Dulcolax 5 mg Gastro-resistant Tablets
- Name:
Dulcolax 5 mg Gastro-resistant Tablets
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/12/20

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SANOFI

Company Products
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 16 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 15 December 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 5 December 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 5 December 2017 SPC
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
The word "daily" has been added before "for immediate effect" in both the first and second paragraphs of the "Short-term treatment for constipation" sub-heading.
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.
Updated on 1 December 2017 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- 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 name of the excipient "Soluble maize starch" has been changed to "Modified starch (Corn starch, oxidized)" following an update to the specification of the excipient from an in-house version to the USP/NF monograph. The SPC has been updated to reflect the monograph name.
Section 10 (Date of Revision)
The date has been updated to November 2017 (to reflect the HPRA approval date).
Updated on 30 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 30 November 2017 PIL
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 SPC
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 8 (Marketing Authorisation Number) has been amended. PA 7/54/1 has been replaced by PA 540/184/3.
Section 10 (Date of Revision of the Text) has been amended from December 2016 to August 2017.
Updated on 11 August 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 December 2016 SPC
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 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 16 December 2016 PIL
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 SPC
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
The previous first paragraph text of Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children aged 4 years or younger has been deleted from this section.
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 previous penultimate 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 11 September 2014 SPC
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
Updated on 8 September 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 14 June 2013 SPC
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
Updated on 28 May 2012 SPC
Reasons for updating
- 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 4.9 Overdose
The word also has been added to the final paragraph of the Symptoms sub-heading of this section.
Section 10 Date of Revision of the Text
The date has been amended to May 2012.
Updated on 9 May 2012 SPC
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 June 2011 to April 2012.
Updated on 18 January 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 30 August 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to product name
Updated on 28 June 2011 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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 1 Name of the Medicinal Product
The text … Gastro-resistant has been added to and the strength text moved in this section i.e. to now read Dulcolax 5 mg Gastro-resistant Tablets as opposed to Dulcolax Tablets 5 mg.
Section 2 Qualitative and Quantitative Composition
The word Excipients and text regarding Lactose monohydrate and Sucrose has been added to this section.
The words … a full list of have been added to the final sentence of this section to now read: For a full list of excipients, see section 6.1.
Section 3 Pharmaceutical Form
The text … (tablet) has been added to the first sentence of this section.
Section 4.4 Special Warnings and Precautions for Use
The text … galactose intolerance, the Lapp Lactase deficiency has been added to the final paragraph of this section.
Section 10 Date of Revision of the Text
The date has been updated from March 2011 to June 2011.
Updated on 7 April 2011 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 5 April 2011 SPC
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 26 January 2011 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 21 January 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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. Three of the original paragraphs remain the same, the rest of the section’s text is new.
Section 4.6 Pregnancy and Lactation
The header of this section has been amended to now read Fertility, pregnancy and lactation as opposed to Pregnancy and lactation.
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 1 July 2010 SPC
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 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.
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 12 May 2010 SPC
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 15 July 2009 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only