Last Updated on eMC 09-12-2016 View medicine  | Leo Laboratories Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:08-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 - minor typographical correction.
Section 4.8 Undesirable Effects - "
hair colour changes" added with frequency "Not known" and comment "
Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported."   
Section 10 Date of revision updated

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:11-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 6.1 (list of excipients), the number "11" has been removed from the excipient Polyoxypropylene stearyl ether
- In Section 6.5 (nature and contents of container), new pack sizes 80 g and 2 x 80 g have been added
- the date of revision is updated

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-02-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In Sections 2, 4.2, 6.3, 6.4 and 6.5, information on the Dovobet Gel Applicator has been added.
  • In Section 10 the date of revision has been updated.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:19-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 - contraindications in syphilis, perianal and genital pruritus are removed (but warning about use on genitals remains)

Section 4.4 - local adverse reactions in relation to accidental administration to the eye have been removed (they are included in         section 4.8).  No experience of concurrent use with other antipsoriatic drugs amended to "limited experience". 
Section 4.6 - new statement that "less than 300 pregnancy outcomes" have been studied

Section 4.8 - section fully revised in line with study/post marketing data and new table of adverse events included.  Number of           patients treated and % experiencing an AE is no longer included (not required in SmPC guideline).  Adverse event are grouped          under new subheadings in the tables. New uncommon side effect: Skin infection.  New rare side effects: hypersensitivity, skin striae, skin exfoliation, rebound effect
Section 4.9 - symptoms of hypercalcaemia revised

Section 5.3 - statements regarding new non-clinical carcinogenicity studies (showing no special risk to humans) added
Section 10 - revision date updated

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In Section 4.2, 4.8 and 5.1 statements regarding use in adolescents have been added
- In Section 10 the date of revision has been updated

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:03-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 2 butylated hydroxytoluene is renamed to buylhydroxytoluene (E321) and QRD template changes are made.
- In section 4.4 butylated hydroxytoluene is renamed to buylhydroxytoluene.
- In section 4.8 a statement regarding reporting side effects is added.
- In section 6.1 polyoxypropylene-15 stearyl ether is renamed to polyoxypropylene-11 stearyl ether
- The revision date is updated.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:13-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 6.5 (nature and contents of container), a new pack size of 3x60g has been added.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:27-01-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In section 7 the Marketing Authorisation Holder name has been changed from LEO Pharmaceutical Products Ltd. A/S to LEO Pharma A/S.
  • In section 10 the Date of Revision of the Text has been updated.

Reasons for adding or 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 4.6 - 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 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC:12-12-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

changes to SmPC following harmonisation procedure

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO