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

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’).

2. What you need to know before you use Versatis
Do not use Versatis
– f you are allergic to lidocaine or any of the other ingredients of this medicine (listed in
i
section 6).
– f you have had an allergic reaction to other products which are similar to lidocaine,
i
such as bupivacaine, etidocaine, mepivacaine or prilocaine.
– on injured skin or open wounds


Your doctor will check how well Versatis is working at regular intervals.

Warnings and precautions
Talk to your doctor or pharmacist before using Versatis.

– f you have had a recent bath or shower, you should wait until your skin cools before
I
using the plaster.

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.

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.

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

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.


• 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
• he plaster contains water, and will dry out if the sachet is not
t
closed properly.

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.

Step 3: cut the plaster, if necessary
• f required, cut the plaster to the required size to fit the painful
i
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
•  ress for at least 10 seconds to make sure the plaster sticks
p
firmly

The plasters should be removed after 12 hours of use, so that you have a 12 hour period
with no plaster.

• make sure that all of it sticks to your skin, including the edges

schwarz
GI versatis pflaster

Größe:

210 X 297 MM

Sprache:

en uk

8 pt

Faserlauf:

297 mm

Code:

45

Artikel-Nr.:

93019374

Druckfarbe:

schwarz

Datum:

13.11.2014 V 2

Klass.-Nr.:

50/017/23

Flattermarken:

Name:

Bez. der Vorgängerdatei:

93015918

Vorgängerdatei gelöscht:



Leistungsindex:

5

RZ geprüft:

–/X3

Mazur

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.

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 re-sealable 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

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

Reference number

Versatis 5% medicated plaster

If you have any further questions on use of this product, ask your doctor or pharmacist.

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,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden,
United Kingdom: Versatis
Portugal: Vessatis
This leaflet was last revised in 10/2014.

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
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)

93019374

schwarz
GI versatis pflaster

Größe:

210 X 297 MM

Sprache:

en uk

8 pt

Faserlauf:

297 mm

Code:

45

Artikel-Nr.:

93019374

Druckfarbe:

schwarz

Datum:

13.11.2014 V 2

Klass.-Nr.:

50/017/23

Flattermarken:

Name:

Bez. der Vorgängerdatei:

93015918

Vorgängerdatei gelöscht:



Leistungsindex:

5

RZ geprüft:

3B/X3

Mazur

50/017/23

Expand view ⇕

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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