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Dovonex Cream

*
Pharmacy Only: Prescription

  • Company:

    LEO Pharma

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Calcipotriol Hydrate

    *Additional information is available within the SPC or upon request to the company

Updated on 30 January 2023

File name

spc-dovonex-cream-50mcg-g-2209024-20180629-240g_removal.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 June 2019

File name

spc-dovonex-cream-50mcg-g-2209024-20180629-240g_removal.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 July 2018

File name

spc-dovonex-cream-50mcg-g-2209024-20180629-240g_removal.docx

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Removal of 240 g polyethylene aluminium laminate tube

Updated on 04 July 2018

File name

ie-dovonex-cream-mockup-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 20 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 December 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 2, "Contains diazolidinyl urea 3 mg/g" has been added
In section 4.4 the following warning has been added: "Dovonex cream contains diazolidinyl urea as an excipient. Diazolidinyl urea releases formaldehyde, which may cause local skin reactions (e.g. contact dermatitis)."
In section 5.1 "Antipsoriatics" has been changed to "Other antipsoriatics" in the pharmacotherapeutic group.
In section 6.1 the excipient chloroallylhexaminium chloride (dowicil 200) has been removed and the excipients diazolidinyl urea and 2,4-dichlorobenzyl alcohol have been added
In section 6.4, "do not freeze" has been added
The heading for section 6.6 has been aligned to the QRD template
In section 10 the date of last revision has been changed to December 2017
Throughout the document various typographical and formatting issues have been resolved.

Updated on 18 December 2017

File name

PIL_8158_304.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 21 July 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 2, 4.1 to 4.9, 6.1 to 6.6  in line with QRD template$0Update to section 4.4 re calcium metabolism, local adverse reactions and unevaluated use$0$0Update to section 4.6 regarding breast feeding and fertility$0$0$0Update to section 4.8 to reformat AEs and add section for reporting side effects$0$0Update to section 4.9 to include additional symptoms of overdose$0$0Additional data in section 5.3 re fetal toxicity$0

Updated on 06 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 31 August 2012

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction of spelling and typo errors throughout the SPC

Updated on 14 February 2012

Reasons for updating

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

Updated on 03 February 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition

The following text has been added to this section: "Contains cetostearyl alcohol. For full list of excipients, see section 6.1."

Section 6.1 List of Excipients

The excipient, all-rac-

a-tocopherol (which is an antioxidant) has been added to this section.

 

Section 6.3 Shelf Life

An in-use shelf life has been added to this product. It now states:

After opening: 6 months.

Updated on 07 October 2011

Reasons for updating

  • Change to side-effects
  • Change due to user-testing of patient information

Updated on 17 August 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 4.8 Undesirable effects

Lesional/perilesional skin reactions are now listed as the most frequently reported adverse reactions. This replaces application site reactions.

Hypercalcaemia has been replaced by the broader term 'Systemic effects (hypercalcaemia and hypercalciuria)' as being reported very rarely and especially if the recommended total dose is exceeded.

The frequencies of the side effects have been listed next to each undesirable effect.

The following undesirable effcts have been added: Allergic reactions, hypercalcaemia, hypercalciuria, erythema and contact dermatitis

The reporting rate has been removed from this section.

Section 5 Pharmacological Properties

5.1 Pharmacodynamic Properties

The following wording has been inserted:

Pharmacotherapeutic group: Antipsoriatics for topical use

ATC code: D05AX02

Section 10 Date of Revision of the text

This has been updated from July 2008 to August 2011

Updated on 14 January 2009

Reasons for updating

  • Change of inactive ingredient
  • Deletion of a pack size

Updated on 18 September 2008

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1 - Sodium hydroxide added to List of Excipients
Section 10 - Date of revision of the text changed to July 2008

Updated on 29 November 2006

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated Section 4.4, 4.5 and 5.3 of the SPC in line with clinical data relating to carcinogenicity and photocarcinogenicity

Updated on 14 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1: Change to Product Name

Updated on 14 August 2006

Reasons for updating

  • Change of active ingredient

Updated on 19 July 2005

Reasons for updating

  • Change of inactive ingredient

Updated on 29 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 August 2004

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 May 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • Addition of legal category

Legal category:Product subject to medical prescription which may not be renewed (A)