Dioderm 0.1% w/w Cream

  • Name:

    Dioderm 0.1% w/w Cream

  • Company:
    info
  • Active Ingredients:

    Hydrocortisone

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/04/15

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 31/8/2018

Click on this link to Download PDF directly

Dermal Laboratories Limited

Dermal Laboratories Limited

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 Dioderm 0.1% w/w Cream Active Ingredients Hydrocortisone
Medicine Name Dithrocream Active Ingredients Dithranol
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, Lidocaine Hydrochloride
Medicine Name Psoriderm Cream Active Ingredients Distilled Coal Tar
Medicine Name Psoriderm Emulsion 40% w/v Bath Additive 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 16 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 31 August 2018 SmPC

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 7 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 December 2017 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.1 (List of excipients), Anhydrous Citric Acid has been updated to Citric Acid.

In section 10 (Date of revision of the text), the date has changed to January 2017.

Updated on 22 April 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 April 2015 PIL

Reasons for updating

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

Updated on 20 February 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: 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 "February 2015"

Updated on 11 June 2014 PIL

Reasons for updating

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

Updated on 6 May 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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 2 (Qualitative and Quantitative Composition), the following text has been added: "For a full list of excipients, see section List of excipients."

In section 6.1 (List of excipients) the following text has changed: "Emulsifying Ointment" has been replaced by "Emulisfying Wax"; "White Soft Paraffin" and "Liquid Paraffin"

In section 10 (Date of revision of the text) the date has changed to: "April 2014"

Updated on 6 May 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 16 June 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 7 August 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 (Undesirable effects):  The second paragraph has been changed to read: "Dioderm is usually well tolerated although the excipient propylene glycol may on rare occasions cause skin irritation in sensitive people.  In the rare event of skin irritation or a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued".
 
Section 10 (Date of revision of the text):  The date has changed to "April 2008".

Updated on 29 August 2007 PIL

Reasons for updating

  • Change of trade or active ingredient name

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: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Special warnings and precautions for use: The text 'For external use only'  has been removed.
 
Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.

Updated on 18 August 2006 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 24 July 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 (Undesirable effects) - the wording has been changed from "Topical hydrocortisone preparations are normally well tolerated unless used excessively" to "Reported side effects of corticosteroids include skin thinning and striae.  Although rare, these could occur even with hydrocortisone, especially when used under occlusion or in the folds of the skin.  Dioderm is usually well tolerated but in the event of a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued." 

Updated on 28 June 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 1: "0.1% w/w Cream" has been added to the name of the medicinal product.
 
Section 6.1: "Anhydrous" has been added to "Citric Acid" to read "Anhydrous Citric Acid."
 
Section 6.2: Text has changed from "None known" to "Not applicable."
 
Section 6.3: The shelf-life has changed from "30 months" to "18 months."
 
Section 6.6: Text has changed from "Not applicable" to "No special requirements."
 
Section 9: Renewal of the Authorisation date has changed to "1 December 2005."
 
Section 10: Date of Revision of the Text has changed to "March 2006."
 
 

Updated on 7 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)