Emla 5% Cream (No Dressings) Emla 5% Cream (No Dressings)

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

Warnings and precautions 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 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.

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 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). 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 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 polyoxyethylene hydrogenated castor oil polyoxyethylene hydrogenated castor oil may cause skin reactions.

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. 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. 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. Rare (may affect up to 1 in 1,000 people) 

 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) during treatment of the skin.  Small dot-shaped bleeding on the treated area (particularly on children with eczema after longer application times) during treatment of the skin.  Irritation of the eyes if EMLA Cream accidentally comes into contact with them during treatment of the skin.

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 via the Yellow Card Scheme at: 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.

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.

What EMLA Cream contains

 The active ingredient in EMLA is lidocaine and prilocaine. Each gram of cream contains 25mg lidocaine and 25mg prilocaine. The other ingredients are polyoxyethylene hydrogenated castor oil, carboxy polymethylene, sodium hydroxide and purified water.

What EMLA Cream looks like and the contents of the pack

 EMLA is a white soft cream. EMLA will come in a tube containing 30g of cream, without any dressings. A wooden spatula is enclosed for applying your cream.