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LIDOCAINE GRUNENTHAL 5% MEDICATED PLASTER

Active substance(s): LIDOCAINE

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Lidocaine 5% medicated plaster
UK PIL –type IB variation

Version: 10

PACKAGE LEAFLET: INFORMATION FOR THE USER
Package leaflet: Information for the user
Lidocaine 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. Section 4.
What is in this leaflet:
1.
What Lidocaine 5% medicated plaster is and what it is used for
2.
What you need to know before you use Lidocaine 5% medicated plaster
3.
How to use Lidocaine 5% medicated plaster
4.
Possible side effects
5.
How to store Lidocaine 5% medicated plaster
6.
Contents of the pack and other information
1.

What Lidocaine 5% medicated plaster is and what it is used for

contains lidocaine, a local analgesic, which works by reducing the pain in your skin.
You have been given Lidocaine 5% medicated plaster 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 5% medicated plaster

Do not use Lidocaine 5% medicated plaster
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 Lidocaine 5% medicated plaster.
If you have severe liver disease, or severe heart problems, or severe kidney problems, you should talk to
your doctor before using Lidocaine 5% medicated plaster
Lidocaine 5% medicated plaster 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

Lidocaine 5% medicated plaster
UK PIL –type IB variation

Version: 10

Lidocaine 5% medicated plaster 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 5% medicated plaster
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 5% medicated plaster,
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 5% medicated plaster on the ability to drive and use machines is unlikely. Therefore
you may drive or operate machinery whilst using Lidocaine 5% medicated plaster.
Lidocaine 5% medicated plaster 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 5% medicated plaster

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 5% medicated plaster 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 5% medicated plaster 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 5% medicated plaster 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 5% medicated plaster is working at regular intervals.
Before you stick Lidocaine 5% medicated plaster 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.

Lidocaine 5% medicated plaster
UK PIL –type IB variation

Version: 10

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.




remove the transparent liner from the plaster
try not to touch the sticky part of the plaster

Step 4: remove the liner

Lidocaine 5% medicated plaster
UK PIL –type IB variation

Version: 10

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 5% medicated plaster 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 5% medicated plaster
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 5% medicated plaster.
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 5% medicated plaster
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 5% medicated plaster
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

Lidocaine 5% medicated plaster
UK PIL –type IB variation

Version: 10

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.
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 effecrs 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 Lidocaine 5% medicated plaster

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 Lidocaine 5% medicated 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.
6.

Contents of the pack and other information

What Lidocaine 5% medicated plaster contains
- The active substance is lidocaine.
- Each 10 cm x 14 cm plaster contains 700 mg (5% w/w) lidocaine

Lidocaine 5% medicated plaster
UK PIL –type IB variation

-

Version: 10

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 Lidocaine 5% medicated plaster 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

Reference number

Lidocaine 5% medicated
plaster

PL 21727/0017

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

Lidocain Grünenthal
Lidocaϊne Grünenthal
Лидокаин Grünenthal
λιδοκαΐνη Grünenthal

Lidocaine 5% medicated plaster
UK PIL –type IB variation

Czech Republic
Germany
Denmark
Estonia
Greece
Spain
Finland
France
Hungary
Ireland
Iceland
Italy
Lithuania
Luxembourg
Latvia
Malta
Norway
Poland
Portugal
Romania
Sweden
Slovenia
Slovakia
United Kingdom

Lidocaine Grünenthal
Lidocain LIBRAPHARM
Lidocain Grünenthal
Lidokaiin Grünenthal
λιδοκαΐνη Grünenthal
Lidocaína Grünenthal
Lidocaine Grünenthal
Lidocaine Grünenthal
Lidokain Grünenthal
Lidocaine Grünenthal
Lidocaine Grünenthal
Lidocaina Formenti
Lidokainas Grünenthal
Lidocaϊne Grünenthal
Lidocaine Grünenthal
Lidocaine Grünenthal
Lidokain Grünenthal
Lidokaina Grünenthal
Lidocaína Grünenthal
Lidocaina Grünenthal
Lidokain Grünenthal
Lidokain Grünenthal
Lidokaín Grünenthal
Lidocaine

This leaflet was last revised in 10/2014.

Version: 10

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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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