Emla Cream (Prilocaine/Lidocaine)

Serious Warnings and Precautions

EMLA Cream is for use on healthy, unbroken skin. Do not apply to open wounds, nor to burns or rashes or other skin conditions, including diaper rash.

BEFORE you use EMLA Cream talk to your doctor or pharmacist if:

• you/your child have glucose-6-phosphate dehydrogenase deficiency;
• you/your child have ever had a bad, unusual or allergic reaction to lidocaine or prilocaine, also available under brand names such as Xylocaine (lidocaine) and Citanest (prilocaine);
• you think you/your child may be sensitive or allergic to other ingredients of the cream or Tegaderm dressing
• there is an infection, skin rash or cut at, or near, the area where you want to apply EMLA Cream;
• you/your child have atopic dermatitis, eczema or any other skin problems or diseases;
• you/your child have severe kidney or liver disease
• you are pregnant, trying to become pregnant or are breast-feeding;
• you would like to use EMLA Cream prior to treatment of a leg ulcer(s);
• you would like to use EMLA Cream on the genital area of children.

Serious Warnings and Precautions

EMLA Cream is for use on healthy, unbroken skin. Do not apply to open wounds, nor to burns or rashes or other skin conditions, including diaper rash.

BEFORE you use EMLA Cream talk to your doctor or pharmacist if:

• you/your child have glucose-6-phosphate dehydrogenase deficiency;
• you/your child have ever had a bad, unusual or allergic reaction to lidocaine or prilocaine, also available under brand names such as Xylocaine (lidocaine) and Citanest (prilocaine);
• you think you/your child may be sensitive or allergic to other ingredients of the cream or Tegaderm dressing
• there is an infection, skin rash or cut at, or near, the area where you want to apply EMLA Cream;
• you/your child have atopic dermatitis, eczema or any other skin problems or diseases;
• you/your child have severe kidney or liver disease
• you are pregnant, trying to become pregnant or are breast-feeding;
• you would like to use EMLA Cream prior to treatment of a leg ulcer(s);
• you would like to use EMLA Cream on the genital area of children.

Tell your doctor or pharmacist about any other drugs you take or have recently taken, including the ones you can buy without a prescription, including:

• antiarrhythmic drugs for heart problems (e.g. mexilitine, amiodarone);
• other anesthetics;
• other drugs which may trigger methomoglobin formation, including: sulfonamides, acetanilide, aniline dyes, benzocaine (or other “-caine” type anesthetics), chloroquine, dapsone, naphthalene, nitrates or nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine and high doses of acetaminophen.

Usual dose:

If your doctor tells you to use EMLA Cream, follow your doctor's instructions for use. In any other situation, follow the directions below.

Do not put EMLA Cream near the eyes, as it may cause some irritation. If you accidentally get EMLA in the eye, rinse it well with lukewarm water and protect it until sensation returns.

Do not apply EMLA Cream inside the ear. Do not put EMLA Cream in the mouth, or swallow it. If EMLA Cream is accidentally swallowed, call your doctor.

Do not re-use EMLA Cream dressings once applied.

The numbing effect of EMLA starts working about 1 hour after it is applied. You may still feel pressure and touch in the area where you apply EMLA. The numbness of the skin may continue to increase after the cream is removed, and will last for at least 2 hours following a 1-2 hour application.

If you feel that the effect of EMLA Cream is too strong or too weak, tell your doctor or pharmacist.

Conditions where adjustments in dose may be required

• elderly patients
• acutely ill patients
• patients with severe liver disease
• patients with severe kidney disease
• patients also treated with other anesthetics or certain antiarrhythmic drugs (e.g. mexilitine, amiodarone)
• patients with skin conditions such as atopic dermatitis or molluscum contagiosum

EMLA should be used with caution in these patients, who may be more sensitive to the effects of lidocaine and prilocaine.

Talk to your doctor if you have skin problems such as atopic dermatitis or eczema.

Adults:

Be careful to apply no more than the maximum recommended dose of EMLA Cream.

Serious and life threatening side effects have occurred when EMLA Cream was used on large areas of skin for topical analgesia during cosmetic procedures.

Dosage of EMLA Cream on Healthy Skin:

For minor procedures on skin such as surgical treatment of lesions or when getting a needle or having blood taken, apply a thick layer of cream, about half of a 5 g tube (2 g), on an area slightly larger than a two dollar coin or “toonie”. After covering EMLA Cream with an air-tight dressing, leave on for at least 1 hour. It is important to cover EMLA Cream with an air-tight dressing to ensure that the cream penetrates the skin properly and numbness of the area is felt.

Your doctor may use EMLA Cream on larger areas for such procedures as split-skin grafting. If you are instructed by the doctor to apply EMLA Cream yourself for this procedure, apply a thick layer of cream to the area to be treated (about 1.5 to 2 g/10 cm2; 1.5 to 2 g is about half of a 5 g tube; a 10 cm2 area is a little larger than the size of a two dollar coin or "toonie"). Make sure your doctor has clearly explained the size of the area to be treated. Leave the EMLA Cream on for at least 2 hours.

You will not get any added benefit from leaving EMLA Cream on for longer than 5 hours.

1 g of EMLA Cream administered from the 30 g aluminium tube is equivalent to a ribbon of cream of approximately 3.5 cm (or approximately 1.5 inches).

Dosage of EMLA Cream on Leg Ulcers:

Talk to your doctor before using EMLA Cream on leg ulcers.

For topical anesthesia before cleansing of leg ulcer(s), apply a thick layer of EMLA Cream over the leg ulcer(s), about 1 to 2 g/10 cm2 (a little larger than the size of a two dollar coin or "toonie"). Use no more than 10 g (two 5 g tubes).

After covering EMLA Cream with an air-tight dressing, leave on the leg ulcer for at least 30 minutes. Leaving EMLA Cream on for 60 minutes may improve the anesthesia. The cleansing of the leg ulcer should begin within 10 minutes after removing the cream.

When used on leg ulcers, discard the tube of EMLA Cream with any remaining contents after each treatment.

Dosage of EMLA Cream on Genital Mucosa:

Talk to your doctor before using EMLA Cream on the genital mucosa. For best results, do not apply EMLA Cream on the genital mucosa until you are with your doctor.

For needle insertion, use half of a 5 g tube (2 g) at the selected site before the procedure.

For the surgical treatment of small lesions, such as the removal of genital warts or when having a biopsy, use about half of a 5 g tube (2 g) per lesion 5 to 10 minutes before the procedure.

You do not need an airtight dressing when using EMLA Cream on the genital mucosa. Your doctor should begin the surgical procedure immediately after removing the cream.

Pediatrics:

Be careful to apply no more than the maximum recommended dose of EMLA Cream.

Children should be closely observed during and after use of topical anesthetics, as they are at greater risk than adults for serious side effects, such as methemoglobinemia (a blood disorder that causes the skin, especially around lips and nails, to turn brownish or greyish).

For children under the age of 6: take care not to apply more EMLA Cream or give it more frequently than the doctor recommended. Please make sure that your child does not ingest any of the cream.

When using EMLA Cream for your child's pain relief, remember it is also very important to provide comfort and emotional support.

For minor skin procedures. It is important to cover EMLA Cream with an air-tight dressing to ensure that the cream penetrates the skin properly and numbness of the area is felt.

In children, EMLA Cream should only be applied to healthy, unbroken skin.

Do not apply EMLA Cream to infants under 3 months of age unless a doctor tells you to do so. Infants under 3 months of age are at a higher risk than older children for methemoglobinemia. This is a condition in which there is not enough oxygen in the blood, and it can be caused by an overdose of EMLA.

Neonates Under the Age of 3 Months (ONLY IF INSTRUCTED BY A DOCTOR):

Apply up to 1 g of cream on a skin area not larger than 10 cm2 (a little larger than the size of a two dollar coin or “toonie”). After covering EMLA Cream with an air-tight dressing, leave on for 1 hour. DO NOT LEAVE EMLA ON THE SKIN FOR LONGER THAN 1 HOUR.

Infants Between 3 and 12 Months of Age:

Apply up to 2 g of cream on a total skin area not larger than 20 cm2 (a little larger than the size of a credit card). After covering EMLA Cream with an air-tight dressing, leave on for at least 1 hour. Do not leave on the skin for more than 4 hours.

Children Between 1-6 Years:

Apply up to 10 g of cream on a total skin area not larger than 100 cm2 (a little larger than the size of two credit cards). After covering EMLA Cream with an air-tight dressing, leave on for at least 1 hour. Do not leave on the skin for more than 5 hours.

Children Between 7-12 Years:

Apply up to 20 g of cream on a total skin area not larger than 200 cm2 (a little larger than a standard postcard). After covering EMLA Cream with an air-tight dressing, leave on for at least 1 hour. Do not leave on the skin for more than 5 hours.

Overdose:

In case of EMLA overdose or if you think you, or anyone else, are experiencing any of the side effects described below or methemoglobinemia, contact your doctor, hospital emergency department or regional Poison Control Centre immediately. You may require medical attention.