Last Updated on eMC 27-01-2016 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:30-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- Spelling errors are corrected in Section 4.8 and 5.1
- In section 6.1, the number 11 is removed from "polyoxypropylene stearyl ether" in line with an updated monograph
- The date of revision is updated

Reasons for adding or updating:

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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:

In section 9 the date has been corrected to reflect the most recent licence renewal.

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
  • 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". No                               experience of use of ointment on the scalp 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. Skin exfoliation is a new common side effect.  Rash and Skin burning are moved from               common to uncommon.  New uncommon side effects: Skin infection, skin atrophy, purpura or ecchymosis.  New rare side effects:       furuncle, hypersensitivity, hypercalcaemia, skin striae, photosensitivity reaction, acne, dry skin, 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 4.8 - 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 4.8 a statement regarding reporting side effects has been added.
- In section 6.1 polyoxypropylene-15 stearyl ether is renamed to polyoxypropylene-11 stearyl ether.
- In section 10 the date of revision of the text 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 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:13-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 2, butylated hydoxytoluene was added as an excipient with known effect
- In section 4.2, 4.8 and 5.1 statements regarding a new study in adolescents were 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:16-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In section 7 the Name of the Marketing Authorisation Holder 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 4.4 - Special warnings and precautions for Use
  • 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:01-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • Update to section 4.4 (Special warnings and precautions for use), addition of the following:
    Dovobet ointment contains butylhydroxytoluene (E321). This may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
  • Update to section 6.1 (Excipients), addition of the following:
    Butylhydroxytoluene (E321)
  • Update to section 10 (Date of revision of the text):  April 2011

Reasons for adding or 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 4.8 - 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 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • 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:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC:01-01-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4: Warning re exposure to sunlight added.
Section 5.3: Information from new studies added.

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-03-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Amendment to section 4.4, Special warnings and precautions for use. The sentence 'When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis.' has been amended to 'When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.'

Reasons for adding or 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Removal of Black Triangle

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text

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 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for new product