Dulcolax 10 mg Suppositories *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal Category:

    Supply through pharmacy only
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 08 August 2019

File name

Cropped PI_1060026781_V1_1565190848.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 05 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 05 December 2017

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 (Special Warnings and Precautions for Use)
The fourth paragraph has been amended to include the text "Stimulant" and "including DULCOLAX".

Section 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction)
A new final sentence has been added (regarding the concomitant use of other laxatives enhancing the gastrointestinal side effects).

Section 4.8 (Undesirable Effects)
New text of "including ischaemic colitis" has been added to the last sentence of the Gastrointestinal disorders part of this section.

Section 10 (Date of Revision of the Text)
The date has been amended to November 2017.

Updated on 30 November 2017

File name

PIL_14495_48.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 November 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 15 August 2017

Reasons for 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

Legal category:Supply through pharmacy only

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 sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/54/3 has been replaced by PA 540/184/2.

Section 10 (Date of Revision of the Text) has been amended from December 2016 to August 2017.

Updated on 11 August 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 06 January 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The dosage information for the tablet presentation has been deleted from section 4.2.

 

The suppository dosage information in section 4.2 has been amended to add the word “daily”.

The dosage information for children 4-10 years has been deleted and replaced with the statement “For children 4 - 10 years of age the SmPC for Dulcolax 5 mg Suppositories for Children should be consulted”.

Updated on 23 December 2016

Reasons for updating

  • Change to section 3 - use in children/adolescents

Updated on 19 December 2016

Reasons for 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

Legal category:Supply through pharmacy only

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). 

The ATC code has been added to section 5.1 (Pharmacodynamic Properties) in line with the Company Core Data Sheet.

 

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) in line with the Company Core Data Sheet.

 

The revision date in section 10 has been updated to December 2016.

Updated on 19 December 2016

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 23 November 2016

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 October 2014

Reasons for 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 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

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.

 

A new first paragraph starting For preparation of diagnostic procedures … has been added to the For preparation of diagnostic procedures and preoperatively 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. 

 

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 between in and anal in what is now the final paragraph of this section.

 

The previous final paragraph text of DULCOLAX should not be taken by children under 10 years without medical advice has been deleted from this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

A new sub-heading of Fertility has been added above the last sentence of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2013 to October 2014. 

Updated on 16 September 2014

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 25 July 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 July 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable Effects

Details regarding the reporting of suspected adverse reactions have been added to the end of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2013 to July 2014.

Updated on 14 June 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 - In section 4.2 (Posology and method of administration), Information with regard to the time it takes the suppositories to be effective has been updated. A usual range of 10 to 30 minutes has been added.

Updated on 09 May 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration

The penultimate paragraph of this section has been amended with text both added to and deleted from.  The text … , but in some cases it may take up to 45 minutes has been added and the text … (range 10 to 30 minutes) has been deleted.

 

Section 5.2 Pharmacokinetic Properties

This whole section has been amended, with text both added to and deleted from.  The first paragraph has had mainly text deleted from, but has also had some text added to.

 

The text of what are now the second and third paragraphs of this section is mainly new text.

 

The text of what were previously the last four paragraphs of this section has been deleted.

 

Section 10 Date of Revision of the Text

The date has been amended from March 2011 to April 2012. 

Updated on 18 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 28 June 2011

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 Name of the Medicinal Product

The strength text i.e. 10 mg has been moved to now come after the word Dulcolax i.e. from Dulcolax Suppositories 10 mg to Dulcolax 10 mg Suppositories.

 

Section 2 Qualitative and Quantitative Composition

The words … a full list of have been added to the second sentence of this section to now read: For a full list of excipients, see section 6.1.

 

Section 6.4 Special Precautions for Storage

The text In order to protect from light has been moved to the end of the second sentence of this section.

 

The sentence now reads: Keep the blister in the outer carton, in order to protect from light. 

Updated on 07 April 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 April 2011

Reasons for 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.6 Fertility, Pregnancy and Lactation

A new final sentence/paragraph has been added to the Lactation paragraph of this section i.e. No studies on the effect on human fertility have been conducted.

 

Section 4.7 Effects on Ability to Drive and Use Machines

A new second/final paragraph regarding vasovagal response and dizziness/syncope has been added to this section.

 

Section 4.8 Undesirable Effects

A new first sentence/paragraph regarding abdominal pain and diarrhoea has been added to this section.

 

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

 

This complete section has been reworded, with text being both added to and deleted from.

 

A new sub-heading, Nervous system disorders, has been added.

 

Section 10 Date of Revision of the Text

The date has been updated from January 2011 to March 2011.

Updated on 18 February 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration

This section has been reworded.  Two of the original paragraphs remain the same, the rest of the section’s text is new.

Updated on 27 January 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration

This section has been reworded.  Two of the original paragraphs remain the same, the rest of the section’s text is new.

 

Section 5.1 Pharmacodynamic Properties

This section has been reworded, with text being both added and deleted.

 

Section 5.2 Pharmacokinetic Properties

This section has been reworded, with text being both added and deleted.

 

Section 10 Date of Revision of the Text

The date has been updated from June 2010 to January 2011.

 

Updated on 26 January 2011

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 06 July 2010

Reasons for 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 Special Warnings and Precautions for Use

New third and fourth paragraphs have been added to this section regarding intestinal loss of fluids and haematochezia (blood in stool).

 

The paragraph commencing with the text Dizziness and / syncope has been amended with both text being deleted from and added to. 

 

Section 4.6 Pregnancy and Lactation

This section has been completely re-written, with the exception of the final paragraph, with new separate sub-headings regarding Pregnancy and Lactation.

 

The word DULCOLAX in the final paragraph of this section has been replaced with the word bisacodyl and the following text has been deleted from this paragraph:

 

… in pregnancy, especially the first trimester

 

Section 4.8 Undesirable Effects

The following text has been added to the Immune system disorders sub-heading of this section:

 

Rare: hypersensitivity

 

The second sentence of the Immune system disorders sub-heading has been amended to now read:

 

Not known: anaphylactic reactions, angioedema

 

i.e. deletion of the words neurotic and other hypersensitivity

 

A new sub-heading regarding Metabolism and nutrition disorders has been added to this section.

 

The following text has been added to the Uncommon sentence of the Gastrointestinal disorders sub-heading of this section:

 

…, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort

 

The words Abdominal discomfort have been deleted from the Common sentence of the Gastrointestinal disorders sub-heading of this section.

 

What was the final paragraph of this section (regarding local irritation when the suppository formulation has been administered) has been deleted.

 

Section 4.9 Overdose

The first paragraph of this section has been amended to include the text watery stools, brackets round the word diarrhoea and the text fluid.

 

The first paragraph of the Therapy sub-heading has had the text or gastric lavage added to the end of the first sentence.

 

The text Within a short time, Otherwise gastric lavage should be performed and (particularly hypokalaemia) has been deleted from the first paragraph of the Therapy sub-heading.

 

The word some has been deleted from between the words of and value in the second paragraph of the Therapy sub-heading of this section.

 

Section 10 Date of Revision of the Text

The date has been updated to June 2010.

Updated on 11 May 2010

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.7 Effects on Ability to Drive and Use Machines

The following text:

 

None stated.

 

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 10 Date of Revision of the Text

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

Updated on 30 November 2009

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 July 2009

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided