EMLA Cream 5% - 5g

EMLA numbing cream contains two medicines:

• Lidocaine
• 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. Applied to the skin before certain medical procedures, EMLA cream helps to stop pain on the skin. It does not stop all sensations of pressure and touch.

Do not use EMLA Cream if you:

• Are allergic (hypersensitive) to lidocaine, prilocaine, or any other ingredients of EMLA Cream.

Check with your doctor, pharmacist, or nurse before using EMLA Cream if you:

• Are anaemic (a blood problem with too few red blood cells).
• Have a rare inherited illness affecting blood called ‘glucose-6-phosphate dehydrogenase deficiency’.
• Have a problem with blood pigment levels called ‘methaemoglobinaemia’.
• Have a skin condition called ‘atopic dermatitis’. The cream may need to be applied for a shorter time.
• Your child is a pre-term newborn infant.
• Your child under 12 months is being treated with other medicines affecting blood pigment levels.

Inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including:

• Sulphonamides (e.g., sulfamethoxazole).
• Other local anaesthetics.
• Medicines for an uneven heart beat (e.g., mexiletine or amiodarone).

Pregnancy and Breast-Feeding:

• The medicines in EMLA Cream (lidocaine and prilocaine) are passed into breast milk, but the amount is generally considered safe.
• Ask your doctor or pharmacist for advice if you are pregnant, may become pregnant, or are breast-feeding.

Important Information About Ingredients:

• EMLA Cream contains polyoxyethylene hydrogenated castor oil, which may cause skin reactions.

Usage Instructions:

• Use EMLA Cream exactly as directed by your doctor, pharmacist, or nurse. If unsure, consult them for guidance.
• Do not use EMLA Cream on:
  • Cuts, grazes, or wounds (excluding leg ulcers).
  • 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.
• Do not use on newly shaven skin areas larger than 600 cm². The maximum dose is 60 g.
• Avoid getting EMLA Cream in your eyes. Rinse with lukewarm water or saline solution if contact occurs.
• If accidentally swallowed, contact your doctor, pharmacist, or nurse immediately.
• In case of overdose or using more cream than recommended, contact a healthcare professional immediately. Symptoms of overdose include dizziness, tingling around the mouth, blurred vision, and in severe cases, fits or altered heart beat.

Possible Side Effects:

• Severe Allergic Reactions (rare, affect less than 1 in 1,000 people): Stop using EMLA Cream and seek medical help immediately if you experience rash, shortness of breath, low blood pressure, or swelling of the face, lips, tongue, or other body parts.
• Common (affect less than 1 in 10 people): Redness, slight swelling, or pale skin where applied. This usually resolves quickly.
• Uncommon (affect less than 1 in 100 people): Mild burning or itching sensation, tingling feeling.
• Rare (affect less than 1 in 1,000 people): Mild allergic reactions, small red dots on the skin, eye irritation if cream contacts eyes.

Storage:

• Keep out of reach of children.
• Store below 30°C. Do not freeze.
• Do not use after the expiry date shown on the tube.
• Dispose of unused medicines properly. Consult your pharmacist for disposal methods to protect the environment.

EMLA numbing cream can be used to numb the skin before:

• Having a needle put in (e.g., injection or blood test).
• Minor skin operations.
• Some types of skin graft.
• Cleansing and debridement of leg ulcers.

It can also be used on adults 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.

Application Instructions:

• Where to put the cream, how much to use, and how long to leave it on will depend on the procedure. Your doctor, pharmacist, or nurse will provide guidance.
• If applying the cream yourself, obtain dressings from your doctor, nurse, or pharmacist.
• When used on the genitals, a doctor or nurse should supervise its use.

Dosage for Adults and Adolescents (12 years and older):

• Small Procedures (e.g., needle insertion or minor skin operations): Apply 2g of cream for 1 to 5 hours under a dressing.
• Hospital Procedures (e.g., split-skin grafting): Apply 1.5g to 2g of cream for each 10 cm² area for 2 to 5 hours under a dressing.
• Larger Areas of Newly Shaven Skin (e.g., hair removal): Apply 1.5g of cream for each 10 cm² area for 1 to 5 hours under a dressing.
• Genital Skin (adult men only): Apply 1g of cream for each 10 cm² area for 15 minutes under a dressing.
• Genital Skin (minor skin surgery for adults only): Apply 5g to 10g of cream for 10 minutes without a dressing. Start the procedure immediately.
• Leg Ulcers (cleaning or debridement): Apply 1-2g of cream for each 10 cm² area, up to 10g total, under an airtight dressing for 30 to 60 minutes before cleansing. Remove the cream with cotton gauze and start cleansing without delay. Can be used up to 15 times over 1-2 months.

Dosage for Children:

• Infants under 3 months: Up to 1g of cream on a 10 cm² area for 1 hour. Only one dose in 24 hours.
• Infants (3-12 months): Up to 2g of cream on a 20 cm² area for 1 hour (maximum 4 hours).
• Children (1-6 years): Up to 10g of cream on a 100 cm² area for 1 hour (maximum 5 hours).
• Children (7-11 years): Up to 20g of cream on a 200 cm² area for 1 hour (maximum 5 hours).
• Maximum of 2 doses in 24 hours for children over 3 months. Application time for children with atopic dermatitis is 30 minutes.

Application Method:

• Squeeze the cream into a mound where needed (e.g., where the needle will be inserted). A 3.5 cm line of cream is equal to 1g.
• Do not rub the cream in.
• Peel the ‘centre cut-out’ from the dressing.
• Peel the paper layer from the dressing.
• Remove the covers of the dressing and place it over the mound of cream without spreading the cream.
• Remove the plastic backing and smooth down the edges of the dressing. Leave it in place for at least 60 minutes.
• Your doctor or nurse will remove the dressing and cream just before the medical procedure.

EMLA Cream contains the following ingredients:

• Lidocaine
• Prilocaine
• Polyoxyethylene hydrogenated castor oil
• Carbomer 974P
• Sodium hydroxide
• Purified water