EMLA Cream 5% 5g with 2x Dressings

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.

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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 in 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)

• 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.

If you get any side effects, talk to your doctor, our Rightdose pharmacists or nurse. This includes any possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet Emla Cream 5% 5g with 2x Dressings

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 macrogolglycerol hydroxystearate
Macrogolglycerol hydroxystearate may cause skin reactions.

How to store EMLA Cream

Keep this medicine out of the sight and reach of children.

• Do not store above 30°C and do not freeze.
• Do not use this medicine after the expiry date which is stated on the package and tube after “EXP:”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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.

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 5 g tube corresponds to about 2 g EMLA. One gram of EMLA cream pressed out of a tube of 30g is approximately 3.5 cm.

• 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.

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.
• In certain cases your healthcare professional has to apply the cream.

Do not use EMLA Cream on the following areas:

• Where there is a skin rash or eczema.
• Cuts, grazes or wounds, excluding leg ulcers.
• In or near the eyes.
• Inside the nose, ear or mouth.
• In the back passage (anus).
• On the genitals of children.

The usual dose for adults and adolescents over 12 years is 2 g (grams).

For adults and adolescents over 12 years old, 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.

The usual dose for 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 1 g of cream on a skin area not larger than 10 cm2 (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 2 g of cream on a total skin area not larger than 20 cm2
(20 square centimetres) in size. Application time: approx 1 hour.
Children aged 1-5 years: Up to 10 g 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 20 g of cream on a total skin area not larger than 200 cm2 (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.

When you apply the cream, it is very important to exactly follow the instructions below.

Directions:

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). Half a 5 g tube corresponds to about 2 g EMLA Cream. One gram of EMLA Cream pressed out of a tube of 30g is approximately 3.5 cm. 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 application 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):

• Follow the instructions from your healthcare professional.
  
  

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 the 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, see also Section 2 Other medicines and EMLA Cream).

EMLA Cream should not be used in preterm newborn infants.

Ingredients:

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

The other ingredients are macrogolglycerol hydroxystearate, Carbomer 974P, sodium hydroxide and purified water.

What EMLA Cream 5% looks like and contents of the pack

• EMLA Cream 5% is a white soft cream. 
• Each pack contains 2 dressings.

This product is available in different pack sizes. You will have been provided with a suitable pack size for your intended use.