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Fucibet Cream

*
Pharmacy Only: Prescription

  • Company:

    LEO Pharma

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Betamethasone ValerateFusidic Acid

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

Updated on 13 September 2024

File name

Package leaflet-Fucibet cream-addition of Segrate manufacturing site-IE-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of manufacturing site Segrate Italy to section 6 and revision date changed to March 2022

Updated on 30 January 2023

File name

spc-fucibet-2205135-WS084-prac-cl.pdf

Reasons for updating

  • Document format updated

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

Updated on 15 November 2019

File name

ie-pl-fucibet-classlabel-2205135.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 21 August 2018

File name

spc-fucibet-2205135-WS084-prac-cl.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-cream-2205135-classlabel-cl.pdf

Reasons for updating

  • 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 6 - date of revision

Updated on 17 August 2018

File name

spc-fucibet-2205135-WS084-prac-cl.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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 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 for Fucibet in regards to children. Information on HPA axis suppression has been added following systemic use of topical corticosteroids.

Section 4.5: Section 6.6: Update in line with the 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 4.7: Minor editorial update.

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_8465_298.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

Updated on 07 September 2011

Reasons for updating

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

Updated on 29 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 List of excipinets. The following excipient has been added:

all-rac-α-tocopherol

Section 10. Date of (Partial) revision of the text. UPdated to:

July 2011

Updated on 09 February 2011

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 3. Pharmaceutical form

Cream

A white to off white homogenous cream

 

Section 6.3 Shelf life

3 years

After first opening of container: 3 months

 

Section 6.4 Special precautions for storage

Store below 30°cThis medicinal product does not require any special storage conditions

 

Section 10. Date of (Partial) Revision of the text

November 2009December 2010

Updated on 09 February 2011

Reasons for updating

  • Change to storage instructions
  • 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 08 September 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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 quantity of the excipients has been added.

Updated on 06 August 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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 6.1 'for pH adjustment' added after sodium hydroxide
Section 6.4 updated as per guideline
Section 6.5 sample pack and sentence 'Not all pack sizes may be marketed' added
Section 10 revised to 10th July 2009

Updated on 06 August 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 10 December 2008

Reasons for updating

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

Updated on 24 November 2008

Reasons for 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 4.8 - 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

Safety sections of SPC (4.3, 4.4, 4.6 & 4.8) updated in line with updated Company Core Safety Information.

Updated on 24 July 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 January 2007

Reasons for updating

  • 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 10. Date revised to December 2006

Updated on 20 July 2006

Reasons for updating

  • 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 10 - date changed (Part 1 of PA revised)

Updated on 09 August 2005

Reasons for updating

  • Change of inactive ingredient

Updated on 19 July 2005

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Updated on 09 March 2005

Reasons for updating

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

Updated on 23 February 2005

Reasons for 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 02 February 2005

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 29 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 July 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003

Reasons for updating

  • Addition of legal category

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