VERSATIS lidocaine (lignocaine) 5% w/w dermal patch

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lidocaine, Quantity: 0.7 g

Available from:

Seqirus Pty Ltd

INN (International Name):

lidocaine (lignocaine)

Pharmaceutical form:

Patch, dermal

Composition:

Excipient Ingredients: urea; propylene glycol; polyvinyl alcohol; heavy kaolin; Gelatin; methyl hydroxybenzoate; aluminium glycinate; sorbitol solution (70 per cent) (crystallising); sodium polyacrylate; polyacrylic acid; carmellose sodium; tartaric acid; glycerol; propyl hydroxybenzoate; purified water; disodium edetate

Administration route:

Topical

Units in package:

1 sachet (5 patches), 5 sachets (25 patches), 6 sachets (30 patches), 2 sachets (10 patches), 4 sachets (20 patches)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN)

Product summary:

Visual Identification: adhesive patch with 'lidocaine 5%' embossed on one side; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-03-16

Patient Information leaflet

Version3 March 202
Page 1 of 5
VERSATIS

5% w/w Dermal Patch
Lidocaine (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
lidocaine, 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 lidocaine

any of the ingredients listed at
the end of this leaflet, especially
methyl hydroxybenzoate and
propyl hydroxybenzoate

any other medicines similar to
lidocaine such as bupivacaine,
etidocaine, mepivacaine or
prilocaine.
Some of the symptoms of an
allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

Summary of Product characteristics

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Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION VERSATIS
® (LIDOCAINE (LIGNOCAINE)) 5% W/W DERMAL PATCH
1
NAME OF THE MEDICINE
Lidocaine (Lignocaine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dermal patch (10 cm x 14 cm) contains 700 mg (5% w/w) lidocaine
(lignocaine) (50 mg
lidocaine per gram adhesive base).
Excipients with known effect: hydroxybenzoates.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VERSATIS
®
is indicated for the symptomatic relief of neuropathic pain associated
with
previous herpes zoster infection (PHN).
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND ELDERLY PATIENTS
The painful area should be covered with VERSATIS
®
once daily for up to 12 hours within a
24-hour period. Only the number of patches that are needed for an
effective treatment should
be used. When needed, the patches may be cut into smaller sizes with
scissors prior to
removal of the release liner. In total, not more than three patches
should be used at the same
time.
VERSATIS
®
must be applied to intact, dry, non-irritated skin (after healing of
the shingles).
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Page 2 of 16
Each patch must be worn no longer than 12 hours. The subsequent
patch-free interval must be
at least 12 hours.
The patch must be applied to the skin immediately after removal from
the sachet and
following removal of the release liner from the gel surface. Hairs in
the affected area must be
cut off with a pair of scissors (not shaved).
Treatment outcome should be re-evaluated after 2–4 weeks. If there
has been no response to
VERSATIS
®
after this period or if any relieving effect can solely be related to
the skin
protective properties of VERSATIS
®
, treatment must be discontinued as potential risks may
ou