Xylonor 150 mg/g + 1.5 mg/g oromucosal spray, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetrimide; Lidocaine

Available from:

Septodont

ATC code:

D08AJ; D08AJ04; N01BB02

INN (International Name):

Cetrimide; Lidocaine

Dosage:

10 mg/0.1 milligram(s)/dose

Pharmaceutical form:

Oromucosal spray, solution

Prescription type:

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

Therapeutic area:

Quaternary ammonium compounds; cetrimide; lidocaine

Authorization status:

Marketed

Authorization date:

1999-09-17

Patient Information leaflet

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.
Oromucosal spray, solution containing 36g of solution.
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 of
the mucous membrane in the
oral cavity.
Xylonor is used for production of topical
anaesthesia and disinfection of
the mucous membrane in the buccal cavity.
Xylonor is indicated in adults, adolescents and children from aged 6.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONOR
DO NOT USE XYLONOR SPRAY
-
if
you are hypersensitive (allergic) to lidocaine and/or cetrimide or to
any of the other ingredients of this medicine (listed in section 6).
-
in children under 6 years of age.
WARNINGS AND PRECAUTIONS
Take special care with Xylonor :
-
in debilitated,
elderly patients,
acutely ill
patients and children.
In
these cases, reduced doses should be given, commensurate with the
age and the physical status of the patient.
-
if
there is sepsis or
extremely traumatised mucosa in the area of
application.
-
in persons with known drug sensitivities.
Do not spray back of throat or mouth.
OTHER MEDICINES AND XYLONOR
Tell
your doctor, pharmacist or dentist if you are taking or have recently
taken any other medicines, even those not prescribed.
-
soaps and anionic surfactants known to decrease the bactericidal
activity of cetrimide
-
other local anaesthetics or antiarrhythmic drugs
-
beta-adrenergic blocking agents which may slow metabolism of
lidocaine because of decreased hepatic blood flow
-
cimetidine (drugs against
stomach ulcer) which may inhibit
hepatic

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2019
CRN008M2S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylonor 150 mg/g + 1.5 mg/g oromucosal spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of solution contains 150 mg of lidocaine and 1.5 mg of
cetrimide
Each actuation delivers approximately a dose of 10 mg of lidocaine and
0.1 mg of cetrimide.
Excipients with known effect: this medicinal product contains 45.45 g
of ethanol 96% per 100g of solution.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution.
Colourless to slightly yellow liquid with an odour of spearmint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xylonor is indicated for the production of 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 is indicated in adults, adolescents and children from aged 6.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Recommended doses:
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 patient