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 5.1 Pharmacodynamic Properties
This section has been updated with both text being added and text being deleted.
Section 5.2 Pharmacokinetic Properties
Section 10 Date of Revision of the Text
The date has been amended from May 2010 to January 2012.
Section 1 Name of the Medicinal Product
The product name has been changed to Dulcolax Pico Liquid i.e. addition of the word Pico.
Section 4.3 Contraindications
References to the product name in this section have been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.
Section 4.4 Special Warnings and Precautions for Use
The first sentence of the third paragraph of this section has been updated to now read: Dizziness and/or syncope have been reported in patients who have taken products in the DULCOLAX or DULCOLAX PICO ranges.
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Reference to the product name in this section has been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.
Section 4.6 Pregnancy and Lactation
Section 4.9 Overdose
The second paragraph of this section has been updated to now read: Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of products in the DULCOLAX PICO range …
Section 4.1 Therapeutic Indications
The previous text of:
For the short term management of constipation and for bowel clearance prior to surgery, childbirth or radiological investigations.
has been amended to read:
For the short term management of constipation.
i.e. removal of the bowel clearance indication.
The date has been updated to May 2010.
The following text:
broad spectrum
has been deleted from the final paragraph of this section i.e. the sentence now reads:
Concurrent administration of antibiotics may reduce the laxative action of this product.
A completely new second paragraph has been added to this section i.e. one with the text commencing:
Clinical data show that neither the active moiety of sodium picosulfate …
Section 4.8 Undesirable Effects
Uncommon: Nausea, vomiting.
has been added as a second sentence to the Gastrointestinal disorders paragraph.
The date has been updated to April 2010.
The following information has been added to section 4.4
"Dizziness and / or syncope have been reported in patients who have taken DULCOLAX. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of sodium picosulfate itself."
Information on excipients has been added to section 2:
“Excipients:
Methyl Parahydroxybenzoate (E218) 2.5 mg / 5 ml
Propyl Parahydroxybenzoate (E216) 0.5 mg / 5 ml
Ethanol 96% 250 mg / 5ml
Sunset Yellow FCF (E110) 0.15 mg / 5ml”
Details of the pharmacotherapeutic group ahs been added to section 5.2:
“Pharmacotherapeutic group: contact laxatives
ATC code: A06A B08”
All other changes are minor in nature.