When a pharmaceutical company changes an SPC or PIL, 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.
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.
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.
The date has been updated from March 2011 to June 2011.
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.
The date has been updated from January 2011 to March 2011.
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.
The date has been updated from June 2010 to January 2011.
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.
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
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.
The date has been updated to June 2010.
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.
The date has been updated from January 2009 to April 2010.