Citocartin 200

Package leaflet: Information for the user

CITOCARTIN 200, (40 mg + 0.005 mg)/ml, solution for injection
CITOCARTIN 100, (40 mg + 0.01 mg)/ml, solution for injection
Articaini hydrochloridum + Adrenalini tartras
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your dentist, doctor, or pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your dentist, doctor, or pharmacist. See section 4.

Table of contents

1. What Citocartin 200 / Citocartin 100 is and what it is used for
2. Important information before using Citocartin 200 / Citocartin 100
3. How to use Citocartin 200 / Citocartin 100
4. Possible side effects
5. How to store Citocartin 200 / Citocartin 100
6. Contents of the pack and other information

1. What Citocartin 200 / Citocartin 100 is and what it is used for

Citocartin 200 / Citocartin 100 is used for local anaesthesia of the oral cavity during dental procedures.
This medicine contains two active substances:

• Articaine, a local anaesthetic agent that prevents the sensation of pain, and
• Adrenaline, a vasoconstrictor that narrows blood vessels at the injection site, thereby prolonging the effect of articaine. It also reduces bleeding during the procedure.

Citocartin 200 or Citocartin 100 is administered by the dentist.
Citocartin 200 / Citocartin 100 is intended for children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure being performed, the dentist will decide which of the two medicines to use:

• Citocartin 200 is usually used for simple and short dental procedures.
• Citocartin 100 is more suitable for procedures that are longer or associated with potentially heavier bleeding.

2. Important information before using Citocartin 200 / Citocartin 100

When not to use Citocartin 200 / Citocartin 100 if the patient suffers from any of the following conditions:

• the patient is allergic to articaine or adrenaline, or to any of the other ingredients of this medicine (listed in section 6);
• the patient is allergic to other local anaesthetic agents;
• the patient has epilepsy that is not adequately controlled by medication.

Warnings and precautions
Before using Citocartin 200 / Citocartin 100, discuss with the dentist if the patient has any of the following conditions:

• severe heart rhythm disorders (e.g. second- or third-degree atrioventricular block);
• acute heart failure (acute weakening of the heart, e.g. sudden chest pain at rest or after myocardial infarction (i.e. heart attack));
• low blood pressure;
• abnormally rapid heartbeat;
• myocardial infarction within the last 3–6 months;
• the patient underwent coronary artery bypass grafting within the last 3 months;
• the patient is taking antihypertensive medicines called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of heart function (see section Citocartin 200 / Citocartin 100 and other medicines);
• very high blood pressure;
• the patient is concurrently taking certain medicines used to treat depression and Parkinson's disease (tricyclic antidepressants). These medicines enhance the effects of adrenaline;
• epilepsy;
• lack of a natural blood chemical called cholinesterase (plasma cholinesterase deficiency);
• kidney problems;
• severe liver disease;
• a condition called myasthenia, which causes muscle weakness;
• porphyria, which causes neurological complications or skin problems;
• the patient is using other local anaesthetic agents, medicines causing temporary loss of sensation (including inhaled anaesthetics such as halothane);
• the patient is taking antiplatelet or anticoagulant medicines to prevent narrowing or hardening of blood vessels in arms and legs;
• the patient is over 70 years of age;
• the patient has had or currently has heart disease;
• uncontrolled diabetes;
• severe hyperthyroidism (thyrotoxicosis);
• a tumour called pheochromocytoma;
• a condition called closed-angle glaucoma, which is an eye disease;
• inflammation or infection at the site of injection;
• reduced oxygen levels in body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disturbances due to excessive levels of acidic components in the blood (metabolic acidosis).

Citocartin 200 / Citocartin 100 and other medicines
Inform the dentist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take. It is especially important to inform the dentist if the patient is taking any of the following medicines:

• other local anaesthetic agents, medicines causing reversible loss of sensation (including inhaled anaesthetics such as halothane);
• sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• medicines acting on the heart and lowering blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used in the treatment of depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used in the treatment of Parkinson's disease (such as entacapone or tolcapone);
• MAO inhibitors used in the treatment of depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• medicines used to treat irregular heartbeat (e.g. digitalis, quinidine);
• medicines used to treat migraine attacks (e.g. methysergide or ergotamine);
• sympathomimetic vasoconstrictor medicines (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to raise blood pressure: if these have been used within the last 24 hours, planned dental treatment should be postponed;
• neuroleptic medicines (e.g. phenothiazines).

Citocartin 200 / Citocartin 100 and food
Avoid eating, including chewing gum, until normal sensation returns, due to the risk of biting the lip, cheek, or tongue, especially in children.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient may use Citocartin 200 / Citocartin 100 during pregnancy.
Breastfeeding may be resumed 5 hours after administration of the anaesthetic.
Fertility is not expected to be affected by doses used during dental procedures.

Driving and operating machinery
If adverse effects occur, such as dizziness, blurred vision or fatigue, the patient should not drive or operate machinery until normal well-being returns (usually within 30 minutes after the dental procedure).

Citocartin 200 / Citocartin 100 contains sodium and sodium metabisulphite.

• Sodium: less than 23 mg of sodium per dose, meaning the medicine is practically sodium-free.
• Sodium metabisulphite: in rare cases, may cause severe allergic reactions and breathing problems (bronchospasm). If there is a risk of an allergic reaction, the dentist will choose another anaesthetic medicine.

3. How to use Citocartin 200 / Citocartin 100

Only physicians or dentists who have received appropriate training should administer Citocartin 200 /
Citocartin 100.
The dentist will decide whether to use Citocartin 200 or Citocartin 100 and determine the appropriate
dose based on the patient's age, body weight, general health status, and dental procedure.
The lowest effective dose required to achieve adequate anaesthesia should be used.
This medicine is administered by slow injection into the oral cavity.
Administration of a higher than recommended dose of Citocartin 200 / Citocartin 100
It is unlikely that a patient would receive an overdose of this medicine, but if the patient feels unwell,
they should inform the dentist immediately. Symptoms of overdose may include severe weakness,
pallor, headache, restlessness or agitation, disorientation, loss of balance, involuntary tremor or
seizures, dilated pupils, blurred vision, difficulty focusing clearly on an object, speech disturbances,
dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid
breathing which may lead to temporary respiratory arrest, and ineffective heart contractions (known
as circulatory arrest).
If there are any further doubts regarding the use of this medicine, consult the dentist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
While the patient is in the dental office, they will be closely monitored by the dentist for the effects of the medicine Citocartin 200 / Citocartin 100.
Immediately inform the dentist, doctor, or pharmacist if the patient experiences
any of the following serious adverse reactions:

• swelling of the face, tongue, or throat, difficulty swallowing, urticaria, or breathing difficulties (angioedema)
• rash, itching, throat swelling, and breathing difficulties: these may be symptoms of an allergic reaction (hypersensitivity)
• combination of drooping eyelid and pupil constriction (Horner's syndrome). These adverse reactions may occur rarely (affecting up to 1 in 1,000 patients).

Other adverse reactions not listed above may also occur in some patients.
Common adverse reactions: may affect up to 1 in 10 patients:

• gingivitis
• neuropathic pain – caused by nerve damage
• numbness or reduced sensation to touch in the mouth and around the mouth
• metallic taste, taste disturbances, or loss of taste sensation
• heightened, unpleasant, or abnormal sensation to touch
• increased sensitivity to heat
• headache
• abnormally rapid heartbeat
• abnormally slow heartbeat
• low blood pressure
• swelling of the tongue, lips, and gums

Uncommon adverse reactions: may affect up to 1 in 100 patients:

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

Rare adverse reactions: may affect up to 1 in 1,000 patients:

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

Very rare adverse reactions: may affect up to 1 in 10,000 patients:

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

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

• extremely elevated mood (euphoria)
• disturbances in heart coordination (conduction disorders, atrioventricular block)
• increased blood flow to a body part, leading to vascular congestion
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• cheek swelling and local swelling
• burning mouth syndrome
• skin redness (erythema)
• abnormally excessive sweating
• exacerbation of neuromuscular symptoms of Kearns-Sayre syndrome
• sensation of heat or cold
• bruxism (teeth grinding).

Reporting of adverse reactions
If the patient experiences any adverse symptoms, including any adverse reactions not listed in this leaflet, inform the dentist, doctor, or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Citocartin 200 / Citocartin 100

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label, blister pack, and carton
after EXP. The expiry date refers to the last day of the specified month.
Store below 25°C.
Keep the units in the outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy or discoloured.
The units are intended for single use only. They should be used immediately after opening.
Any unused portion of the solution must be discarded.
Medicines must not be disposed of via sewage systems or household waste. Your dentist knows
how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Citocartin 200 / Citocartin 100 contains

• The active substances are articaine hydrochloride and adrenaline bitartrate.

Each 1.7 ml ampoule of Citocartin 200 injection solution contains 68 mg of articaine hydrochloride and 0.0085 milligrams of adrenaline (as adrenaline bitartrate).
1 ml of Citocartin 200 contains 40 mg of articaine hydrochloride and 0.005 milligrams of adrenaline (as adrenaline bitartrate).
Each 1.7 ml ampoule of Citocartin 100 injection solution contains 68 mg of articaine hydrochloride and 0.017 milligrams of adrenaline (as adrenaline bitartrate).
1 ml of Citocartin 100 contains 40 mg of articaine hydrochloride and 0.01 milligrams of adrenaline (as adrenaline bitartrate).

• Other ingredients: sodium chloride, sodium metabisulfite, and water for injections.

What Citocartin 200 / Citocartin 100 looks like and contents of the pack
Citocartin 200 / Citocartin 100 is a clear, colourless solution.
It is packaged in single-dose glass ampoules, sealed with an elastomeric closure consisting of a plunger on one side and a stopper (made of single- or double-layered rubber) secured with an aluminium cap on the other side, placed in aluminium/PVC or paper/PVC blisters within a cardboard box.
Pack containing 10 x 1.7 ml glass ampoules.
Pack containing 50 x 1.7 ml glass ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Molteni Dental s.r.l., Via Ilio Barontini 8,
Località Granatieri, 50018 Scandicci (Florence), Italy

Manufacturer
Laboratorios Normon S.A.,
Ronda de Valdecarrizo 6,
28760 Tres Cantos, Madrid,
Spain

For further information, please contact the Marketing Authorisation Holder's representative.
Molteni Stomat Sp. z o.o.,
30-733 Kraków, ul. Obrońców Modlina 3,
Tel. (12) 653 25 85; Fax. (12) 654 15 60

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (http://urpl.gov.pl/pl)

Information intended exclusively for medical professionals:

Dosage
For all patient populations, the lowest dose providing effective anesthesia should be used. The required dose must be determined individually.
For routine procedures in adults, one cartridge is usually administered, but effective anesthesia may be achieved with less than the content of one cartridge. For more extensive procedures, multiple cartridges may be necessary, without exceeding the maximum recommended dose; the decision is made by the dentist.
For most routine dental procedures, Citocartin 200, (40 mg + 0.005 mg)/ml, is preferred.
For more complex dental procedures, such as those requiring intense hemostasis, Citocartin 100, (40 mg + 0.01 mg)/ml, is preferred.

Concomitant use of sedatives to reduce patient anxiety:
In patients receiving sedative medication, the maximum safe dose of local anesthetic may be reduced due to additive central nervous system depressant effects.

Children and adolescents (aged 12 to 18 years):
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, and the absolute maximum dose of articaine must not exceed 500 mg. A maximum articaine dose of 500 mg corresponds to the dose for a healthy adult weighing over 70 kg.

Children (aged 4 to 11 years):
The safety of Citocartin has not been established in children under 4 years of age. No data are available. The amount of drug to be injected should be determined based on the child's age, body weight, and the extent of the procedure. The average effective dose of articaine is 2 mg/kg body weight for simple procedures and 4 mg/kg body weight for complex procedures. The smallest dose providing effective dental anesthesia should be used. In children aged 4 years and older (or with body weight ≥20 kg), the maximum dose of articaine is 7 mg/kg body weight, and the absolute maximum dose of articaine must not exceed 385 mg in a healthy child weighing 55 kg.

Special patient groups:
Elderly patients and patients with renal impairment:
Due to lack of clinical data, special caution should be exercised to administer the lowest dose providing effective anesthesia in elderly patients and in patients with renal impairment.
Elevated plasma concentrations of the product may occur in these patients, especially after repeated administration. If repeat injection of the medicinal product is necessary, the patient should be carefully monitored for signs of relative overdose.

Patients with hepatic impairment:
Special caution should be exercised to administer the lowest dose providing effective anesthesia in patients with hepatic impairment, particularly after repeated administration, even though 90% of articaine undergoes initial inactivation by nonspecific plasma esterases in tissues and blood.

Patients with plasma cholinesterase deficiency:
Elevated plasma concentrations of the product may occur in patients with plasma cholinesterase deficiency or in patients receiving acetylcholinesterase inhibitors, as the product is inactivated by plasma esterases in 90%. Therefore, the smallest dose providing effective anesthesia should be used.

Administration method
Infiltration and regional nerve block injections in the oral cavity.
Local anesthetics should be injected cautiously in the presence of inflammation and/or infection at the injection site. The injection rate should be very slow (1 ml/min).

Precautions prior to use or administration of the medicinal product:
This medicinal product should be used only by physicians or dentists who are adequately trained and familiar with the recognition and treatment of systemic toxic reactions, or under the supervision of such physicians. Before inducing local anesthesia with a local anesthetic agent, ensure that resuscitation equipment and medications are available to allow immediate treatment of any emergency involving the airway or cardiovascular system. After each injection of a local anesthetic agent, the patient's level of consciousness should be monitored.
When using Citocartin for infiltration or conduction anesthesia, the injection must always be performed slowly and with prior aspiration.

Special warnings
Adrenaline may impair blood flow in the gingiva, potentially leading to local tissue necrosis.
Very rare cases of prolonged or irreversible nerve damage and taste disturbances have been reported following mandibular conduction anesthesia.

Precautions for use
Risks associated with accidental intravascular injection:
Accidental intravascular injection may result in sudden high systemic concentrations of adrenaline and articaine. This may lead to severe adverse effects such as seizures, followed by central nervous system and cardiovascular and respiratory depression, coma, and progression to respiratory and cardiac arrest.
Therefore, prior to administering the local anesthetic, aspiration should 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.

Risks associated with intraneural injection:
Accidental intraneural injection may cause retrograde spread of the drug along the nerve.
To avoid intraneural injection and prevent nerve injury related to nerve block, the needle should always be gently withdrawn if the patient experiences an electric shock-like sensation during needle insertion or if the procedure is particularly painful. If nerve injury occurs, neurotoxic effects may be intensified due to the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may impair perineural blood flow and prevent local washout of articaine.

Treatment of overdose
Before inducing local anesthesia with a local anesthetic agent, ensure that resuscitation equipment and medications are available to allow immediate treatment of any airway or cardiovascular emergencies.
The severity of overdose symptoms should prompt physicians/dentists to initiate protocols ensuring timely airway protection and respiratory support.
After each injection of a local anesthetic agent, the patient's level of consciousness should be monitored.
In case of acute systemic toxic reaction, administration of the local anesthetic should be immediately discontinued. If necessary, the patient should be repositioned to the supine position.
Central nervous system symptoms (seizures, CNS depression) should be promptly treated with appropriate airway management, respiratory support, and administration of anticonvulsant medications.
Ensuring optimal oxygen delivery, respiratory and circulatory support, and treatment of acidosis may prevent cardiac arrest.
In case of circulatory depression (hypotension, bradycardia), consider appropriate treatment with intravenous fluids, vasoconstrictors, and/or inotropic agents. Pediatric doses should be adjusted according to age and body weight.
In case of cardiac arrest, immediate cardiopulmonary resuscitation should be initiated.

Special precautions for disposal and preparation of the medicinal product for use
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 fresh and sterile.
Cartridges are intended for single use only. If only part of the cartridge content is used, the remainder must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.