Last Updated on eMC 11-09-2017 View medicine  | SANOFI 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:07-09-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7 (Marketing Authorisation Holder) has been amended to replace the West Malling, Kent details with the Guildford, Surrey details.  The previous text of Aventis Pharma Limited, 50 Kings Hill Avenue, West Malling, Kent, ME19 4AH, United Kingdom has been replaced with Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom.

Section 10 (Date of Revision of the Text) has been updated to amend the date from 01/08/2017 to 07/09/2017.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-08-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by Aventis Pharma Limited details.

Section 8 (Marketing Authorisation Number) has been amended.  PL 00015/0243 has been replaced by PL 04425/0716.

Section 10 (Date of Revision of the Text) has been amended from February 2016 to 01/08/2017.

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:23-02-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 9 Date of First Authorisation / Renewal of the Authorisation
The previous date of 01 April 1999 has been deleted.
New text of 22 January 1992 / 25 February 2005 has been added.

Section 10 Date of Revision of the Text
The date has been updated from December 2015 to February 2016.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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:01-12-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The statement ‘Laxatives do not help with weight loss (see section 5.1 Pharmacodynamic properties)’ has been added to section 4.4 (Special Warnings and Precautions for Use) at the request of the MHRA.

 

The ATC code has been added to section 5.1 (Pharmacodynamic Properties).

 

The text ‘As a laxative that acts on the colon, bisacodyl specifically stimulates the natural evacuation process in the lower region of the gastrointestinal tract. Therefore, bisacodyl is ineffective in altering the digestion or absorption of calories or essential nutrients in the small intestine’ has been added to section 5.1 (Pharmacodynamic Properties).

 

The date has been amended from October 2014 to December 2015 in section 10 (Date of Revision of the Text).

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 4.6 - Fertility, pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-10-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Posology and Method of Administration

Three new paragraphs have been added to the end of the Short-term treatment for constipation sub-heading text of this section.

 

The previous first sentence text of Should only be used under medical supervision has been deleted from the For preparation of diagnostic procedures and preoperatively sub-heading text of this section.  A new first paragraph starting For preparation of diagnostic procedures … has been added.

 

The text Instructions for use has been added to this section.

 

The previous text of:

 

When using DULCOLAX to prepare the patient for radiographic examination of the abdomen or employing it preoperatively, tablets should be combined with suppositories in order to achieve complete evacuation of the intestine.

 

In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.

 

has been deleted from this section.

 

Section 4.4 Special Warnings and Precautions for Use

The words … patients with … have been added to the penultimate paragraph of this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

Sub-headings of Fertility, Pregnancy and Lactation have been added to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from January 2014 to October 2014. 

Reasons for adding or updating:

  • 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:01-01-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 Undesirable Effects

A new paragraph regarding the reporting of suspected adverse reactions has been added at the end of this section. 

 

Section 10 Date of Revision of the Text

The date has been amended from September 2012 to January 2014.

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:01-09-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Posology and Method of Administration

The penultimate paragraph of this section has had both text added to and deleted from it. 

 

The following text has been added:

 

… (usual range 10 to 30 minutes).  Rarely the laxative effect has been reported …

 

… after administration.

 

The following text has been deleted:

 

… but in some cases it may take up to …

 

Section 10 Date of Revision of Text

The date has been updated from March 2011 to September 2012.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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:01-03-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Name of product changed from Dulcolax Suppositories, 10 mg to Dulcolax 10 mg Suppositories.

Date of revision amended.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2
Consequential changes to section 4.2.

Section 5.2
Section 5.2 has been extensively updated.

Reasons for adding or updating:

  • 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 10 date of revision of the text

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.6 Pregnancy and Lactation

A new final (now fourth) paragraph has been added regarding the conduction of studies on the effect on human fertility.

 

Section 4.7 Effects on Ability to Drive and Use Machines

A new final (now second) paragraph has been added regarding vasovagal response and dizziness and/or syncope.

 

Section 4.8 Undesirable Effects

A new first paragraph has been added entitled “The most commonly reported adverse events …”.

 

The text “Not known – incidence cannot be estimated from the available data” has been deleted from after the “Adverse events have been ranked under headings of frequency …” paragraph.

 

All Immune System Disorders now come under the “Rare” heading.  The “Not known” heading has been deleted from the Immune System Disorders paragraph.

 

The text “Not known” has been replaced with the text “Rare” in the Metabolism and Nutrition Disorders paragraph.

 

A new paragraph regarding Nervous System Disorders has been added to this section.

 

The colitis listing in the Gastrointestinal Disorders paragraph has been changed from “Not known” to “Rare”.  The “Not known” text has been deleted.

 

Section 10 Date of Revision of the Text

The date has been updated from August 2010 to October 2010.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 Pharmacodynamic Properties

Text has been both added to and deleted from this section to align with Company Core Data Sheet.

 

Section 5.2 Pharmacokinetic Properties

Text has been both added to and deleted from this section to align with Company Core Data Sheet.

 

Section 10 Date of Revision of the Text

The date has been updated to August 2010.

Reasons for adding or updating:

  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.7 Effects on Ability to Drive and Use Machines

The previous text of:

 

DULCOLAX has no effect on ability to drive and use machinery.

 

has been replaced with the following text:

 

No studies on the effects of DULCOLAX on the ability to drive and use machines have been performed.

 

Section 6.6 Special Precautions for Disposal

The previous text regarding directions for use of Dulcolax Suppositories (6 listed numbered items in total)

 

has been replaced with the following text:

 

None stated.

 

Section 10 Date of Revision of the Text

The date has been updated to May 2010.

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:01-03-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Posology and Method of Administration

Text for the entire section has been reworded and replaced, with the exception of the two paragraphs commencing with the following:

 

When using DULCOLAX to prepare the patient for radiographic examination …

 

and

 

No specific information on the use of this product is the elderly is available …

 

which remain as before.

 

Section 10 Date of Revision of the Text

The date has been updated to March 2010.

 

Reasons for adding or updating:

  • 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:01-03-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 Special Warnings and Special Precautions for Use

New third and fourth paragraphs have been inserted as follows:

 

Third paragraph now starts with Intestinal loss of fluids can promote dehydration.

 

Fourth paragraph now starts with Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.

 

What is now the fifth paragraph (that starting with Dizziness and/or syncope…) has had text both deleted from and added to.

 

Section 4.6 Pregnancy and Lactation

What used to be the second paragraph has been deleted i.e. text There is no evidence as to whether bisacodyl is excreted into breast milk.

 

A new second paragraph has been inserted which now starts with the text Clinical data show that neither the active moiety of bisacodyl …

 

Section 4.8 Undesirable Effects

The text Rare: hypersensitivity has been added to the Immune system disorders.

 

The text … neurotic o… and … and other hypersensitivity has been deleted from the Not known paragraph in Immune system disorders.

 

A whole new paragraph regarding Metabolism and nutrition disorders has been added.

 

The text …, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort has been added to the Uncommon paragraph in Gastrointestinal disorders.

 

The text … abdominal discomfort has been deleted from the Common paragraph in Gastrointestinal disorders.

 

The text Local irritation has been reported when the suppository formulation has been administered has been deleted as the last paragraph of this section.

 

Section 4.9 Overdose

The words watery stools, brackets either side of the word diarrhoea and word fluid have all been added to the first paragraph of the Symptoms section.

 

Text (including reference to gastric lavage) has both been deleted from and added to the Therapy section.

 

Section 10 Date of Revision of the Text

The date has been updated from January 2009 to March 2010.

 

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-01-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Dulcolax Suppositories 10 mg SPC changes

 

Section 4.6 Pregnancy and Lactation

The words … adequate and well-controlled studies in pregnant women.  Long experience has shown no evidence of undesirable or damaging effects during pregnancy have been added to the first paragraph of this section.

 

The words … reports of undesirable or damaging effects during pregnancy or to the foetus attributable to the use of DULCOLAX have been deleted from the first paragraph of this section.

 

The words There is no evidence as to whether bisacodyl is excreted into breast milk have been added as a new second paragraph.

 

In what was previously the second paragraph of this section, the following text has been deleted:

 

used

to the foetus

 

In what was previously the second paragraph of this section, the following text has been added:

 

as with all

DULCOLAX

taken

and during breast feeding

and only on medical advice

 

The following text has been deleted (from what was previously the third paragraph):

 

Although the active ingredient of DULCOLAX is not known to be excreted in breast milk, its use during breast feeding is not recommended.

 

Section 10 Date of Revision of the Text

The date has been updated to January 2009.

 

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:01-12-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Dulcolax Suppositories 10 mg SPC changes

 

Section 4.4 – Special Warnings and Precautions for Use

The text “There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl.  Some cases have been shown to be associated with colonic mucosal ischaemia.” has been added as a new fourth paragraph.

 

Section 4.8 – Undesirable Effects

The whole of this section has been removed and replaced with the following text:

 

“Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000).

 

Not known – incidence cannot be estimated from the available data.

 

Immune system disorders

Not known: anaphylactic reactions, angioneurotic oedema and other hypersensitivity.

 

Gastrointestinal disorders

Uncommon: vomiting.

Common: Abdominal discomfort, abdominal pain, abdominal cramps, nausea and diarrhoea.

Not known: colitis.

 

Local irritation has been reported when the suppository formulation has been administered.”

 

Section 10 – Date of revision of the text:

The date has been updated to December 2008. 

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:01-11-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 – Special Warnings and Precautions for Use

 

The words “without investigating the cause of constipation” have been added at the end of the first paragraph i.e. after the words “… more than five days”.

 

The words “If laxatives are needed every day, the cause of constipation should be investigated” have been deleted as the second paragraph.

 

The words “and may precipitate the onset of rebound constipation” have been deleted from what was the third paragraph.

 

The words “Children under 10 years should not take DULCOLAX without medical advice” have been deleted from what was the sixth paragraph and the words “DULCOLAX should not be used by children under 10 years without medical advice” added.

 

Section 10 – Date of revision of the text:

 

The date has been updated to November 2008.

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-08-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.5 – Interactions

 

The words “if excessive doses of DULCOLAX are taken” have been added to the second paragraph and the words “However, this situation only arises if excessive doses of DULCOLAX are taken (See Overdose Section)” deleted.

 

The words “Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides” have been added as a third paragraph.

 

Section 4.9 – Overdose:

 

The words “This may also lead to increased sensitivity to cardiac glycosides” have been deleted from the Symptoms paragraph.

 

The words “Laxatives, when taken in” have been added to the first sentence of paragraph 2.  The words “with laxatives” have been deleted from the first sentence of paragraph 2.

 

Section 10 – Date of revision of the text:

 

The words “July 2008” have been replaced with the words “August 2008”.

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-07-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3

DULCOLAX is contraindicated must not be used in patients with ileus, intestinal obstruction, acute surgical abdominal conditions including such as acute appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

 

DULCOLAX is also contraindicated in severe dehydration and DULCOLAX is also contraindicated in patients with a known hypersensitivity to bisacodyl or any other component of ingredient in the product.

Section 10
Revision Date amended

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-11-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Consumer Healthcare added to licence holder address

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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:01-09-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 - hyphen removed from the product name
Section 7 - Self Medication Division deleted

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:01-11-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4: a statement concerning continuous daily usage for 5 days has been added

Reasons for adding or updating:

  • Change to section 6. 4 - Special Precautions for Storage

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied