CITOCARTIN 40 mg /5 Mcg/Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. CITOCARTIN 200, (40 mg + 0.005 mg)/ml, solution for injection
3. CITOCARTIN 100, (40 mg + 0.01 mg)/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Citocartin 200 / Citocartin 100 and what is it used for
5. Important information before using Citocartin 200 / Citocartin 100
   1. When not to use Citocartin 200 / Citocartin 100, if the patient suffers from any of the following diseases:
   2. Warnings and precautions
   3. Citocartin 200 / Citocartin 100 and other medicines
   4. Citocartin 200 / Citocartin 100 with food
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Citocartin 200 / Citocartin 100 contains sodium and sodium metabisulfite.
6. How to use Citocartin 200 / Citocartin 100
   1. Using a higher dose of Citocartin 200 / Citocartin 100 than recommended
7. Possible side effects
   1. The patient should immediately inform their dentist, doctor, or pharmacist if they experience any of the following serious side effects:
   2. Common side effects: may occur in up to 1 in 10 patients:
   3. Uncommon side effects: may occur in up to 1 in 100 patients:
   4. Rare side effects: may occur in up to 1 in 1,000 patients:
   5. Very rare side effects: may occur in up to 1 in 10,000 patients:
   6. Frequency not known: frequency cannot be estimated from the available data
   7. Reporting side effects
8. How to store Citocartin 200 / Citocartin 100
9. Contents of the pack and other information
   1. What Citocartin 200 / Citocartin 100 contains
   2. What Citocartin 200 / Citocartin 100 looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Other sources of information
   6. Dosage
   7. Method of administration
   8. Special warnings
   9. Precautions for use
   10. Treatment of overdose
   11. Special precautions for disposal and preparation of the medicinal product for use

Leaflet attached to the packaging: 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

Articaine hydrochloride + Adrenaline tartrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a dentist, doctor, or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their dentist, doctor, or pharmacist. See section 4.

Table of contents of the leaflet

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

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

• articaine, a local anesthetic that prevents 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 to the patient by a dentist.
Citocartin 200 / Citocartin 100 is intended for children over 4 years old (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure, 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 take longer or are associated with potentially more severe 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 diseases:

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

Warnings and precautions

Before starting treatment with Citocartin 200 / Citocartin 100, the patient should discuss with their dentist if they have any of the following conditions:

• severe heart rhythm disorders (e.g., atrioventricular block II and III);
• acute heart failure (sudden heart weakness, e.g., unexpected chest pain at rest or after a heart attack);
• low blood pressure;
• abnormally fast heart rate;
• heart attack within the last 3-6 months;
• the patient has undergone coronary artery bypass grafting within the last 3 months;
• the patient is taking antihypertensive medications called beta-adrenergic blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe bradycardia (slow heart rate) (see section Citocartin 200 / Citocartin 100 and other medicines);
• very high blood pressure;
• the patient is taking certain medications for depression and Parkinson's disease (tricyclic antidepressants). These medications enhance the effect of adrenaline;
• epilepsy;
• the patient has a lack of a natural chemical substance called cholinesterase in the blood (cholinesterase deficiency);
• kidney problems;
• severe liver disease;
• a disease called myasthenia, which causes muscle weakness;
• porphyria, which can cause neurological complications or skin problems;
• the patient is using other local anesthetics, medications that cause temporary loss of sensation (including inhalation anesthetics, such as halothane);
• the patient is taking antiplatelet or anticoagulant medications to prevent narrowing or hardening of blood vessels in the hands and feet;
• the patient is over 70 years old;
• the patient has had or currently has heart disease;
• uncontrolled diabetes;
• severe hyperthyroidism (thyrotoxicosis);
• a tumor called pheochromocytoma;
• a disease called glaucoma, which is an eye disease;
• inflammation or infection at the injection site;
• low oxygen levels in body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disorders due to excessive acid components in the blood (metabolic acidosis).

Citocartin 200 / Citocartin 100 and other medicines

The patient should inform their dentist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
It is especially important to inform the dentist if the patient is taking any of the following medications:

• other local anesthetics, medications that cause reversible loss of sensation (including inhalation anesthetics, such as halothane);
• sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• medications that affect the heart and lower blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used to treat Parkinson's disease (such as entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• medications used to treat irregular heartbeat (such as digitalis, quinidine);
• medications used to treat migraine attacks (such as methysergide or ergotamine);
• sympathomimetic vasoconstrictor medications (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the last 24 hours, planned dental treatment should be postponed;
• neuroleptic medications (such as phenothiazines).

Citocartin 200 / Citocartin 100 with food

Food, including chewing gum, should be avoided 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 or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient can use Citocartin 200 / Citocartin 100 during pregnancy.
Breastfeeding can be resumed 5 hours after anesthesia administration.
No effect on fertility is expected with doses used in dental procedures.

Driving and using machines

In case of dizziness, blurred vision, or fatigue, the patient should not drive or operate machinery until they feel normal again (usually within 30 minutes after the dental procedure).

Citocartin 200 / Citocartin 100 contains sodium and sodium metabisulfite.

• Sodium: less than 23 mg of sodium per cartridge, which means the medicine is essentially sodium-free.
• Sodium metabisulfite: in rare cases, may cause severe allergic reactions and respiratory disorders (bronchospasm). If there is a risk of an allergic reaction, the dentist will choose a different anesthetic.

3. How to use Citocartin 200 / Citocartin 100

Only doctors or dentists with proper training should use Citocartin 200 / Citocartin 100.
The dentist will decide whether to use Citocartin 200 or Citocartin 100 and determine the appropriate dose, taking into account the patient's age, body weight, overall health, and dental procedure.
The smallest dose that allows for effective anesthesia should be used.
This medicine is administered by slow injection into the oral cavity.

Using a higher dose of Citocartin 200 / Citocartin 100 than recommended

It is unlikely that the patient will receive too much of this medicine, but if they feel unwell, they should inform their dentist. Symptoms of overdose include severe weakness, paleness, headache, feeling of excitement or overexcitement, feeling of disorientation, loss of balance, involuntary trembling or convulsions, pupil dilation, blurred vision, problems with focusing eyes on an object, speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or fast breathing, which can lead to temporary cessation of breathing, lack of effective heart contractions (called cardiac arrest).
In case of any further doubts about using the medicine, the patient should consult their dentist.

4. Possible side effects

Like all medicines, Citocartin 200 / Citocartin 100 can cause side effects, although not everybody gets them.
During the patient's stay in the dentist's office, the patient will be closely monitored by the dentist for the effect of Citocartin 200 / Citocartin 100.

The patient should immediately inform their dentist, doctor, or pharmacist if they experience any of the following serious side effects:

• swelling of the face, tongue, or throat, difficulty swallowing, hives, or breathing problems (angioedema)
• rash, itching, swelling of the throat, and breathing problems: these may be symptoms of an allergic reaction (hypersensitivity)
• drooping of the eyelid and constriction of the pupil (Horner's syndrome). These side effects can occur rarely (may affect up to 1 in 1,000 patients).

Other side effects, not listed above, may also occur in some patients.

Common side effects: may occur in up to 1 in 10 patients:

• gingivitis
• neuropathic pain - caused by nerve damage
• numbness or weakness of sensation in the mouth and around the mouth
• metallic taste, taste disorders, or loss of taste
• intensified, unpleasant, or abnormal sensation of touch
• increased sensitivity to heat
• headache
• abnormally fast heart rate
• abnormally slow heart rate
• low blood pressure
• swelling of the tongue, lips, and gums

Uncommon side effects: may occur in 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 side effects: may occur in up to 1 in 1,000 patients:

• nervousness, anxiety
• facial nerve disorders (facial nerve palsy)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness
• drooping of the eyelid and constriction of the pupil (Horner's syndrome)
• displacement with lowering of the eyeball into the orbit (enophthalmos)
• ringing in the ears, hypersensitivity to sound
• palpitations
• hot flashes
• wheezing (bronchospasm), asthma
• breathing problems
• scaling and ulceration of the gums
• scaling at the injection site
• hives
• minor muscle spasms, involuntary muscle spasms,
• fatigue, weakness
• chills

Very rare side effects: may occur in 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 good mood (euphoria)
• heart rhythm disorders (conduction disorders, atrioventricular block)
• increased blood flow to a part of the body, leading to congestion in blood vessels
• vasodilation or vasoconstriction
• hoarseness
• swallowing difficulties
• swelling of the cheeks and local swelling
• burning mouth syndrome
• redness of the skin (flushing)
• abnormally increased sweating
• exacerbation of neuromuscular symptoms of Kearns-Sayre syndrome
• feeling of heat or cold
• bruxism.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their dentist, doctor, or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Citocartin 200 / Citocartin 100

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the label, blister, and carton after the expiry date (EXP). The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Cartridges should be stored in the outer packaging to protect from light.
Do not use this medicine if the solution is cloudy or discolored.
Cartridges are for single use. Use immediately after opening the cartridge.
Unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The dentist knows how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Citocartin 200 / Citocartin 100 contains

• The active substances of the medicine are articaine hydrochloride and adrenaline tartrate.

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

• Other ingredients are sodium chloride, sodium metabisulfite, and water for injection.

What Citocartin 200 / Citocartin 100 looks like and contents of the pack

Citocartin 200 / Citocartin 100 is a clear and colorless solution.
It is packaged in single-dose glass cartridges with a rubber stopper at one end and a rubber cap at the other end, placed in aluminum/PVC or paper/PVC blisters in a cardboard box.
A box containing 10 x 1.7 ml glass cartridges.
A box containing 50 x 1.7 ml glass cartridges.
Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information, please contact the representative of the marketing authorization holder.
Molteni Stomat Sp. z o.o.,
30-733, Kraków, ul. Obrońców Modlina 3,
Tel. (12) 653 25 85; Fax. (12) 654 15 60
Date of last revision of the leaflet:03/02/2023

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (http://urpl.gov.pl/pl)
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Information intended only for healthcare professionals:

Dosage

In all populations, the smallest dose should be used that allows for effective anesthesia. The required dose should be determined individually.
For routine procedures in adults, usually 1 cartridge is used, but less than the contents of one cartridge may be sufficient to achieve effective anesthesia. During more extensive procedures, it may be necessary to administer more cartridges, 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.
In more complex dental procedures, such as those requiring intensive hemostasis, Citocartin 100, (40 mg + 0.01 mg)/ml is preferred.
Concomitant use of sedatives to reduce patient anxiety:
In patients who have been given a sedative, the maximum safe dose of local anesthetic may be reduced due to the additive effect of these medications causing central nervous system depression.
Children and adolescents (12-18 years old)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, with a maximum dose of articaine of 500 mg. The maximum dose of articaine of 500 mg corresponds to a dose for a healthy adult with a body weight of over 70 kg.
Children (4-11 years old)
The safety of Citocartin in children under 4 years old has not been established. There are no available data. The amount of medicine to be injected should be determined based on the child's age and body weight, as well as the scope of the procedure. The average effective dose of articaine is 2 mg/kg body weight and 4 mg/kg body weight for simple and complex procedures, respectively. The smallest dose that allows for effective dental anesthesia should be used. In children over 4 years old (or over 20 kg body weight), the maximum dose of articaine is 7 mg/kg body weight, with a maximum dose of 385 mg of articaine for a healthy child with a body weight of 55 kg.
Special patient groups
Elderly patients and patients with kidney disorders:
Due to the lack of clinical data, special precautions should be taken to administer the smallest dose that allows for effective anesthesia in elderly patients and patients with kidney disorders.
In the serum of these patients, increased levels of the product may occur, especially after repeated administration. If it is necessary to repeat the administration of the medicinal product, the patient should be closely monitored to recognize any signs of relative overdose of the product.
Patients with liver function disorders:
Special precautions should be taken to administer the smallest dose that allows for effective anesthesia in patients with liver function disorders, especially after repeated administration, although 90% of articaine undergoes first-pass inactivation by non-specific esterases in tissues and blood.
Patients with cholinesterase deficiency:
Patients with cholinesterase deficiency or those treated with acetylcholinesterase inhibitors may have increased levels of the product in the serum, as the product is inactivated by 90% by serum esterases. Therefore, the smallest dose that allows for effective anesthesia should be used.

Method of administration

Infiltration injection and perineural injection in the oral cavity.
Local anesthetics should be injected cautiously in the presence of inflammation and/or infection at the injection site. The rate of injection should be very slow (1 ml/min).
Precautions to be taken before using or administering the medicinal product
This medicinal product should only be used by doctors or dentists with sufficient training and familiarization with the diagnosis and treatment of systemic toxic effects, or under their supervision. Before inducing local anesthesia with a local anesthetic, it should be ensured that appropriate resuscitation equipment and medications are available to immediately treat any emergency situations related to the respiratory and cardiovascular systems. After each injection of a local anesthetic, the patient's level of consciousness should be monitored.
When using Citocartin for infiltration or conduction anesthesia, the injection should always be performed slowly and with prior aspiration.

Special warnings

Adrenaline disrupts blood flow in the gums, which can lead to local tissue necrosis.
After nerve block anesthesia of the mandible, very rare cases of prolonged or irreversible nerve damage and loss of taste have been reported.

Precautions for use

Risks associated with accidental intravascular injection:
Accidental intravascular injection can cause sudden high levels of adrenaline and articaine in the systemic circulation. This can be associated with severe side effects, such as convulsions, followed by central nervous system and cardiovascular depression, and coma, progressing to respiratory and cardiac arrest.
To ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before administering the medicinal product. However, the absence of blood in the syringe does not guarantee that the injection will not be made into a blood vessel.
Risks associated with injection into a nerve:
Accidental injection into a nerve can cause retrograde spread of the medicine along the nerve.
To avoid injection into a nerve and prevent nerve damage associated with its blockade, the needle should always be carefully withdrawn if the patient experiences a sensation similar to an electric shock during insertion or if the insertion is particularly painful. If nerve damage occurs, neurotoxic effects may be exacerbated due to the potential neurotoxicity of articaine and the presence of adrenaline, as it may impair perineural blood flow and prevent local washing out of articaine.

Treatment of overdose

Before inducing local anesthesia with a local anesthetic, it should be ensured that resuscitation equipment and medications are available to immediately treat any emergency situations related to the respiratory and cardiovascular systems.
The severity of overdose symptoms should prompt doctors/dentists to implement protocols that provide for securing the airway and ensuring respiratory support in a timely manner.
After each injection of a local anesthetic, the patient's level of consciousness should be monitored.
In case of acute systemic toxic effects, the injection of the local anesthetic should be stopped immediately. If necessary, the patient's position should be changed to a supine position.
Symptoms from the central nervous system (convulsions, central nervous system depression) should be treated immediately with appropriate airway management and respiratory support, as well as the administration of anticonvulsant medications.
Ensuring optimal oxygen supply and supporting respiration and circulation, as well as treating acidosis, can prevent cardiac arrest.
In case of cardiovascular depression (hypotension, bradycardia), the use of appropriate treatment with intravenous fluids, vasoconstrictors, and/or inotropic agents should be considered. Children should be given doses appropriate for their age and body weight.
In case of cardiac arrest, cardiopulmonary resuscitation should be started immediately.

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 for single use. If only part of the contents has been used, the remainder should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.