Acnecide Gel 5%

Product Information *

  • Company:

    Galderma International S.A.S. c/o Galderma (U.K) Ltd.
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 09 February 2020

File name

ie-spc-current-Acnecide-May19_1581287183.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 21 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 21 September 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.2 - Update to method of administration
Section 4.3 - QRD change
Section 4.4 - Addition of warning regarding swelling/blistering of the skin
Section 4.6 - Restructuring/Rewording of the section 
Section 4.8 - Addition of ADRs regarding allergic reactions
Section 4.9 - Restructuring/rewording of the section
Section 5.3 - Restructuring/Rewording of the section
Section 10 - Updated revision date

Updated on 20 September 2017

File name

PIL_9664_947.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 08 April 2015

Reasons for updating

  • Product/presentation re-marketed

Updated on 10 October 2013

Reasons for updating

  • Change to further information section

Updated on 09 September 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 (pharmaceutical form), off-white has been added to the apprearance of the gel.

Updated on 13 June 2011

Reasons for updating

  • Introduction of new pack/pack size

Updated on 03 June 2011

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of 30g pack size.

Updated on 01 April 2011

Reasons for updating

  • Change to side-effects

Updated on 04 March 2011

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The shelf life of the product has been reduced from 36 months to 24 months.

Updated on 02 February 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The adverse events listed in section 4.8 have been presented in a table accroding to system organ class and frequency of occurence. Some additional adverse events have also been added to the table in section 4.8.

Updated on 09 July 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 February 2008

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

Update to section 4.4 - Special Warnings and Special Precautions for Use

Updated on 19 March 2007

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 30 August 2006

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 Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8 JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS

Updated on 16 May 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only