Dulcolax Pico Liquid, 5 mg/5 ml, oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/07/20

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Summary of Product Characteristics last updated on medicines.ie: 15/8/2017
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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 10 July 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 July 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 15 August 2017 SmPC

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 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/55/1 has been replaced by PA 540/182/1.

Section 10 (Date of Revision of the Text) has been amended from March 2016 to August 2017.

Updated on 11 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 August 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 September 2016 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 4 April 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 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.

Updated on 5 June 2015 SmPC

Reasons for updating

  • 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

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.

Updated on 11 November 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Introduction of new pack/pack size
  • Addition of information on reporting a side effect.
  • Change of contraindications
  • Change to side-effects
  • Correction of spelling/typing errors

Updated on 11 November 2014 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

Updated on 14 August 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

Updated on 23 July 2014 SmPC

Reasons for updating

  • 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 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.

Updated on 10 June 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 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.

Updated on 3 October 2012 SmPC

Reasons for updating

  • 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 4.8 Undesirable Effects

The text:

 

… (including skin rash)

 

has been added to the end of the Not known: sentence of the Immune system disorders paragraph of this section.

 

Section 10 Date of Revision of the Text

 

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

Updated on 4 July 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • 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 4.3 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.

Updated on 16 January 2012 SmPC

Reasons for updating

  • 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 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.

Updated on 28 June 2010 SmPC

Reasons for updating

  • Change to product name
  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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 …

Updated on 22 June 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 24 May 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.1 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.

Updated on 24 May 2010 PIL

Reasons for updating

  • Change to date of revision
  • Changes to therapeutic indications

Updated on 11 May 2010 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.5 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.

Updated on 6 May 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 14 December 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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."

Updated on 27 November 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • 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



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.

Updated on 20 July 2009 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Correction legal category to Pharmacy only

Updated on 20 July 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 July 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided