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LIDOCAINE 5% MEDICATED PLASTER

Active substance(s): LIDOCAINE / LIDOCAINE / LIDOCAINE

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Package Leaflet: Information for the user

Revision date: 12.01.2017
Leaflet reference: VERS5%

Versatis® 5% medicated plaster
(lidocaine)
Your medicine is called Versatis® 5% medicated plaster but will be
referred to as Versatis® throughout the leaflet.

Versatis® contains propylene glycol, methyl parahydroxybenzoate
and propyl parahydroxybenzoate

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.

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.

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.

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.

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.

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

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.
 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

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®

Step 2: close the sachet

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

 close the sachet tightly after use
 the plaster contains water, and will dry out
if the sachet is not closed properly.

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®.

4

1

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.

If you forget to use Versatis®

What Versatis® looks like and contents of the pack

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.

The medicated plaster is 14 cm long and 10 cm wide.
It is a 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 in a re-sealable paper/foil sachet.
Each carton contains 30 plasters packed in 6 re-sealable sachets.
Each sachet contains 5 plasters.

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.

Step 4: remove the liner
 remove the transparent liner from the
plaster
 try not to touch the sticky part of the plaster

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.

Manufacturer and Product Licence Holder
This medicine is manufactured by Grünenthal GmbH, Zieglerstrasse 6,
52078 Aachen, Germany. Procured from within the EU and repackaged
by Product Licence Holder Beachcourse Limited, 20 Alliance Court,
Alliance Road, London W3 0RB, UK.
Revision Date: 12.01.2017
Leaflet reference: VERS5%

Uncommon side effects which may affect up to 1 in 100 people are
listed below.
POM

Skin injury and skin wounds
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

Very rare side effects which may affect up to 1 in 10,000 people are
listed below.

PL 16378/0590 Versatis® 5% medicated plaster

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.

Versatis® is a registered trademark of Grünenthal GmbH.

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.

Leave the plaster on for 12 hours only
®

5. HOW TO STORE VERSATIS

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.

®

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse, Tel: 020 8896 9054
for help.

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.

Bathing, showering and swimming

How to throw away Versatis®

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.

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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

How to remove Versatis®

What Versatis® contains

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.

The active substance is lidocaine.
Each 14 cm x 10 cm plaster contains 700 mg (5% w/w) lidocaine.
The other ingredients in the plaster are glycerol, sorbitol liquid
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 and
purified water.
Backing fabric and release liner: polyethylene terephthalate (PET).

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.

2

3

Package Leaflet: Information for the user

Revision date: 12.01.2017
Leaflet reference: LIDO5%

Lidocaine 5% medicated plaster
Your medicine is called Lidocaine 5% medicated plaster but will be
referred to as Lidocaine throughout the leaflet.

Lidocaine contains propylene glycol, methyl parahydroxybenzoate
and propyl parahydroxybenzoate

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.

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 LIDOCAINE
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. Lidocaine 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 Lidocaine 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
Lidocaine 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 Lidocaine is working at regular intervals.

What is in this leaflet:
1. What Lidocaine is and what it is used for
2. What you need to know before you use Lidocaine
3. How to use Lidocaine
4. Possible side effects
5. How to store Lidocaine
6. Contents of the pack and other information
1. WHAT LIDOCAINE IS AND WHAT IT IS USED FOR
Lidocaine contains lidocaine, a local analgesic, which works by reducing
the pain in your skin.
You have been given Lidocaine to treat a painful skin condition called
post-herpetic neuralgia. This is generally characterised by localised
symptoms such as burning, shooting or stabbing pain.

Before you stick Lidocaine 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIDOCAINE
Do not use Lidocaine
 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.

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

Warnings and precautions
Talk to your doctor or pharmacist before using Lidocaine.
If you have severe liver disease, or severe heart problems, or severe
kidney problems, you should talk to your doctor before using Lidocaine.
Lidocaine 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.
 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

Children and adolescents
Lidocaine 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 Lidocaine

Step 2: close the sachet

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

 close the sachet tightly after use
 the plaster contains water, and will dry out
if the sachet is not closed properly

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.
Lidocaine should not be used in pregnancy unless clearly necessary.
There are no studies of the plaster in breast-feeding women. When using
Lidocaine, 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 Lidocaine on the ability to drive and use machines is unlikely.
Therefore, you may drive or operate machinery whilst using Lidocaine.

4

1

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.

If you forget to use Lidocaine

What Lidocaine looks like and contents of the pack

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.

The medicated plaster is 14 cm long and 10 cm wide.
It is a 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 in a re-sealable paper/foil sachet.
Each carton contains 30 plasters packed in 6 re-sealable sachets.
Each sachet contains 5 plasters.

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.

Step 4: remove the liner
 remove the transparent liner from the
plaster
 try not to touch the sticky part of the plaster

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.

Manufacturer and Product Licence Holder
This medicine is manufactured by Grünenthal GmbH, Zieglerstrasse 6,
52078 Aachen, Germany. Procured from within the EU and repackaged
by Product Licence Holder Beachcourse Limited, 20 Alliance Court,
Alliance Road, London W3 0RB, UK.
Revision Date: 12.01.2017
Leaflet reference: LIDO5%

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

Very rare side effects which may affect up to 1 in 10,000 people are
listed below.

PL 16378/0590 Lidocaine 5% medicated plaster

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.

Blind or partially sighted?

Reporting of side effects

Is this leaflet hard to see or read?

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.

Leave the plaster on for 12 hours only

POM

Phone Beachcourse, Tel: 020 8896 9054
for help.

5. HOW TO STORE LIDOCAINE

It is important that Lidocaine 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 Lidocaine
at 7am in the morning, and remove it at
7pm in the evening.

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.

Bathing, showering and swimming

How to throw away Lidocaine

If at all possible, contact with water should be avoided whilst using
Lidocaine. 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.

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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

How to remove Lidocaine

What Lidocaine contains

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.

The active substance is lidocaine.
Each 14 cm x 10 cm plaster contains 700 mg (5% w/w) lidocaine.
The other ingredients in the plaster are glycerol, sorbitol liquid
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 and
purified water.
Backing fabric and release liner: polyethylene terephthalate (PET).

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.

2

3

Expand Transcript

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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