LIDOCAINE/PRILOCAINE

g. needle insertion and surgical treatment of localised lesions The patch is applied to the skin area selected Adults and adolescents 12 years and above One or two patches to be applied at least 1 hour before intervention, Application time: 1 – 5 hours 1) Newborn infants and infants (0-2 months)2,3,4,7) No more than one patch.

Application time: up to 1 hour 5) Infants (3-11 months) 2, 3, ) Up to 2 patches. Application time: up to 1 hour6) Toddlers & Children (1-5 years) Up to 10 patches Application time: 1 – 5 hours1) Children (6-11 years) Up to 20 patches Application time: 1 – 5 hours1) Children with atopic dermatitis Prior to curettage of mollusca Application time: 30 minutes 1) The anaesthetic effect is reduced 5 hours after application.

2) In term newborn infants and infants below 3 months, only one single dose should be applied in any 24-hour period. 8. 8. 4) Until further clinical data is available, Lidocaine/Prilocaine 5 % should not be used in preterm infants with a gestational age less than 37 weeks.

5) A longer application time than 1 hour has not been documented. 6) No clinically significant increase in methaemoglobin levels has been observed after an application time of up to 4 hours on 16 cm² 7) Due to its size, the use of the patch should be avoided for some part of the bodies for new born and neonates (0-2 months).

Method of administration For cutaneous use. The cutaneous patch must be applied at least one hour before the intervention. Make sure that the cutaneous surface to anesthetize is clean and dry. To open the patch, take the aluminium corner for this purpose.

The white part of the cutaneous patch contains the anaesthetic, do not touch it. Apply the cutaneous patch so that the white disc covers the area to be anesthetized. Do not press the central part of the patch, to prevent leakage under the adhesive.

To ensure a good adhesion of the cutaneous patch, apply firmly around the edge. Indicate the time of application on the cutaneous patch.

Adverse reactions are divided into groups according to the MedDRA convention frequencies: 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), unknown (cannot be estimated with the available data).

System Organ Class Uncommon Rare Blood and lymphatic system disorders Methaemoglobinaemia Immune system disorders Hypersensitivity Eye disorders Corneal irritation after accidental eye exposure. Skin and subcutaneous tissue disorders Rare cases of discrete local lesions at site of administration such as Purpura, Petechiae (especially after longer application times in children with atopic dermatitis or mollusca contagiosa) General disorders and administration site conditions Burning sensation, itching sensation or warmth at the application site.

Transient local reactions at the application site such as paleness, erythema (redness) and oedema In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe cases anaphylactic shock).

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.

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Patients with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia are more susceptible to drug induced signs of methaemoglobinaemia. Lidocaine/prilocaine patches should not be used in children/neonates younger than 3 months with a G6PD deficiency or suspected.

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. • Lidocaine/prilocaine patches should not be applied to damaged skin or open wounds (excluding leg ulcers) because the data on the absorption of the active substances are not sufficient.

• The efficacy of lidocaine/prilocaine during the capillary samples in the heel has not been clinically demonstrated. • Care should be taken when applying lidocaine/prilocaine patches to patients with atopic dermatitis. 1). 8). • Prior to removal of mollusca in children with atopic dermatitis it is recommended to apply patches for 30 minutes.

3). Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye with water or sodium chloride solution and protect the eye until sensation returns. • In children/neonates younger than 3 months a transient, clinically insignificant increase in methaemoglobin plasma levels is commonly observed up to 12 hours after an application of lidocaine/prilocaine patches within the recommended dosing.

g. 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 is not affected when lidocaine/prilocaine patches are used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

Paediatric population Studies have been unable to demonstrate the efficacy of lidocaine/prilocaine for heel lancing in newborn infants. 9). Until further clinical data is available, lidocaine/prilocaine should not be used in the following cases: o in infants between 0 and 12 months of age receiving treatment with methaemoglobin inducing agents; o in preterm infants with a gestational age less than 37 weeks; • This product contains hydrogenated castor oil, which can cause skin reactions.

• Due to the presence of castor oil, there is a risk of sensitization, especially in children under 3 years. • Athletes must be aware that this product contains an active substance that may lead to a positive result in case of anti-doping controls.

Precautions for use • In young children, a special monitoring is recommended to maintain the cutaneous patch and to prevent a possible risk of ingestion or contact with the eyes, secondary to a manipulation of the patch by the child.

• In case of use of lidocaine/prilocaine prior to a regional anaesthetic, the quantities of local anaesthetics administered by transcutaneous route should be considered.

1; • Patients with congenital or idiopathic methaemoglobinaemia; • Porphyria; • Children/neonates younger than 3 months with a G6PD deficiency or suspected.