Emulsiderm Emollient Bath Additive/Cutaneous Emulsion * Pharmacy Only: Non-prescription
Company:
Dermal Laboratories (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 January 2023
File name
63ce9b8d391dd.pdf
Reasons for updating
- Document format updated
Legal category:Supply through pharmacy only
Updated on 17 December 2020
File name
EMDX-IPHA.SPC_1608206584.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 08 June 2020
File name
EMDX-IPHA.PIL.RP16-20-1 Apk_1591630807.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 25 November 2019
File name
EMDX-IPHA.PIL.RP16-19-1_1574698820.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
In section 2 Before you use Emulsiderm Emollient, the following text has been added under Warnings and precautions, "Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it."
In section 6 Further Information, the date the leaflet was last revised has changed to "May 2019"
Updated on 25 November 2019
File name
EMDX-IPHA.SPC_1574697863.pdf
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:Supply through pharmacy only
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 "Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it."
In section 10 Date of revision of the text, the date has changed to "November 2019"
Updated on 31 August 2018
File name
EMDX-IPHA.SPC.04.08.15.06.08.15_1535725186.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 13 February 2018
File name
PIL_14293_66.pdf
Reasons for updating
- New PIL for new product
Updated on 13 February 2018
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 28 April 2017
Reasons for updating
- Change to further information section
- Change to date of revision
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
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 22 April 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 10 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
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 01 September 2014
Reasons for updating
- Change to date of revision
- Removal/change of distributor
Updated on 01 October 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 July 2009
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 10 (Date of revision of the text) the date has changed to: "June 2009"
Updated on 29 May 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 February 2009"
In section 10 (Date of revision of the text) : the date has changed to "April 2009"
Updated on 29 May 2009
Reasons for updating
- New PIL for medicines.ie
Updated on 13 August 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 28 April 2004
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
Updated on 12 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only