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Novartis Consumer Health

Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1276 687202
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1276 687288

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Summary of Product Characteristics last updated on the eMC: 10/02/2014
SPC Eurax Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 10/02/2014 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jan-2014
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



SPC changes – Eurax Cream – 13 January 2014

 

 

Section 4.9

 

Added: “Rare cases of loss of consciousness and seizure were reported”.

 

 

Section 10

 

Change of date from 20 June 2013 to 13 January 2014

 

Updated on 10/07/2013 and displayed until 10/02/2014
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   20-Jun-2013
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 6.3

 

Shelf life reduced from 60 to 30 months

Updated on 21/11/2012 and displayed until 10/07/2013
Reasons for adding or updating:
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   06-Nov-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.2

Add sub heading “Adults (including the elderly)”

Remove “Eurax Cream can be used in children”

Add subheading “Paediatric population”  Information for use in children expanded

Under Scabies heading Add “There are no special dosage recommendations in the elderly”.

Add subheading “Paediatric population”  Information for use in children expanded.

Section 4.3

Clarification of hypersensitivity contra-indications.

Delete  “Eurax Cream should not be used in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.

 

Section 4.4

Rewording on guidance for use in children.  Warnings around contact with mouth and eyes expanded.  Clarification given for use on skin conditions.  Rewording of last paragraph to include pregnancy.

Add “Eurax cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed).”

Section 4.5

 Replaced “None” with Add  “No interaction studies have been performed.”

 

Section 4.6  

Heading Add “Fertility”

Add subheading “Pregnancy”

Rewording of pregnancy recommendations.

Add subheading “Breastfeeding”

Include  “ Therefore mothers should not use Eurax Cream whilst breastfeeding unless directed by a physician” in addition to previous information.

Section 4.7

Replaced “None” with “Eurax Cream has no influence on the ability to drive and use machines.

Section 4.8

Clarification of specific side effects and frequencies added as per convention “

 

Section 4.9

 

Delete “Eurax Cream is for application to the skin only “

Add “acute intoxication symptoms may be observed such as”  Delete “have been reported.  If accidental ingestion of large quantities occurs, there is no specific antidote”

Replace information about risk of methaemoglobinaemia “Moreover although very rare, in case of accidental ingestion as well as in case of excessive cutaneous absorption.  The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.”

Section 5.1

Add “Pharmacotherapeutic group: other antipruritics (ATC code D04AX).”

“ As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.

Eurax Cream will provide relief from irritation for 6 to  10 hours after each application.”

 

Section 5.3

Add “Preclinical data do not show teratogenic nor genotoxic risk for crotamiton”.    Add “topically”   Replace “250mg”  with “200 mg”

Delete “Crotamiton does not induce mutations in bacteria nor chromosomal damage in mammalian cells.  Studies to detect a possible effect on fertility and reproductive behaviour also gave negative results.”

Updated on 19/03/2010 and displayed until 21/11/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Jun-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 10

Date change from 27 April 2004 to 30 June 2009

Updated on 28/09/2007 and displayed until 19/03/2010
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   04/2004
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to separate SPcs for Eurax cream and lotion.
Section 10 revision date changes
Updated on 30/09/2003 and displayed until 28/09/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics