Fucibet Lipid Cream
*Company:
LEO PharmaStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 January 2023
File name
spc-fucibet-lipid-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 lipid-classlabel.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 21 August 2018
File name
spc-fucibet-lipid-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-lipid-classlabel-cl.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.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 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
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 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 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