SECTION_START: Overview

What is EMLA Cream

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.

This product is not eligible for returns

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SECTION_START: Ingredients

Active ingredient: lidocaine and prilocaine.

Other ingredients: polyoxyethylene hydrogenated castor oil, carboxy polymethylene, sodium hydroxide and purified water.

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SECTION_START: Usage

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 5g tube corresponds to about 2g EMLA Cream. One gram of EMLA Cream pressed out of a tube is approximately 3.5cm. 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 2g 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 1g of cream on a skin area not larger than 10cm2 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 2g 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 10g 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 20g of cream on a total skin area not larger than 200cm2 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.

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SECTION_START: Warnings

Precautions to consider before using Emla Cream 5% 5g With 2 Dressings
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.
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.
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.
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 providing 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 the 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.
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.

What are the common 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.

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:

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.
Methaemoglobinaemia blood disorder, which in rare cases may develop during treatment of the skin, and may cause signs and symptoms of hypoxaemia abnormally low level of oxygen in the blood. Methaemoglobinaemia is more frequently observed, often in connection with overdose, in newborn infants and infants aged 0 to 12 months.

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.

For Uncommon and rare side effects, please read the enclosed leaflet or click here.

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 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.

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Emla Cream 5% 5g With 2 Dressings 1 Pack

Product information