Emla 5%

/ Perrigo

Administration of this medical product on genital mucosa, genital skin or leg ulcers should only be performed by or under the supervision of a healthcare professional, except when used in neonates for circumcision.
See prescribing information for full details.

Topical anaesthesia of the skin in connection with:
* Needle insertion, e.g. intravenous catheters or blood sampling;
* Superficial surgical procedures; in adults and in the paediatric population.
Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia;
Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only.

Hypersensitivity to amide type local anesthesia.
See package insert (OTC).

* 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.
* Repeated doses of lidocaine and prilocaine may increase blood levels of lidocaine and prilocaine. This medical product should be used with caution in patients who
may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients, and patients with severe hepatic impairment.
* Due to insufficient data on absorption, this medical product 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.
Care should be taken when applying to patients with atopic dermatitis. A shorter application time, 15-30 minutes, may be sufficient. 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. 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, this medical product 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.
* This medical product should not be applied to an impaired tympanic membrane.
* 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.
Paediatric population
Studies have been unable to demonstrate the efficacy of this medical product for heel lancing in newborn infants. In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application within the recommended dosing. If the recommended dose is exceeded the patient should be monitored for system adverse reactions secondary to methaemoglobinaemia.
This medical product should not be used:
• in newborn infants/infants up to 12 months of age receiving concomitant treatment with methaemoglobin-inducing agents.
• in preterm newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methaemoglobin levels.
See prescribing information for full details.

Common: Burning sensation, Application site pruritus, Application site erythema, Application site oedema, Application site warmth, Application site pallor.
See prescribing information for full details.

* Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital). This list is not exhaustive.
* With large doses, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicinal products structurally related to local anaesthetics, since the toxic effects are additive.
* Specific interaction studies with lidocaine/prilocaine and anti-arrhythmics class III (e.g. amiodarone) have not been performed, but caution is advised.
* Medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period
See prescribing information for full details.

Pregnancy: Although topical application is associated with only a low level of systemic absorption, the use in pregnant women should be undertaken with care because insufficient data are available in pregnant women.
Lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissues. It is reasonable to assume that lidocaine and prilocaine have been used in a large number of pregnant women and women of childbearing age. No specific disturbances to the reproductive process have so far been reported, e.g. an increased incidence of malformations or other directly or indirectly harmful effects on the foetus.
Lactation: Lidocaine and, in all probability, prilocaine are excreted into breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels. This medical product can be used during breast-feeding if clinically needed.

Rare cases of clinically significant methaemoglobinaemia have been reported. Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in susceptible individuals, with too frequent dosing in newborn infants and infants below 12 months of age and in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin and phenobarbital). Consideration should be given to the fact that pulse oximeter values may overestimate the actual oxygen saturation in case of increased methaemoglobin fraction; therefore, in cases of suspected methaemoglobinaemia, it may be more helpful to monitor oxygen saturation by co-oximetry.
Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue.
Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes of administration. Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression. Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products; circulatory signs are treated in line with recommendations for resuscitation.
Since the rate of absorption from intact skin is slow, a patient showing signs of toxicity should be kept under observation for several hours following emergency treatment.