1. Name Of The Medicinal Product
Fucidin® H cream
2. Qualitative And Quantitative Composition
Fucidin® H cream contains Fusidic acid Ph.Eur.2% and Hydrocortisone acetate Ph.Eur.1%.
3. Pharmaceutical Form
Cream for topical administration
4. Clinical Particulars
4.1 Therapeutic Indications
Fucidin® H cream is indicated in eczema and dermatitis with secondary bacterial infections, including atopic eczema, primary irritant dermatitis and allergic and seborrhoeic dermatitis where the organisms responsible are known to be or believed to be sensitive to fusidic acid.
4.2 Posology And Method Of Administration
Adults and Children:
Uncovered lesions – a small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks.
Covered lesions - less frequent applications may be adequate.
4.3 Contraindications
Known hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or any of the excipients.
As with other topical corticosteroid preparations, Fucidin® H cream is contraindicated in the following conditions: Primary skin Infections caused by bacteria, fungi or viruses (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.
4.4 Special Warnings And Precautions For Use
Long term continuous topical therapy should be avoided. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with topical steroids. Caution should be exercised, if Fucidin® H cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance.
Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.
As Fucidin® H cream contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritis. Contact with open wounds and mucous membranes should be avoided. As with all corticosteroids, prolonged use on the face should be avoided.
Fucidin® H Cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known
4.6 Pregnancy And Lactation
Pregnancy
For fusidic acid no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Absorption of hydrocortisone acetate following topical application is limited and data from exposed pregnancies indicate no adverse effects on the foetus/newborn child. Caution should be exercised when prescribing to pregnant women.
Lactation
No effects on the infant are anticipated since the systemic exposure of the breast feeding woman to fusidic acid and hydrocortisone acetate is negligible following topical application. Fucidin® H can be used when breast-feeding. If used on the nipples, any cream on the nipples should be cleaned off before breast-feeding.
4.7 Effects On Ability To Drive And Use Machines
Fucidin® H has no or negligible influence on the ability to drive or to use machines.
4.8 Undesirable Effects
Based on clinical data for Fucidin® H 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.
The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
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• Immune system disorders
Not known
Allergic reaction
• Skin and subcutaneous tissue disorders
Uncommon
Skin irritation
Skin burning sensation
Skin stinging sensation
Pruritus
Eczema aggravated
Not known
Rash
Allergic contact dermatitis
Depigmentation
Class effect
Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia and skin striae, especially during prolonged application, folliuculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and adrenocortical suppression.
4.9 Overdose
Acute overdosage is very unlikely to occur. However, chronic overdosage or misuse may result in increased risk of topical or systemic side effects.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Fucidin® H cream combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of hydrocortisone. Concentrations of 0.03 - 0.12 micrograms fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.
5.2 Pharmacokinetic Properties
There are no data which define the pharmacokinetics of Fucidin® H cream, following topical administration in man.
However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.
Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin, all-rac-α-tocopherol, purified water.
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Do not store above 30°C
6.5 Nature And Contents Of Container
Aluminium tube of 3 gram, 5 gram, 10 gram, 15 gram, 25 gram, 30 gram and 60 gram.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
LEO Laboratories Limited
Princes Risborough
Bucks
HP27 9RR
8. Marketing Authorisation Number(S)
PL 00043/0093
9. Date Of First Authorisation/Renewal Of The Authorisation
16/10/2006
10. Date Of Revision Of The Text
13 April 2011
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