Capasal Therapeutic Shampoo *

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

CAPX-IPHA.SPC_1608206877.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 22 July 2020

File name

CAPX-IPHA.PIL.FP33-20-1-Apk_1595433376.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 July 2020

File name

CAPX-IPHA.SPC_1595432844.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

Legal category:Supply through pharmacy only

Updated on 31 August 2018

File name

CAPX-IPHA.SPC.04.08.15.06.08.15_1535724143.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 06 August 2015

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, in the HPRA address "IRL - Dublin" has been updated to "IRL - Dublin 2" 

Updated on 06 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 05 March 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

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; 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 "February 2015"

Updated on 05 March 2015

File name

PIL_14749_232.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 March 2015

Reasons for updating

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

Updated on 13 May 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Removal/change of distributor

Updated on 13 May 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

In section 2 (Qualitative and Quantitative Composition) the following text has been added: "For excipients, see Section List of excipients."

In section 6.1 (List of excipients) "Sulphate" has been replaced with "Sulfate" in "Triethanolamine Lauryl Sulfate Solution" and "Ammonium Sulfate

In section 10 (Date of revision of the text) the date has changed to "March 2014"

Updated on 16 November 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 October 2011

Reasons for updating

  • 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

In section 6.1 (List of excipients) the following text has been added "Ammonium Sulphate" and "Water"

In section 10 (Date of Revision of the Text) the date has changed to "August 2011"

Updated on 11 August 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 August 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.1 (List of excipients) : the following excipient wording has been amended to read "Coco Amido Propyl Dimethyl Betaine Solution" and "Triethanolamine Lauryl Sulphate Solution"

In section 6.4 (Special precautions for storage) : the following text has been deleted "Keep away from direct sunlight"

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

Updated on 07 February 2006

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 12 June 2003

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Supply through pharmacy only

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only