Fucibet Lipid Cream *

  • Company:

    LEO Pharma
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • *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 15 November 2019

File name

ie-pl-fucibet lipid-classlabel_1573811790.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 21 August 2018

File name

spc-fucibet-lipid-2205135-WS084-prac-cl_1534842515.pdf

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
  • 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 17 August 2018

File name

ie-pl-fucibet-lipid-classlabel-cl_1534495308.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 17 August 2018

File name

spc-fucibet-lipid-2205135-WS084-prac-cl_1534493447.pdf

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)

Updated on 22 July 2014

Reasons for updating

  • New SPC for new product

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

Updated on 22 July 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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: Minor editorial update.

Section 4.3: General update.

Section 4.4: New warning and precautions added in regards to children. Information on HPA axis suppression has been added following systemic use of topical corticosteroids.

Section 4.5: Update in line with QRD

Section 4.6: Updated information on Pregnancy, Breastfeeding and Fertility mostly in line with QRD. A statement is added regarding no reproductive toxicity is shown in animals following topical application of betamethasone valerate.

Section 4.8: Undesirable effects are not tabulated and adverse even reporting statement has been added.

Section 4.9: Updated information on overdose for topically applied corticosteroids.

Section 5.3: Corticosteroid studies in animals showing reproductive toxicity has been added.

Section 6.6: Update in line with the QRD.

Section 10: Date of Revision updated.

Updated on 18 July 2014

File name

PIL_12095_144.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 July 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 12 August 2011

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

Updated to include all-rac-α-tocopherol

Section 10

Updated from August 2010 to July 2011

Updated on 15 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 June 2011

Reasons for updating

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

Updated on 22 September 2010

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 13 September 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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, the quantities of excipients are now listed.

In section 4.3, there is a change to the skin conditions in which Fucibet Lipid is contraindicated. The new text with regard to this is highlighted in bold below:


Due to the content of corticosteroid, Fucibet® Lipid is contraindicated in the following conditions: skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

In section 4.4, there have been the following changes:

1. Warning has been included regarding the preparation entering the eye.

2. A statement regarding bacterial resistance with the use of fusidic acid has been included.

3. The use of a steroid/antibiotic should be limited to two weeks. This has been changed from a previous limit of 3 weeks.


In section 4.6, there has been editorial changes.

In section 4.8, the amount of patients expected to experience an undesirable effect, based on clinical study data has changed from 5% to 3%. The undesirable effects have been listed under the frequency heading.

In section 5.1, the ATC code has been added.

Updated on 19 August 2009

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 06 August 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 quantitative composition declaration
Section 10 revised to 10th July 2009

Updated on 12 June 2007

Reasons for updating

  • New SPC for new product

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

Updated on 12 June 2007

Reasons for updating

  • New PIL for new product