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 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 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:



4.2       Posology and method of administration

QRD updates

4.3       Contraindications

QRD updates

4.4       Special warnings and precautions for use

The following sentence has been added:

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 updates

4.8       Undesirable effects

Adverse events have been tabulated and reporting of suspected ADR has been added.

10        DATE OF REVISION OF THE TEXT

 

March 2016

Reasons for adding or updating:

  • 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 10 - Date of revision of the text

Date of revision of text on the SPC:01-11-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2:
Frangula was updated from Frangula to Frangula bark.


 

Section 3:

 


‘Brown granules’ was replaced with the following: ‘Light brown to dark brown coated granules.’



Section 6.1:
‘Sodium bicarbonate’ was updated to ‘Sodium hydrogen carbonate’

‘Paraffin wax’ was updated to ‘Hard paraffin’


Section 10:
‘October 2010’ was updated to ‘November 2012’


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 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

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

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3; Addition of - 'Pregnancy and lactation (see section 4.6).'
Section 4.4; Addition of - '
Possible fluid and electrolyte depletion in association with diarrhoea.'
Section 4.6; Update prgnancy information
Section 5.3; Update pre-clinical safety data
Section 10; Date of revision of the text October 2010

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 4.6 - Pregnancy and Lactation
  • 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:01-12-2008

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

Caution should be exercised in the use of NORMACOL Plus in cases of ulcerative colitis.  Patients should be advised to maintain an adequate fluid intake, to avoid NORMACOL Plus immediately before going to bed or in a recumbent position (especially if they are elderly) and to suspend treatment if bowel movements do not occur within four days.

Prolonged and excessive use of stimulant laxatives can cause dependence and loss of normal bowel function

 

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

4.6              Pregnancy and lactation

Not recommended. 

NORMACOL (Sterculia alone) is available if required in pregnancy and lactation

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.

Abdominal distension may occur.

4.9       Overdose

Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake.  Management is as for intestinal obstruction from other causes.

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

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 of the sachet is 3 years and the lined cartons 4 years.

Sachet and lined carton: 2 years.

10         DATE OF REVISION OF THE TEXT

January 1996

October 2006

 

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