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VERSATIS 5% MEDICATED PLASTER

Active substance: LIDOCAINE

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Package leaflet: Information for the user

Versatis® 5% 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.
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 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 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 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.
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 parahydroxybenzoate
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.
3. 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.

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.
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 off.
- 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 plaster.
Sticking the plaster on
Step 1: open the sachet and remove one or more plasters

• tear open or cut the sachet along the dotted line
• 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 properly.

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 morning.
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 plaster.
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.
4. Possible side effects
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
blisters.
Uncommon side effects which may affect up to 1 in 100 people are
listed below.
Skin injury and skin wounds
Very rare side effects which may affect up to 1 in 10,000 people are
listed below.
Open wound, severe allergic reaction and allergy.
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
5. How to store Versatis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet
and carton after EXP. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
After first opening: Keep the sachet tightly closed.
After opening the sachet, the plasters should be used within 14 days.
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.

Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other 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 (excipients) are 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)
What Versatis looks like and contents of the pack
The medicated plaster is 14 cm long and 10 cm wide. It is white and made
of fleece fabric marked with “lidocaine 5%”. The plasters are packed in resealable sachets, each containing 5 plasters.
Each carton contains 5, 10, 20, 25 or 30 plasters packed in 1, 2, 4, 5 or
6 sachets, respectively. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Grünenthal Ltd
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex
UB11 1BD
United Kingdom
Manufacturer:
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Reference number

Versatis 5% medicated plaster

PL 21727/0016

This is a service provided by the Royal National Institute of the Blind.
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
France, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Norway, Poland, Romania, Slovak Republic,
Slovenia, Spain, Sweden, United Kingdom: Versatis
Portugal: Vessatis
This leaflet was last revised in 06/2012.

93015918

50/017/23

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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