Leaflet: information for the user

Xylonor Spray, 150 mg + 1.5 mg per gram, solution for buccal spraying

Lidocaine and cetrimonium

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your dentist, doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your dentist, doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Xylonor Spray and how is it used

2. What you need to know before starting to use Xylonor Spray

3. How to use Xylonor Spray

4. Possible adverse effects

5. Storage of Xylonor Spray

6. Contents of the pack and additional information

Xylonor Spray is a topical anesthetic containing a local anesthetic, lidocaine and an antibacterial agent, cetrimonium. It belongs to the group of local anesthetics of the nervous system.

Xylonor Spray is indicated for topical anesthesia of the internal parts of the mouth (lips, cheeks, gums, palate, the base of the mouth, tongue) in dental procedures. It can only be administered by your dentist. It is intended for adults, adolescents and children over 6 years old.

Do not use Xylonor Spray

• If you are allergic to lidocaine or cetrimonium or to any of the other components of this medication (listed in section 6).
• If you are allergic to other local anesthetics.
• In children under 6 years old.

Warnings and precautions

Speak with your dentist before using Xylonor Spray if you have inflammation or infection in the area to be anesthetized.

Other medications and Xylonor Spray

Inform your dentist, doctor or pharmacist if you are using, have used recently or may have to use any other medication.

Consult with your dentist if you have mouth injuries because lidocaine can easily pass into the blood and interact with other medications.

Use of Xylonor Spray with food

Avoid chewing gum or eating until you recover normal sensation after using this medication. Otherwise, there is a risk of biting your lips, cheeks or tongue.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your dentist, doctor or pharmacist before using this medication.

This medication can be used during pregnancy and breastfeeding without any risk to the fetus or newborn as long as it is used as directed.

No effects on fertility have been observed.

Driving and operating machines

Xylonor Spray has no influence or insignificant influence on the ability to drive and operate machines.

Xylonor Spray contains alcohol (ethanol 96%)

This medication contains 606 mg of alcohol (ethanol at 96%) in a maximum daily dose of 1.3 g of product, which is equivalent to 45.45% (p/p).

It may cause a mild burning sensation on open wounds.

Only dentists and stomatologists are trained to use Xylonor Spray.

The lowest effective dose should be used.

Dosage:

Adults:

One spray releases a dose of approximately 10 mg of lidocaine covering an area of about 1 cm2. The maximum daily dose should not exceed 20 sprays equivalent to 200 mg of lidocaine.

Pediatric population (from 6 years old)

One spray releases a dose of approximately 10 mg of lidocaine covering an area of about 1 cm2. The maximum daily dose of the medication in the pediatric population depends on the patient's age.

From 6 to 11 years (or 25 kg of body weight), the maximum daily dose of the medication should not exceed 5 sprays, equivalent to 50 mg of lidocaine.

From 12 to 18 years old (or 40-55 kg of body weight), the maximum daily dose of the medication should not exceed 10 sprays, equivalent to 100 mg of lidocaine.

It should not be used in children under 6 years old due to the risk of asphyxiation.

Use in children

Special care should be taken when treating children.

Dentists will adjust the dose according to the child's age and weight.

If you use more Xylonor Spray than you should

Under normal use conditions in dentistry, overdoses are not expected with a product for local use only.

However, the following symptoms may be signs of toxicity due to excessive doses of Xylonor Spray:

burning, itching, tingling sensation around the mouth without apparent physical cause, dizziness, nervousness, anxiety, apprehension, euphoric mood, confusion, drowsiness, hypersensitivity to hearing, buzzing in the ears, blurred vision, vomiting, nausea, sensation of heat, cold, numbness, spasms, tremors, convulsions, unconsciousness, depression, respiratory or cardiac arrest, abnormally low or high heart rate, other rhythm coordination problems, low or high blood pressure, circulatory insufficiency, angina pectoris.

If you experience any of these symptoms, talk to your dentist, doctor, or pharmacist.

If you have any other questions about the use of this medication, ask your dentist, doctor, or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your dentist, doctor, or pharmacist immediately if you experience any of the following severe side effects::

• Hives, itching, urticaria, facial, lip, gum, tongue, and/or throat inflammation, and difficulty breathing, wheezing, asthma: these may be symptoms of a hypersensitivity reaction (allergy/allergic reaction)

Other side effects not mentioned earlier may also occur:

Not known (frequency cannot be estimated from available data):

• Hives, redness
• Itching
• Gum slippage and ulceration
• Abnormal sensation inside and around the mouth
• Site of application inflammation, burn at the site of application

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains. Ask your dentist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

Composition of Xylonor Spray

-The active principles are lidocaine 150 mg/g and cetrimonium 1.5 mg/g

Each pulse releases approximately a dose of 10 mg of lidocaine and 0.1 mg of cetrimonium.

-The other components are saccharin (E954), peppermint flavor, dipropylene glycol, ethanol (96%).

Appearance of the product and contents of the container

This medication is a clear solution. It is packaged in a multi-dose container.

The commercial presentation is a 36g bottle.

Holder of the marketing authorization and responsible for manufacturing

SEPTODONT

58, Rue du Pont de Créteil

94100 Saint-Maur-des-Fossés - France

Last review date of the leaflet: May 2022

This information is intended solely for healthcare professionals:

For professional use by dentists and stomatologists.

The lowest effective dose should be used.

Dosage

Adults

One spray releases a dose of approximately 10 mg of lidocaine covering an area of about 1cm2. The maximum daily dose should not exceed 20 sprays, equivalent to 200 mg of lidocaine.

Paediatric population (from 6 years old)

One spray releases a dose of approximately 10 mg of lidocaine covering an area of about 1cm2. The maximum daily dose of the drug in the paediatric population depends on the patient's age.

From 6 to 11 years (or 25 kg body weight), the maximum daily dose of the drug should not exceed 5 sprays, equivalent to 50 mg of lidocaine.

From 12 to 18 years old (or 40-55 kg body weight), the maximum daily dose of the drug should not exceed 10 sprays, equivalent to 100 mg of lidocaine.

It should not be used in children under 6 years old for safety reasons.

Geriatric population

Special precautions should be taken to administer the minimum effective dose in elderly patients.

Patients with liver function disorders

Special precautions should be taken to administer the minimum effective dose in patients with liver function disorders.

Patients with renal function disorders

Special precautions should be taken to administer the minimum effective dose in patientswith renal function disorders.

Patients with cardiovascular system function disorders

Special precautions should be taken to administer the minimum effective dose in patientswith cardiovascular system function disorders.

Patients with epilepsy

Special precautions should be taken to administer the minimum effective dose in patients with epilepsy.

Administration form

Oral route..

The solution should be applied to a previously dried mucous membrane.

Place the end of the cannula 2 to 4 cm from the area to be anesthetized. This operation can be repeated in three different areas of the mouth during the same session.

Warnings and special precautions for use

• Although a negligible systemic passage of lidocaine is expected, the drug should be used with caution when applied to an inflamed or infected area, due to the risk of rapid systemic absorption of lidocaine.
• Saliva aspiration and isolation with aroll ofgauze at the site treated with local anesthesia is required.
• There is a risk of trauma by biting (lips, cheeks, tongue), but with the drug, it is expected to be very low, due to the limited area of administration. When associated with injectable local anesthetics, the patient should be instructed to avoid chewing gum or eating until they regain sensitivity.
• The use of local anesthetics in the oral cavity should be avoided, as it may interfere with the ability to swallow, especially in children, and cause choking. Accidental orientation of the anesthetic towards the uvula (soft palate) or pharynx may trigger a transient paralysis of these areas and temporary discomfort for the patient. It disappears quickly. To avoid problems with choking and others related to it, the product should not be sprayed in the back of the throat.
• This product contains 606 mg of alcohol (ethanol at 96%) in a maximum daily dose of 1.3g of product, which corresponds to 45.45% (p/p).

It may cause a mild burning sensation on open wounds.

Overdose

In normal doses and under normal conditions of administration, it is unlikely that an overdose will occur with a drug 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 toxicity and cardiovascular toxicity may occur with high plasma levels of lidocaine due to excessive or rapid absorption. To date, no cases of overdose have been reported.

Symptoms:

The following reactions may occur with high plasma levels of lidocaine due to excessive doses or rapid absorption, particularly when associated with the use of injectable local anesthetics:

Central Nervous System (CNS):

High plasma concentration 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, drowsiness, nervousness, anxiety, apprehension, euphoria, confusion, dizziness, somnolence, hyperacusis, tinnitus, blurred vision, vomiting, nausea, sensation of heat or cold, numbness, spasms, tremors, seizures, unconsciousness, depression, and respiratory arrest. Excitatory manifestations (e.g. spasms, tremors, and seizures) may be very brief or not occur at all, in which case the first manifestation of toxicity may be somnolence that merges into unconsciousness and respiratory arrest.

Circulatory system:

Circulatory 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

Availability of resuscitation equipment should be ensured before starting dental anesthesia with local anesthetics.

If signs of acute toxicity are suspected, the drug should be immediately rinsed out.

Administer oxygen quickly, if necessary, assisted ventilation should be used. Change the patient's position to a supine position if necessary.

In case of cardiac arrest, immediate cardiopulmonary resuscitation should be performed.