Last Updated on eMC 12-01-2018 View medicine  | Dr. Falk Pharma UK Ltd 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Photosensitivity added

Reasons for adding or updating:

  • 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:06-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Renewal date

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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-06-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Section 2:  Addition of sucrose as excipient$0$0Section 4.4:  Warning for those with fructose intolerance,glucose galactose malabsorption or sucrose-isomaltase insufficiency.$0$0Section 4.8:  Addition of ADR reporting information$0$0Section 6.1:  Addition of sucrose as excipient$0$0$0$0Section 10:  Revision date$0$0Minor admin/template/typo updates throughout.$0

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:01-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Addition of 3g strength option.  Addition that when taken once daily, ideally it should be in the morning.  Addition that duration of treatment is determined by the physician.
Section 5.1 - Updated the pharmacotherapeutic group.
Section 6.5 - Added weight of granules in each sachet.
General minor, typographical changes throughout.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 10 date of revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.3 Contraindications - removed contraindications relating to ulcers and haemorrhagic diathesis
4.5 Interactions - removed majority of contraindications.  Added contraindications relating to thioguanine and warfarin.
4.8 Undesirable effects - added effects under "cardiac disorders", Respiratory, thoracic and mediastinal disorders" and "gastrointestinal disorders"
4.9 Overdose - new advice
10  Approved Jan 2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - updated information for maintenance of remission
Section 4.3 - remove contraindications "pre existing gastric or duodenal ulcer" and "haemorrhagic diathesis"
Section 10 - updated revision date

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 10 date of revision of the text

Date of revision of text on the SPC:01-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2  Posology and method of administration

Updated information concerning use in children.

 

4.4  Special warnings and precautions for use

Deleted statement concerning use in children.

 

10  Date of revision of the text

Updated date

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-12-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to add once daily dosage for acute treatment ulcerative colitis.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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:01-03-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

"In sachets" has been removed from the name of the product, peripheral neuropathy and oligospermia has been added to section 4.8.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-07-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

cholestatic hepatitis has been added to section 4.8

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

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