NUMECA

Administration of Numeca Cream 5% on genital mucosa, genital skin or leg ulcers should only be performed by or under the supervision of a healthcare professional. Posology Adults and adolescents The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.

For further guidance on the appropriate use of the product in such procedures, please refer to Method of administration. g. needle insertion and surgical treatment of localised lesions. 2 g (approx half a 5 g tube) or approx. 5 g/10 cm2 for 1 to 5 hours1).

g. laser hair removal (selfapplication by patient) Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1). g. split-skin grafting. 5-2 g/10 cm2 for 2 to 5 hours1). g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics Approx 5-10 g of cream for 5-10 minutes1)3)4).

Prior to cervical curettage 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes. Leg ulcer(s) Adults only Mechanical cleansing/debridement Approx 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s) 3) 5).

Application time: 30-60 minutes. 1After a longer application time anaesthesia decreases. 2On female genital skin, Lidocaine/Prilocaine cream alone applied for 60 or 90 minutes does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.

2). 4In adolescents weighing less than 20 kg the maximum dose of Numeca Cream 5% on genital mucosa should be proportionally reduced. 5 Lidocaine/Prilocaine cream has been used for the treatment of leg ulcers up to 15 times over a period of 1 to 2 months without loss of efficacy or increased number or severity of adverse events.

g. needle insertion and surgical treatment of localised lesions. Approx 1g/10 cm2 for one hour (see details below) Newborn infants and infants 0-2 months1)2)3) Up to 1 g and 10 cm2 for one hour4) Infants 3-11 months1) 2) Up to 2 g and 20 cm2 for one hour5) Toddlers and children 1-5 years Up to 10 g and 100 cm2 for 1-5 hours6) Children 6-11 years Up to 20 g and 200 cm2 for 1-5 hours6) Paediatric patients with atopic dermatitis Prior to removal of mollusca Application time: 30 minutes 1In term newborn infants and infants below 3 months, only one single dose should be applied in any 24 hour period.

Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at the application site), reported as common. Tabulated list of adverse reactions The incidences of the Adverse Drug Reactions (ADRs) associated with Lidocaine/Prilocaine cream therapy is tabulated below.

The table is based on adverse events reported during clinical trials, and/or post-marketing use. Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level. Within each System Organ Class, adverse reactions are listed under frequency categories of: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 9), in newborn infants and infants aged 0 to 12 months. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

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.

Due to insufficient data on absorption, Numeca Cream should not be applied to open wounds (excluding leg ulcers). 2). Care should be taken when applying Numeca Cream to patients with atopic dermatitis. 1). 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, Numeca 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.

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

, amiodarone) should be carefully monitored and ECG monitoring considered, as cardiac effects may be additive. 5 – 2%. For this reason, although one clinical study suggests that the immunisation response, as assessed by local wheal formation, is not affected when Lidocaine/Prilocaine cream is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

NumecaCream contains macrogolglycerol hydroxystearate, which may cause skin reactions. Paediatric population Studies have been unable to demonstrate the efficacy of Lidocaine/Prilocaine cream for heel lancing in newborn infants. In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin levels is commonly observed up to 12 hours after an application of Lidocaine/Prilocaine cream within the recommended dosing.

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