Psoriderm Cream *
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

PSCR-IPHA.SPC_1608205923.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 24 February 2020

File name

PSCR-IPHA.PIL.NP4-19-2_1582557767.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 February 2020

File name

PSCR-IPHA_1582557258.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 31 August 2018

File name

PSCR-IPHA.SPC.29.03.18.05.04.18_1535726298.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 04 May 2018

File name

PSCR-IPHA.PIL.NP4-17-1.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 05 April 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

In section 2 Qualitative and Quantitative Composition, the text 'Lecithin 0.4% w/w' has been deleted.

In section 5.1 Pharmacodynamic properties, the text 'Lecithin is a well known phospholipid which is present in foodstuffs.  It is added to Psoriderm Cream to soften psoriasis scales and thereby enhance the absorption of the coal tar' has been deleted.

In section 6.1 List of excipients, the text 'Lecithin' has been added.

In section 10 Date of Revision of the Text, the date has changed to 'March 2018'

Updated on 05 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 06 August 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 "July 2015"

Updated on 06 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 06 August 2015

Reasons for updating

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

Updated on 06 August 2015

File name

PIL_14713_556.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 September 2014

Reasons for updating

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

Updated on 08 June 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 March 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3 - Contra-indications: Additional text added: "Not to be used for acute, sore or pustular psoriasis or in the presence of infection."
 
Section 4.8 - Undesirable effects: Additional text added: "Local side effects do not normally occur although the excipient propylene glycol may on rare occasions cause skin irritation in sensitive people. In the rare event of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm Cream may stain skin, hair or fabric."

Updated on 18 August 2006

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

Section 6.1 - List of excipients: "Triethanolamine" changed to "Trolamine"
 
Section 6.2 - Incompatibilities: "None known" changed to "Not applicable"
 
Section 6.6 - Instructions for use and handling: "Not applicable" changed to "No special requirements"
 
Section 9 - Renewal of the Authorisation: Changed to "1 December 2005"
 
Section 10 - Date of Revision of the Text: Changed to "February 2006"

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only