The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL39699/0088.
EMLA Cream 5% (for 30 g surgical packs)
EMLA Cream 5%
(for 30 g packs)
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
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
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.
It can be used to numb the skin before:
It can also be used:
A doctor or nurse should apply EMLA Cream on the genitals.
It can also be used to numb the skin before:
For other purposes than application to intact skin, the product should be used only upon recommendation of a doctor, nurse or pharmacist.
Talk to your doctor, pharmacist or nurse before using EMLA Cream:
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.
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.
Tell your doctor, pharmacist or nurse 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, pharmacist or nurse if you or your child have recently used or been given any of the following medicines:
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.
EMLA Cream has no or negligible influence on the ability to drive and use machines when used at the recommended doses.
Macrogolglycerol hydroxystearate may cause skin reactions.
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.
This product is available in different pack sizes. You will have been provided with a suitable pack size for your intended use.
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) 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.
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 of 30g 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.
5. Remove the paper backing. Smooth down the edges of the dressing carefully. Then leave it in place for at least 60 minutes if the skin has not been damaged. The cream should not be left in place for more than 60 minutes in children under 3 months or for more than 30 minutes in children with an itchy skin condition called ‘atopic dermatitis’. If the cream is used on the genitals or on ulcers, shorter applications times may be used as described below.
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).
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 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.
EMLA can be used in this way in adults, but only under the supervision of a doctor or nurse.
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.
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.
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.
If you experience any of the following effects while you are using EMLA Cream, stop using it and check with your doctor or pharmacist as soon as possible:
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)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
EMLA Cream 5% is a white soft cream. Your cream will come in a pack containing single 30g tube of cream without any dressings. A wooden spatula is enclosed to aid application of your cream if required.
The Marketing Authorisation for EMLA Cream 5% is held by
EMLA Cream 5% 30 g pack is manufactured by
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%
France EMLA 5 POUR CENT, crème
Ireland EMLA 5% w/w Cream
Latvia Emla 5 % krēms
Luxembourg Emla 25mg/25mg crème
Malta EMLA 5% w/w Cream
Spain EMLA 25 mg/g + 25 mg/g crema
The Netherland Emla
United Kingdom Emla Cream 5%
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Product name EMLA Cream 5%
Reference number PL 39699/0088
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This leaflet was last revised in 12/2023.