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EMLA CREAM 5%

Active substance(s): LIDOCAINE / PRILOCAINE

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ASPEN Artwork Panel
AW Version:
01

Page:
1 of 2

New Item Code:
482160028
Replacement:
480036128
Market:
UK

482160028

EMLA Cream 5%

Number of Colours:
1

(for 5 g and pre-medication packs)
lidocaine/prilocaine

1. What EMLA Cream is and what it is used for
EMLA Cream contains two active substances called
lidocaine and prilocaine. These belong to a group of
medicines called local anaesthetics.
EMLA Cream works by numbing the surface of the
skin for a short time. It is put on the skin before
certain medical procedures. This helps to stop pain
on the skin; however you may still have the feelings
of pressure and touch.
Adults, Adolescents and Children
It can be used to numb the skin before:
• Having a needle put in (for example, if you are
having an injection or a blood test).
• Minor skin operations.
Adults and Adolescents
It can also be used:
• To numb the genitals before:
- Having an injection.
- Medical procedures such as removal of warts.
A doctor or nurse should apply EMLA Cream on the
genitals.
Adults
It can also be used to numb the skin before:
• 
Cleansing or removal of damaged skin of leg ulcers.
For other purposes than application to intact skin, the
product should be used only upon recommendation
of a doctor, nurse or pharmacist.

PHARMA CODE № 4804

2. What you need to know before you use
EMLA Cream
Do not use EMLA Cream:
• if you are allergic to lidocaine or prilocaine, other
similar local anaesthetics or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
EMLA Cream:
• if you or your child have a rare inherited illness
that affects the blood called ‘glucose-6-phosphate
dehydrogenase deficiency’.
• if you or your child have a problem with blood
pigment levels called ‘methaemoglobinaemia’.
• Do not use EMLA Cream on areas with skin
rash, cuts, grazes or other open wounds, with the
exception of a leg ulcer. If any of these problems
are present, check with your doctor, pharmacist or
nurse before using the cream.
• if you or your child have an itchy skin condition
called ‘atopic dermatitis’, a shorter application
time may be sufficient. Application times of longer
than 30 minutes may result in an increased
incidence of local skin reaction (see also
section 4 “Possible side effects”).
• if you take particular products for heart rhythm
disorders (class III antiarrhythmics, such as
amiodarone). In that case the doctor will monitor
your heart function.
Due to the potentially enhanced absorption
on the newly shaven skin, it is important to
follow the recommended dosage, skin area and
application time.
Avoid getting EMLA Cream in the eyes, as it may
cause irritation. If you accidentally get EMLA Cream
in your eye, you should immediately rinse it well with
lukewarm water or salt (sodium chloride) solution.
Be careful to avoid getting anything in your eye until
feeling returns.
EMLA Cream should not be applied to an impaired
eardrum.
When you use EMLA Cream before being vaccinated
with live vaccines (e.g. tuberculosis vaccine), you
should return to your doctor or nurse after the time
period requested to follow-up the vaccination result.
Children and adolescents
In infants/newborn infants younger than 3 months
a transient, clinically not relevant increase in blood
pigment levels “methaemoglobinaemia” is commonly
observed up to 12 hours after EMLA Cream is put on.
The effectiveness of EMLA Cream when drawing
blood from the heel of newborn infants or to provide
adequate analgesia for circumcision could not be
confirmed in clinical studies.
EMLA Cream should not be applied to the genital
skin (e.g. penis) and genital mucosa (e.g. in the
vagina) of children (below 12 years of age) owing to
insufficient data on absorption of active substances.
EMLA Cream should not be used in children younger
than 12 months of age who are being treated at
the same time with other medicines that affect
blood pigment levels “methaemoglobinaemia” (e.g.
sulphonamides, see also Section 2 Other medicines
and EMLA Cream).
EMLA Cream should not be used in preterm
newborn infants.
Other medicines and EMLA Cream
Tell your doctor or pharmacist if you are using /
taking, have recently used / taken or might use / take
any other medicines. This includes medicines that
you buy without a prescription and herbal medicines.
This is because EMLA Cream can affect the way
some medicines work and some medicines can have
an effect on EMLA Cream.
In particular, tell your doctor or pharmacist if you or
your child have recently used or been given any of
the following medicines:
• Medicines used to treat infections, called
‘sulphonamides’ and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin
and phenobarbital.
• Other local anaesthetics.
• Medicines to treat an uneven heartbeat, such as
amiodarone.

BLACK

• Cimetidine or beta-blockers, which may cause
an increase in the blood levels of lidocaine. This
interaction is of no clinical relevance in short-term
treatment with EMLA Cream in recommended
doses.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before using this medicine.
Occasional use of EMLA Cream during pregnancy is
unlikely to have any adverse effects on the foetus.
The active substances in EMLA Cream (lidocaine
and prilocaine) are passed into breast milk. However,
the amount is so small that there is generally no risk
to the child.
Animal studies have shown no impairment of male or
female fertility.
Driving and using machines
EMLA Cream has no or negligible influence on the
ability to drive and use machines when used at the
recommended doses.
EMLA Cream contains macrogolglycerol
hydroxystearate
Macrogolglycerol hydroxystearate may cause skin
reactions.
3. How to use EMLA Cream
Always use EMLA Cream exactly as described in
this leaflet or as your doctor, pharmacist or nurse
has told you. Check with your doctor, pharmacist or
nurse if you are not sure.
Using EMLA Cream
• Where to put the cream, how much to use and
how long to leave it on will depend on what it is
used for. Half a 5 g tube corresponds to about
2 g EMLA. One gram of EMLA pressed out of a
tube is approximately 3.5 cm.
• EMLA Cream should be used on the genitals only
by a doctor or nurse.
• When EMLA Cream is used on leg ulcers, a
doctor or nurse should supervise its use.
Do not use EMLA Cream on the following areas:
• Cuts, grazes or wounds, excluding leg ulcers.
• Where there is a skin rash or eczema.
• In or near the eyes.
• Inside the nose, ear or mouth.
• In the back passage (anus).
• On the genitals of children.
Persons frequently applying or removing cream
should ensure that contact is avoided in order to
prevent the development of hypersensitivity.
The protective membrane of the tube is perforated
by applying the cap.
Use on the skin before small procedures
(such as having a needle put in or minor skin
operations):
• The cream is put on to the skin in a thick layer.
Follow the instructions on the leaflet or those from
your health care professional. In certain cases your
healthcare professional has to apply the cream.
• The cream is then covered by a dressing [plastic
wrap]. This is taken off just before the procedure
starts. If you are applying the cream yourself,
make sure that you have been given dressings by
your doctor, pharmacist or nurse.
• The usual dose for adults and adolescents over
12 years is 2 g (grams).
• For adults and adolescents over 12 years put the
cream on at least 60 minutes before the procedure
(unless the cream is being used on the genitals).
However, do not put it on more than 5 hours before.
Children
Use on the skin before small procedures (such as
having a needle put in or minor skin operations)
Application time: approx. 1 hour.
Newborn infants and infants 0-2 months: Up
to 1 g of cream on a skin area not larger than
10 cm2 (10 square centimetres) in size.  
Application time: 1 hour, not more. Only one single
dose should be given in any 24 hour period.
Infants aged 3-11 months: Up to 2 g of cream on
a total skin area not larger than 20 cm2 (20 square
centimetres) in size.
Application time: approx 1 hour, maximum 4 hours.
Children aged 1-5 years: Up to 10 g of cream on
a total skin area not larger than 100 cm2 (100 square
centimetres) in size.  
Application time: approx 1 hour, maximum 5 hours.
Children aged 6-11 years: Up to 20 g of cream on
a total skin area not larger than 200 cm2 (200 square
centimetres) in size.  
Application time: approx 1 hour, maximum 5 hours.
A maximum of 2 doses at least 12 hours apart may
be given to children over 3 months of age in any
24 hour period.
EMLA Cream can be used on children with a skin
condition called “atopic dermatitis” but the application
time is then 30 minutes, no longer.
When you apply the cream, it is very important to
exactly follow the instructions below:
1. Squeeze the cream into a
mound where it is needed
on your skin (for example
where the needle is going
to be put in). Half a 5 g tube
corresponds to about
2 g EMLA Cream. One gram
of EMLA Cream pressed out
of a tube is approximately
3.5 cm. Do not rub the
cream in.
2. Peel the paper layer from
the ‘centre cut-out’ of the
non-adhesive side of the
dressing (leaving a frame of
paper).

3. Remove the cover of the
adhesive side of the dressing.

4. Place the dressing carefully
over the mound of cream. Do
not spread the cream under
the dressing.

Manufacturing Site:
GES

Drawing Version:
N/A
Originated by:
Dejan Vilenica
Originated at:
Perigord AS
Originated on:
27 Jan 2018
Amended on:
N/A

ASPEN Artwork Panel • May 2013 • Version 5

Drawing Ref. Number:
RKAL011/A

PHARMA CODE № 4804

Read all of this leaflet carefully before you or
your child start using this medicine because it
contains important information for you.
Always use this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse has
told you.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, pharmacist or nurse if you need
more information or advice.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What EMLA Cream is and what it is used for
2. What you need to know before you use
EMLA Cream
3. How to use EMLA Cream
4. Possible side effects
5. How to store EMLA Cream
6. Contents of the pack and other information

mm Measuring Bar 160

Product Name:
Emla Cream

Package leaflet: Information for the user

ASPEN Artwork Panel
AW Version:
01

Page:
2 of 2

New Item Code:
482160028
Replacement:
480036128

PHARMA CODE № 4804

Use on larger areas of newly shaven skin before
outpatient procedures (such as hair removal
techniques):
Follow the instructions from your healthcare
professional.
The usual dose is 1 g of cream for each area of skin
that is 10 cm² (10 square centimetres) in size, applied
for 1 to 5 hours under a dressing. EMLA Cream
should not be used on an area of newly shaven skin
larger than 600 cm² (600 square centimetres, e.g.
30 cm by 20 cm) in size. The maximum dose is 60 g.
Use on the skin before hospital procedures
(such as split-skin grafting) that require deeper
skin anaesthesia:
• EMLA Cream can be used in this way on adults
and adolescents over 12 years, but only under the
supervision of a doctor or nurse.
• 
The usual dose is 1.5 g to 2 g of cream for each area
of skin that is 10 cm² (10 square centimetres) in size.
• 
The cream is put on under a dressing for 2 to 5 hours.
Use on the skin prior to removal of wart-like
spots called “mollusca”
• EMLA Cream can be used on children and
adolescents with a skin condition called “atopic
dermatitis”.
• The usual dose depends on the child’s age and
is used for 30 to 60 minutes (30 minutes if the
patient has atopic dermatitis). Your doctor, nurse
or pharmacist will tell you how much cream to use.
Use on genital skin before injections of local
anaesthetics
• EMLA Cream can be used in this way only
by healthcare professionals on adults and
adolescents over 12 years.
• The usual dose is 1 g of cream (1 g to 2 g for female
genital skin) for each area of skin that is 10 cm²
(10 square centimetres) in size.
• The cream is put on under a dressing. This is
done for 15 minutes on male genital skin and for
60 minutes on female genital skin.
Use on the genitals before minor skin surgery
(such as removal of warts)
• EMLA Cream can be used in this way only
by healthcare professionals on adults and
adolescents over 12 years.
• The usual dose is 5 g to 10 g of cream for
10 minutes. A dressing is not used. The medical
procedure should then start straight away.
Use on leg ulcers before cleaning or removal of
damaged skin
• EMLA Cream can be used in this way in adults,
but only under the supervision of a doctor or nurse.
• The usual dose is 1 g to 2 g of cream for each
area of skin that is 10 cm2 up to a total of 10 g.
• The cream is put on under an airtight dressing
such as plastic wrap. This is done for 30 to
60 minutes before the ulcer is to be cleansed.
Remove the cream with cotton gauze and start
cleansing without delay.
• EMLA Cream can be used before cleansing of
leg ulcers for up to 15 times over a period of
1 - 2 months.
• The EMLA Cream tube is intended for single
use when used on leg ulcers: The tube with any
remaining contents should be discarded after
each occasion that a patient has been treated.
If you use more EMLA Cream than you should
If you use more EMLA Cream than is described in
this leaflet or more than your doctor, pharmacist or
nurse has told you to, talk to one of them straight
away, even if you do not feel any symptoms.
Symptoms of using too much EMLA Cream are
listed below. These symptoms are unlikely to happen
if EMLA Cream is used as recommended.
• Feeling light-headed or dizzy.
• Tingling of the skin around the mouth and
numbness of the tongue.
• Abnormal taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of ‘acute
methaemoglobinaemia’ (a problem with blood
pigment levels). This is more likely when certain
medicines have been taken at the same time. If
this happens, the skin becomes bluish-grey due
to a lack of oxygen.
In serious cases of overdose, symptoms may include
fits, low blood pressure, slowed breathing, stopped
breathing and altered heartbeat. These effects may
be life-threatening.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Contact your doctor or pharmacist if any of the
following side effects bother you or do not seem to
go away. Tell your doctor about anything else that
makes you feel unwell while you are using EMLA Cream.
A mild reaction (paleness or redness of the skin,
slight puffiness, initial burning or itching) may occur
on the area on which EMLA is used. These are
normal reactions to the cream and the anaesthetics
and will disappear in a short while without any
measures being needed.
If you experience any troublesome or unusual effects
while you are using EMLA, stop using it and check
with your doctor or pharmacist as soon as possible.
Common (may affect up to 1 in 10 people)
• Transient local skin reactions (paleness, redness,
swelling) in the treated area during treatment of
skin, genital mucosa or leg ulcers.
• An initially mild sensation of burning, itching or
warmth at the treated area during treatment of
genital mucosa or leg ulcers.
Uncommon (may affect up to 1 in 100 people)
• 
An initially mild sensation of burning, itching or warmth
at the treated area during treatment of the skin).
• Numbness (tingling) in the treated area during
treatment of genital mucosa.
• Irritation of the treated skin during treatment of leg
ulcers.
Rare (may affect up to 1 in 1,000 people)
• Allergic reactions, which in rare cases may
develop into anaphylactic shock (skin rash, swelling,
fever, respiratory difficulties and fainting) during
treatment of skin, genital mucosa or leg ulcers.

Number of Colours:
1
BLACK

Manufacturing Site:
GES
Drawing Ref. Number:
RKAL011/A
Drawing Version:
N/A
Originated by:
Dejan Vilenica
Originated at:
Perigord AS

5. How to store EMLA Cream
• Keep this medicine out of the sight and reach of
children.
• Do not store above 30°C and do not freeze.
• 
Do not use this medicine after the expiry date which
is stated on the package and tube after “EXP:”. The
expiry date refers to the last day of that month.
• 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 EMLA Cream 5% contains
• The active substances are lidocaine and
prilocaine. Each gram of cream contains 25 mg of
lidocaine and 25 mg of prilocaine.
• The other ingredients are macrogolglycerol
hydroxystearate, Carbomer 974P, sodium
hydroxide and purified water.
What EMLA Cream 5% looks like and contents of
the pack
EMLA Cream 5% is a white soft cream. Your cream
will come in a pre-medication pack containing
5 tubes of cream and 12 dressings, or in a pack
containing 1 tube of cream and 2 dressings, or in a
tube containing 5 g of cream without any dressings.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for EMLA Cream 5% is
held by
Aspen Pharma Trading Limited, 3016 Lake Drive,
Citywest Business Campus, Dublin 24, Ireland
Tel: +44 (0)1 748 828 391
EMLA Cream 5% pre-medication pack and 5g
pack is manufactured by Recipharm Karlskoga AB,
Björkbornsvägen 5,
SE-691 33 KARLSKOGA, Sweden.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Emla 5% - Creme
Belgium

Emla 25mg/25mg crème

Cyprus

Emla Cream 5%

Czech Republic

Emla krém 5%

Denmark

Emla

Finland

EMLA

France

EMLA 5 POUR CENT, crème

Germany

EMLA

Greece

EMLA

Iceland

Emla

Ireland

EMLA 5% w/w Cream

Italy

EMLA

Latvia

Emla 5 % krēms

Luxembourg

Emla 25mg/25mg crème

Malta

EMLA 5% w/w Cream

Norway

Emla

Poland

EMLA

Portugal

Emla

Spain

EMLA 25 mg/g + 25 mg/g crema

Sweden

EMLA

The Netherland

Emla

United Kingdom

Emla Cream 5%

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 EMLA Cream 5%
Reference number
39699/0088
This is a service provided by the
Royal National Institute of Blind
People.
This leaflet was last revised in 10/2017.
© AstraZeneca 2017
EMLA is a trade mark of the AstraZeneca group of
companies.

mm Measuring Bar 160

Product Name:
Emla Cream

Originated on:
27 Jan 2018
Amended on:
N/A

ASPEN Artwork Panel • May 2013 • Version 5

6. Your doctor or nurse will take
the dressing off and remove the
cream just before they do the
medical procedure (for example
just before the needle is put in).

• Methaemoglobinaemia (blood disorder) during
treatment of the skin.
• Small dot-shaped bleeding on the treated area
(particularly on children with eczema after longer
application times) during treatment of the skin.
• Irritation of the eyes if EMLA Cream accidentally
comes into contact with them during treatment of
the skin.
Additional side effects in children
Methaemoglobinaemia, a blood disorder, which is
more frequently observed, often in connection with
overdose in newborn infants and infants aged 0 to
12 months.
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,
Website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information
on the safety of this medicine.

PHARMA CODE № 4804

5. Remove the paper backing.
Smooth down the edges of
the dressing carefully. Then
leave it in place for at least
60 minutes.

Market:
UK

Annotations
ID

Page Date

First Name

Last Name

Content

Approvals
Date

First Name

Last Name

Type

29-Jan-18 17:44:01

Susanne

Antonson

approved

+ 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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