Xilodont 2%

2. Important information before using Xylodont

When not to use Xylodont:

• if the patient is allergic to lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6). The use of a medicine containing a vasoconstrictor agent is contraindicated in patients with severe heart disease and peripheral vascular disease, hypertension, migraine, hyperthyroidism, diabetes, prostatic hyperplasia, glaucoma, and nephropathy.

Warnings and precautions

Rare cases of death have been reported in patients who had not previously been diagnosed with hypersensitivity.
Xylodont with adrenaline contains sodium metabisulfite.
This substance can cause allergic reactions and severe asthma attacks in sensitive individuals.
The efficacy and safety of lidocaine in dentistry depend on the proper dosage and administration of the medicine, as well as the observance of appropriate precautions.
Before starting to use Xylodont, the patient should discuss it with their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should consult their doctor before using this medicine.
Xylodont should not be used during pregnancy.

Driving and using machines

Xylodont has a minor influence on the ability to drive and use machines.
The doctor should decide whether the patient can drive or use machines after administration of the medicine.

Xylodont and other medicines

Preparations containing adrenaline should be used with caution in patients treated with MAO inhibitors and tricyclic antidepressants (used in psychiatry).
In each case, the lowest doses and concentrations necessary to achieve the desired effect should be used. The patient must be under close supervision, and the administration of the medicine should be stopped immediately after the occurrence of the first disturbing symptom (e.g., disorders from the sensory organs).
Solutions containing adrenaline may exhibit clinically significant interactions with MAO inhibitors and tricyclic antidepressants (severe hypertension), with phenothiazine or butyrophenone derivatives (possible reversal of the adrenaline effect increasing blood pressure).
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

3. How to use Xylodont

1 to 2 ml or more, depending on the procedure, infiltratively or as a peripheral nerve block. The anesthetic solution should be injected in small doses at a rate of about 1 ml/min, after prior aspiration.
In a healthy adultwho has not received sedatives, the maximum dose administered either as a single dose or in several consecutive injections over a period not exceeding 90 minutes is 7 mg of lidocaine hydrochloride per kilogram of body weight, up to a total dose not exceeding 550 mg of lidocaine hydrochloride, and 0.2 mg of adrenaline. Maximum dose: 1000 mg of lidocaine per 24 hours.
In children, the administered doses should be reduced depending on body weight and age.
If the patient feels that the effect of Xylodont is too strong or too weak, they should inform their doctor.

Using a higher dose of Xylodont than recommended

Overdose of the anesthetic should be avoided, and never administer two maximum doses consecutively if the interval between them is less than 24 hours.
Lower concentrations and doses should be used, which will allow the desired anesthetic effect to be achieved.
The following toxic effects have been reported due to overdose:

• central nervous system stimulation with excitement, tremors, disorientation, dizziness, dilated pupils, accelerated metabolism, and elevated body temperature;
• after very large doses: jaw contraction and convulsions.

Procedure
After the occurrence of the first disturbing symptom, the administration of the medicine should be stopped. The patient should be placed in a horizontal position and ensured to breathe freely; if not, oxygen should be administered, and in the case of apnea, artificial respiration should be used.
The use of analeptics acting on the prolonged medulla should be avoided, so as not to worsen the patient's condition by increasing oxygen consumption.
Convulsions can be controlled by administering diazepam in doses of 10 to 20 mg intravenously.
Barbiturates are not recommended, as they may exacerbate depression of the prolonged medulla.
Improvement of the cardiovascular system can be achieved by intravenous administration of glucocorticoids. Additionally, diluted solutions of agents stimulating alpha and beta receptors with vasoconstrictor effects (e.g., mefentermine, metaraminol, etc.) or atropine sulfate can be used.
Always have a suitable set of equipment for immediate assistance and properly trained personnel available.
In several cases, after the use of local anesthetics, without individual hypersensitivity in the history, the occurrence of severe complications, even with a tragic course, has been reported.
Xylodont with adrenaline contains sodium metabisulfite; this compound can cause an allergic reaction in sensitive individuals, especially those with asthma.

4. Possible side effects

Like all medicines, Xylodont can cause side effects, although not everybody gets them.
Side effects that may occur during the use of lidocaine are similar to those observed during the use of other local anesthetics of amide structure.
These effects depend on the dose and may be caused by high concentrations of the medicine in the blood, resulting from overdose, rapid absorption, or accidental injection into a vessel, or may be caused by hypersensitivity, idiosyncrasy, or reduced tolerance on the part of the patient.
The following side effects have been reported:
Nervous system disorders:
Central nervous system stimulation with excitement, tremors, disorientation, dizziness, dilated pupils, accelerated metabolism, and elevated body temperature. After very large doses: jaw contraction and convulsions.
Vascular disorders:
Vasodilation, hypertension.
Cardiac disorders:
Arrhythmias, bradycardia.
Immune system disorders:
Allergic reactions (in the most severe cases, anaphylactic shock).
Allergic reactions to lidocaine are very rare (<1>Respiratory, thoracic, and mediastinal disorders:
Accelerated breathing, bronchodilation.
Gastrointestinal disorders:
Nausea, vomiting.
Skin and subcutaneous tissue disorders:
Skin changes, urticaria, edema, sweating.
The vasoconstrictor agent may cause the following reactions, especially in patients with cardiovascular disease: anxiety, sweating, respiratory disorders, arrhythmias, hypertension (which may be dangerous in patients with fixed hypertension and in patients with hyperthyroidism), severe headache, photophobia, costochondritis, vomiting.
If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309. Website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information on the safety of the medicine can be collected.

5. How to store Xylodont

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.

6. Package contents and other information

What Xylodont contains
XYLODONT 2%
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum).
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini
hydrochloridum).
XYLODONT 2% with adrenaline 1:100 000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.01 mg of adrenaline in the form of adrenaline tartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini
hydrochloridum) and 0.018 mg of adrenaline in the form of adrenaline tartrate.
XYLODONT 2% with adrenaline 1:80 000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.0125 mg of adrenaline in the form of adrenaline tartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini
hydrochloridum) and 0.0225 mg of adrenaline in the form of adrenaline tartrate.
XYLODONT 2% with adrenaline 1:50 000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.02 mg of adrenaline in the form of adrenaline tartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini
hydrochloridum) and 0.036 mg of adrenaline in the form of adrenaline tartrate.
Other ingredients:Xylodont 2% contains auxiliary substances: sodium chloride and water for injections, while Xylodont 2% with adrenaline also contains sodium metabisulfite.

What the package looks like and what it contains:

A cardboard box contains 50 cartridges for dental syringes, packaged in blisters.

Responsible entity:

Molteni Dental s.r.l., Via Ilio Barontini 8, Localita Granatieri 50018 Scandicci (Firenze),
Italy

Manufacturer:

Laboratorios Normon S.A., Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid, Spain
To obtain more detailed information, please contact:
Molteni Stomat Sp. z o.o.,
30-733, Krakow, ul. Obrońców Modlina 3,
Phone: (012) 653 25 85; Fax: (012) 654 15 60
Date of last update of the leaflet:19/04/2022