Artin

Package leaflet: Information for the user

ARTIN 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline, 40 mg/ml + 10 micrograms/ml injectable solution with adrenaline

Articaine hydrochloride/adrenaline
Generic medicine
Please read this leaflet carefully before using this medicine as 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, talk to your dentist, doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ARTIN is and what it is used for

ARTIN 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, 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.

ARTIN 40 mg/ml + 5 micrograms/ml
or
ARTIN 40 mg/ml + 10 micrograms/ml solution for injection with adrenaline
will be administered by a dentist.
ARTIN 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:

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

2. What you should know before using ARTIN

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

• severe cardiac 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 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 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 ARTIN
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, medicines causing reversible loss of sensation (including volatile anesthetics such as halothane); 2/10
• sedatives (e.g., benzodiazepines, opioids), for example to reduce anxiety before the dental procedure;
• medicines for heart conditions 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).

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

Driving and operating machinery
If you experience adverse 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).

ARTIN contains sodium and sodium metabisulfite.

• Sodium: contains less than 1 mmol of sodium (23 mg) per 1.8 ml of solution, meaning it is essentially “sodium-free”.
• Sodium metabisulfite: may rarely cause severe allergic reactions and breathing difficulties (bronchospasm). If there is a risk of an allergic reaction, your dentist will choose a different medicine for anesthesia.

3. How to use ARTIN

Only physicians and dentists are qualified to use ARTIN.
The dentist will decide whether to use
ARTIN 40 mg/ml + 5 micrograms/ml or
ARTIN 40 mg/ml + 10 micrograms/ml
and will determine the appropriate dose based on your age, weight, general
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health status, and dental procedure.
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 ARTIN than you should
It is unlikely that you will be given an excessive amount of the injection; however, if you
start 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 shivering, 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 cessation of breathing, 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 may cause side effects, although not everyone experiences them.
While you are at the dental clinic, your dentist will carefully monitor the effects of ARTIN.
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 in 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 in 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 in 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 contraction
• 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 sense of well-being (euphoria)
• heart rate coordination problems (conduction disorders, atrioventricular block)
• increased blood flow to a body area, causing vascular congestion
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• swelling of the cheeks and localized swelling
• burning mouth syndrome
• redness of the skin (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 effect, including those not listed in this leaflet, talk to 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.
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5. How to store ARTIN

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 on the
carton, following "Exp". The expiry date refers to the last day of that month.
Store below 30°C. Do not freeze.
Keep cartridges in their outer packaging, tightly closed, to protect the medicine
from light. Do not use this medicine if you notice that the solution is cloudy or has changed
colour.
The 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 no longer used.
This will help protect the environment.

6. Package Contents and Other Information What ARTIN Contains

• The active substances are articaine hydrochloride and adrenaline tartrate. Each 1.8 ml cartridge of injectable solution
  ARTIN 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline
  contains 72 mg of articaine hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).
  1 ml of
  ARTIN 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 1.8 ml cartridge of injectable solution
ARTIN 40 mg/ml + 10 micrograms/ml injectable solution with adrenaline
contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as
adrenaline tartrate).
1 ml of
ARTIN 40 mg/ml + 10 micrograms/ml injectable solution 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), and water for injectable preparations.

Description of the appearance of ARTIN and contents of the package
Box containing 50 glass cartridges of 1.8 ml.
Box containing 100 glass cartridges of 1.8 ml.
Marketing Authorization Holder and Manufacturer
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OMNIA s.r.l., VIA F Del Nevo, 190 - San Michele Campagna, Fidenza (PR)
MANUFACTURER
Laboratorios INIBSA, S.A.
Ctra. Sabadell-Granollers Km. 14.5
Lliçà de Vall, Barcelona - Spain.
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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,
ARTIN 40 mg/ml + 5 micrograms/ml
is preferred.
For more complex procedures, such as those requiring pronounced hemostasis,
ARTIN 40 mg/ml + 10 micrograms/ml
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 weighing more than 70 kg.
Children (aged 4 to 11 years)
The safety of ARTIN 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 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 and patients with renal disease
Due to the lack of clinical data, particular precautions must 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 injection is necessary, the patient must be closely monitored for signs of relative overdose.
Patients with hepatic impairment
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Particular precautions must 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 plasma esterases by 90%. 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 must 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 equipment and drugs for resuscitation must be available to ensure immediate treatment of any respiratory or cardiovascular emergencies. The patient's level of consciousness must be monitored after each injection of local anesthetic.
When using ARTIN for infiltration or locoregional anesthesia, the injection must always be performed slowly and preceded by aspiration.
Special Warnings
Adrenaline reduces blood flow in the gums, which may cause local tissue necrosis.
Very rare cases of nerve injury and prolonged or irreversible 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 adrenaline and articaine levels in the systemic circulation. 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, before injecting the local anesthetic, aspiration must be performed to ensure that the needle has not entered a blood vessel. However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
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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 case of nerve injury, the neurotoxic effect may be worsened by the potential chemical neurotoxicity of articaine and the presence of adrenaline, since adrenaline may reduce perineural blood supply and impair local elimination of articaine.
Treatment of Overdose
Before administering regional anesthesia with local anesthetics, appropriate equipment and drugs for resuscitation must be available to ensure immediate treatment of any respiratory or cardiovascular emergencies.
The severity of overdose symptoms requires that the physician/dentist 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 the 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 respiratory/airway support and administration of anticonvulsant drugs.
Optimal oxygenation, ventilation, and circulatory support, along with treatment 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 weight.
In case of cardiac arrest, cardiopulmonary resuscitation must be started immediately.
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 draw up 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 medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
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