When a pharmaceutical company changes an SPC or PIL, 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.
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
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'.
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
Product Name: Fucidin® 250 mg tablets
Product strength: 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
Section 10 - date changed (Part 1 of PA revised)