Salatac Gel *
Pharmacy Only: Non-prescription

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 17 December 2020

File name

SALG-IPHA.SPC_1608208013.pdf

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

Updated on 17 December 2020

File name

EXTL-IPHA.SPC_1608206779.pdf

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

Updated on 31 August 2018

File name

SALG-IPHA.SPC.12.05.15.18.05.15_1535727122.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 18 May 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 18 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "April 2015"

Updated on 18 May 2015

File name

PIL_8670_54.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 May 2015

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 25 July 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 18 February 2010

Reasons for updating

  • 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

In section 9 (Renewal of the authorisation) - the date has changed to "21 November 2009"

In section 10 (Date of revision of the text) - the date has changed to "November 2009"

Updated on 30 November 2009

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 16 May 2005

Reasons for updating

  • 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

Updated on 20 January 2005

Reasons for updating

  • Improved electronic presentation

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only