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. The following statement has been added:
Fucidin ointment contains Butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis).
Section 6.1 List of Excipients: The following excipients have been added:
All-rac-α-tocopherol, Butylhydroxytoluene (E321)
Section 10. Date of (Partial) Revision of the Text: Updated to:
July 2011
Section 1 Name of the Medicinal Product
The name has been changed from 'Fucidin® ointment' to 'Fucidin® 20 mg/g ointment'
Section 2 Qualitative and Quantitative Composition
The excipients 'cetyl alcohol 4 mg/g' and 'wool fat (lanolin) 46 mg/g' are now listed.
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: 3 months'
Section 6.4 Special precautions for storage
The following is now registered: 'Do not store above 30
oC' 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.'
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 following text has been added: Not all pack sizes may be marketed.
Not all pack sizes may be marketed.