Last Updated on eMC 08-01-2018 View medicine  | Tillotts Pharma UK 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:24-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Correction of formatting/typographical errors in sections 4.4 and 4.8, no content changes have been made

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:24-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of photosensitivity as a rare side effect based on EMA guidance

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:27-04-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC was updated in line with revised core company safety information.

Section 4.4 was updated to simplify information on testing of blood counts, liver function and kidney function

Section 4.8 was updated to tabulate side effects and to add new side effects of unknown frequency: pleurisy (to the section Respiratory, thoracic and mediastinal disorders) and intolerance to mesalazine with C-reactive protein increased and/or exacerbation of symptoms of underlying disease (to the section General disorders and administration site conditions)

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:30-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 4.2 (posology and method of administration), the posology in adults has been updated in line with that of Octasa 800mg and now includes the option of once daily administration at doses up to 2.4g

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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:12-03-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To update the SPC in line with the company Core Safety Profile
4.3: Removal of contraindications gastric or duodenal ulcer, haemorrhagic tendency
4.4: Reorganisation and expansion of information and addition of cardiac hypersensitivity reactions, gastric and duodenal ulcers and tablets in stools
4.5: Reorganisation and expansion of information
4.6: Addition of fertility and minor editorial changes
4.7: Editorial changes
4.8: Reorganisation in line with QRD template
5.1: Expansion of information
5.2: Expansion of information
Also to update the SPC in line with the latest QRD template and to make minor administrative changes throughout

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The date of revision of the text has changed to 15/10/2013  

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • 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:27-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.1 (list of excipients), the excipient dibutyl phthalate has changed to triethyl citrate.

In section 7 (marketing authorisation holder), the address has changed to:

Tillotts Pharma UK Ltd
Wellingore Hall
Wellingore
Lincolnshire
LN5 0NX
United Kingdom

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