Versatis 700mg medicated plasters

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine

Available from:

Grunenthal Ltd

ATC code:

N01BB02

INN (International Name):

Lidocaine

Dosage:

50mg/1gram

Pharmaceutical form:

Medicated plaster

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 4032129038844 4032129038813

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VERSATIS
® 700 MG MEDICATED PLASTER
_ _
(lidocaine)
The name of your medicine is Versatis 700 mg medicated plaster but
will be
referred to as Versatis throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Versatis 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 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.
PREGNAN

Summary of Product characteristics

OBJECT 1
VERSATIS 700MG MEDICATED PLASTER
Summary of Product Characteristics Updated 11-Jun-2018 | Grunenthal
Ltd
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).
Treatment outcome should be re-evaluated after 2-4 weeks. If there has
been no response to Versatis after
this period (during the weari