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 4.2 Posology and Method of Administration
Adults:
The dose is now expressed in millilitres in addition to milligrams.
There is more detail with regard to taking the dose in divided doses; it must now be taken in 'three equally divided doses'.
Children:
Section 4.4 Special warnings and precautions for use
The product is now referenced as 'Fucidin suspension' in this section, it was previously described as 'Fucidin administered systemically'.
'Impaired liver function' has been replaced with the term 'Hepatic dysfunction'.
Section 4.6 Fertility, Pregnancy and Lactation
This heading is now used, the previous heading was 'Pregnancy and lactation'.
Section 4.7 Effects on ability to drive and use machines
This heading has been renamed from the previous heading of 'Effects on ability to drive and use machinery'
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'.
The following wording has now been included: 'Based on clinical data, undesirable effects occurred in approximately 15% of patients receiving Fucidin orally', this replaces ''Based on clinical data, undesirable effects occurred in approximately 5% of children receiving Fucidin orally.'
'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'.
The following wording in bold in this statement has changed:
'Haematological disorders affecting the white cell line (neutropenia, granulocytopenia,agranulocytosis) and more rarely disorders affecting the other two cell lines have been reported, either as isolated events or associated. This has been observed especially in cases of treatment with duration of more than 15 days and is reversible upon drug withdrawal'.
The word 'associated' replaces the word 'together'.
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
Section 2 Qualitative and Quantitative Composition
The following sentence regarding excipients has been added to the section: 'Excipients: Contains Glucise liquid 250 mg/ml, Sorbitol (E420) 100 mg/ml, Sodium 2 mg/ml and orange dry flavour (containing sucrose)
Section 6.3 Shelf life
The following wording has been added to the section and an inuse shelf life has been added to this product:
Unopened: 3 years
After first opening: 1 month
Section 6.4 Special precautions for storage
The storage conditions have been changed for this product from 'Do not store above 25C' to:
'This medicinal product does not require any special storage conditions.'
Section 9 Date of first authorisation/renewal of authorisation
The date of last renewal has been updated to 13 March 2010