Versatis 700 mg medicated plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

Primecrown 2010 Limited

ATC code:

N01BB; N01BB02

INN (International Name):

Lidocaine

Dosage:

700 milligram(s)

Pharmaceutical form:

Medicated plaster

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Amides; lidocaine

Authorization status:

Authorised

Authorization date:

2014-07-04

Patient Information leaflet

VERSATIS
® 700 MG MEDICATED PLASTER
Lidocaine
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are
planning to have a

Summary of Product characteristics

Health Products Regulatory Authority
08 September 2020
CRN009W8R
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Versatis 700 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Product imported from Italy:_
Each 10 cm x 14 cm plaster contains 700 mg lidocaine (equivlent to 5%
w/w)
_Product imported from France:_
Each medicated plaster (10 cm x 14 cm) contains 700 mg lidocaine
(equivalent to 5% w/w)
Excipients with known effect:
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Propylene glycol (E1520)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
_Product imported from Italy:_
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.
_Product imported from France:_
The medicated plaster is 14 cm long and 10 cm wide and marked
"lidocaine 5%.
4 CLINICAL PARTICULARS
As per PA2242/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2242/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_SELF-ADHESIVE LAYER: _
glycerol
liquid sorbitol, crystallising
carmellose sodium
propylene glycol (E1520)
urea
heavy kaolin
tartaric acid
gelatin
polyvinyl alcohol
aluminium glycinate
disodium edetate
methyl parahydroxybenzoate (E218)
propyl parahydroxybenzoate (E216)
Health Products Regulatory Authority
08 September 2020
CRN009W8R
Page 2 of 3
polyacrylic acid
sodium polyacrylate
purified water
_BACKING FABRIC: _
Polyethylene terephthalate (PET)
_RELEASE LINER: _
Polyethylene terephthalate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf –life expiry date of this product shall be the date shown
on the container and outer package of the product on the
market in the country of origin.
After first opening the sachet, the plasters must be used within 14
days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
After first opening: Keep the sachet