Fucibet Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucibet® Cream.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucibet® Cream contains Fusidic acid Ph.Eur.2% and Betamethasone 0.1% (as the valerate ester Ph.Eur)
Excipients with known effect:
Cetostearyl alcohol contains 72mg.
Chlorocresol contains 1mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM Cream
A white cream
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Fucibet® is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema, discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.
4.2. Posology and method of administration
Posology
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.
In the more resistant lesions the effect of Fucibet® cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.
Method of administration Cutaneous use
4.3 Contraindications
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients listed in section 6.1.
Due to the content of corticosteroid, Fucibet is contraindicated in the following conditions:
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.
Perioral dermatitis and rosacea.
4.4 Special warnings and precautions for use
Long-term continuous topical therapy with Fucibet® should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucibet®.
Due to the content of corticosteroid, Fucibet® should be used with care near the eyes. Avoid getting Fucibet® into the eyes (see section 4.8).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucibet® should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing’s syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see section 4.8)
Due to the content of betamethasone valerate, prolonged topical use of Fucibet® may cause skin atrophy.
Bacterial resistance has been reported to occur with the use of topical fusidic acid. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, Fucibet® may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see section 4.3).
Fucibet® Cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.
4.6 Fertility, pregnancy and lactation
Pregnancy Fusidic acid:
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.
Betamethasone valerate:
There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities (see section 5.3).
Fucibet should not be used during pregnancy unless clearly necessary. Breast-feeding
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valerate to a limited area of skin of breast-feeding woman is negligible. Fucibet can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant.
Fertility
There are no clinical studies with Fucibet regarding fertility.
4.7 Effects on ability to drive and use machines
Fucibet® has no or negligible influence on the ability to drive or to use machines.
4.8 Undesirable effects
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 (see section 4.4).
Raised intra-ocular pressure, glaucoma or 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 (see section 4.4).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis 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 (see section 4.4). 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.
4.9 Overdose
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 Fucibet® does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
ATC code: D07CC0 1
Pharmacotherapeutic group: Betamethasone and antibiotics
Fucibet® 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.
5.2. Pharmacokinetic properties
There are no data which define the pharmacokinetics of Fucibet® 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.
5.3
Preclinical safety data
Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol cetostearyl ether Cetostearyl alcohol Chlorocresol Liquid paraffin
Sodium dihydrogen phosphate White soft paraffin All-rac-a-tocopherol Purified water Sodium hydroxide
6.2. Incompatibilities
Not applicable.
6.3 Shelf life
Unopened container: 3 years
After first opening of the container: 3 months
6.4 Special precautions for storage
Do not store above 30°C. Store in the original package.
For storage conditions after first opening of the medicinal product, see section 6.3.
6.5. Nature and contents of container
Aluminium tube of 3 g, 5 g, 10 g, 15 g, 25 g, 30 g, 50 g and 60 g.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
LEO Laboratories Limited
Horizon
Honey Lane
Hurley
Maidenhead
Berkshire
SL6 6RJ
UK
8. MARKETING AUTHORISATION NUMBER
PL 00043/0091
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/01/2006