Versatis 5% medicated plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

LTT Pharma Limited

ATC code:

N01BB; N01BB02

INN (International Name):

Lidocaine

Dosage:

5 percent

Pharmaceutical form:

Medicated plaster

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides; lidocaine

Authorization status:

Authorised

Authorization date:

2013-01-11

Patient Information 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:
What Versatis is and what it is used for
What you need to know before you use
Versatis
How to use Versatis
Possible side effects
How to store Versatis
Contents of the pack and other information
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.
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
kn

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Versatis 5% 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) 14 mg
Propyl parahydroxybenzoate (E216) 7 mg
Propylene glycol 700 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
Product imported from the UK 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 PA1189/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1189/009/001
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
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_BACKING FABRIC:_
Polyethylene terephthalate (PET)
_RELEASE LINER:_
Polyethylene terephthalate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SH