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VERSATIS 5% MEDICATED PALSTER

Active substance(s): LIDOCAINE

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PATIENT INFORMATION LEAFLET

2844
12.04.16[2]

Versatis® 5% medicated plaster
(lidocaine)
Read all of this leaflet carefully before you start using this medicine.
 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 any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist
Your medicine is available using the above name but will be referred to as
Versatis throughout this leaflet
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. Further 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.

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

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.

 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.

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.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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. 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 (excipients) are glycerol, liquid
sorbitol crystallising, 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.

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.

Backing fabric: polyethylene terephthalate (PET).
Release liner: polyethylene terephthalate.

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.

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 10 or 30 medicated plasters packed in sachets.

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

Manufacturer and Product Licence Holder
Manufactured by Grunenthal GmbH, Zieglerstrasse 6, D-52078 Aachen,
Germany.

Very rare side effects which may affect up to 1 in 10,000 people are
listed below.
Open wound, severe allergic reaction and allergy.

Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.

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.

POM

PL 20636/2844

Leaflet revision and issue date (Ref) 12.04.16[2]
Versatis is a trademark of Grunenthal GmbH.

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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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