Versatis 700 mg medicated plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

IMED Healthcare Ltd.

ATC code:

N01BB; N01BB02

INN (International Name):

Lidocaine

Dosage:

700 milligram(s)

Pharmaceutical form:

Medicated plaster

Therapeutic area:

Amides; lidocaine

Authorization date:

2012-08-17

Patient Information leaflet

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 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
tu

Summary of Product characteristics

Health Products Regulatory Authority
10 May 2022
CRN00CWWW
Page 1 of 2
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 (5% w/w) lidocaine (50 mg
lidocaine per gram adhesive base)
Excipient(s) with known effect: methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216) and propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
_Product imported from France and 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.
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)
Polyacrylic acid
Sodium polyacrylate
Purified water
_Backing fabric and release liner:_
Polyethylene terephthalate (PET)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
10 May 2022
CRN00CWWW
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry of the unopened product is the date shown on the
sachet and outer carton of the product as marketed in
the country of origin.
After first opening the sachet, the plasters must be used within 14
days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_From Italy_
Do not refrigerate or freeze.
After first opening: Keep the sachet tightly closed.
_From France_
Do not refrigerate or freeze.
After first opening: Keep the sachet tightly closed to protect from
light.
6.5 NATURE AND CONTENTS OF CONTAINER
An over-labelled carton containing 30 plasters packed in 6 re-sealable
sachets.
6.6 SPECI