Xylocaine 10mg/metered dose Spray

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

lidocaine 10 mg

Available from:

AstraZeneca AB

ATC code:

N01BB02

INN (International Name):

lidocaine

Pharmaceutical form:

cutaneous spray

Authorization status:

Authorised

Authorization date:

2006-01-24

Patient Information leaflet

IM PIL Xylocaine Spray PAI 12 0011 (based on PAI 09 0038a)
18/01/2012 KS 
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 XYLOCAINE SPRAY IS GIVEN TO
YOU. 
•
  Keep this leaflet. You may need to read it again. 
•
  If you have any further questions, ask your doctor, dentist or
pharmacist. 
•
  This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their 
symptoms are the same as yours. 
•
  If any of the side effects get serious, or
if you notice any side effects not listed in this leaflet, please
tell 
your doctor or dentist. 

IN THIS LEAFLET: 
1.  What Xylocaine Spray is and what it is used for 
2.  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.  Further 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’. It is referred to as 
‘Xylocaine Spray’ in the rest of this leaflet. 

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 stops pain happening during: 
•
  Medical examinations and operations of the nose and throat. 
•
  Childbirth, and after the birth if stitches are needed. 
•
  Treatment at the dentist. 

2. 
BEFORE XYLOCAINE SPRAY IS GIVEN TO YOU 

YOU MUST NOT BE GIVEN XYLOCAINE SPRAY IF: 
•
  You are allergic (hypersensitive) to lidocaine or any of the
other ingredients of Xylocaine Spray (see 
Section 6: Further information). 
•
  You are allergic to any other local anaesthetics of the same
class (such as prilocaine or bupivacaine).  
You must not be given Xylocaine Spray if

Summary of Product characteristics

Page 1 of 8

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. 
Excipients: Each depression also delivers 1 mg of propylene glycol (an excipient of the 
banana essence). 
For a 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 
-  Puncture of the maxillary sinus and minor surgical procedures in the nasal cavity, pharynx 
and epipharynx. 
-  Paracentesis. 
Obstetrics 
During the final stages of delivery and before episiotomy and perineal suturing as 
supplementary pain control. 
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 tube or the 
passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy and 
oesophagoscopy. 
Dental practice 
Before injections, dental impressions, X-ray photography, removal of calculus. 
Page 2 of 8

4.2

POSOLOGY AND METHOD OF ADMINISTRATION 
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. Xylocaine Spray should not be used on 
cuffs of endotracheal tubes (ETT) made of plastic (see