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Emulsiderm Emollient Bath Additive/Cutaneous Emulsion

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/06/20

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Summary of Product Characteristics last updated on medicines.ie: 17/12/2020

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Dermal Laboratories (Ireland) Ltd

129_1619620886

Address: Dermal Laboratories (Ireland) Ltd, 38 Main Street, Swords, Co Dublin, K67 E0A2, Ireland

Medical Information E-mail: info@dermal.ie

Company Products

Medicine NameActive Ingredients
Medicine Name Anhydrol Forte 20% w/v Cutaneous Solution Active Ingredients Aluminium Chloride Hexahydrate
Medicine Name Betacap Scalp Application 0.1% w/w Cutaneous Solution Active Ingredients Betamethasone Valerate
Medicine Name Capasal Therapeutic Shampoo Active Ingredients Coconut Oil, Distilled Coal Tar, Salicylic Acid
Medicine Name Emulsiderm Emollient Bath Additive/Cutaneous Emulsion Active Ingredients Benzalkonium Chloride, Isopropyl Myristate, Liquid Paraffin
Medicine Name Exterol 5% w/w Ear Drops, Solution Active Ingredients Urea Hydrogen Peroxide
Medicine Name Glutarol 10% w/v Cutaneous Solution Active Ingredients Glutaraldehyde
Medicine Name Ibugel 5% w/w Gel Active Ingredients Ibuprofen
Medicine Name Nicam 4% w/w Gel Active Ingredients Nicotinamide
Medicine Name Perinal Cutaneous Spray Active Ingredients Hydrocortisone
Medicine Name Psoriderm Cream Active Ingredients Distilled Coal Tar
Medicine Name Psoriderm Scalp Lotion Shampoo Active Ingredients Distilled Coal Tar
Medicine Name Salactol Collodion Active Ingredients Lactic Acid, Salicylic Acid
Medicine Name Salatac Gel Active Ingredients Lactic Acid, Salicylic Acid
1 - 0 of 13 items.Total: Infinity pages

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 SPC

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 8 June 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 6 August 2015 SPC

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 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 SPC

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 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 SPC

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 4.8 (Undesirable effects) the following text has been added: "Although the emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.  These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic/hypersensitive in nature.  Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area."

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 SPC

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 1 (Name of the medicinal product) : the name has changed from "Emulsiderm Emollient" to "Emulsiderm Emollient Bath Additive/Cutaneous Solution"

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 SPC

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

Section 4.4 - Special warnings and precautions for use: Text has changed from 'Keep out of the reach of children' to 'Keep out of the reach and sight of children'
 
Section 6.5 - Nature and contents of container: The text 'These are supplied as original packs (OP)' has been removed.

Updated on 28 April 2004 SPC

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 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only