Versatis 700 mg medicated plaster

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Lidocaine

Tilgjengelig fra:

Merit Pharmaceuticals Limited

ATC-kode:

N01BB02

INN (International Name):

Lidocaine

Dosering :

700 milligram(s)

Legemiddelform:

Medicated plaster

Terapeutisk område:

lidocaine

Autorisasjon dato:

2014-07-04

Informasjon til brukeren

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 sho

Preparatomtale

Health Products Regulatory Authority
08 March 2024
CRN00F565
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 lidocaine (equivalent to 5%
w/w)
_ _
Excipient(s) 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 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
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:_
Polyethylene terephthalate (PET)
_ _
Health Products Regulatory Authority
08 March 2024
CRN00F565
Page 2 of 2
_RELEASE LINER:_
Polyethylene terephthalate
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 package 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
Do not refrigerate or freeze.
After first opening: Keep the sachet tightly closed to protect from
light.
6.5 NATURE AND CONTENTS OF CONTAINER
Re-sealable sachet composed of paper/polyethylene/aluminium/ethylene
meta-acrylic acid co-polymer containing 5 plasters.
Each carton contains 10 or 30 plasters.
Not all pack sizes may be mark