« Back to Medicines list

Hydrocortisyl Skin Cream 1%w/w

  • Name:

    Hydrocortisyl Skin Cream 1%w/w

  • Company:
    info
  • Active Ingredients:

    Hydrocortisone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 4/11/2020

Click on this link to Download PDF directly

SANOFI

SANOFI

Company Products

Medicine NameActive Ingredients
Medicine Name Adenocor Active Ingredients Adenosine
Medicine Name Amaryl 1mg Tablets Active Ingredients Glimepiride
Medicine Name Amaryl 3mg Tablets Active Ingredients Glimepiride
Medicine Name Anthisan Cream Active Ingredients Mepyramine Maleate
Medicine Name Apidra 100 units/ml solution for injection in a cartridge Active Ingredients Insulin Glulisine
Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
Medicine Name Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen Active Ingredients Insulin Glulisine
Medicine Name Aprovel 150mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 300mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 75mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Arava 10 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arava 20 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Bisolvon Oral Solution Active Ingredients Bromhexine hydrochloride
Medicine Name Brolene 0.1%w/v Eye Drops Solution Active Ingredients Propamidine Isethionate
Medicine Name Brolene 0.15% w/w Eye Ointment Active Ingredients Dibromopropamidine Isethionate
Medicine Name Buscopan 10 mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Ampoules Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Rx 10mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Calcium Resonium Active Ingredients Calcium polystyrene sulfonate
Medicine Name Cerubidin 20mg Powder for Solution for Injection Active Ingredients daunorubicin hydrochloride
Medicine Name Cidomycin Paediatric 20mg/2ml Solution For Injection Active Ingredients Gentamicin sulfate
Medicine Name Claforan Powder for Solution for Injection 1g Active Ingredients Cefotaxime sodium
Medicine Name Claforan Powder for Solution for Injection 500mg Active Ingredients Cefotaxime sodium
Medicine Name Clexane 10,000 IU (100mg)/1ml Solution for Injection Active Ingredients Enoxaparin sodium
Medicine Name Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection Active Ingredients Enoxaparin sodium
1 - 0 of 167 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 4 November 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 4 November 2020 SPC

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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 5 September 2018 PIL

Reasons for updating

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

Updated on 5 September 2018 SPC

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 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 30 November 2017 SPC

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 28 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 November 2017 PIL

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 9 August 2016 SPC

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 8 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 May 2016 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

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

Updated on 31 August 2009 SPC

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 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 8 August 2007 SPC

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 8 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 August 2007 SPC

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 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006 SPC

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 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 April 2005 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 June 2003 SPC

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 3 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 3 June 2003 SPC

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)