Xylonor Gel, gingival gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIDOCAINE, CETRIMIDE

Available from:

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

ATC code:

N01BB52

INN (International Name):

CETRIMIDE 1.5 mg/g LIDOCAINE 5 mg/g

Pharmaceutical form:

OROMUCOSAL GEL

Composition:

CETRIMIDE 1.5 mg/g LIDOCAINE 5 mg/g

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 Gel 
Proposed changes on Sept2014 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
XYLONOR GEL 50 MG/1.5 MG PER GRAM, GINGIVAL GEL 

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 only. 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 Gel is and what it is used for 
2.  What you need to know before you use Xylonor Gel 
3.  How to use Xylonor Gel 
4.  Possible side effects 
5.  How to store Xylonor Gel 
6.  Contents of the pack and other information 

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

Xylonor Gel contains an effective anaesthetic agent, lidocaine, and
an antiseptic of the quaternary 
ammonium group, cetrimide.  
Xylonor Gel is used for topical anaesthesia in the buccal cavity. 
Xylonor Gel 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 GEL 

DO NOT USE XYLONOR GEL 
- 
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 Gel if:  
- 
You have a severe infection or an inflammation in the area where the
application will be done. 
- 
You are allergic to other medicinal products 

OTHER MEDICINES AND XYLON

Summary of Product characteristics

Page 1 of 5 

1. 
NAME OF THE MEDICINAL PRODUCT 

XYLONOR GEL, 50 mg/1.5 mg per gram, gingival gel. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1g of gel contains 50 mg lidocaine and 1.5 mg cetrimide. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Gingival gel. 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

XYLONOR GEL is indicated for the production of topical anesthesia in
the buccal cavity, 
especially in the following procedure: 

- 
anaesthesia of the mucous membrane before injection, lancing of
abscesses, or scaling. 
- 
surface anaesthesia for the extraction of mobile, deciduous
or permanent teeth. 
- 
prevention of gagging during impression taking. 

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

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

To be used only once from 0.1 - 0.5g gel (2 mm or volume of a rice
grain to 1 cm) by topical local 
application (i.e. 5-25 mg lidocaine base). 

Under aseptic conditions, extrude about 2 mm (equivalent to
approximately 0.1 g) of gel from the 
tube onto a cotton pellet. Then massage previously dried mucosa. 

Depending upon the surface to be anaesthetised and the status of the
patient (age, physical 
condition), the dose of the gel used may be increased, up to 0.5 g. 

A dose of 4 g gel (200 mg lidocaine) must not be exceeded in one
session. 

Method of administration 

Apply gel to previously dried oral mucosa. Subsequent removal
of excess saliva with cotton rolls or 
saliva ejector minimises dilution of the gel and permits
maximum penetration.  

4.3. 
CONTRAINDICATIONS 

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

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4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

The safety and effectiveness of lidocaine depend on proper dosa