Emla Cream 5%

  • Name:

    Emla Cream 5%

  • Company:
    info
  • Active Ingredients:

    Lidocaine, Prilocaine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/12/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 21/9/2017
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Aspen

Aspen

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1 - 0 of 54 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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.

Updated on 2 December 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to date of revision

Updated on 21 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 September 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Text in red = new text

Marketing Authorisation holder

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland.

 

AstraZeneca UK Ltd.,

600 Capability Green,

Luton,

 

Marketing authorisation number(s)

PA 1691/023/001

PA 970/38/1

 

Date of revision of the text

September 2017

20 Oct 2016

 

 

 

Updated on 21 September 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 1 November 2016 SmPC

Reasons for updating

  • Transfer of marketing authorisation holder
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2– Editorial changes to harmonise text

Section 3– Editorial changes to harmonise text.

Section 4.2 – Editorial changes to harmonise text

Section 4.4 – Editorial changes to harmonise text

Section 5.1 – Editorial changes to harmonise text

Section 5.2 – Editorial changes to harmonise text

Section 6.1 – Editorial changes to harmonise text (rearrangement of excipients and renaming)

Section 6.4 – Editorial changes to harmonise text (addition of ‘do not freeze’ and removal of storage temp)

Section 6.5 – Editorial changes to harmonise text – mention of all pack types (module 3 harmonisation)

Section  9– additional of correct dates of authorisation and renewal

Section  10– Update to Date of Revision

Updated on 28 October 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to name of medicinal product
  • Improved presentation of PIL
  • Change to section 6 - date of revision
  • Transfer of Marketing Authorisation licence

Updated on 16 April 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2

Editorial changes to harmonise text with Article 30 Referral. Change of excipient name from polyoxyethylene hydrogenated castor oil to macrogolglycerol hydroxystearate.

 

Section 4.1

Editorial changes to harmonise text with Article 30 Referral. Clarification of populations that each indication is licensed for.

 

Section 4.2

Separation of dosage tables into “Adults and adolescents of 12 years of age and above” and “Paediatric patients 0-11 years of age”.

Addition of requirement to proportionally reduce dosage in adolescents under 20kg.

Move precaution about preventing hypersentivity during frequent application to section 6.6.

Add information around dose reductions for newborns and infants below 12 months.

Addition of statement around safety and efficacy for use of EMLA on genital skin and genital mucosa of children under 12 years.

Elderly, Hepatic impairment and Renal impairment dosages added.

Instructions for use added – perforate protective membrane of tube by applying the cap, and apply elastic bandage on top of occlusive dressing on larger areas of skin.

Addition of information about single use of tube for leg ulcers.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.3

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.4

Addition of warnings and precautions regarding methaemoglobinaemia and antidotes.

Addition that safety and efficacy for use on genital skin in children under 12 years has not been established.

Addition of “Available paediatric data do not demonstrate adequate efficacy for circumcision.”

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.5

Addition of further examples of methaemoglobin inducing medicinal products.

Removal of statement that interactions between EMLA and medicinal products that reduce the clearance of lidocaine should be of no clinical importance following short term treatment at recommended doses.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.6

Addition of reproduction toxicity information added following subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine.

Addition that EML A can be used during breastfeeding if clinically needed.

Addition of animal study information.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.7

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.8

Addition of information regarding frequency, type and severity of paediatric undesirable effects.

Amendment of Irish reporting address for ADRs.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 4.9

Addition of information about methaemoglobin plasma level increases and dealing with suspected methaemoglobinaemia.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 5.1

Addition of detailed information around mechanism of action for EMLA used on skin, genital mucosa, leg ulcers, and in the paediatric population.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 5.2

Addition of information about absorption, distribution, biotransformation and elimination of EMLA.

Removal of instructions for use on skin.

Addition of plasma concentration information when used for split skin grafting.

Addition of plasma concentration information when used in leg ulcers.

Addition of plasma concentration information when used in elderly and paediatric populations.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 5.3

Additon of details of animal study results.

Addition of details of in vivo and in vitro genotoxicity tests and genotoxic activity.

Addition of local tolerance study information.

Editorial changes to harmonise text with Article 30 Referral.

 

Section 6.1

Editorial changes to harmonise text with Article 30 Referral.

 

Section 6.6

Addition of precaution about preventing hypersentivity during frequent application moved from section 4.2.

Addition of Editorial changes to harmonise text with Article 30 Referral.

 

Section 10

Update to "Date of Revision"

Updated on 15 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Changes to therapeutic indications
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 21 November 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.1, 4.2, 4.4 in relation to paediatrics

Section 4.8 to reflect AE wording
Section 10 Updated date of revision

Updated on 20 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 4 December 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1

 

Modified to state the age groups in which the product is indicated, specifying the age limit for paediatric indication.

 

 

Section 4.2

 

Minor administrative revisions and addition of statement “Until further clinical data are available, EMLA should not be used at less than 37 weeks gestational age.” to align to updated CSP.

 

 

Section 10

 

Date of Revision updated to 27th November 2012.

 

Updated on 28 November 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 18 May 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Change of text in most of table and addition of footnotes.

 

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

Updated on 17 May 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use

Updated on 6 September 2010 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 10 updated to reflect latest approval date of 1st June 2010

Updated on 22 January 2010 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 16 December 2009 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2

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

Updated on 29 October 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2
Additional information in table regarding children with atopic dermatitis.

Section 4.4
Additional information regarding Atopic dermatitis.

Section 5.1
Additional information regarding Atopic dermatitis.

Section 10
Revision date of text: 15 October 2009

Updated on 17 November 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2

Excipients: Contains Polyoxyethylene hydrogenated castor oil (19 mg).

 

Section 4.4

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

 

Section 6.1

Additional text for sodium hydroxide:

for pH adjustment

 

 

Section 6.4

Additional new text:

Keep the container tightly closed when not in use.

Section 9
25 January 2008
 

Section 10

Revision date of text: 18 April 2008

Updated on 9 May 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 3 August 2007 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 28 March 2006 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 November 2005 PIL

Reasons for updating

  • Change of licence holder
  • Change to storage instructions

Updated on 21 September 2005 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 January 2005 PIL

Reasons for updating

  • Change to date of revision

Updated on 5 January 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 July 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)