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LEO Pharma
Cashel Road, Dublin 12,
Telephone: +353 1 490 8924
Fax: +353 1 708 2054
Medical Information e-mail: medical-info.ie@leo-pharma.com
Medical Information Facsimile: +353 1 708 2089
Summary of Product Characteristics last updated on medicines.ie: 03/02/2012
SPC Dovonex Cream

When a pharmaceutical company changes an SPC or PIL, 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 03/02/2012 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   17-Jan-2012
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 17/08/2011 and displayed until 03/02/2012
Reasons for adding or 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
Date of revision of text on the SPC:   10-Aug-2011
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Hypercalcaemia has been replaced by the broader term 'Systemic effects (hypercalcaemia and hypercalciuria)' as being reported very rarely and especially if the recommended total dose is exceeded.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 18/09/2008 and displayed until 17/08/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

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 29/11/2006 and displayed until 18/09/2008
Reasons for adding or 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
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

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 14/08/2006 and displayed until 29/11/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1: Change to Product Name
Updated on 05/08/2004 and displayed until 14/08/2006
Reasons for adding or 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
Updated on 12/05/2004 and displayed until 05/08/2004
Reasons for adding or 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
Updated on 26/06/2003 and displayed until 12/05/2004
Reasons for adding or updating:
  • Addition of legal category
Updated on 26/06/2003 and displayed until 26/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Calcipotriol hydrate