Emla Patch 25 mg Patch

EMLA PATCH is indicated for:

Topical anaesthesia of intact skin for minor procedures, such as needle insertion and superficial surgical treatment of localised lesions, where application of EMLA PATCH 1 hour before the procedure is feasible.

Posology

Adults

One or more patch(es) are applied to the skin area(s) selected. Minimum application time: 1 hour. After a longer application time than 5 hours the anaesthesia decreases. Minor procedures, for example, needle insertion:

EMLA PATCH should be applied to the skin area selected with a minimum application time of 1 hour. After a longer application time (more than 5 hours), the anaesthesia decreases. In the event of any allergic reaction developing, EMLA PATCH should be removed immediately.

Paediatric population

Paediatric population over 1 year of age

One or more patch(es) are applied to the skin area(s) selected. Minimum application time: 1 hour. After a longer application time than 5 hours the anaesthesia decreases. Maximum dose for children aged 1 to 5 years is 10 patches. Maximum dose for children aged 6 to 11 years is 20 patches. Prior to curettage of mollusca in children with atopic dermatitis, an application time of 30 minutes is recommended.

Infants aged 3 to 11 months

The patch is applied to the skin area selected. Approximate application time: 1 hour. Not more than 2 patches should be applied at the same time. No clinically significant increase in methaemoglobin fractions has been observed following the application of 2 g EMLA cream for up to 4 hours.

Term newborn infants and infants under 3 months of age

The EMLA PATCH is applied to the selected skin area. Approximate application time: 1 hour, not more. A longer application time than 1 hour has not been documented. Not more than one EMLA PATCH should be applied at the same time. The size of the patch makes it less suitable for use on certain parts of the body in neonates and infants. Until further clinical data is available, EMLA PATCH should not be used in infants between 0 and 12 months of age receiving treatment with methaemoglobin inducing medicines.

Method of administration

EMLA PATCH must be applied at least 1 hour before the start of the procedure (if necessary, shave the area prior to application).

1. Make sure that the area of skin to be anaesthetised is clean and dry. Take hold of the aluminium flap at the corner of the patch and bend it backwards. Next, take hold of the corner of the skin-coloured patch layer.
2. Pull the two layers apart, separating the adhesive surface from the protective liner, as shown. Make sure that you do not touch the white round pad, which contains EMLA.
3. Do not press on the centre of the patch. This may cause EMLA to spread under the adhesive. Press firmly around the edges to ensure good adhesion to the skin.
4. The time of application may be easily marked directly on the patch (a ballpoint pen may be used for this purpose).

EMLA PATCH is contraindicated in:

• Patients with hypersensitivity to local anaesthetics of the amide type or to any other component of EMLA PATCH.
• Infants between 0 and 12 months receiving treatment with methaemoglobin-inducing medicines e.g. dapsone, local anaesthetics such as prilocaine and benzocaine, nitrates and sulphonamides.

Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicine-induced 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.

EMLA PATCH should not be applied to open wounds owing to insufficient data on absorption. Studies have been unable to demonstrate the efficacy of EMLA PATCH for heel lancing in neonates.

Care should be taken when applying EMLA PATCH to patients with atopic dermatitis. A shorter application time of 15 to 30 minutes, may be sufficient (see section 5.1). Prior to curettage of mollusca in children with atopic dermatitis, an application time of 30 minutes is recommended (see section 4.2).

Care should be taken not to allow EMLA PATCH to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye in water or saline and protect it until sensation returns.

Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0,5 % to 2 %. For this reason, the results of intracutaneous injections of live vaccines should be monitored.

EMLA PATCH should not be used in any clinical situation where it can penetrate or migrate into the middle ear as ototoxic effects have been shown in laboratory animals.

Clinical trial data on the safety and efficacy of EMLA PATCH use in dermal peels is limited and EMLA PATCH should be used with caution in these cases.

Patients treated with anti-dysrhythmic medicines class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

Paediatric population

In neonates younger than 3 months a transient, clinically insignificant increase in methaemoglobin fraction is commonly observed up to 12 hours after an application of EMLA PATCH.

Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0,5 to 2 %. For this reason, although one clinical study suggests that the immunization response is not affected when EMLA PATCH is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

EMLA PATCH is applied to the skin area selected. Approximate application time: 1 hour, not more. A longer application time than 1 hour has not been documented. Not more than one EMLA PATCH should be applied at the same time. The size of the patch makes it less suitable for use on certain parts of the body in neonates and infants.

Until further clinical data is available, EMLA PATCH should not be used in infants between 0 and 12 months of age receiving treatment with methaemoglobin inducing medicines.

Prilocaine in high doses may cause an increase in the methaemoglobin fraction particularly in conjunction with methaemoglobin-inducing medicines (e.g. sulphonamides).

With large doses of EMLA PATCH, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicines structurally related to local anaesthetics, since the toxic effects are additive.

Specific interaction studies with lidocaine/prilocaine and anti-dysthymic drugs class III (e.g. amiodarone) have not been performed, but caution is advised (see Section 4.4).

Medicines that reduce the clearance of lidocaine (e.g. cimetidine or beta-blockers) may cause potentially toxic plasma concentrations of lidocaine when EMLA PATCH is applied concomitantly in repeated high doses.

Pregnancy

Safety in pregnancy and lactation has not been established. Although topical application is associated with only a low level of systemic absorption, the use of EMLA PATCH in pregnant women should be undertaken with care because insufficient data are available concerning the use of EMLA PATCH in pregnant women. Animal studies do not indicate any direct or indirect negative effects on pregnancy, parturition or postnatal development. Embryofoetal toxicity has been shown with subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine much exceeding the exposure from topical application, as in EMLA PATCH. In both animal and humans, lidocaine and prilocaine as in EMLA PATCH, cross the placental barrier and may be absorbed by the foetal tissues.

Breastfeeding

Lidocaine and prilocaine, as in EMLA PATCH cross the placental barrier and may be absorbed by the foetal tissues, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels. Lidocaine and prilocaine are excreted in human breast milk. EMLA PATCH can be used during breastfeeding if clinically needed, provided that EMLA PATCH is not applied directly to the breast where ingestion by the infant may occur.

Fertility

Animal studies have shown no impairment of the fertility of male or female rats.

EMLA PATCH has no or negligible influence on the ability to drive and use machines. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that EMLA PATCH does not adversely affect their ability to do so safely (see section 4.4 and 4.8).

a) Summary of the safety profile

The most frequently reported adverse experiences in association with the use of EMLA PATCH were local reactions such as paleness, erythema (redness) and oedema. Other serious adverse experiences reported rarely include anaphylactic shock.

b) Tabulated list of adverse reactions

System organ class Frequent Less frequent

Blood and the lymphatic system disorders Methaemoglobinaemia 1 . Immune system disorders Allergic reactions (in the most severe instances anaphylactic shock) 1,2,3 . Eye disorders Corneal irritation 1 General disorders and administrative site conditions Transient local reactions at the application site such as paleness, erythema (redness) and oedema 1,2,3 , local sensations (an initial, usually mild, burning sensation, itch or warmth at the application site) 1,2,3 , skin sensations (an initial mild burning or itching sensation at the application site) 3 . Skin sensations (an initial mild burning or itching sensation at the application site) 1 . local lesions at the application site, described as purpuric or petechial 1 , local paraesthesia such as tingling 2 . 1 Skin 2 Genital mucosa 3 Leg ulcer

c) Description of selected adverse reactions

Skin sensations u2013 an initial mild burning or itching sensation at the application site. Methaemoglobinaemia u2013 rare cases of discrete local lesions at the application site, described as purpuric or petechial, have been reported, especially after longer application times in children with atopic dermatitis or mollusca contagiosa. Allergic reactions u2013 in rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8 . Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Symptoms

EMLA PATCH in high doses may cause an increase in the methaemoglobin level particularly in conjunction with methaemoglobin-inducing medicines (e.g. sulphonamides) (see section 4.8). Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue.

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. 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. 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 medicines.

Treatment

Treatment is symptomatic and supportive.