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Hydrocortisyl Skin Cream 1%w/w *
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Hydrocortisone

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

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 22 November 2021

File name

1.3.1.Hydrocortisyl skin cream SmPC S21.019_1637588323.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 22 November 2021

File name

1.3.1 Hydrocortisyl skin cream patient leaflet OTC_1637588235.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 04 November 2020

File name

753893 - NPA HYDROCORTISYL CRM OTC IE-D_1604499432.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 November 2020

File name

1.3.1.Hydrocortisyl skin cream SmPC CRN008SW0 IE799 doc_1604493797.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 06 July 2020

File name

hydrocortisyl RX PIL_1536155134.pdf

Reasons for updating

  • XPIL Removed

Updated on 05 September 2018

File name

hydrocortisyl RX PIL_1536155134.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 September 2018

File name

Hydrocortisyl Skin Cream 1SmPC_1536155102.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

    1. Undesirable effects 
       
                  Striae may occur especially in intertriginous areas.
       
                  Skin and subcutaneous disorders:
                  Striae may occur especially in intertriginous areas.
      Frequency not known: Urticaria
       
                  Endocrine disorders: 
      Frequency not known: Pheochromocytoma crisis
       
      Eye disorders:
      Frequency not known:  Chorioretinopathy, Vision blurredblurred vision, (see also section 4.4).
       
      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.

Updated on 30 November 2017

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

 

Section 4.4 Added:-
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
 
Section 4.8 Added:-
Eye disorders:
Vision blurred (see also section 4.4).

 

Updated on 30 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 November 2017

File name

PIL_8374_443.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 August 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Skin and subcutaneous disorders:

Frequency not known: Urticaria

Updated on 08 August 2016

Reasons for updating

  • Change to side-effects

Updated on 27 May 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

CCDsv 2 update

Updated on 17 October 2012

Reasons for updating

  • 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 6.5: shelf life reduced to 3 years

Updated on 19 October 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 2 - update of excipients
Section 5.1 - addition of ATC code
Section 6.1 - update list of excipients

Updated on 15 October 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 31 August 2009

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 typing errors.

Updated on 22 February 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 August 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Change in date of authorisation.

Updated on 08 August 2007

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update Section
7 - Change MAH to sanofi-aventis Ireland Ltd.
10 - Date of revision

Updated on 08 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update Section
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 April 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 June 2003

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 03 June 2003

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)

Updated on 03 June 2003

Reasons for updating

  • New SPC for medicines.ie

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