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 March 2011 to April 2012.
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.
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. 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.
The date has been updated from June 2010 to January 2011.
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
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.
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.