Last Updated on eMC 06-04-2016 View medicine  | Norgine 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 2 - Qualitative and quantitative composition
  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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:31-03-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2          QUALITATIVE AND QUANTITATIVE COMPOSITION

For the full list of excipients, see section 6.1

 

4.2       Posology and method of administration

            QRD updates throughout this section

 

4.3       Contraindications

            QRD update

 

4.4       Special warnings and precautions for use

            Adequate fluid should be maintained

Possible fluid and electrolyte depletion in association with diarrhoea.

Take with plenty of water to reduce the risk of oesophageal obstruction.

Adequate fluid intake should be maintained.

 

4.6       Fertility, pregnancy and lactation

            QRD update within the heading

 

4.8       Undesirable effects

            Adverse events have been arranged into a table

            AE reporting has been added.

 

4.9       Overdose

If there is profound diarrhoea, dehydration and electrolyte depletion may occur.

 

6.5       Nature and contents of container

Not all pack sizes may be marketed

10        DATE OF REVISION OF THE TEXT

            March 2016

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • 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:01-05-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The additions/changes are highlighted in red below:

3 PHARAMACEUTICAL FORM

Oral granules.

White irregular shaped granules.

 

6.1 List of excipients

Sodium bicarbonate hydrogen carbonate

Sucrose

Talc

Hard pParaffin wax

Titanium Dioxide

Vanillin

 

10 DATE OF TREVISION OF THE TEXT

July 2010 May 2013

 

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:09-07-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - MA holder address updated.

Reasons for adding or updating:

  • 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:01-06-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4        Special warnings and precautions for use

Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Adequate fluid should be maintained. Caution should be exercised in cases of ulcerative colitis. Not to be taken for more than 4 days if there has been no movement of the bowels.

Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Caution should be exercised in cases of ulcerative colitis.

Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Adequate fluid should be maintained.

Not to be taken for more than 4 days if there has been no movement of the bowels.

It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.

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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-12-2008

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.3       Contraindications

Intestinal obstruction, faecal impaction and total atony of the colon.

Known hypersensitivity to the ingredients.

4.4       Special warnings and precautions for use

Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Adequate fluid should be maintained. Caution should be exercised in cases of ulcerative colitis. Not to be taken for more than 4 days if there has been no movement of the bowels.

 

Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.8       Undesirable effects

Immune system disorders: allergic reactions

Gastrointestinal disorders:

Intestinal/colonic obstruction or impaction, abdominal cramp

Oesophageal obstruction is possible if the product is not adequately washed down with fluid.

9          DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 December 2008

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2006

Legal Category:Other

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

6.3          Shelf life

The shelf life is 3 years.

Sachet and lined carton: 2 years

10         DATE OF REVISION OF THE TEXT

21 September 2002

October 2006

 

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied