Dulcolax 10 mg Suppositories
- Name:
Dulcolax 10 mg Suppositories
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 8 August 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
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 4.4 - 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 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 7/54/3 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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 6 January 2017 SPC
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 PIL
Reasons for updating
- Change to section 3 - use in children/adolescents
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 23 November 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
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 PIL
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 25 July 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 July 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
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 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 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 March 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 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 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 7 April 2011 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 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 18 February 2011 SPC
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 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 6 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 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 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 30 November 2009 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 15 July 2009 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only