Emulsiderm Emollient Bath Additive/Cutaneous Emulsion
- Name:
Emulsiderm Emollient Bath Additive/Cutaneous Emulsion
- Company:
Dermal Laboratories Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/11/19
(Click to Download)Click on this link to Download PDF directly
Dermal Laboratories Limited
Company Products
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 25 November 2019 PIL
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 SmPC
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 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 13 February 2018 PIL
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 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 6 August 2015 SmPC
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 6 August 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 22 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 10 March 2015 SmPC
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 1 September 2014 PIL
Reasons for updating
- Change to date of revision
- Removal/change of distributor
Updated on 1 October 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 July 2009 SmPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 29 May 2009 SmPC
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 13 August 2007 SmPC
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 SmPC
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 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only