Emla cream

• Desensitises the skin
• For minor medical procedures
• Takes a while to achieve its numbing effect
• Also suitable for use in children

Emla Cream contains lidocaine and prilocaine, two local anaesthetics that are used to temporarily numb the skin. It is put on the skin before certain medical procedures, such as removal of bandages or warts, or having an injection. When Emla Cream is applied to the skin, otherwise painful procedures can be performed without causing pain.

Where to put the cream, how much to use and how long to leave it on will depend on what it is used for. Always use the 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. A doctor or nurse should apply Emla Cream on the genitals.

When you apply the cream, it is very important to exactly follow the instructions on the package leaflet. After application the cream should be covered by a dressing (plastic wrap) with adhesive sides. Then leave to work for a while. For adults and adolescents over 12 years put the cream on at least 60 minutes before the procedure. If the cream is being used on the genitals, a different application time may apply.

Dosage

• The usual dose for adults and adolescents over 12 years is 2 g (grams).
• In children the dose and application time depend on the child's age. The doctor, nurse or pharmacist will tell you how much cream to use and how long to leave it on.

See the package leaflet for more information on the use of Emla Cream.

Alcohol/driving

This medicine does not interact with alcohol.

Emla Cream has no or negligible influence on the ability to drive and use machines when used at the recommended doses.

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.

• Feeling lightheaded or dizzy.
• Tingling of the skin around the mouth and numbness of the tongue.
• Abnormal taste.
• Blurred vision.
• Ringing in the ears (tinnitus).
• 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 bluishgrey 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.

Emla Cream is not suitable for everyone. Do not use this medicine if you are allergic to any of the ingredients (see section 'What Emla Cream contains').

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.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking using Emla Cream if:

• You or your child have a rare inherited illness that affects the blood called glucose6-phosphate dehydrogenase deficiency.
• You or your child have a problem with blood pigment levels called methaemoglobinaemia.
• 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 'Side effects').
• You take particular products for heart rhythm disorders (e.g., 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 three 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 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), such as sulphonamides. See also section ‘Other medicines and Emla Cream’.

Emla Cream should not be used in preterm newborn infants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before using Emla Cream.

Other medicines and Emla Cream

Tell your doctor if you are taking, have recently taken or might take any other medicines, including:

• Medicines used to treat infections, such as sulphonamides and nitrofurantoin.
• Certain medicines used to treat epilepsy, such as phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines for heart rhythm disorders, such as amiodarone.
• Cimetidine or beta blockers, which may cause an increase in the blood levels of lidocaine.

Like all medicines, this medicine can cause side effects, although some people may not experience any. The side effects of Emla Cream include:

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.

For a list of all possible side effects, see the package leaflet. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this package leaflet.

The active substances are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.

Read the package leaflet before use.