Versatis Medicated Plaster 700mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIDOCAINE

Available from:

Grunenthal GmbH Zieglerstrasse 6, 52078 Aachen, Germany

ATC code:

N01BB02

INN (International Name):

LIDOCAINE 700 mg

Pharmaceutical form:

MEDICATED PLASTER

Composition:

LIDOCAINE 700 mg

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Withdrawn

Authorization date:

2011-07-20

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERSATIS 700 MG MEDICATED PLASTER
Lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you use Versatis
3.
How to use Versatis
4.
Possible side effects
5.
How to store Versatis
6.
Contents of the pack and other information
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 tumo

Summary of Product characteristics

Page 1 of 9
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 (equivalent 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).
Page 2 of 9
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),
tre