Fucidin Tablets
*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
ie-spc-fucidin-tablets-009ZFT-20210126-cl.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 January 2021
File name
ie-pl-fucidin tablets-009ZFT-20210126-excip +ccsi-cl.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 27 January 2021
File name
ie-spc-fucidin-tablets-009ZFT-20210126-cl.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 2. Deletion of sodium as an excipient with known effect
- Section 4.4. Statement regarding galactase/lactase deficiencies updated. Statement regarding sodium modified to state essentially 'sodium free'.
- Section 4.8. Pruritus and erythema moved from 'uncommon' to 'rare' category. Adverse event reporting details updated in line with Annex V.
Updated on 15 November 2019
File name
ie-pl-fucidin-tabs-ccsi-20170714.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 14 July 2017
File name
PIL_8474_191.pdf
Reasons for updating
- New PIL for new product
Updated on 14 July 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Improved presentation of PIL
Updated on 10 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 July 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 Special warnings and precautions for use
Additional text
In exceptional circumstances, where prolonged systemic Fucidin is needed, e.g. for the treatment of severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.
In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.
Section 4.8 Undesirable effects
Additional text
Not known (cannot be estimated from available data)
|
Not known |
Toxic epidermal necrolysis (Lyell´s syndrome)f) Stevens-Johnson syndromef) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome f) |
f) These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see section 4.4).
Section 5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Steroid antibacterials,
ATC code: J01XC01
5.3 Preclinical safety data
Amended text
There are no preclinical There are no preclinical data of relevance to the prescriber which are additional to that already included in other areas of the SPC.
Section 10 Date of Revision of the text
June 2017
Updated on 16 January 2017
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
Updated on 23 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 16 September 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change due to harmonisation of PIL
Updated on 15 September 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change due to user-testing of patient information
Updated on 14 September 2011
Reasons for updating
- 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
- 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
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 Special warnings and precautions for use
In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'
'Impaired liver function' has been replaced with the term 'Hepatic dysfunction'.
Section 4.5 Interaction with other medicical products and other forms of interaction
In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'
The following wording is now approved:
'Co-administration of Fucidin® tablets and HMG-CoA reductase inhibitors such as statins may cause increased plasma concentrations of both agents. This may result in an elevation of creatinine kinase level and risk of rhabdomyolysis, muscle pain and weakness'.
This replaces the previously approved wording:
'Co-administration of Fucidin® administered systemically and HMG-CoA reductase inhibitors such as statins causes increased plasma concentrations of both agents resulting in an elevation of creatine kinase level (rhabdomyolysis), muscle weakness and pain.'
With regard to an interaction with oral anticoagulants, the following wording has been approved:
'The mechanism of this suspected interaction is unknown', this replaces the wording 'The mechanism of this suspected interaction remains unknown.'
Section 4.6 Fertility, Pregnancy and Lactation
This heading is now used, the previous heading was 'Pregnancy and lactation'.
In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'
Section 4.8 Undesirable effects
The frequency listing at the beginning of this section has been removed; frequencies are now listed beside the frequency class, e.g. Uncommon (≥1/1,000 and <1/100).
The actual frequencies have also changed; each frequency is now less than or equal to ≥ the relevant frequncy, previously our frequncies were all 'less than'.
'Symptoms of general disorders' have been removed as a most frequently reported undesirable effect to Fucidin® administered orally.
The following wording has now been included:
'Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.'
Blood and lymphatic system disorders are now described as 'Frequency not known', these were previously described as 'Very rare'.
Anaphylactic reaction is now described as 'Frequency not known', it was previously described as 'Very rare'.
Drowsiness is now described as 'Common', it was previously 'Uncommon'
Dizziness is now described as 'Common'
Hyperbilirubinaemia, jaundice and hepatic enzymes increased are now described as 'Frequency not known', they were previously described as 'Rare'.
'Hepatorenal syndrome' and 'Renal failure' are now described as 'Frequency not known', it was previously described as 'Very rare'
'Cholestasis' is now described as 'Frequency not known', this undesirable effect has been introduced.
Date of Revision of the text: August 2011
August 2011Updated on 18 July 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- 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
Product Name: Fucidin® 250 mg tablets
Product strength: Each tablet contains 250 mg of sodium fusidate.
Each tablet contains 250 mg of sodium fusidate.SmPC Section changed and description of change:
:Section 2 Qualitative and Quantitative Composition
The following sentence regarding excipients has been added to the section: 'Excipients: Contains lactose monohydrate 71.9 mg and sodium 11 mg (per tablet).
Section 4.4. Special Warnings and Precautions for Use
The following wording has been added to the section:
'Each tablet contains 11 milligrams (mg) sodium. To be taken in to consideration by patients on a controlled diet.'
Section 9 Date of first authorisation/renewal of authorisation
The date of last renewal has been updated to 13 March 2010
Updated on 19 August 2009
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 14 July 2009
Reasons for updating
- Change to date of revision
- Change to side-effects
- Change to warnings or special precautions for use
- Change to drug interactions
- Change of contraindications
Updated on 13 July 2009
Reasons for updating
- 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 4.8 - 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 - Deleted paragraph relating to statins
Section 4.5 - Paragraph 'HMG-CoA reductase inhibitors' moved to top of section. 'Concomitant treatment with statins is therefore contraindicated, see section 4.3' added.
Section 4.8 - Information relating to Rhabdomyolysis added
Section 10 - Date of revision of the text updated to June 2009
Updated on 09 June 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Date - updated to May 2009
Updated on 27 November 2008
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 5.1 - Pharmacodynamic properties
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 12 July 2007
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 12 July 2007
Reasons for updating
- Change of inactive ingredient
- Change of manufacturer
- Change to appearance of the medicine
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 05 September 2005
Reasons for updating
- Change to further information section
Updated on 09 August 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 26 August 2003
Reasons for updating
- Change to section 4.1 - Therapeutic indications
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)