VERSATIS lignocaine 5% w/w dermal patch

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Lignocaine

Available from:

Grunenthal Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Version 1.4 April 2012

Page 1 of 4 

VERSATIS 5% w/w Dermal Patch 
Lignocaine 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

READ THIS LEAFLET CAREFULLY 
BEFORE YOU START USING THIS 
MEDICINE.  

This leaflet answers some common 
questions about VERSATIS Dermal 
Patch. 

It does not contain all of the 
available information.  It does not 
take the place of talking to your 
doctor or pharmacist. 

All medicines have benefits and 
risks.  Your doctor has weighed the 
risks of you using VERSATIS Dermal 
Patch against the benefits they 
expect it will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, TALK TO 
YOUR DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH YOUR 
MEDICINE.   
You may need to read it again. 

WHAT VERSATIS DERMAL 
PATCH IS USED FOR 

VERSATIS Dermal Patch contains 
lignocaine, a local anaesthetic, 
which works by reducing the pain in 
your skin. 

You have been given it to treat a 
painful skin condition called post-
herpetic neuralgia. This is the pain 
which persists after Herpes Zoster 
(Shingles) infection.  It is generally 
characterised by localised 
symptoms such as burning, 
shooting or stabbing pain. 

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY VERSATIS 
DERMAL PATCH HAS BEEN 
PRESCRIBED FOR YOU. 

Your doctor may have prescribed it 
for another reason. 

VERSATIS Dermal Patch is available 
only with a doctor's prescription. 

There is no evidence that this 
medicine is addictive. 

This medicine is not expected to 
affect your ability to drive a car or 
operate machinery. 

BEFORE YOU APPLY 
VERSATIS DERMAL PATCH

WHEN YOU MUST NOT USE IT 

DO NOT USE VERSATIS DERMAL 
PATCH IF YOU HAVE AN ALLERGY TO: 
•

any medicine containing 
lignocaine  
•

any of the ingredients listed at 
the end of this leaflet, especially 
methyl hydroxybenzoate and 

Summary of Product characteristics

  
Versatis 
Product 
Information 
Version 1.8 
May 2012 
Page 1 of 12 
VERSATIS (LIGNOCAINE) 5% W/W, DERMAL PATCH 

NAME OF THE MEDICINE 

Lignocaine 

Structural Formula: Chemical Name: 2-(diethylamino)-N-(2,6-dimethylphenyl) 
acetamide 

Molecular Formula: C
14
H
22
N
2
O 
Molecular Weight: 234.3 
CAS Number: 137-58-6 

DESCRIPTION 

Versatis is a white hydrogel patch containing adhesive material,
which is applied 
to a non-woven polyethylene terephthalate backing embossed with
“Lidocaine 
5%” and covered with a polyethylene
terephthalate film release liner. 

Each 10 cm x 14 cm patch contains 700 mg (5% w/w) lignocaine
(50 mg 
lignocaine per gram adhesive base). 

Lignocaine is a white or almost white crystalline powder,
practically insoluble in 
water, very soluble in ethanol, and freely soluble
in ether. The pKa is 7.9.  The 
coefficient (log D) is defined as the
ratio of the equilibrium concentrations of a 
single molecular species in a 1-octanol/aqueous buffered solution
2-phase 
system at pH 7.4. The value of log D for lignocaine
in 1-octanol/water is 1.61. 

PHARMACOLOGY 

Pharmacotherapeutic group: local anaesthetics, amides 

Pharmacodynamics: 
_ _
Lignocaine is a local anaesthetic of the amide type which
stabilises excitable 
membranes by inactivation of sodium channels. Its action on
neuronal 
membranes prevents neuronal conduction. When applied topically in
the form of 
the patch, lignocaine produces a local analgesic effect. 

Versatis 
Product 
Information 
Version 1.8 
May 2012 
Page 2 of 12 

Lignocaine 5% dermal patch has a dual mode of action: the
pharmacological 
action of lignocaine diffusion and the mechanical action of the
hydrogel patch 
that protects the hypersensitive
area. The lignocaine contained in the 5% dermal 
patch diffuses continuously into the skin, providing a
local analg