Xylonor Spray 150 mg + 1.5 mg per gram, solution for oral spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Xylonor Spray, 150 mg + 1.5 mg per gram, solution for oral spray
Lidocaine and cetrimide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your dentist, doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your dentist, doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Xylonor Spray is and what it is used for
- What you need to know before using Xylonor Spray
- How to use Xylonor Spray
- Possible adverse effects
- How to store Xylonor Spray
- Contents of the pack and other information
1. What Xylonor Spray is and what it is used for
Xylonor Spray is a topical anaesthetic containing a local anaesthetic, lidocaine, and an antibacterial agent, cetrimide. It belongs to the group of local anaesthetics of the nervous system.
Xylonor Spray is indicated for topical anaesthesia of the internal parts of the mouth (lips, cheeks, gums, palate, base of the mouth, tongue) during dental procedures. It can only be administered by your dentist. It is intended for use in adults, adolescents, and children over 6 years of age.
2. What you need to know before using Xylonor Spray
Do not use Xylonor Spray
- If you are allergic to lidocaine or cetrimide, or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other local anaesthetics.
- In children under 6 years of age.
Warnings and precautions
Talk to your dentist before using Xylonor Spray if you have inflammation or infection in the area to be anaesthetized.
Other medicines and Xylonor Spray
Tell your dentist, doctor, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Consult your dentist if you have lesions in the mouth, as lidocaine may easily pass into the bloodstream and interact with other medicines.
Use of Xylonor Spray with food
Avoid chewing gum or eating until sensation returns to normal after using this medicine. Otherwise, there is a risk of biting your lips, cheeks, or tongue.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your dentist, doctor, or pharmacist before using this medicine.
This medicine may be used during pregnancy and breast-feeding without risk to the fetus or newborn, provided it is used as directed.
No effects on fertility have been observed.
Driving and using machines
Xylonor Spray has no or negligible influence on the ability to drive and use machines.
Xylonor Spray contains alcohol (ethanol 96%)
This medicine contains 606 mg of alcohol (96% ethanol) in a maximum daily dose of 1.3 g of product, equivalent to 45.45% (w/w).
It may cause a slight burning sensation on open wounds.
3. How to use Xylonor Spray
Only dentists and stomatologists are trained to use Xylonor Spray.
The lowest effective dose required to achieve adequate anesthesia should be used.
Posology:
Adults:
One spray delivers a dose of approximately 10 mg of lidocaine, covering an area of approximately 1 cm². The maximum daily dosage should not exceed 20 sprays, equivalent to 200 mg of lidocaine.
Paediatric population (from 6 years of age):
One spray delivers a dose of approximately 10 mg of lidocaine, covering an area of approximately 1 cm². The maximum daily dosage in the paediatric population depends on the patient's age.
From 6 to 11 years of age (or body weight of 25 kg), the maximum daily dosage should not exceed 5 sprays, equivalent to 50 mg of lidocaine.
From 12 to 18 years of age (or body weight of 40–55 kg), the maximum daily dosage should not exceed 10 sprays, equivalent to 100 mg of lidocaine.
Xylonor Spray must not be used in children under 6 years of age due to the risk of asphyxiation.
Use in children
Special caution must be exercised when treating children.
Dentists will adjust the dosage according to the child's age and body weight.
If you use more Xylonor Spray than you should
Under normal conditions of use in dentistry, overdose effects are not expected with a product intended for local use only.
However, the following symptoms may indicate toxicity due to an excessive dose of Xylonor Spray:
burning, itching, tingling sensation around the mouth without apparent physical cause, dizziness, nervousness, anxiety, apprehension, euphoric mood, confusion, drowsiness, auditory hypersensitivity, tinnitus, blurred vision, vomiting, nausea, sensation of heat, cold, numbness, spasms, tremors, convulsions, unconsciousness, depression, respiratory or cardiac arrest, abnormally low or high heart rate, or other cardiac rhythm coordination problems, low or high blood pressure, circulatory failure, angina pectoris.
If you experience any of these symptoms, consult your dentist, doctor, or pharmacist.
If you have any further questions about the use of this medicine, ask your dentist, doctor, or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Immediately inform your dentist, doctor or pharmacist if you experience any of the following serious side effects:
- Rash, itching, hives, swelling of the face, lips, gums, tongue and/or throat, and difficulty breathing, wheezing, asthma: these may be symptoms of a hypersensitivity reaction (allergy/allergic reaction)
Other side effects not mentioned above may also occur:
Not known (frequency cannot be estimated from available data):
- Rash, redness
- Itching
- Gum sloughing and ulceration
- Abnormal sensation inside and around the mouth
- Swelling at application site, burning at application site
Reporting of adverse effects
If you experience any type of adverse effect, consult your dentist, doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Xylonor Spray
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after EXP. The expiry date refers to the last day of the month indicated.
Store below 25°C.
Medicines should not be disposed of via wastewater. Ask your dentist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Xylonor Spray
- The active substances are lidocaine 150 mg/g and cetrimonium 1.5 mg/g.
Each spray delivers approximately a dose of 10 mg of lidocaine and 0.1 mg of cetrimonium.
- The other components are saccharin (E954), peppermint flavour, dipropylene glycol, ethanol (96%).
Appearance of the product and contents of the container
This medicine is a clear solution. It is packaged in a multidose container.
The marketed presentation is a 36 g bottle.
Marketing Authorization Holder and Manufacturer
SEPTODONT
58, Rue du Pont de Créteil
94100 Saint-Maur-des-Fossés - France
Date of the most recent review of the leaflet: May 2022
This information is intended for healthcare professionals only:
For professional use by dentists and stomatologists.
The lowest effective dose required to achieve adequate anesthesia should be used.
Posology
Adults
One spray delivers a dose of approximately 10 mg of lidocaine, covering an area of approximately 1 cm². The maximum daily dosage should not exceed 20 sprays, equivalent to 200 mg of lidocaine.
Paediatric population (from 6 years of age)
One spray delivers a dose of approximately 10 mg of lidocaine, covering an area of approximately 1 cm². The maximum daily dosage in the paediatric population depends on the patient's age.
From 6 to 11 years (or body weight of 25 kg), the maximum daily dosage should not exceed 5 sprays, equivalent to 50 mg of lidocaine.
From 12 to 18 years of age (or body weight of 40–55 kg), the maximum daily dosage should not exceed 10 sprays, equivalent to 100 mg of lidocaine.
This product must not be used in children under 6 years of age for safety reasons.
Elderly population
Special caution is recommended when administering the minimum effective dose to achieve anesthesia in elderly patients.
Patients with hepatic impairment
Special caution is recommended when administering the minimum effective dose to achieve anesthesia in patients with hepatic impairment.
Patients with renal impairment
Special caution is recommended when administering the minimum effective dose to achieve anesthesia in patients with renal impairment.
Patients with cardiovascular system impairment
Special caution is recommended when administering the minimum effective dose to achieve anesthesia in patients with cardiovascular system impairment.
Patients with epilepsy
Special caution is recommended when administering the minimum effective dose to achieve anesthesia in patients with epilepsy.
Method of administration
Oral route.
The solution should be applied to a previously dried mucosal membrane.
Position the tip of the cannula 2 to 4 cm from the area to be anesthetized. This procedure may be repeated in up to three different areas of the mouth during the same session.
Warnings and special precautions for use
- Although systemic absorption of lidocaine is expected to be negligible, the medicine should be used with caution when applied to inflamed or infected areas due to the risk of rapid systemic absorption of lidocaine.
- Aspiration and saliva isolation using a cotton roll at the site treated with local anesthetic are required.
- There is a risk of biting trauma (lips, cheeks, tongue), although this is expected to be very low with this product due to the limited application area. When used in combination with injectable local anesthetics, patients should be advised to avoid chewing gum or eating until sensation has returned.
- Oro-pharyngeal use of local anesthetics should be avoided, as it may interfere with swallowing ability, especially in children, and thus cause choking. Accidental spraying of the anesthetic onto the uvula (soft palate) or pharynx may trigger transient paralysis of these areas and temporary discomfort for the patient. This resolves rapidly. To avoid choking and other related complications, the product must not be sprayed at the back of the throat.
- This medicine contains 606 mg of alcohol (96% ethanol) in the maximum daily dose of 1.3 g of product, equivalent to 45.45% (w/w).
It may cause a mild burning sensation on open wounds.
Overdose
Under normal dosing and administration conditions, overdose is unlikely with a medicine intended for local use only.
However, caution should be exercised when using the product in combination with injectable local anesthetics, as the risk of central nervous system (CNS) toxicity and cardiovascular toxicity may occur with high plasma levels of lidocaine due to excessive dosing or rapid absorption. To date, no cases of overdose with this product have been reported.
Symptoms:
The following reactions may occur with high plasma levels of lidocaine due to excessive dosing or rapid absorption, particularly when used in combination with injectable local anesthetics:
Central Nervous System (CNS):
High plasma concentrations may cause CNS stimulation (including seizures), followed by CNS depression (including respiratory arrest), and may be characterized by the following signs and symptoms of increasing severity: circumoral paresthesia, dizziness, nervousness, anxiety, apprehension, euphoria, confusion, drowsiness, hyperacusis, tinnitus, blurred vision, vomiting, nausea, sensation of heat or cold, numbness, twitching, tremors, seizures, unconsciousness, depression, and respiratory arrest. Excitatory manifestations (e.g., twitching, tremors, and seizures) may be very brief or may not occur at all; in such cases, the first sign of toxicity may be drowsiness progressing to unconsciousness and respiratory arrest.
Cardiovascular system:
Cardiovascular manifestations are generally depressive and are characterized by bradycardia, hypotension, arrhythmia, and cardiovascular collapse, which may lead to cardiac arrest. Hypertension, tachycardia, and angina may be caused by concomitant use with an injectable local anesthetic containing adrenaline.
Treatment of overdose:
Resuscitation equipment must be available before starting dental anesthesia with local anesthetics.
If signs of acute toxicity are suspected, the mouth should be rinsed immediately.
Oxygen should be administered promptly; assisted ventilation should be used if necessary. Reposition the patient into a supine position if required.
In the event of cardiac arrest, immediate cardiopulmonary resuscitation (CPR) must be performed.