Xylonor, 50 mg/g + 1.5 mg/g, gingival gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine; Cetrimide

Available from:

Septodont

ATC code:

N01BB; N01BB52

INN (International Name):

Lidocaine; Cetrimide

Dosage:

50 mg/1.5 milligram(s)/gram

Pharmaceutical form:

Gingival gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides; lidocaine, combinations

Authorization status:

Marketed

Authorization date:

1999-10-01

Patient Information leaflet

Patient Information Leaflet
Page 1 / 4
Ireland – Xylonor Gel
Revised on June 2018
Formula code: 227S
PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLONOR 50 MG/G + 1.5 MG/G GINGIVAL GEL
Lidocaine and Cetrimide
READ ALL 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 doctor, pharmacist or
dentist.
-
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 doctor, pharmacist or
dentist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xylonor is and what it is used for
2.
What you need to know before you use Xylonor
3.
How to use Xylonor
4.
Possible side effects
5.
How to store Xylonor
6.
Contents of the pack and other information
1.
WHAT XYLONOR IS AND WHAT IT IS USED FOR
Local anaesthetic.
Xylonor contains lidocaine, an anaesthetic agent which stabilises the
neuronal membrane and prevents
the initiation and conduction of nerve impulses, thereby effecting
local anaesthesia. Cetrimide is an
antiseptic of the quaternary ammonium group with both bactericidal and
detergent properties.
Xylonor allows a topical anaesthesia in the buccal cavity.
Xylonor is used for production of topical anaesthesia in the buccal
cavity.
Xylonor is indicated in adults, and in children and adolescents aged 4
to 18 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONOR
DO NOT USE XYLONOR :
-
if you are allergic to lidocaine and cetrimide or any of the other
ingredients of this medicine
(listed in section 6)..
-
if you are allergic to local anaesthetics of the amide type
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or dentist before using Xylonor gel.
Take special care with Xylonor
-
in debilitated, elderly patients, acutely ill patients and children.
In these cases,

Summary of Product characteristics

Health Products Regulatory Authority
03 October 2019
CRN008JZC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylonor, 50 mg/g + 1.5 mg/g, gingival gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of gingival gel contains 50 mg of lidocaine and 1.5 mg of
cetrimide.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gingival gel.
White to ivory translucent gel with a mint odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xylonor is indicated for the production of topical anaesthesia 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 is indicated in adults and in children and adolescents aged 4
to 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended doses:_
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
micrograms 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 4g gel (200mg lidocaine) must not be exceeded in one
session.
_ _
Do not use in children under 4 years of age.
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.
Debilitated, elderly patients, acutely ill patients and children
should be given reduced doses commensurate with their age and
physical status (see section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, lidocaine and cetrimide