Xylocaine 10 mg/delivered dose Mucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

Aspen Pharma Trading Limited

ATC code:

N01BB02

INN (International Name):

Lidocaine

Dosage:

10 milligram(s)/dose

Pharmaceutical form:

Oromucosal spray, solution

Prescription type:

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

Therapeutic area:

lidocaine

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLOCAINE 10 MG/DELIVERED DOSE MUCOSAL SPRAY
lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO
YOU 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, nurse, 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 doctor, nurse, dentist or
pharmacist. This includes any possible
side effects not listed in this leaflet
.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xylocaine Spray is and what it is used for
2.
What you need to know before Xylocaine Spray is given to you
3.
How Xylocaine Spray is given to you
4.
Possible side effects
5.
How to store Xylocaine Spray
6.
Contents of the pack and other information
1.
WHAT XYLOCAINE SPRAY IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Xylocaine 10 mg/delivered dose Mucosal
Spray’. In this leaflet, it is referred
to as ‘Xylocaine Spray’.
Xylocaine Spray contains a medicine called lidocaine. This belongs to
a group of medicines called local
anaesthetics.
Xylocaine Spray is used to numb (anaesthetise) parts of the body. It
is used as a pain relief during:
•
Medical examinations and operations of the nose and throat.
•
Childbirth, and after the birth if stitches are needed.
•
Treatment at the dentist.
2.
WHAT YOU NEED TO KNOW BEFORE XYLOCAINE SPRAY IS GIVEN TO YOU
DO NOT USE XYLOCAINE SPRAY:
•
if you are allergic to lidocaine or any of the other ingredients of
this medicine (listed in section 6).
•
if you are allergic to any other local anaesthetics of the same class
(such as prilocaine or bupivacaine).
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse, dentist or pharmacist before Xylocaine
Spray is given to you:
•
if you have any cuts, sores or ulcers in your throat, mouth or nose.
•
if

Summary of Product characteristics

Health Products Regulatory Authority
18 September 2023
CRN00DTXF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylocaine 10 mg/delivered dose Mucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each depression of the valve delivers 10 mg of lidocaine.
Excipient(s) with known effect
Each depression also delivers 1 mg of propylene glycol (an excipient
of the banana essence). Also contains ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Mucosal Spray
A clear or almost clear, slightly coloured liquid with an odour of
banana, ethanol and menthol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention of pain associated with the following procedures:
Otorhinolaryngology
- Anaethesia prior to minor surgical procedures in the nasal cavity,
maxillary sinus, pharynx and epipharynx.
- Paracentesis.
Obstetrics
As supplementary pain control during labour (before episiotomy and
perineal suturing).
Introduction of instruments and catheters into the respiratory and
digestive tract
Provides surface anaesthesia for the oropharyngeal and tracheal areas
to reduce reflex activity, attenuate haemodynamic
response and to facilitate insertion of the catheter or the passage of
instruments during endotracheal intubation, laryngoscopy,
bronchoscopy and oesophagoscopy.
Dental practice
Before minor dental procedures, dental impressions, X-ray photography,
and removal of calculus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This product is NON-STERILE and therefore not recommended for use
prior to procedures that require aseptic techniques.
As with any local anaesthetic, reactions and complications are best
averted by employing the minimal effective dosage.
Debilitated or elderly patients and children should be given doses
commensurate with their age and physical condition.
Paediatric population
In children under the age of 12 years doses should not exceed 3 mg/kg.
Xylocaine Spray should not be used on cuffs of endotracheal tubes
(ETT) made of plastic (see als