VERSATIS 700 Milligram Medicated Plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE

Available from:

Grünenthal Ltd

ATC code:

N01BB02

INN (International Name):

LIDOCAINE

Dosage:

700 Milligram

Pharmaceutical form:

Medicated Plaster

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Amides

Authorization status:

Transfer Pending

Authorization date:

2010-10-08

Patient Information leaflet

1. WHAT VERSATIS IS AND WHAT IT IS USED FOR
Versatis contains lidocaine, a local analgesic, which works by
reducing the 
pain in your skin.
You have been given Versatis to treat a painful skin condition called
post-
herpetic neuralgia. This is generally characterised by localised
symptoms 
such as burning, shooting or stabbing pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VERSATIS
DO NOT USE VERSATIS
-  if you are allergic to lidocaine or any of the other ingredients
of this 
medicine (listed in section 6).
-  if you have had an allergic reaction to other products which are
similar 
to lidocaine, such as bupivacaine, etidocaine, mepivacaine or
prilocaine.
-  on injured skin or open wounds
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Versatis.
If you have severe liver disease, or severe heart problems, or severe
kidney 
problems, you should talk to your doctor before using Versatis.
Versatis should only be used on the areas of skin after the shingles
has 
healed. It should not be used on or near the eyes or mouth.
Lidocaine is broken down in your liver to several compounds. One of
these 
compounds is 2,6 xylidine which has been shown to cause tumours in
rats 
when given lifelong in very high doses. The significance of these
findings in 
humans is not known.
CHILDREN AND ADOLESCENTS
Versatis has not been studied in patients under 18 years of age.
Therefore it 
is not recommended for use in this patient population.
OTHER MEDICINES AND VERSATIS
Tell your doctor or pharmacist if you are taking, have recently taken
or 
might take any other medicines.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are 
planning to have a baby, ask your doctor or pharmacist for advice
before 
taking this medicine.
Versatis should not be used in pregnancy unless clearly necessary.
There are no studies of the plaster in breast-feeding women. When
using 
Versatis, only very small amounts of the active substance lidocaine
may be 
prese

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Versatis 700 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 cm x 14 cm plaster contains 700 mg lidocaine (equivlent to 5%
w/w)
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 14 mg
Propyl parahydroxybenzoate (E216) 7 mg
Propylene glycol (E1520) 700 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
White hydrogel
plaster
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
(post-herpetic neuralgia, PHN) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ELDERLY PATIENTS_
The painful area should be covered with the plaster once daily for up
to 12 hours within a 24 hours period. Only the
number of plasters that are needed for an effective treatment should
be used. When needed, the plasters may be cut into
smaller sizes with scissors prior to removal of the release liner. In
total, not more than three plasters should be used at
the same time.
The plaster must be applied to intact, dry, non-irritated skin (after
healing of the shingles).
Each plaster must be worn no longer than 12 hours. The subsequent
plaster-free interval must be at least 12 hours. The
plaster can be applied during the day or during the night.
The plaster 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
(during the wearing time and/or during the plaster-free interval),
treatment must be discontinued as