This information is intended for use by health professionals

1. Name of the medicinal product

Fucibet Lipid cream

2. Qualitative and quantitative composition

Fucibet Lipid cream contains Fusidic acid 2% and Betamethasone 0.1% (as the valerate ester).

Excipients with known effect:

Cetostearyl alcohol 40 mg/g.

Methyl parahydroxybenzoate 1 mg/g.

Propyl parahydroxybenzoate 0.2 mg/g.

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 Lipid cream is indicated for the treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

4.2 Posology and method of administration

Posology

Adults and children aged 6 years and over:

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 Lipid 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 topical use of 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 Lipid cream contains methyl and propyl parahydroxybenzoate (E218 and E216), cetostearyl alcohol and potassium sorbate as excipients. Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Potassium sorbate and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

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 topically applied fusidic acid and betamethasone valerate to a limited area of skin of the 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 Lipid cream 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 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 (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, 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 (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 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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

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

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened container: 2 years.

After first opening of container: 3 months.

6.4 Special precautions for storage

Do not store above 25°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 tubes of 5 g, 15 g, 30 g and 60 g.

Not all pack sizes are marketed.

6.6 Special precautions for disposal and other handling

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(s)

PL 00043/0218

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 6 February 2007

Date of latest renewal: 9 September 2011

10. Date of revision of the text

September 2015