNS toxicity (seizures, CNS depression) must be treated immediately with appropriate airway/respiratory support and administration of anticonvulsant drugs.
Optimal oxygenation, ventilation, and circulatory support, together with correction of acidosis, may prevent cardiac arrest.
In case 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, cardiopulmonary resuscitation must be initiated immediately.
Special Precautions for Disposal and Handling
This medicinal product must not be used if the solution is cloudy or changes colour.
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. In case of partial use of a cartridge, discard the remaining solution.
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.