Section 2 Qualitative and Quantitative Composition

The previous text of “Sunset Yellow FCF (E110)” and  “0.15 mg / 5 ml” has been deleted from the list of excipients in this section.

Section 3 Pharmaceutical Form

The previous second sentence of this section: “A clear, yellowish orange, slightly viscous fruit flavoured solution” has been deleted and replaced with the text “Clear, colourless to yellowish or slightly yellowish-brown, slightly viscous liquid”.

Section 4.4 Special Warnings and Precautions for Use

The vol % ethanol details in the fifth paragraph of this section have been updated.  The previous text of “Dulcolax Pico Liquid contains 5.9 vol % ethanol (alcohol), i.e. up to 480 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose” has been updated to “Dulcolax^® Pico Liquid contains 4.8 vol% ethanol (alcohol).  A daily dose of 1 - 2 5 ml spoonfuls is equivalent to 5.2 - 10.4 ml of 5% beer and to 2.2 - 4.3 ml of 12% wine”.

The previous text of “and the colouring agent E110, sunset yellow FCF” has been deleted from the final paragraph of this section.  The text now reads “Dulcolax Pico Liquid contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed)”.

Section 5.1 Pharmacodynamic Properties

The typographical error of “disgestion” in the final sentence of the final paragraph of this section has been corrected to “digestion”.

Section 6.1 List of Excipients

The previous excipient text of “Aroma tutti frutti (flavouring)” has been amended to “Tutti Frutti Flavour” in this section.

The previous excipient text of “Sunset Yellow FCF (E110) (colouring)” has been deleted from this section.

Section 10 (Date of Revision of the Text)

The date has been amended to March 2016.

Section 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group and ATC code details have been added to the beginning of this section.

A new, final paragraph including details of the digestion or absorption of calories or essential nutrients has been added to this section.

Section 10 Date of Revision of the Text

The date has been updated from November 2014 to May 2015.

Section 6.5 Nature and Contents of Container

Details regarding an additional, new pack size of 30 ml have been added to this section.

Section 10 Date of Revision of the Text

The revision date has been amended from July 2014 to November 2014.

Section 4.2 Posology and Method of Administration

The dosage recommendation details have been updated with text both being added to and deleted from this section.

Section 4.3 Contraindications

Text has been both added to and deleted from this section.  The text has also been bulleted.

Section 4.6 Fertility, Pregnancy and Lactation

Pregnancy, Lactation and Fertility sub-headings have been added to this section.

Section 4.8 Undesirable Effects

The list of disorders has been updated with both text being added to and deleted from this section, including the addition of a new sub-heading and corresponding text entitled Skin and subcutaneous tissue disorders.

Details regarding the reporting of suspected adverse reactions have been added as a final paragraph to this section.

Section 5.2 Pharmacokinetic Properties

Text has been both added to and deleted from this section.  Four sub-headings have been introduced to the existing text.  New text under the Elimination sub-heading has been added.

Section 10 Date of Revision of the Text

The date has been amended from September 2012 to July 2014.

Section 7 Marketing Authorisation Holder

The text ‘Self-Medication Division,’ has been deleted from the MAH address.

Section 10 Date of Revision of the Text

The date has been amended from September 2012 to June 2014.

Section 4.3 Contraindications

A new final paragraph regarding hereditary conditions has been added to this section.

Section 4.6 Fertility, Pregnancy and Lactation

This section’s header has had the word Fertility added to the beginning.

A new final paragraph regarding effect on human fertility has been added to this section.

Section 4.7 Effects on Ability to Drive and Use Machines

The previous text of None stated has been deleted and replaced with two new paragraphs.

Section 4.8 Undesirable Effects

New text (…; not known – cannot be estimated from the available data) has been added to the adverse event frequency convention paragraph of this section.

The text Not known has replaced the previous text of Rare in the Immune system disorders sub-heading of this section.  Three asterisks have also been added to this sub-heading text.

A new sub-heading and corresponding text entitled Nervous system disorders has been added to this section.

The text Very common: Diarrhoea has been added to the Gastrointestinal disorders sub-heading of this section.  The text … and diarrhoea which was previously at the end of the Common sentence in this sub-heading has been deleted.

New asterisk corresponding text has been added as a final paragraph to this section.

Section 4.9 Overdose

The word fluid has been added to the first sentence of the Symptoms sub-heading of this section.

Section 5.3 Preclinical Safety Data

The previous text of There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC has been deleted and replaced with a new paragraph.

Section 10 Date of Revision of the Text

The date has been amended from May 2010 to June 2012.

Section 5.1 Pharmacodynamic Properties

This section has been updated with both text being added and text being deleted.

Section 5.2 Pharmacokinetic Properties

This section has been updated with both text being added and text being deleted.

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

References to the product name in this section have been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.

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

Reference to the product name in this section has been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.

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.

Section 10 Date of Revision of the Text

The date has been updated to May 2010.

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

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.

Section 4.6 Pregnancy and Lactation

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

The following text:

Uncommon: Nausea, vomiting.

has been added as a second sentence to the Gastrointestinal disorders paragraph.

Section 10 Date of Revision of the Text

The date has been updated to April 2010.

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.