Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
EMLA should not be used in the following cases:
(a) in pre-term neonates i.e. gestational age less than 37 weeks.
(b) in infants/neonates between 0 and 12 months of age receiving treatment with methaemoglobin-inducing agents due to the possible additive effects.

In infants/neonates younger than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application of EMLA.
Patients with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia.

In glucose-6-phosphate dehydrogenase deficient patients the antidote methylene blue is ineffective at methaemoglobin reduction, and is capable of oxidising haemoglobin itself, and therefore methylene blue therapy cannot be given.
In term newborn infants, infants and children, EMLA should only be used on intact skin and should not be applied to genital mucosa.

In term neonates and infants < 3 months, only one single dose should be applied in any 24 hour period. If, based on clinical need, a decision is nevertheless taken to use two applications in children under the age of 3 months, the child should be clinically monitored for systemic adverse reactions (see sections 4.8 and 4.9).

Due to insufficient data on absorption, EMLA Cream should not be applied to open wounds (excluding leg ulcers).

Due to the potentially enhanced absorption on newly shaven skin, it is important to adhere to the recommended dosage, area and time of application (see section 4.2).
Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in neonates.

EMLA should not be applied to the genital mucosa of children owing to insufficient data on absorption of active substances. However, when used in neonates for circumcision, a dose of 1.0 g EMLA on the prepuce has been proven to be safe.

Care should be taken when applying EMLA Cream to patients with atopic dermatitis. A shorter application time, 15-30 minutes, may be sufficient (see section 5.1). Application times of longer than 30 minutes in patients with atopic dermatitis may result in an increased incidence of local vascular reactions, particularly application site redness and in some cases petechia and purpura (see section 4.8). Prior to removal of mollusca in children with atopic dermatitis, it is recommended to apply cream for 30 minutes.

When applied in the vicinity of the eyes, EMLA cream should be used with particular care since it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.

EMLA Cream should not be applied to an impaired tympanic membrane. Tests on laboratory animals have shown that EMLA cream has an ototoxic effect when instilled into the middle ear. Animals with an intact tympanic membrane, however, show no abnormality when exposed to EMLA cream in the external auditory canal.

Patients treated with anti-arrhythmics of class III (e.g., amiodarone) should be carefully monitored and ECG monitoring considered, as cardiac effects may be additive.


Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5 – 2%. For this reason, although one clinical study suggests that the immunisation response, as assessed by local wheal formation, is not affected when EMLA Cream is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

EMLA Cream contains macrogolglycerol hydroxystearate, which may cause skin reactions.

Effects on Driving

4.7 Effects on ability to drive and use machines
EMLA Cream has no or negligible influence on the ability to drive and use machines when used at the recommended doses.