Versatis 700 mg medicated plaster

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Lidocaine

Tilgængelig fra:

Imbat Limited

ATC-kode:

N01BB; N01BB02

INN (International Name):

Lidocaine

Dosering:

700 milligram(s)

Lægemiddelform:

Medicated plaster

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Amides; lidocaine

Autorisation status:

Authorised

Autorisation dato:

2012-08-17

Indlægsseddel

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERSATIS
® 700 MG MEDICATED PLASTER
(lidocaine)
Your medicine is available using the name Versatis 700 mg medicated
plaster but will be
referred to as Versatis throughout this leaflet.
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 us

Produktets egenskaber

Health Products Regulatory Authority
21 October 2019
CRN009DTQ
Page 1 of 3
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)
Excipients 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, Italy and the UK:_
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
_Product imported from the UK_
_Self-adhesive layer:_
Glycerol
Liquid sorbitol
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)
_Product imported from Italy and France_
_Self-adhesive layer:_
Glycerol
Health Products Regulatory Authority
21 October 2019
CRN009DTQ
Page 2 of 3
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.
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 cou