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Active substance(s): LIDOCAINE

PDF Transcript

Versatis® 5% Medicated Plasters

Ref: 1495/051214/1/F

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.
Your medicine is called Versatis 5% Medicated
Plasters but will be referred to as Versatis
throughout the leaflet.

In this leaflet:
1 What Versatis is and what it is used for
2 What you need to know before you use
3 How to use Versatis
4 Possible side effects
5 How to store Versatis
6 Contents of the pack and other information

Driving and using machines
An effect of Versatis on the ability to drive and use
machines is unlikely. Therefore you may drive or
operate machinery whilst using Versatis.
Versatis contains propylene glycol, methyl
parahydroxybenzoate and propyl
The plasters contain propylene glycol (E1520) which
may cause skin irritation. In addition it contains
methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216) which may
cause allergic reactions. The allergic reactions may
sometimes occur after you have been using the
plaster for some time.


How to use Versatis

Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The usual daily dose is to use between one and
three plasters of the size of the painful areas of your
skin. Versatis may be cut into smaller pieces to fit
the affected area. You should not use more than 3
plasters at the same time. The plasters should be
removed after 12 hours of use, so that you have a
12 hour period with no plaster.

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 postherpetic neuralgia. This is
generally characterised by localised symptoms
such as burning, shooting or stabbing pain.

2 What you need to know before you use

You can choose to apply Versatis during the day or
during the night. Usually, you will feel some pain
relief on the first day you use the plaster, but it may
take up to 2 - 4 weeks until the full pain-relief effect
of Versatis is seen. If after that time you still have a
lot of pain, please talk to your doctor because the
benefits of the treatment must be weighed against
potential risks (see Section 2 under ‘Warnings and
precautions’). Your doctor will check how well
Versatis is working at regular intervals.

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
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 baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Versatis should not be used in pregnancy unless
clearly necessary. There are no studies of the
plaster in breast-feeding women. When using
Versatis, only very small amounts of the active
substance lidocaine may be present in the blood
stream. An effect on breast-fed infants is unlikely.

Before you stick Versatis on the affected area
- If the painful area of skin has hairs on it, you can
cut the hairs off using scissors. Do not shave them
- The skin should be clean and dry.
- Creams and lotions may be used on the affected
skin during the period when you are not wearing
the plaster.
- If you have had a recent bath or shower, you
should wait until your skin cools before using the
Sticking the plaster on
Step 1: open the sachet and remove one or more

tear open or cut the sachet along the dotted
when using scissors, be careful not to damage
the plasters
take out one or more plasters depending on
the size of the painful area on your skin

Step 2: close the sachet

• close the sachet tightly
after use

• the plaster contains

water, and will dry out if
the sachet is not closed

Step 3: cut the plaster, if necessary

• if required, cut the

plaster to the required
size to fit the painful
area of skin before
removing the liner.

Step 4: remove the liner

• remove the transparent
liner from the plaster

• try not to touch the

sticky part of the plaster

Step 5: apply the plaster and press it firmly onto
the skin
• apply up to three
plasters to the painful
area of skin
• press the plaster onto
your skin
• press for at least 10
seconds to make sure
the plaster sticks firmly
• make sure that all of it
sticks to your skin,
including the edges
Leave the plaster on for 12 hours only
It is important that
Versatis is in contact
with your skin for only
12 hours. For example,
if you have more pain at
night you might want to
apply the plaster at 7pm
in the evening and
remove it at 7am in the
If you have more pain during the day than at night
you might want to apply Versatis at 7am in the
morning, and remove it at 7pm in the evening.
Bathing, showering and swimming
If at all possible contact with water should be
avoided whilst using Versatis. Bathing, showering or
swimming can be done in the time period when you
are not wearing the plaster. If you have had a recent
bath or shower, you should wait until your skin cools
before using the plaster.
If the plaster comes off
Very rarely the plaster might fall off, or come
unstuck. If it does, try sticking it back on the same
area. If it does not stay on, remove it and put a new
plaster on the same area.
How to remove Versatis
When changing the plaster, remove the old plaster
slowly. If it does not come off easily, you can soak it
in warm water for a few minutes before removing the
If you forget to remove the plaster after 12 hours
As soon as you remember, remove the old plaster.
A new plaster can be used again after 12 hours.
If you use more plasters than you should
If you use more plasters than necessary or wear
them for too long, this may increase the risk of
getting side effects.
If you forget to use Versatis
After the 12 hour period with no plaster, if you have
forgotten to use a new plaster, you should stick on a
new plaster as soon as you remember. If you have
any further questions on use of this product, ask
your doctor or pharmacist.


Possible side effects

Very rare side effects which may affect up to 1 in
10,000 people are listed below.
Open wound, severe allergic reaction and allergy.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at: By reporting side
effects you can help provide more information on the
safety of this medicine.


How to store Versatis


• Keep the sachet tightly closed.
• Do not refrigerate or freeze.
• After first opening of the sachet, the plasters must
be used within 14 days.
• Do not use after the expiry date which is stated on
the sachet label and on the carton.

• Do not use this medicine if you notice that the
sachet has been damaged. If this has occurred,
the plasters may dry out and become less sticky.
How to throw away Versatis
Used plasters still contain active ingredient, which
may be harmful to others. Fold the used plasters in
half, with the sticky sides together and throw them
away so that they are out of the reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the

Further Information

What Versatis contains
• The active substance is lidocaine.
• Each 10 cm x 14 cm plaster contains 700 mg
(5% w/w) lidocaine
• The other ingredients in the plaster are glycerol,
liquid sorbitol crystallisable, 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).
Release liner: polyethylene terephthalate.
What Versatis looks like and contents of the
White medicated plasters made of a fleece fabric
marked with lidocaine 5%. The plasters are packed
in re-sealable sachets, each containing 5 plasters.
Each carton contains 30 plasters packed in
6 sachets.
Manufacturer and Licence Holder
Versatis is manufactured by Grunenthal GmbH,
Zieglerstrasse 6 -52078 Aachen, Germany and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE
Versatis is a registered trademark of Grünenthal

POM PL 15184/1495
Leaflet revision date: 05/12/14

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If irritation or burning sensation occurs whilst you
are using the plaster, the plaster should be
removed. The area of irritation should remain plaster
free until the irritation stops.
Very common side effects which may affect
more than 1 in 10 people are listed below.
These include skin conditions at or around the site
of plaster application, which may include redness,
rash, itching, burning, dermatitis, and small

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Uncommon side effects which may affect up to 1
in 100 people are listed below.
Skin injury and skin wounds

Ref: 1495/051214/1/B

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.