Last Updated on eMC 20-11-2015 View medicine  | Forest Laboratories UK Limited (a subsidiary of Actavis PLC) 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 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - Fertility, 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 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:29-10-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to sections 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.5, 6.6, 7, 8 and 9 of the SPC in line with the QRD template.

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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:24-01-2011

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 - Qualitative and Quantitative Composition

Was:    Coal Tar Solution 5% v/w
            For a full list of excipients, see 6.1.

Now:    The active ingredient is coal tar solution 5% v/w
            Excipients:    Methyl hydroxybenzoate (E218)     0.10% w/w
                                Propyl hydroxybenzoate (E216)      0.05% w/w
                                Hydrogenated polyoxyl castor oil    0.45% w/w
            For a full list of excipients, see section 6.1.

Section 4.4 - Special Warnings and Precautions for Use

Added:    Hydrogenated polyoxyl castor oil may cause skin reactions.  Methyl and propyl hydroxybenzoates may cause allergic
               reactions that might be delayed.

Section 4.8 - Undesirable Effects

Added:    Skin and subcutaneous tissue disorders: (as subheading)

Section 6.1 - List of Excipients

Removed:    Polysorbate 80
                    Ethanol

Changed:  'Complex of esterified essential fatty acids' now called 'vitamin F ethyl ester'
                  'Water' now 'Purified water'

Section 6.2 - Incompatibilities

Was:    None known

Now:    Not applicable

Section 6.5 - Nature and Contents of Container

Added:    Not all pack sizes may be marketed.

Section 6.6 - Instruction for Use/Handling

Was:    No special requirements.

Now:    Shake the bottle before use.

Section 9 - Date of First Authorisation/Renewal of Authorisation

Was :    3 November 1999 / 16 October 2003

Now:    3 November 1999 / 23 May 2007

Section 10 - Date of (Partial) Revision of the Text

Was:    August 2009

Now:    January 2011

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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:01-08-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 1, the trade name has been changed from "Exorex Lotion 1% w/w cutaneous emulsion" to the following;

1.    Trade Name of the Medicinal product

        Exorex Lotion 5% v/w Cutaneous Emulsion.


In section 2, the composition has changed from "The active ingredient is an alcoholic extract of prepared coal tar 1% w/w (10mg/g) to the following;

2.    Qualitative and Quantitative Composition

        Coal Tar Solution 5% v/w.


In section 6.1, one of the excipients has changed i.e. Industrial methylated spirits has been replaced with Ethanol.

and in section 10 the revision of the text has changed from March 2006 to August 2009.

Reasons for adding or updating:

  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • 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:01-10-2003

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1
 
The name has been changed from 'Exorex Lotion' to 'Exorex Lotion 1% w/w Cutaneous Emulsion'.
 
Section 2
 
The wording 'For excipients, see 6.1' has been added.
 
Section 3
 
The description 'A smooth mustard coloured emulsion' has been added.
 
Section 6.1
 
The names of the excipients 'sodium propyl paraben' and 'methyl paraben' have been changed to 'sodium propyl hydroxybenzoate (E217)' and 'methyl hydroxybenzoate (E218)'.
 
Section 6.4
 
The wording has been amended from 'Store at room temperature below 25°C' to 'Do not store above 25°C'.
 
Section 6.6
 
The wording has been amended from 'None' to 'No special requirements'.
 
Section 9
 
The date of renewal has been added '16/10/2003'
 
Section 10
 
The date of revision of the text has been updated to 16/10/2003

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC