For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than three weeks.
Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of Fucidin® H does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
Unopened container: 3 years
After first opening of container: 3 months
Not applicable
Butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin, all-rac-α-tocopherol, purified water.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are application site reactions including pruritus, burning and irritation.
Adverse reactions are listed by MedDRA system organ class (SOC) and the individual adverse reactions 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 | |
| Uncommon (>1/1,000 and <1/100) | Hypersensitivity |
| Skin and subcutaneous tissue disorders | |
| Uncommon: (>1/1,000 and <1/100) | Dermatitis contact Eczema (condition aggravated) Rash |
| General disorders and administration site conditions | |
| Common: (>1/1,00 and <1/10) | Application site reaction (incl. pruritus, burning and irritation) |
Systemic undesirable effects
Systemic undesirable class effects of mild corticosteroids, like hydrocortisone, include adrenal suppression especially during prolonged topical administration.
Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma.
Dermatological undesirable class effects of mild corticosteroids like hydrocortisone include: Atrophy, dermatitis (incl. dermatitis contact, dermatitis acneiform and perioral dermatitis), skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Paediatric population
The observed safety profile is similar in children and adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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.
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.
October 2014
LEO Laboratories Limited
Horizon
Honey Lane
Hurley
Maidenhead
Berkshire
SL6 6RJ
UK
Do not store above 30°C
Aluminium tube of 3 gram, 5 gram, 10 gram, 15 gram, 25 gram, 30 gram and 60 gram.
PL 00043/0093
Fucidin® H has no or negligible influence on the ability to drive or to use machines.
None
16/10/2006
