Skip to Content

LIDOCAINE 5% MEDICATED PLASTER

Active substance(s): LIDOCAINE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
®

The name of your medicine is Versatis 5% medicated plaster but will be referred to as
Versatis throughout 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.

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

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.
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.

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.

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.

Step 3: cut the plaster, if necessary

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.

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

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.

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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on safety of this
medicine.
5. How to store Versatis
Keep out of the sight and reach of children.
Do not use Versatis 5% medicated plasters after the expiry date which is stated on
the carton or sachet label 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 must 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.
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 environment.
6. Contents of the pack and other information
What Versatis contains
The active ingredient in Versatis is lidocaine.
Each patch of 14cm x 10cm plaster contains 700mg (5% w/w) lidocaine
Self-adhesive layer: purified water, glycerol, sorbitol liquid crystallising (E420),
polyacrylic acid solution, sodium polyacrylate solution (20%w/w), carmellose
sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin,
polyvinyl alcohol, aluminium glycinate, disodium edetate, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216). Backing fabric
and release liner: polyethylene terephthalate (PET).
What Versatis looks like and contents of the pack
Each medicated plaster are white, 14cm × 10cm wide, soft material labeled with
‘LIDOCAINE 5%’.The plasters are packaged in re-sealable sachets, each containing 5
plasters. The medicated plaster with the drug is 14cm long and 10cm wide.
Each pack contains 30 medicated plasters packed in 6 sachets.
Manufactured by: Grunenthal GmbH, Zweifaller Strasse 112, 52224 Stolberg,
Germany.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Versatis 5% medicated plaster;
PL 18799/2840
Leaflet date: 23.05.2016

POM

Package leaflet: Information for the user

Lidocaine 5% medicated plaster

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 name of your medicine is Lidocaine 5% medicated plaster but will be referred to as
Lidocaine throughout this leaflet.
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.

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

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.
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.

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.

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.

Step 3: cut the plaster, if necessary

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.

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

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
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
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.
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.
Lidocaine 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 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.

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 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.
Bathing, showering and swimming
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.
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 Lidocaine
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 Lidocaine
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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on safety of this
medicine.
5. How to store Lidocaine
Keep out of the sight and reach of children.
Do not use your plasters after the expiry date which is stated on the carton or
sachet label 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 must 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 Lidocaine
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 environment.
6. Contents of the pack and other information
What Lidocaine contains
The active ingredient in Lidocaine is lidocaine.
Each patch of 14cm x 10cm plaster contains 700mg (5% w/w) lidocaine
Self-adhesive layer: purified water, glycerol, sorbitol liquid crystallising (E420),
polyacrylic acid solution, sodium polyacrylate solution (20%w/w), carmellose
sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin,
polyvinyl alcohol, aluminium glycinate, disodium edetate, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216). Backing fabric
and release liner: polyethylene terephthalate (PET).
What Lidocaine looks like and contents of the pack
Each medicated plaster are white, 14cm × 10cm wide, soft material labeled with
‘LIDOCAINE 5%’. The plasters are packaged in re-sealable sachets, each containing 5
plasters. The medicated plaster with the drug is 14cm long and 10cm wide.
Each pack contains 30 medicated plasters packed in 6 sachets.
Manufactured by: Grunenthal GmbH, Zweifaller Strasse 112, 52224 Stolberg,
Germany.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Lidocaine 5% medicated plaster;
PL 18799/2840
Leaflet date: 23.05.2016

POM

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.

Hide