EMLA CREAM 5%

Active substance: PRILOCAINE

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Other possible side effects:
Common (affect less than 1 in 10 people)
• Redness, slight swelling, or pale skin where the cream was used. This usually goes away after a
short time.
Uncommon (affect less than 1 in 100 people)
• A mild burning or itching sensation when the cream is put on the skin. (When EMLA Cream is used on
the genitals, this is a common side effect, affecting less than 1 in 10 people.)
• A tingling feeling where the cream was put on the skin.
Rare (affect less than 1 in 1,000 people)
• Mild allergic reactions (which may cause rash or swelling).
• Small red dots on the skin where the cream was applied. This is more likely in children with skin
problems such as ‘atopic dermatitis’ or ‘mollusca’.
• Eye irritation after getting cream into your eyes by mistake.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor, pharmacist or nurse.
5. How to store EMLA Cream





Keep out of the reach and sight of children.
Do not store above 30°C and do not freeze.
Do not use the EMLA Cream after the expiry date which is shown on the tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines that are no longer required. This will help to protect the environment.

6. Further 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 polyoxyethylene hydrogenated castor oil, 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 AstraZeneca UK Limited, 600 Capability Green,
Luton, LU1 3LU, UK.
EMLA Cream 5% pre-medication pack is manufactured by AstraZeneca AB, S-151 85, Södertälje,
Sweden. EMLA Cream 5% 5 g pack is manufactured by AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

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 17901/0120
This is a service provided by the Royal National Institute of
Blind People.
Leaflet prepared: June 2012
© AstraZeneca 2012
EMLA is a trade mark of the AstraZeneca group of companies.
PAI 12 0073

PACKAGE LEAFLET: INFORMATION FOR THE USER

P034411

EMLA Cream 5%

(for 5 g and pre-medication packs)
lidocaine 2.5%, prilocaine 2.5%
Read all of this leaflet carefully before you or your child start using this medicine.
This medicine is available without prescription. However, you still need to use EMLA Cream carefully
to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor, pharmacist or nurse.
In this leaflet:
1. What EMLA Cream is and what it is used for
2. Before you use EMLA Cream
3. How to use EMLA Cream
4. Possible side effects
5. How to store EMLA Cream
6. Further information
1. What EMLA Cream is and what it is used for
EMLA Cream contains two medicines 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
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.
• Some types of skin graft.
• Cleansing or debridement of leg ulcers.
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 supervise the use of EMLA Cream on the genitals.
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.
2. Before you use EMLA Cream
Do not use EMLA Cream if:
• You are allergic (hypersensitive) to lidocaine, prilocaine or any of the other ingredients of EMLA Cream
(listed in Section 6: Further information).
Take special care with EMLA Cream
Check with your doctor, pharmacist or nurse before using EMLA Cream if:
• You or your child are anaemic (a blood problem which means you have too few red blood cells).
• You or your child have a rare inherited illness that affects the blood called ‘glucose-6-phosphate
dehydrogenase deficiency’.
• You or your child have a problem with blood pigment levels called ‘methaemoglobinaemia’.
• You or your child have a skin condition called ‘atopic dermatitis’. This is because the cream may need to
be put on the skin for a shorter time.
• Your child is a pre-term newborn infant.
• Your child is younger than 12 months and is being treated at the same time with other medicines that
affect blood pigment levels ‘methaemoglobinaemia’.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking, or have recently taken, 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, pharmacist or nurse if you or your child have recently used or been given any
of the following medicines:
• Medicines called ‘sulphonamides’ such as sulfamethoxazole.
• Other local anaesthetics.
• Medicines to treat an uneven heart beat, such as mexiletine or amiodarone.

4

1

Pregnancy and breast-feeding
• Talk to your doctor, pharmacist or nurse before using EMLA Cream if you are pregnant, may become
pregnant or are breast-feeding.
• The medicines 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.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Important information about some of the ingredients of EMLA Cream
EMLA cream contains polyoxyethylene hydrogenated castor oil. This may cause skin reactions.
3. How to use EMLA Cream
Always use EMLA Cream exactly as your doctor, pharmacist or nurse has told you. You should check with
your doctor, pharmacist or nurse if you are not sure.
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.

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”. The application time
is 30 minutes.
Applying the correct dose
Cream applied to a circular area with a diameter of about 18 mm (a 1 pence coin) and depth of about
5 mm is equal to 1 g of EMLA cream.
When you apply the cream, it is very important to exactly follow the instructions below:
1. Squeeze the cream into a
5. Remove the covers of the
mound where it is needed
dressing. Then place the
on your skin (for example
dressing carefully over the
where the needle is going
mound of cream. Do not
to be put in). Cream applied
spread the cream under the
to a circular area with a
dressing.
diameter of about 18 mm
(a 1 pence coin) and depth of
about 5 mm is equal to 1 g of
EMLA cream.
2. Do not rub the cream in.

Using EMLA Cream
• Where to put the cream, how much to use and how long to leave it on for will depend on what it is
needed for.
• Your doctor, pharmacist or nurse will put the cream on or show you how to do it yourself.
• If applying the cream yourself, before you do you must get dressings from your doctor, nurse or
pharmacist to use with EMLA.
• When EMLA Cream is used on the genitals, a doctor or nurse should supervise its use.
Adults and adolescents aged 12 years and over
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. Your doctor, pharmacist or nurse will tell you where to put it.
The usual dose is 2 g applied for 1 to 5 hours under a dressing.
Use on the skin before hospital procedures (such as split-skin grafting) that require deeper skin
anaesthesia:
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,
applied for 2 to 5 hours under a dressing.
Use on larger areas of newly shaven skin before outpatient procedures (such as hair removal
techniques):
The usual dose is 1.5 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 genital skin before injections of local anaesthetics (adult men only):
The usual dose is 1 g of cream for each area of skin that is 10 cm² (10 square centimetres) in size, applied
for 15 minutes under a dressing.
Use on genital skin before minor skin surgery (such as removal of warts for adults only):
The usual dose is 5 g to 10 g of cream applied for 10 minutes with no dressing. The medical procedure
should then start immediately.
Use on leg ulcers before cleaning or debridement:
The usual dose is 1-2g 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.
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 under the age of 3 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 3-12 months: Up to 2 g of cream on a total skin area not larger than 20 cm
(20 square centimetres) in size. Application time: approx 1 hour, maximum 4 hours.

2

Children aged 1-6 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 7-11 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.

2

3. Peel the ‘centre cut-out’ from
the dressing.

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

4. Peel the paper layer from the
dressing.

7. 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).

What to do if you get EMLA Cream in your eye
• Do not get EMLA Cream in your eyes. This is because it may irritate your eyes.
• If you get EMLA Cream in your eye by mistake, rinse your eye well with lukewarm water or salt
(sodium chloride) solution. Be careful to avoid getting anything in your eye until feeling returns.
If EMLA Cream is accidentally swallowed, talk to your doctor, pharmacist or nurse straight away.
If you use more EMLA Cream than you should
• If you use more EMLA Cream 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 heart beat. These effects may be life-threatening.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, EMLA Cream can cause side effects, although not everybody gets them.
Severe allergic reactions (rare, affect less than 1 in 1,000 people)
If you have a severe allergic reaction, stop using EMLA Cream and see a doctor straight away. The
signs may include sudden onset of:
• Rash.
• Feeling short of breath.
• Low blood pressure, which may make you feel faint or dizzy.
• Swelling of the face, lips, tongue or other parts of the body.
Bluish-grey skin (rare, affects less than 1 in 1,000 people)
The skin may become bluish-grey due to a lack of oxygen. If this happens to you, see a doctor straight away.
3

481580028

PACKAGE LEAFLET: INFORMATION FOR THE USER

EMLA Cream 5%
(for 5 g and pre-medication packs)
lidocaine 2.5%, prilocaine 2.5%

Read all of this leaflet carefully before you or your child start using this
medicine.
This medicine is available without prescription. However, you still need to use
EMLA Cream carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, pharmacist or nurse.
In this leaflet:
1. What EMLA Cream is and what it is used for
2. Before you use EMLA Cream
3. How to use EMLA Cream
4. Possible side effects
5. How to store EMLA Cream
6. Further information
1. What EMLA Cream is and what it is used for
EMLA Cream contains two medicines 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
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.
• Some types of skin graft.
• Cleansing or debridement of leg ulcers.
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 supervise the use of EMLA Cream on the genitals.
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.
2. Before you use EMLA Cream
Do not use EMLA Cream if:
• You are allergic (hypersensitive) to lidocaine, prilocaine or any of the other
ingredients of EMLA Cream (listed in Section 6: Further information).
Take special care with EMLA Cream
Check with your doctor, pharmacist or nurse before using EMLA Cream if:
• You or your child are anaemic (a blood problem which means you have too
few red blood cells).
• You or your child have a rare inherited illness that affects the blood called
‘glucose-6-phosphate dehydrogenase deficiency’.
• You or your child have a problem with blood pigment levels called
‘methaemoglobinaemia’.
• You or your child have a skin condition called ‘atopic dermatitis’. This is
because the cream may need to be put on the skin for a shorter time.
• Your child is a pre-term newborn infant.
• Your child is younger than 12 months and is being treated at the same time
with other medicines that affect blood pigment levels ‘methaemoglobinaemia’.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking, or have recently
taken, 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, pharmacist or nurse if you or your child have
recently used or been given any of the following medicines:
• Medicines called ‘sulphonamides’ such as sulfamethoxazole.
• Other local anaesthetics.
• Medicines to treat an uneven heart beat, such as mexiletine or amiodarone.
Pregnancy and breast-feeding
• Talk to your doctor, pharmacist or nurse before using EMLA Cream if you
are pregnant, may become pregnant or are breast-feeding.
• The medicines 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.
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.

Important information about some of the ingredients of EMLA Cream
EMLA cream contains polyoxyethylene hydrogenated castor oil. This may
cause skin reactions.
3. How to use EMLA Cream
Always use EMLA Cream exactly as your doctor, pharmacist or nurse has told
you. You should check with your doctor, pharmacist or nurse if you are not sure.
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.
Using EMLA Cream
• Where to put the cream, how much to use and how long to leave it on for
will depend on what it is needed for.
• Your doctor, pharmacist or nurse will put the cream on or show you how to
do it yourself.
• If applying the cream yourself, before you do you must get dressings from
your doctor, nurse or pharmacist to use with EMLA.
• When EMLA Cream is used on the genitals, a doctor or nurse should
supervise its use.
Adults and adolescents aged 12 years and over
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. Your doctor, pharmacist or
nurse will tell you where to put it. The usual dose is 2 g applied for 1 to 5 hours
under a dressing.
Use on the skin before hospital procedures (such as split-skin grafting)
that require deeper skin anaesthesia:
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, applied for 2 to 5 hours under a dressing.
Use on larger areas of newly shaven skin before outpatient procedures
(such as hair removal techniques):
The usual dose is 1.5 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 genital skin before injections of local anaesthetics (adult men only):
The usual dose is 1 g of cream for each area of skin that is 10 cm²
(10 square centimetres) in size, applied for 15 minutes under a dressing.
Use on genital skin before minor skin surgery (such as removal of warts
for adults only):
The usual dose is 5 g to 10 g of cream applied for 10 minutes with no dressing.
The medical procedure should then start immediately.
Use on leg ulcers before cleaning or debridement:
The usual dose is 1-2g 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.
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 under the age of 3 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 3-12 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 1-6 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 7-11 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”. The application time is 30 minutes.
Applying the correct dose
Cream applied to a circular area with a diameter of about 18 mm (a 1 pence coin)
and depth of about 5 mm is equal to 1 g of EMLA cream.
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). Cream applied to a circular area with a diameter of
about 18 mm (a 1 pence coin) and depth of about 5 mm is
equal to 1 g of EMLA cream.
2. Do not rub the cream in.
3. Peel the ‘centre cut-out’ from the dressing.

4. Peel the paper layer from the dressing.

5. Remove the covers of the dressing. Then place the
dressing carefully over the mound of cream. Do not spread
the cream under the dressing.

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

7. 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).

What to do if you get EMLA Cream in your eye
• Do not get EMLA Cream in your eyes. This is because it may irritate your eyes.
• If you get EMLA Cream in your eye by mistake, rinse your eye well with
lukewarm water or salt (sodium chloride) solution. Be careful to avoid
getting anything in your eye until feeling returns.
If EMLA Cream is accidentally swallowed, talk to your doctor, pharmacist or
nurse straight away.
If you use more EMLA Cream than you should
• If you use more EMLA Cream 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 heart beat. These effects may
be life-threatening.
If you have any further questions on the use of this product, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, EMLA Cream can cause side effects, although not
everybody gets them.
Severe allergic reactions (rare, affect less than 1 in 1,000 people)
If you have a severe allergic reaction, stop using EMLA Cream and see a
doctor straight away. The signs may include sudden onset of:
• Rash.
• Feeling short of breath.
• Low blood pressure, which may make you feel faint or dizzy.
• Swelling of the face, lips, tongue or other parts of the body.
Bluish-grey skin (rare, affects less than 1 in 1,000 people)
The skin may become bluish-grey due to a lack of oxygen. If this happens to
you, see a doctor straight away.
Other possible side effects:
Common (affect less than 1 in 10 people)
• Redness, slight swelling, or pale skin where the cream was used. This
usually goes away after a short time.
Uncommon (affect less than 1 in 100 people)
• A mild burning or itching sensation when the cream is put on the skin.
(When EMLA Cream is used on the genitals, this is a common side effect,
affecting less than 1 in 10 people.)
• A tingling feeling where the cream was put on the skin.
Rare (affect less than 1 in 1,000 people)
• Mild allergic reactions (which may cause rash or swelling).
• Small red dots on the skin where the cream was applied. This is more likely
in children with skin problems such as ‘atopic dermatitis’ or ‘mollusca’.
• Eye irritation after getting cream into your eyes by mistake.
If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor, pharmacist or nurse.
5. How to store EMLA Cream
• Keep out of the reach and sight of children.
• Do not store above 30°C and do not freeze.
• Do not use the EMLA Cream after the expiry date which is shown on the tube.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. This will help to protect the environment.
6. Further 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 polyoxyethylene hydrogenated castor oil,
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
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.
EMLA Cream 5% pre-medication pack is manufactured by AstraZeneca AB,
S-151 85, Södertälje, Sweden. EMLA Cream 5% 5 g pack is manufactured by
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.

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
17901/0120
This is a service provided by the Royal
National Institute of Blind People.
Leaflet prepared: June 2012
© AstraZeneca 2012
EMLA is a trade mark of the AstraZeneca group of companies.
PAI 12 0073

User Leaflet for Healthcare Professionals

EMLA Cream 5%

PACKAGE LEAFLET: INFORMATION FOR THE USER

EMLA Cream 5%
(for 30 g surgical packs)
lidocaine 2.5%, prilocaine 2.5%

Application instructions for surgical use only (split skin grafting).
Apply approximately 1.5–2 g/10 cm2 EMLA Cream 5%, at least 2 hours and not more than 5 hours before split skin
graft procedure.

1. Shave the skin of the
selected donor site area.
Clean the area of skin with
alcohol.

2. Select the exact area of
the donor site by using the
graduated ruled edge of this
leaflet, e.g. 10 cm x 10 cm or
10 cm x 20 cm – and mark
this area using an indelible
thick marker pen to delineate
the margins of the site.

3. Squeeze out between
½–1 (30 g) tube of
EMLA Cream 5% per
100 cm2 on the area
of the donor site to be
anaesthetised.

Read all of this leaflet carefully before you or
your child start using this medicine.
This medicine is available without prescription.
However, you still need to use EMLA Cream
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse.

• You or your child have a rare inherited illness that
affects the blood called ‘glucose-6-phosphate
dehydrogenase deficiency’.
• You or your child have a problem with blood pigment
levels called ‘methaemoglobinaemia’.
• You or your child have a skin condition called ‘atopic
dermatitis’. This is because the cream may need to
be put on the skin for a shorter time.
• Your child is a pre-term newborn infant.
• Your child is younger than 12 months and is being
treated at the same time with other medicines that
affect blood pigment levels ‘methaemoglobinaemia’.

In this leaflet:
1. What EMLA Cream is and what it is used for
2. Before you use EMLA Cream
3. How to use EMLA Cream
4. Possible side effects
5. How to store EMLA Cream
6. Further information

Taking other medicines
Please tell your doctor, pharmacist or nurse if you are
taking, or have recently taken, 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.

1. What EMLA Cream is and what it is used for

4. Spread the EMLA Cream 5%
using the enclosed spatula
to form an even, thick layer.
It is important to cover
completely the entire donor
area including over the
marked margins of the site.

7. Wrap the entire site using
an elastic crepe bandage
to protect the site and
avoid leakage of the
EMLA Cream 5% – but avoid
undue compression and do
not wrap too tight. Leave
the EMLA Cream 5% and
occlusive wrapping in place
for at least 2 hours. As a
reminder, the time can be
written on the wrapping or
bandage.

5. Take a strip of transparent
occlusive plastic film wrapping
cut to the appropriate size
(slightly larger than the area
of the donor site). Carefully
apply the wrapping to cover
completely the layer of
EMLA Cream 5%.

8. After 1 hour and hourly
thereafter – remove only
the crepe bandage (not
the adhesive tape or film
wrapping) and massage the
EMLA Cream 5% through
the film wrapping to ensure
a thick, even layer of EMLA
is maintained over the entire
donor site. Replace the
bandage.

4

6. Smooth down and tape
the edges of the occlusive
film wrapping to the skin
using a surgical synthetic
adhesive tape.

In particular, tell your doctor, pharmacist or nurse if you
or your child have recently used or been given any of
the following medicines:
• Medicines called ‘sulphonamides’ such as
sulfamethoxazole.
• Other local anaesthetics.
• Medicines to treat an uneven heart beat, such as
mexiletine or amiodarone.

EMLA Cream contains two medicines 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
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.
• Some types of skin graft.
• Cleansing and debridement of leg ulcers.

9. After a minimum of 2 hours –
just prior to surgery – remove
the bandage and occlusive
wrapping. Wipe off the
EMLA Cream 5%. Analgesic
efficacy may decline if
application time is >5 hours.
The anaesthetised donor
site may appear either pale
or red. These reactions are
normal and are associated
with the skin anaesthesia.
Disinfect and prepare the
anaesthetised donor site prior
to cutting the split skin graft.

P034378

Pregnancy and breast-feeding
• Talk to your doctor, pharmacist or nurse before using
EMLA Cream if you are pregnant, may become
pregnant or are breast-feeding.
• The medicines 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.

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 supervise the use of EMLA Cream
on the genitals.

Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.
Important information about some of the ingredients
of EMLA Cream
EMLA cream contains polyoxyethylene hydrogenated
castor oil. This may cause skin reactions.

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.

3. How to use EMLA Cream
Always use EMLA Cream exactly as your doctor,
pharmacist or nurse has told you. You should check with
your doctor, pharmacist or nurse if you are not sure.

2. Before you use EMLA Cream
Do not use EMLA Cream if:
• You are allergic (hypersensitive) to lidocaine, prilocaine
or any of the other ingredients of EMLA Cream (listed
in Section 6: Further information).

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.

Take special care with EMLA Cream
Check with your doctor, pharmacist or nurse before
using EMLA Cream if:
• You or your child are anaemic (a blood problem
which means you have too few red blood cells).
1

Using EMLA Cream
• Where to put the cream, how much to use and how long
to leave it on for will depend on what it is needed for.
• Your doctor, pharmacist or nurse will put the cream
on or show you how to do it yourself.
• If applying the cream yourself, before you do you
must get dressings from your doctor, nurse or
pharmacist to use with EMLA.
• When EMLA Cream is used on the genitals, a doctor
or nurse should supervise its use.

Infants aged 3-12 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 1-6 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 7-11 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.

Adults and adolescents aged 12 years and over
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. Your doctor,
pharmacist or nurse will tell you where to put it. The usual
dose is 2 g applied for 1 to 5 hours under a dressing.

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”. The application time
is 30 minutes.

Use on the skin before hospital procedures (such
as split-skin grafting) that require deeper skin
anaesthesia:
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,
applied for 2 to 5 hours under a dressing. The attached
‘User Leaflet for the Healthcare Professional’ contains
further information for your doctor or nurse.

Applying the correct dose
Cream applied to a circular area with a diameter of
about 18 mm (a 1 pence coin) and depth of about 5 mm
is equal to 1 g of EMLA cream.
Alternatively, a line of cream of about 3.5 cm squeezed
from the 30 g tube is equal to 1 g of cream.
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).
A line of cream of about 3.5 cm is equal
to 1 g of cream.
2. Do not rub the cream in.
3. Peel the ‘centre cut-out’ from the dressing.

Use on larger areas of newly shaven skin before
outpatient procedures (such as hair removal
techniques):
The usual dose is 1.5 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 genital skin before injections of local
anaesthetics (adult men only):
The usual dose is 1 g of cream for each area of skin that
is 10 cm² (10 square centimetres) in size, applied for
15 minutes under a dressing.

4. Peel the paper layer from the dressing.

Use on genital skin before minor skin surgery (such
as removal of warts for adults only):
The usual dose is 5 g to 10 g of cream applied for
10 minutes with no dressing. The medical procedure
should then start immediately.

5. Remove the covers of the dressing.
Then place the dressing carefully over
the mound of cream. Do not spread the
cream under the dressing.

Use on leg ulcers before cleaning or debridement:
The usual dose is 1-2g 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.

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

EMLA Cream can be used before cleansing of leg ulcers
for up to 15 times over a period of 1 -2 months.

7. 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).

Children
Use on the skin before small procedures (such as
having a needle put in or minor skin operations)
Application time: approx. 1 hour.

What to do if you get EMLA Cream in your eye
• Do not get EMLA Cream in your eyes. This is
because it may irritate your eyes.
• If you get EMLA Cream in your eye by mistake,
rinse your eye well with lukewarm water or salt
(sodium chloride) solution. Be careful to avoid getting
anything in your eye until feeling returns.

Newborn infants and infants under the age of
3 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.
2

If EMLA Cream is accidentally swallowed, talk to your
doctor, pharmacist or nurse straight away.

If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor, pharmacist or nurse.

If you use more EMLA Cream than you should
• If you use more EMLA Cream 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 heart beat. These effects may
be life-threatening.

5. How to store EMLA Cream
• Keep out of the reach and sight of children.
• Do not store above 30°C and do not freeze.
• Do not use the EMLA Cream after the expiry date
which is shown on the tube.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines that are no longer required.
This will help to protect the environment.
6. Further 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 polyoxyethylene
hydrogenated castor oil, 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 tube containing 30 g of cream without any
dressings. A wooden spatula is enclosed for applying
your cream.

If you have any further questions on the use of this product,
ask your doctor, pharmacist or nurse.
4. Possible side effects

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for EMLA Cream 5% is
held by AstraZeneca UK Limited, 600 Capability Green,
Luton, LU1 3LU, UK.

Like all medicines, EMLA Cream can cause side effects,
although not everybody gets them.
Severe allergic reactions (rare, affect less than 1 in
1,000 people)
If you have a severe allergic reaction, stop using
EMLA Cream and see a doctor straight away. The
signs may include sudden onset of:
• Rash.
• Feeling short of breath.
• Low blood pressure, which may make you feel faint
or dizzy.
• Swelling of the face, lips, tongue or other parts of
the body.

EMLA Cream 5% 30 g pack is manufactured by
AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

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 17901/0120
This is a service provided by the
Royal National Institute of Blind People.

Bluish-grey skin (rare, affects less than 1 in 1,000 people)
The skin may become bluish-grey due to a lack of oxygen.
If this happens to you , see a doctor straight away.
Other possible side effects:
Common (affect less than 1 in 10 people)
• Redness, slight swelling, or pale skin where the cream
was used. This usually goes away after a short time.
Uncommon (affect less than 1 in 100 people)
• A mild burning or itching sensation when the cream
is put on the skin. (When EMLA Cream is used on
the genitals, this is a common side effect, affecting
less than 1 in 10 people.)
• A tingling feeling where the cream was put on the skin.

Leaflet prepared: June 2012
© AstraZeneca 2012
EMLA is a trade mark of the AstraZeneca group of
companies.

Rare (affect less than 1 in 1,000 people)
• Mild allergic reactions (which may cause rash or
swelling).
• Small red dots on the skin where the cream was
applied. This is more likely in children with skin
problems such as ‘atopic dermatitis’ or ‘mollusca’.
• Eye irritation after getting cream into your eyes by
mistake.

PAI 12 0074

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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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