2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Known effect has been added:

Each gram of cream contains 20 mg fusidic acid

Excipients with known effect:  

 Contains Butylhydroxyanisole (E320) 0.04 mg/g, Potassium Sorbate 2.7 mg/g and cetyl alcohol 111 mg/g

For the full list of excipients, see section 6.1

4.3 Contraindications

This section has been reworded in line with the CCSI.
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

This section has been reworded and updated. 

Bacterial resistance among Staphylococcus  aureus  has been reported to occur with the use of topical Fucidin^®. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.

Fucidin^® cream contains butylhydroxyanisole, potassium sorbate and cetyl alcohol.  These excipients   may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.  Fucidin^® Cream should therefore be used with care when applied in the proximity of the eyes. 

 
4.5 Interaction with other medicinal products and other forms of interaction

New text has been added. None known has been removed.

 No interaction studies have been performed.  Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin^® is negligible.  

4.6 Fertility, pregnancy and lactation

Fertility wording has been added, the preganncy section has been reworded and so has the breast-feeding section as well. It has also been reworded from lactation to breast feeding.

Fertility:

There are no clinical studies with topical Fucidin^® regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate  is negligible.  Topical Fucidin^® can be used during pregnancy. 

Breast-feeding 

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding women is negligible. Topical Fucidin^® can be used during breast-feeding but it is recommended to avoid applying topical Fucidin^® on the breast. 

4.8 Undesirable effects

Section 4.8 has been completely re-written according to the latest version of the CCSI.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.

Based on pooled data from clinical studies including 4724 patients who received Fucidin^® cream or Fucidin^® ointment,  the frequency of undesirable effects is 2.3%

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.

Hypersensitivity and angioedema have been reported.

Undesirable effects are listed by the MedDRA system Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported.  Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Very common ≥ 1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥ 1/10,000 and < 1/1,000

Very rare <1/10,000

Immune system disorders

Rare (≥1/10,000 and <1/1,000):          

Hypersensitivity

Eye disorders

Rare (≥1/10,000 and <1/1,000):          

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 and <1/100):

Dermatitis (incl. dermatitis contact, eczema)

Rash*
Pruritus

Erythema

* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papularhave been reported.  Rash generalised has also occurred.

Rare (≥ 1/10,000 and < 1/1,000)

Angioedema

Urticaria

Blister

General disorders and administration site conditions

Uncommon ≥1/1,000 and <1/100

Application site pain (incl. skin burning sensation)

Application site irritation

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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.