Last Updated on eMC 05-01-2018 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 4.4 - Special warnings and precautions for use
  • 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: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 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

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 and harmonise wording with 400mg
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 6.5 - Nature and contents of container
  • 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:07-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.5 (nature and contents of the container), the 60 pack size has been removed.

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

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

In section 10 (date of revision of the text), the date has changed to 24.09.2013

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:14-05-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2, the adult dose for mild acute disease has changed from '2.4 g (three tablets) a day in divided doses' to '2.4 g (three tablets) once daily or in divided doses'.

For moderate acute disease, the adult dose has changed to: '2.4 g to 4.8 g (three to six tablets) a day in divided doses, with concomitant corticosteroid therapy where clinically indicated. 2.4 g may be taken once daily or in divided doses. Above 2.4 g should be taken in divided doses'. 

The maximum adult dose has changed to:  'The maximum adult dose should not exceed six tablets a day and not exceed 3 tablets taken together at any one time'.   

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - 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 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:05-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3 (Contraindications), has been revised to reflect hypersensitivity to salicylates or any of the excipients. 'Severe hepatic impairment' has been changed to 'severe impairment of hepatic or renal function'.$0$0$0$0Section 4.4 (Special warnings and precautions for use), has been revised to give updated details of blood tests, and timing. Additional warnings have been added not to use Octasa in patients with impaired renal function, and to discontinue treatment in patients if renal function deteriorates. $0$0$0$0$0Patients with lung function impairment, especially asthma, has been revised to 'patients with pulmonary disease, especially asthma', and these patients should be monitored carefully during treatment with Octasa.$0$0$0$0$0Patients with a history of 'sensitivity to sulphasalazine' has been changed to 'patients with a history of adverse drug reactions to preparations containing sulphasalazine', and these patients should also be kept under close medical surveillance on commencement of treatment with Octasa. $0$0$0$0$0The detail of haematological investigations which are necessary for patients with blood dyscrasia developed during treatment has been removed, and now is stated as 'blood tests should be performed'.$0$0$0$0$0Section 4.5 (Interaction with other medicinal products and other forms of interaction) now includes a statement 'specific interaction studies have not been performed', and a statement to reflect 'weak evidence that mesalazine might decrease the anticoagulant effect of warfarin'. $0$0$0$0$0'Mesalazine can increase the immunosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine' has been changed to ' in patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-mercaptopurine or thioguanine should be taken into account'.   $0$0$0$0$0Section 4.6 (Pregnancy and lactation) has been revised to include a statement 'there are no adequate data on the use of Octasa 800 mg MR tablets in pregnant women'. Hypersensivity reactions such as diarrhoea in the infant have been highlighted.$0$0$0$0$0Section 4.7 (Effects on ability to drive and use machines) has been slightly reworded. $0$0$0$0$0Section 4.8 (Undesirable effects) has been revised to include details of side effects classification, and additional 'very rare' and 'rare' side effects.$0$0$0$0$0Section 4.9 (Overdose) has been revised to include ' There are rare data on overdose (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive'.$0$0$0$0$0Section 10 (Date of revision of the text) has been updated.                                        $0$0$0$0$0  $0$0

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:23-06-2011

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 maintenance therapy for adults has changed, now including 'once daily'.
 The changed phrase is: '1.6 g to 2.4 g (two to three tablets) taken once daily or in divided doses'.

 'The maximum adult dose should not exceed six tablets a day', has also been added to this section.  

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:01-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 (posology and method of administration) has been updated to allow for an increase in the maximum daily dose for moderate acute disease of up to 4.8g/day.

Reasons for adding or updating:

  • 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:12-01-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 5.1 (pharmacodynamic properties) a statement for the activation of PPAR-y receptors has been added.

Reasons for adding or updating:

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

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

Legal Category:POM

Black Triangle (CHM): NO