资料单张
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
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产品特点
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
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