ARTICAINA KON ADRENALINA PIERREL 40 mg/ml + 10 МИКРОГРАММ/ml Injectable solution

Содержание инструкции

1. ARTICAINA CON ADRENALINA PIERREL
2. Articaine hydrochloride/ Adrenaline
   1. What is ARTICAINA CON ADRENALINA PIERREL and what is it used for
   2. What you need to know before using ARTICAINA WITH ADRENALINE PIERREL
   3. How to use ARTICAINA CON ADRENALINA PIERREL
   4. Possible side effects
   5. How to store ARTICAINA CON ADRENALINA PIERREL
   6. Package contents and other information

ARTICAINA CON ADRENALINA PIERREL

40 mg/ml + 5 micrograms/ml injectable solution
40 mg/ml + 10 micrograms/ml injectable solution

Articaine hydrochloride/ Adrenaline

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 any side effects occur, including those not listed in this leaflet, ask your dentist, doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ARTICAINA CON ADRENALINA PIERREL and what is it used for

ARTICAINA CON ADRENALINA PIERREL is used to numb (anaesthetize) the oral cavity during dental
procedures.
This medicine contains two active ingredients:

• Articaine, a local anesthetic that prevents pain
• Adrenaline, a vasoconstrictor that constricts blood vessels at the injection site, thus prolonging the effect of articaine. Furthermore, adrenaline reduces bleeding during surgical intervention.

ARTICAINA CON ADRENALINA PIERREL 40 mg/ml + 5 micrograms/ml or ARTICAINA CON
ADRENALINA PIERREL 40 mg/ml + 10 micrograms/ml injectable solution will be administered to you
by a dentist.
ARTICAINA CON ADRENALINA PIERREL 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 following medicines:

• ARTICAINA CON ADRENALINA PIERREL 40 mg/ml + 5 micrograms/ml injectable solution is generally used for simple and short dental procedures;
• ARTICAINA CON ADRENALINA PIERREL 40 mg/ml + 10 micrograms/ml injectable solution is more suitable for longer procedures or those that may involve significant bleeding;

2. What you need to know before using ARTICAINA WITH ADRENALINE PIERREL

Do not use ARTICAINA WITH ADRENALINE PIERREL if you suffer from any of the following conditions:

• allergy to articaine or adrenaline or to any of the other ingredients of these medicines (listed in section 6);
• allergy to other local anaesthetics;
• epilepsy that is not adequately controlled with pharmacological treatment.

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Warnings and precautions
Consult your dentist before using ARTICAINA WITH ADRENALINE PIERRELif you suffer from any
condition among the following:

• severe heart rhythm disorders (e.g. second and third degree atrioventricular block);
• acute heart failure (acute weakness of the heart muscle, e.g. sudden chest pain at rest or after a myocardial infarction (e.g. heart attack));
• low blood pressure;
• abnormally rapid heart rate;
• heart attack in the last 3-6 months;
• coronary artery bypass surgery in the last 3 months;
• taking medicines for blood pressure called beta-blockers, such as propranolol. There is a risk of a hypertensive crisis (very high blood pressure) or a severe slowing of the heart rate (see section Other medicines);
• very high blood pressure;
• taking medicines at the same time for the treatment of depression and Parkinson's disease (tricyclic antidepressants). These medicines can intensify the effects of adrenaline;
• epilepsy;
• deficiency of a natural 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 anaesthetics, medicines that cause a reversible loss of sensitivity (including volatile anaesthetics such as halothane);
• taking medicines, called antiplatelet agents or anticoagulants, to prevent the 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 (hyperthyroidism);
• a tumour called pheochromocytoma;
• a disease called closed-angle glaucoma affecting the eyes;
• inflammation or infection in the area where the injection is to be given;
• reduced amounts of oxygen in body tissues (hypoxia), high levels of potassium in the blood (hyperpotassaemia) and metabolic disorders resulting from an excess of acid in the blood (metabolic acidosis).

Other medicines and ARTICAINA WITH ADRENALINE PIERREL
Tell your dentist if you are taking, have recently taken or might take any other
medicine.
It is particularly important to tell your dentist if you are taking any of the following medicines:

• other local anaesthetics, medicines that cause a reversible loss of sensitivity (including volatile anaesthetics such as halothane);
• sedatives (e.g. benzodiazepines, opioids), for example to reduce anxiety before dental procedure;
• medicines for the heart and blood pressure (e.g. guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used for the treatment of depression (e.g. amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline);
• COMT inhibitors used for the treatment of Parkinson's disease (e.g. entacapone or tolcapone);
• MAO inhibitors used for the treatment of depressive or anxiety disorders (e.g. moclobemide, phenelzine, tranylcypromine, linezolid);
• medicines used for irregular heartbeats (e.g. digitalis, quinidine);
• medicines used for migraine attacks (e.g. methysergide or ergotamine); 2/9
• sympathomimetic vasopressors (e.g. cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline); used to increase blood pressure: if used within the 24 hours prior, the scheduled dental treatment should be postponed;
• neuroleptic drugs (e.g. phenothiazines).

ARTICAINA WITH ADRENALINE PIERREL with food
Avoid eating or chewing gum until normal sensitivity 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 or are planning a pregnancy, or if you are breastfeeding,
ask your dentist or doctor for advice before using this medicine.
Your dentist or doctor will decide whether you can take ARTICAINA WITH ADRENALINE PIERREL
during pregnancy.
Breastfeeding can be resumed 5 hours after anaesthesia.
No adverse effects on fertility are expected at the doses used for dental procedures.

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

ARTICAINA WITH ADRENALINE PIERREL contains sodium chloride and sodium metabisulfite

• Sodium: less than 23 mg per cartridge; this means it is practically “sodium-free”.
• Sodium metabisulfite: rarely may 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 anaesthesia.

3. How to use ARTICAINA CON ADRENALINA PIERREL

Only doctors and dentists are competent in the use of ARTICAINA CON ADRENALINA PIERREL.
The dentist will choose whether to use ARTICAINA CON ADRENALINA PIERREL40 mg/ml + 10
micrograms/ml or ARTICAINA CON ADRENALINA PIERREL40 mg/ml + 5 micrograms/ml and
will determine the appropriate dose considering their age, weight, general health status
and the dental procedure.
The lowest effective dose capable of inducing anesthesia must be used.
This medicine is administered by slow injection into the oral cavity.

If you are given more ARTICAINA CON ADRENALINA PIERREL than you should
It is unlikely that you will be given an excessive amount of injection; however, if you should begin to
feel unwell, inform your dentist. Symptoms of overdose include severe weakness, paleness
of the skin, headache, agitation or restlessness, disorientation, loss of balance, tremor
involuntary or chills, dilation of the pupils, blurred vision, problems focusing objects,
speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormal
breathing slowed or accelerated which may cause temporary cessation of breathing, 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.
During your stay in the dental practice, the dentist will carefully monitor the effects of

ARTICAINA CON ADRENALINA PIERREL.
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Immediately inform the dentist, doctor or pharmacist if you experience any of the following serious side effects:

• swelling of the face, tongue or throat, difficulty swallowing, hives or difficulty breathing (angioedema);
• skin rash, itching, swelling of the throat and difficulty breathing: these could be symptoms of an allergic reaction (hypersensitivity);
• a combination of drooping eyelid and constricted pupil (Horner's syndrome). These side effects 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 affect up to 1 in 10 people):

• inflammation of the gums;
• neuropathic pain: pain due to nerve damage;
• numbness or decreased sensitivity 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;
• pain in the neck or 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 constricted pupil (Horner's syndrome);
• dislocation with recession of the eyeball within the orbit due to changes in the volume of the orbit (enophthalmos);
• ringing in the ears, hypersensitivity of hearing;
• palpitations;
• hot flushes;
• wheezing (bronchospasm), asthma;
• difficulty breathing;
• 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 sensitivity, widespread numbness and loss of taste;

Not known: (frequency cannot be estimated from the available data)
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• excessive good mood (euphoria);
• problems with the coordination of the heartbeat (conduction disturbances, atrioventricular block);
• increased amount of blood in a part of the body, resulting in congestion of blood vessels;
• dilation or constriction of blood vessels;
• hoarseness;
• difficulty swallowing;
• swelling of the cheeks and localized;
• burning mouth syndrome;
• redness of the skin (erythema);
• abnormally increased sweating;
• worsening of neuromuscular symptoms in Kearns-Sayre syndrome;
• feeling of warmth or cold;
• jaw locking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
dentist, doctor or pharmacist. You can also report side effects directly through
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 ARTICAINA CON ADRENALINA PIERREL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“Expiry.”. The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25 °C.
Do not use this medicine if you notice that the solution is cloudy or changes colour.
The cartridges are for single use. Use immediately after opening the cartridge. Discard any unused solution.
Do not dispose of any medicine in drain water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARTICAINA CON ADRENALINA PIERREL contains

• The active ingredients are: articaine hydrochloride and adrenaline tartrate
• Each ml of Articaina con adrenalina Pierrel 40 mg/ml + 10 micrograms/ml injectable solution contains 40.00 mg of articaine hydrochloride and 18.20 micrograms of adrenaline tartrate (equivalent to 10 micrograms of adrenaline)
• Each ml of Articaina con adrenalina Pierrel 40 mg/ml + 5 micrograms/ml injectable solution contains 40.00 mg of articaine hydrochloride and 9.10 micrograms of adrenaline tartrate (equivalent to 5 micrograms of adrenaline).
• The other ingredients are: sodium chloride, sodium metabisulfite, water for injections.

Description of the appearance of ARTICAINA CON ADRENALINA PIERREL and contents of the pack
ARTICAINA CON ADRENALINA PIERREL is a clear and colorless solution.
It is packaged in single-use glass cartridges with high hydrolytic resistance (Type I) with a bromobutyl rubber plunger.
Closure consisting of a rubber gasket and an aluminum ring.
The cartridge is available in the following packaging:
Cardboard box containing No. 100 cartridges of 1.8 ml.
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.
Or
Cardboard box containing No. 50 cartridges of 1.8 ml.

Not all pack sizes may be marketed
Marketing Authorization Holder
Pierrel Sp.A.
Strada Statale Appia 7 bis, 46/48 – 81043 Capua (CE)

Manufacturer
Pierrel S.p.A.
Strada Statale Appia 7 bis , 46/48 – 81043 Capua (CE)
( Bulk solution production, primary and secondary packaging, batch control and release).

The following information is intended exclusively for doctors or healthcare professionals
Dosage and Administration
For all populations, the lowest effective dose capable of inducing anesthesia should be used. The necessary dosage must be determined on an individual basis.
For a routine procedure, the normal dose for adult patients is 1 cartridge, but the content of 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 maximum recommended dose.
For most routine dental procedures, it is preferable to use ARTICAINA CON ADRENALINA PIERREL 40 mg/ml + 5 micrograms/ml injectable solution.
For more complex procedures, for example, those requiring pronounced hemostasis, it is preferable to use ARTICAINA CON ADRENALINA PIERREL 40 mg/ml + 10 micrograms/ml injectable solution.

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 effect of central nervous system depression.

Adults and adolescents (aged between 12 and 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 refers to a healthy adult with a body weight greater than 70 kg.

Children (aged between 4 and 11 years):
The safety of ARTICAINA CON ADRENALINA PIERREL in children under 4 years of age has not been established. No data are available.
The amount to be injected must be established based on the child's age and weight, as well as the extent of the procedure. The average effective dose is 2 mg/kg and 4 mg/kg respectively for simple and complex procedures. The lowest effective dose capable of inducing anesthesia should be used. In children 4 years of age (or at least 20 kg (44 pounds) of body weight) and older, the maximum dose of articaine is only 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 impairment
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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 impairment.
Elevated plasma levels of the product may occur in these patients, especially after repeated use. If repeated injection is necessary, the patient should be carefully monitored to identify any signs of relative overdose.
Patients with hepatic impairment
Particular precautions must be taken to administer the lowest effective dose capable of inducing anesthesia in patients with hepatic impairment, especially after repeated use, although 90% of articaine is inactivated by nonspecific plasma esterases in the tissues and blood.
Patients with plasma cholinesterase deficiency
Elevated plasma levels of the product may occur in patients with cholinesterase deficiency or undergoing treatment with acetylcholinesterase inhibitors, as the product is 90% inactivated by plasma esterases. Therefore, the lowest effective dose capable of inducing anesthesia should be used.

Route 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 medicine
This medicine must be used only by doctors 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, it is necessary to ensure the availability of appropriate equipment and drugs for resuscitation, to ensure the immediate treatment of any respiratory and cardiovascular emergencies. The patient's state of consciousness must be monitored after each injection of local anesthetic.
When using ARTICAINA CON ADRENALINA PIERREL for anesthesia by infiltration or loco-regional block, the injection must always be performed slowly and after aspiration.

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

Precautions for use

Risks associated with accidental intravascular injection
Accidental intravascular injection can 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, which evolve into respiratory and circulatory arrest.
Therefore, to ensure that the needle does not penetrate a blood vessel during injection, it is necessary to aspirate 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 can cause the drug to rise along the nerve.
To avoid intraneural injection and prevent nerve injury related to nerve blocks, the needle should be slightly retracted if the patient feels a sensation of electric shock during injection or if the injection is particularly painful. In case of nerve injury, the neurotoxic effect may be aggravated by the potential neurotoxicity of articaine and the presence of adrenaline, as this may reduce perineural blood supply and prevent local elimination of articaine.
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Overdose treatment
Before administering regional anesthesia with local anesthetics, it is necessary to ensure the availability of equipment and drugs for resuscitation, to ensure the immediate treatment of any respiratory and cardiovascular emergencies.
The severity of the overdose symptoms should cause the doctor/dentist to implement protocols that provide for the timely protection of the airways and assisted ventilation. The patient's state 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 the CNS (seizures, CNS depression) should be treated immediately with appropriate respiratory/airway support and the administration of anticonvulsant drugs.
Optimal oxygenation, ventilation and circulatory support, together with the treatment of acidosis, can prevent cardiac arrest.
In case of cardiovascular depression (hypotension, bradycardia), it is appropriate to consider the opportunity to carry out appropriate treatment with intravenous fluids, vasopressors and/or inotropes. In children, the dose administered must be adjusted to age and weight.
In case of cardiac arrest, cardiopulmonary resuscitation must be started immediately.
Special precautions for disposal and handling
This medicine should not be used if the solution is cloudy or changes color. To avoid the risk of infection (e.g. transmission of hepatitis), the syringes and needles used to draw the solution must always be new and sterile.
The cartridges are for single use. If a cartridge is only partially used, discard the remaining solution. Unused medicine and waste derived from such medicine must be disposed of in accordance with local regulations.

For further information, see the Summary of Product Characteristics.
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