Xylonor Spray, oromucosal spray

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CETRIMIDE, LIDOCAINE

Available from:

Septodont 58 Rue du Pont de Créteil, 94100 SAINT MAUR DES FOSSES, France

ATC code:

N01BB52

INN (International Name):

CETRIMIDE 0.1 µg/dose LIDOCAINE 10 µg/dose

Pharmaceutical form:

OROMUCOSAL SPRAY

Composition:

CETRIMIDE 0.1 µg/dose LIDOCAINE 10 µg/dose

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

Authorization date:

2006-02-01

Patient Information leaflet

Patient Information Leaflet 

Page 1 / 4 
Malta – Xylonor Spray 
Proposed changes on Sept2014 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
XYLONOR SPRAY, 10 MG/0.1 MG PER METERED DOSE, OROMUCOSAL SPRAY  

LIDOCAINE – CETRIMIDE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your dentist
or pharmacist. 
- 
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if 
their signs of illness are the same as yours. 
- 
If you get any side effects, talk to your dentist or
pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4 
WHAT IS IN THIS LEAFLET: 
1.  What Xylonor Spray is and what it is used for 
2.  What you need to know before you use Xylonor Spray 
3.  How to use Xylonor Spray 
4.  Possible side effects 
5.  How to store Xylonor Spray 
6.  Contents of the pack and other information 

1. 
WHAT XYLONOR SPRAY IS AND WHAT IT IS USED FOR 

Xylonor Spray contains an effective anaesthetic agent, lidocaine,
and an antiseptic of the quaternary 
ammonium group, cetrimide.  
Xylonor Spray is used for topical anaesthesia and disinfection of
the mucous membrane in the buccal 
cavity. 
Xylonor Spray is indicated in adults, and in children and adolescents
aged 3 to 18 years of age. 
Only a dentist can administer this product. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONOR SPRAY 

DO NOT USE XYLONOR SPRAY 
- 
If you are allergic to lidocaine or cetrimide or any of the other
ingredients of this medicine (listed 
in section 6). 
- 
In children under 3 years old. 

WARNINGS AND PRECAUTIONS 
Talk to your dentist before taking Xylonor Spray if:  
- 
You have a severe infection or an inflammation in the area where the
application will be done. 
- 

Summary of Product characteristics

Page 1 of 6 

1. 
NAME OF THE MEDICINAL PRODUCT 

Xylonor Spray, 10 mg/0.1 mg per metered dose, oromucosal spray 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One metered dose contains 10 mg Lidocaine and 0.10 mg Cetrimide 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Oromucosal spray, solution. 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Xylonor Spray is indicated in topical anaesthesia and disinfection of
the mucous membrane in the 
buccal cavity, especially: 

- 
before the performance of a local or nerve block injection, 
- 
prior to the extraction of mobile, deciduous or permanent teeth, 
- 
prior to the adjustment and fitting of crowns and bridges or the
adjustment of band in 
orthodontic treatments, 
- 
prior to scaling, 
- 
prior to the lancing of sub-mucosal abscesses. 

Xylonor Spray is indicated in adults, and in children and adolescents
aged 3 to 18 years of age. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

1 metered dose containing 10 mg of lidocaine is usually sufficient
to achieve anaesthesia on a 
particular site. Two may be used. 

Dosage schedule: 

The application of one dose may be repeated in 4 or 5 (40-50 mg)
different areas of the buccal 
mucosa during the same sitting; but no more than 3 doses should be
applied to the same quadrant. 
Only one quadrant should be anaesthetized during the course of one
sitting. 

A dose of 200 mg lidocaine should not be exceeded. 

Method of administration 

The tip of the nozzle should be placed at about two cm from the
area to be anaesthetized. The 
actuation of the valve emits a dose of spray covering an area of
about 1 cm in diameter. 

The product may be used on all categories of patients. 

Page 2 of 6 

4.3. 
CONTRAINDICATIONS 

Hypersensitivity to lidocaine or cetrimide or to any of the
excipients listed in section 6.1. 
Children below 3 years of