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 3 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 Fucibet does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
Unopened container: 2 years.
After first opening of container: 3 months.
Not applicable.
Steareth-21
Cetostearyl alcohol
White soft paraffin
Liquid paraffin
Hypromellose
Citric acid monohydrate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Potassium sorbate
All-rac-α-tocopherol
Purified water
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA 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 | |
| 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) Skin burning sensation Pruritus Dry skin |
| Rare: (>1/10,000 and <1/1,000) | Erythema Urticaria Rash (including rash erythematous and rash generalised) |
| General disorders and administration site conditions | |
| Uncommon: (>1/1,000 and <1/100) | Application site pain Application site irritation |
| Rare: (>1/10,000 and <1/1,000) | Application site swelling Application site vesicles |
Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration.
Raised intra-ocular pressure, glaucoma and cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract.
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhydrosis and depigmentation. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucibet as described in the frequency table above.
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.
Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).
ATC code: D07CC01
Pharmacotherapeutic group: Betamethasone and antibiotics.
Fucibet Lipid cream combines the well-known anti-inflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone valerate is a topical steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphyloccus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of S. aureus. The antibacterial activity of fusidic acid is not diminished in the presence of betamethasone.
There are no data which define the pharmacokinetics of Fucibet Lipid 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.
Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.
September 2015
LEO Laboratories Limited
Horizon
Honey Lane
Hurley
Maidenhead
Berkshire
SL6 6RJ
UK
Do not store above 25°C.
Aluminium tubes of 5 g, 15 g, 30 g and 60 g.
Not all pack sizes are marketed.
PL 00043/0218
No special requirements for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 6 February 2007
Date of latest renewal: 9 September 2011
