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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 30/09/2011
SPC Cutivate Cream 0.05%

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 30/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2   Updated to include additional medical advice on using the medicine in a safe and effectivemethod

10    New revison date
Updated on 02/08/2011 and displayed until 30/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
7.    Removal of 'Glaxo Laboratories' as a trading style
10 . Date of revision changed
Updated on 20/07/2011 and displayed until 02/08/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.5  - updated with the potential for interaction between CYP 3A4 inhibitors and corticosteroids
10.0   -  date revised
Updated on 01/07/2011 and displayed until 20/07/2011
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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.3

updated and new contraindications to not use in pruritus without inflammation have been added.

 

4.4

Unless a systemic hypersensitivity reaction is confirmed, it is now GSK policy to include a hypersensitivity statement in Warnings and Precautions. Additional mandatory text has been included in this section on risk factors for systemic absorption and potential for occurrence of hypercortisolism and reversible HPA axis suppression. Most of the text proposed in this section has been moved, for clarity, from other sections of the current SmPC.

 

Warning of the risk of cataracts from repeated exposure has been included. Warning for use in chronic leg ulcers has been included.

 

4.6

updated in line with SmPC guideline and information added on avoiding accidental ingestion, by an infant, by not applying to the breasts.

4.7

updated in line with SmPC guideline for this section.

 

4.8

This section has been reformatted to list adverse reactions under the appropriate MedDRA SOC (system organ class) and according to frequency. The terminology may have changed in line with that used in this classification system.

4.9

This section has been updated to provide clarity on the method for withdrawing a topical steroid.

 

10.

 Date of revision
Updated on 15/07/2008 and displayed until 01/07/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   30-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 - (Cutivate Ointment - PL 10949/0012) - 17 February 1993 30 May 2008

                (Cutivate Cream - PL 10949/0013) - 17 February 1993 30 May 2008

Section 10 - (Cutivate Ointment - PL 10949/0012) - 02 January 2007 30 May 2008

                   (Cutivate Cream - PL 10949/0013) - 19 February 2007 30 May 2008
Updated on 22/02/2007 and displayed until 15/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 05/01/2007 and displayed until 22/02/2007
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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 15/08/2003 and displayed until 05/01/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 04/06/2003 and displayed until 15/08/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/03/2003 and displayed until 04/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 25/02/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 14/02/2002 and displayed until 25/02/2002
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 28/06/2001 and displayed until 14/02/2002
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 19/01/2001 and displayed until 28/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 19/01/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  fluticasone propionate