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 1 Name of the Medicinal Product
The name has been changed from 'Fucidin® cream' to 'Fucidin® 20 mg/g cream'
Section 2 Qualitative and Quantitative Composition
The excipients 'Butylhydroxyanisole (E320) 0.04 mg/g', 'potassium sorbate 2.7 mg/g' and 'cetyl alcohol 111 mg/g' are now listed.
Section 4.4 Special Warning and Precautions for Use
Potassium sorbate has now been added as an excipient which carries the excipient warning of the possibility of local allergic skin reactions (e.g. contact dermatitis).
Section 4.6 Fertility, Pregnancy and Lactation
The heading has changed from 'Pregnancy and Lactation' to the above
Section 6.3 Shelf Life
An 'in use' shelf life has been added:
'After first opening: 28 days'
Section 6.6 Instructions for Use and Handling
The following has been included: 'Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the enviornment.'
4.8 Undesirable effects
Based on combined clinical data for Fucidin® cream and Fucidin® ointment, approximately 5% of patients can be expected to experience an undesirable effect.
The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.
Allergic reactions and contact dermatitis have been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
Immune system disorders
Rare (≥1/10,000 and <1/1,000):
Allergic reaction
Eye Disorders
Rare (≥1/10,000 and <1/1,000)
Conjuctival irritation
Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 aand <1/100):
Rash*
Irritation at site of application (incl. pain, stinging, burning and erythema)
Pruritis
Contact Dermatitis
*Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported.
Frequency unknown:
Urticaria
Angioneurotic oedema
Eczema
Periorbital oedema
Section 6.5 the text in bold denotes new text 6.5 Nature and Contents of Container Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap. Contents: 5 g, 15 g or 30 g cream. Not all pack sizes may be marketed.
6.5 Nature and Contents of Container
Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap.
Contents: 5 g, 15 g or 30 g cream.
Not all pack sizes may be marketed.