Emla Cream 5%

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. 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

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 supervise the use of 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.

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 or pharmacist 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 or pharmacist 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 medicines 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 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.
• 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 excreted 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.

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.
• When EMLA Cream is used on the genitals, 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. Your doctor, pharmacist or nurse will tell you where to put it.
• 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.
• For children the amount of EMLA Cream used and how long depends on their age. Your doctor, nurse or pharmacist will tell you how much to use and when it should be applied.

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 from the 30 g tube is equal to 1 g of cream. Half a 5 g tube corresponds to about 2 g EMLA Cream. 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).

Use on larger areas of newly shaven skin before outpatient procedures (such as hair removal techniques):

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.
• The usual dose is 1.5 g to 2 g of cream for each of 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 on adults and adolescents over 12 years only.
• 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 on adults and adolescents over 12 years only.
• 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

• 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 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.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

Ireland

Malta

By reporting side effects you can help provide more information on the safety of this medicine.

What EMLA Cream contains

• The active substances are: lidocaine and prilocaine.
• 1 g cream contains: 25 mg lidocaine and 25 mg prilocaine.
• The other ingredients are carbomers, macrogolglycerol hydroxystearate, sodium hydroxide for pH adjustment, purified water.

What EMLA Cream looks like and contents of the pack

White, homogenous cream.

It is packed in an aluminium tube with a polypropylene cap with a piercing device.

EMLA is available in packs of:

1 tube containing 5 g cream

1 tube containing 5 g cream + 2 dressings

1 tube containing 5 g cream + 3 dressings

3 tubes containing 5 g cream + 8 dressings

5 tubes containing 5 g cream

5 tubes containing 5 g cream + 10 dressings

5 tubes containing 5 g cream + 12 dressings

10 tubes containing 5 g cream + 25 dressings

25 tubes containing 5 g cream

25 tubes containing 5 g cream + 50 dressings

1 tube containing 30 g cream

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for EMLA 5% w/w Cream marketed in Ireland and Malta is held by

EMLA 5% w/w Cream is manufactured by

or