Emla

EMLA 25 mg/g + 25 mg/g cream + 2 Tegaderm pfl.

Important notes (mandatory information)

Emla 25 mg/g + 25 mg/g Cream. Areas of application: Emla works by temporarily numbing the skin's surface. It is applied to the skin before certain medical procedures.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Emla 25 mg/g + 25 mg/g Cream
Active ingredients: Lidocaine/Prilocaine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. WHAT IS EMLA AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMLA?
3. HOW TO USE EMLA?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE EMLA?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EMLA AND WHAT IS IT USED FOR?

Emla contains two active ingredients, called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics. Emla works by temporarily numbing the skin's surface. It is applied to the skin before certain medical procedures. This helps to stop pain on the skin. However, you may still feel pressure or touch.

Adults, adolescents and

children

It can be used to numb the skin before:

• a needle prick (e.g. when you have an injection or blood is taken).
• minor surgical procedures on the skin.

Adults and adolescents

It can also be used:

• to numb the genitals before:
  • o an injection.
  • o medical procedures such as wart removal.

A doctor or healthcare professional should apply Emla to the genitals.

Adults

It can also be used to numb the skin before

cleaning or removing damaged skin on leg ulcers.

For all other uses than application to intact skin, the medicine should only be used on the recommendation of a doctor, healthcare professional or pharmacist.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMLA?

Emla must not be used if you are allergic to lidocaine or prilocaine, other similar local anaesthetics or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor. pharmacist or healthcare professional before using Emla:

• if you or your child have a rare, inherited condition called "glucose–6–phosphate–dehydrogenase deficiency", which affects the blood.
• if you or your child have a problem with the blood concentration of the blood pigment methhaemoglobin, called "methhaemoglobinaemia".
• With the exception of leg ulcers, do not apply Emla to areas of broken, cut, grazed or other open skin. If any of these occur, talk to your doctor, pharmacist or healthcare professional before using the cream.
• if you or your child have an itchy skin condition called "atopic dermatitis", a shorter application time may be sufficient. An application time longer than 30 minutes may lead to an increased occurrence of local vascular reactions (see also section 4 "What side effects are possible?").
• if you are taking special medicines for heart rhythm problems (class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your heart function.

Due to the potential for increased absorption through freshly shaved skin, it is important to adhere to the recommended dosage, skin area and application time. Avoid getting Emla in your eyes, as this may cause irritation. If Emla accidentally gets into your eye, you should rinse it out thoroughly with lukewarm water or saline (sodium chloride). Take care not to get any in your eye until the feeling has returned. Emla should not be used on a damaged ear drum. If you are using Emla before vaccinations with live vaccines (e.g. tuberculosis vaccinations), you should see your doctor or healthcare professional again within the recommended time period to check that the vaccination has worked.

Children and adolescents

In infants/newborns under 3 months of age, a transient, clinically insignificant increase in the concentration of the blood pigment methhaemoglobin in the blood ("methhaemoglobinaemia") is frequently observed up to 12 hours after application of Emla. The efficacy of Emla for heel prick blood sampling in neonates or for providing sufficient analgesia for circumcision could not be confirmed in clinical studies. Due to insufficient data on absorption, Emla should not be used in children (under 12 years of age) on genital skin (e.g. penis) and genital mucous membranes (e.g. in the vagina). Emla should not be used in children under 12 months of age who are concomitantly treated with other medicines that affect the blood concentration of the blood pigment methhaemoglobin ("methhaemoglobinaemia") (e.g. sulfonamides, see also in section 2 "Using Emla with other medicines"). Emla should not be used in premature babies.

Using Emla with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Emla can affect the way some other medicines work and some other medicines can have an effect on Emla. In particular, tell your doctor if you or your child have recently used or been given any of the following medicines:

• Medicines called sulfonamides, which are used for infections, and nitrofurantoin.
• Medicines called phenytoin and phenobarbitone, which are used for epilepsy.
• Other local anaesthetics.
• Medicines to treat irregular heart beat, such as amiodarone.
• Cimetidine or beta-blockers, which may cause an increase in the blood concentration of lidocaine. This interaction is not clinically significant for short-term treatment with Emla within the recommended dosages.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is unlikely that occasional use of Emla during pregnancy will have any harmful effects on the unborn baby. The active ingredients in Emla (lidocaine and prilocaine) pass into breast milk. However, the amount is so small that there is generally no risk to the baby. Animal studies have shown no impairment of male or female fertility.

Driving and using machines

Emla has no or negligible influence on the ability to drive and use machines when used within the recommended dosages.

Emla contains macrogolglycerol hydroxystearate (Ph.Eur.)

Macrogolglycerol hydroxystearate (Ph.Eur.). may cause skin irritation.

3. HOW TO USE EMLA?

Always use this medicine exactly as described in this leaflet or exactly as your doctor, pharmacist or healthcare professional has told you. Check with your doctor, pharmacist or healthcare professional if you are not sure.

Using Emla:

• Where the cream is applied, how much is used and how long it is left on the skin depends on what it is needed for. Half a 5–g tube is about 2 g of Emla. One gram of Emla cream squeezed out of the tube is about 3.5 cm long.
• Emla should only be applied to the genitals by a doctor or healthcare professional.
• If Emla is used on leg ulcers, a doctor or healthcare professional should supervise its use.

Do not apply Emla to the following areas of skin:

• Cuts, grazes or wounds, except for leg ulcers.
• areas of broken or eczematous skin.
• on or near the eyes.
• in the nose, ear or mouth.
• In the anal region (anus).
• on the genitals of children.

People who frequently apply or remove the cream should ensure that contact with the cream is avoided to prevent the development of hypersensitivity. The protective membrane on the opening of the tube can be pierced using the cap.

Using on the skin before minor procedures (such as a needle prick or minor skin surgery):

• A thick layer of cream is applied to the skin. Follow the instructions in the package leaflet or those given by your healthcare professional. In certain cases, your healthcare professional will need to apply the cream.
• The cream is then covered with a plaster (plastic film). This is removed just before the procedure starts. If you are applying the cream yourself, make sure that you have been given plasters by your doctor, pharmacist or healthcare professional.
• The usual dose for adults and adolescents over 12 years of age is 2 g.
• For adults and adolescents over 12 years of age, the cream is applied at least 60 minutes before the procedure (unless the cream is being used on the genitals). However, do not apply it more than 5 hours before the procedure.

Children

Using on the skin before minor procedures (such as a needle prick or minor skin surgery): Application time: about 1 hour.

Newborns and infants aged 0 to 2 months

Up to 1 g of cream on an area of skin no larger than 10 cm2 (10 square centimetres). Application time: not more than 1 hour. Only one single dose should be used within a 24 hour period.

Infants aged 3 to 11 months

Up to 2 g of cream on an area of skin no larger than 20 cm2 (20 square centimetres). Application time: about 1 hour, maximum 4 hours.

Children aged 1 to 5 years

Up to 10 g of cream on an area of skin no larger than 100 cm2 (100 square centimetres). Application time: about 1 hour, maximum 5 hours.

Children aged 6 to 11 years

Up to 20 g of cream on an area of skin no larger than 200 cm2 (200 square centimetres). Application time: about 1 hour, maximum 5 hours.

In children over 3 months of age, a maximum of 2 doses may be used within a 24 hour period, with an interval of 12 hours between doses. Emla cream can be used in children with a skin condition called "atopic dermatitis", however the application time should not be longer than 30 minutes.

When applying the cream, it is important that you follow these instructions exactly

1. Squeeze a blob of cream out of the tube onto the area where it is needed (for example, where the needle prick is going to be). Half a 5–g tube is about 2 g of Emla. One gram of Emla cream squeezed out of the tube is about 3.5 cm long. Do not rub the cream in.
2. Peel the paper layer off the middle section of the plaster on the non-sticky side (a paper frame will be left).
3. Peel off the backing on the sticky side of the plaster.
4. Carefully place the plaster over the blob of cream. Do not spread the cream around under the plaster.
5. Remove the paper backing. Press the edges of the plaster down carefully. Then leave it in place for at least 60 minutes.
6. Your doctor or healthcare professional will remove the plaster and wipe off the cream just before they carry out the medical procedure (e.g. just before the needle prick).

Using on larger areas of freshly shaved skin for outpatient procedures (such as hair removal techniques)

Follow the instructions given by your healthcare professional. The usual dose is 1 g of cream for every 10 cm2 (ten square centimetres) of skin area, applied under a plaster for 1 to 5 hours. Emla should not be used on a freshly shaved skin area that is larger than 600 cm2 (600 square centimetres, e.g. 30 cm by 20 cm). The maximum dose is 60 g.

Using on the skin before inpatient procedures (e.g. skin grafts) that require stronger numbing of the skin:

• Emla can be used in this way in adults and adolescents over 12 years of age, but only under the supervision of a doctor or healthcare professional.
• The usual dose is 1.5 g to 2 g of cream for every 10 cm2 (ten square centimetres) of skin area.
• The cream is applied under a plaster for 2 to 5 hours.

Using on the skin before removal of wart-like skin lesions called "mollusca":

• Emla can be used in children and adolescents with a skin condition called "atopic dermatitis".
• The usual dose depends on the age of the child. It is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis), your doctor, healthcare professional or pharmacist will tell you how much cream to use.

Using on genital skin before injections of local anaesthetics:

• Emla can be used in this way in adults and adolescents over 12 years of age only by healthcare professionals.
• The usual dose is 1 g of cream (1 g to 2 g on female genital skin) for every 10 cm2 (10 square centimetres) of skin area.
• The cream is applied and covered with a plaster. This is left in place for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Using on genital skin before minor surgical procedures (such as wart removal):

• Emla can be used in this way in adults and adolescents over 12 years of age only by healthcare professionals.
• The usual dose is 5 g to 10 g of cream for 10 minutes. No plaster is used. The medical procedure should start immediately afterwards.

Using on leg ulcers before cleaning or removing damaged skin

Emla can be used in this way in adults, but only under the supervision of a doctor or healthcare professional.

• The usual dose is 1 g to 2 g of cream for every 10 cm2 of skin area up to a total dose of 10 g.
• The cream is applied under an airtight plaster, such as plastic film. This is left in place for 30 to 60 minutes before the ulcer is cleaned. Remove the cream with gauze and start cleaning without delay.
• Emla can be used up to 15 times over a period of 1 to 2 months before cleaning leg ulcers.
• Emla is for single use only on leg ulcers. Discard the tube with any remaining contents after each treatment.

If you use more Emla than you should

If you use more Emla than is stated in this leaflet, or more than your doctor, pharmacist or healthcare professional has told you to use, tell them immediately, even if you do not notice any signs of illness. Symptoms of using too much Emla are listed below. These symptoms are unlikely to occur if Emla is used as recommended.

• Feeling light-headed or dizzy.
• Tingling around the mouth and numbness of the tongue.
• Unusual taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of "acute methhaemoglobinaemia" (a problem with the blood pigment concentration). This is more likely if certain other medicines are taken at the same time. If this occurs, the skin turns a blue–grey colour due to lack of oxygen.

In severe cases of overdose, symptoms such as convulsions, low blood pressure, slowed breathing, stopping breathing and abnormal heart beat may occur. These effects can be life-threatening.