Last Updated on eMC 28-07-2016 View medicine  | Ferring Pharmaceuticals Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:17-06-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - timing for taking the picolax sachets has changed
Section 5.1 - section updated with new clinical data from OPTIMA study, tailored dosing regimen

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:21-04-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.2: Updated with recommended amounts of clear fluid to intake and also what is defined as clear fluids.
section 4.4: Updated to include info. on - Drinking only water to replace the fluid losses may lead to electrolyte imbalance.
section 4.6: Updated to include info. on Fertility - There are no data on the effect of PICOLAX on fertility in humans. Male and female rat fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg (see section 5.3).
section 4.8: Updated with ADR details.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:31-12-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Paediatric dosage measurment amended to introduce a measuring spoon.


1 - 2 years: 1 spoonful morning, 1 spoonful afternoon

2 - 4 years: 2 spoonfuls morning, 2 spoonfuls afternoon

4 - 9 years: 1 sachet morning, 2 spoonfuls afternoon

9 and above: adult dose

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:18-10-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - new pack size of 300 sachets added

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:27-06-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

Reasons for adding or updating:

  • Change due to harmonisation of SPC
  • Introduction of new pack/pack size

Date of revision of text on the SPC:02-09-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of a new pack size - 100 sachets. This pack size will not be marketed in UK.

Harmonisation of the SPC due to Mutual Recognition Procedure. Some sections reworded and some updated.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:24-09-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 2 - include details regarding potassium and lactose excipients
In section 4.4 - include details regarding potassium and lactose excipients
section 9 - updated due to renewal approved.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:19-05-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 - Additional info. added;

"Isolated cases of mild reversible aphthoid ileal ulcers have been reported".

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied