When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.1
Change of text in all of section.
Section 4.2
Change of text in most of table and addition of footnotes.
Section 4.3
Deletion of some text.
Section 4.4
Paediatric information included
Section 4.5
Change of text first two paragraphs.
Section 4.7
Revised text:
EMLA has no influence on driving ability and the ability to operate machines when used at the recommended doses.
Section 4.8
Section 4.9
Repositioning of 1st paragraph to last paragraph
Additional text: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs, circulatory signs are treated in line with recommendations for resuscitation.
Section 10
Revision date of text: 4th May 2011
Section 10 updated to reflect latest approval date of 1st June 2010
Information regarding maximum dose Section 4.5 Additional text last paragraph of section: Drugs 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. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. EMLA cream) at recommended doses. Section 4.8 & Section 4.9 Methaemoglobinaemia reported not only in children Section 5.2 Addition of shaving as a factor that may affect systemic absorption. Section 5.3 Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Additional text last paragraph of section: Drugs 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. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. EMLA cream) at recommended doses. Section 4.8 & Section 4.9 Methaemoglobinaemia reported not only in children Section 5.2 Addition of shaving as a factor that may affect systemic absorption. Section 5.3 Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Drugs 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. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. EMLA cream) at recommended doses. Section 4.8 & Section 4.9 Methaemoglobinaemia reported not only in children Section 5.2 Addition of shaving as a factor that may affect systemic absorption. Section 5.3 Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Methaemoglobinaemia reported not only in children Section 5.2 Addition of shaving as a factor that may affect systemic absorption. Section 5.3 Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Section 5.2
Addition of shaving as a factor that may affect systemic absorption. Section 5.3 Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Section 5.3
Change of text to section: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, o-toluidine, showed evidence of mutagenic activity. These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. This has not been shown in subsequent clinical studies. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use. Section 10 Revision date of text: 6 November 09
Excipients: Contains Polyoxyethylene hydrogenated castor oil (19 mg).
Additional new text 9th paragaph:
EMLA Cream contains polyoxyethylene hydrogenated castor oil which may cause skin reactions.
Section 5.1
Additional new text at beginning of section
Pharmacotherapeutic group: Local anaesthetics of the amide-type,
ATC code: N01B B20
Additional text for sodium hydroxide:
for pH adjustment
Section 6.4
Additional new text:
Keep the container tightly closed when not in use.