Dithrocream
Product Information *
Company:
Dermal Laboratories LimitedStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may be renewed (B)
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 31 August 2018
File name
DICX-IPHA.SPC.06.07.15.10.07.15_1535724918.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
File format updated to PDF
Updated on 10 July 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 July 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.8 Undesirable effects, the following text has been added: "Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy."
In section 10 Date of revision of the text, the date has changed to "June 2015".
In section 10 Date of revision of the text, the date has changed to "June 2015".
Updated on 15 December 2014
File name
PIL_8659_355.pdf
Reasons for updating
- New PIL for new product
Updated on 15 December 2014
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:Product subject to medical prescription which may be renewed (B)
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 "October 2014"
"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 "October 2014"
Updated on 15 December 2014
Reasons for updating
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
- Removal/change of distributor
Updated on 08 February 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use), the following text has been added:
"After use on the scalp, a shampoo may be used to remove the Dithrocream residue. Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face. This is particularly important when the higher strengths of Dithrocream have been used".
In section 10 (Date of revision of the text), the date has changed to "January 2013".
"After use on the scalp, a shampoo may be used to remove the Dithrocream residue. Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face. This is particularly important when the higher strengths of Dithrocream have been used".
In section 10 (Date of revision of the text), the date has changed to "January 2013".
Updated on 20 December 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 9 (Renewal of the Authorisation) the date for 1.0% has changed to "17 April 2010"
In section 10 (Date of revision of the text) the date has changed to "October 2012"
In section 10 (Date of revision of the text) the date has changed to "October 2012"
Updated on 19 December 2012
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 25 August 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 29 August 2007
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 9 - Renewal of the Authorisation - The date has changed from '3 July 2002' to '3 July 2007'
Section 10 - Date of Revision of the Text - The date has changed from 'August 2006' to 'July 2007'
Updated on 29 August 2007
Reasons for updating
- Change to date of revision
Updated on 13 August 2007
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.5 - Nature and contents of container: The text 'These are supplied as original packs (OP)' has been removed.
Updated on 25 August 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1 - Therapeutic Indications: Text added "Dithrocream has been developed as a cream formulation of dithranol for particular convenience for home treatment, and is especially suitable for the exposed surfaces and hairy regions of the body."
Updated on 07 February 2006
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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:Product subject to medical prescription which may be renewed (B)
Updated on 16 August 2005
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 July 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
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:Product subject to medical prescription which may be renewed (B)