Fucibet Lipid cream

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).

Fucibet^® Lipid cream also contains methyl parahydroxybenzoate 0.1% and propyl parahydroxybenzoate 0.02%. For full list of excipients, see Section 6.1

3. Pharmaceutical Form

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

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 polyethylene film. Overnight occlusion is usually adequate.

4.3 Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients.

As with other topical corticosteroid preparations, Fucibet^® Lipid Cream is contraindicated in the following conditions: Skin lesions of viral, fungal or bacterial origin (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, particularly in children. 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 potent topical steroids. Caution should be exercised if Fucibet^® Lipid 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.

Fucibet^® Lipid Cream contains methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains cetostearylalcohol which may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Pregnancy

Safety for use of Fucibet^® Lipid Cream during pregnancy has not been established. Studies in animals have not shown teratogenic effects with fusidic acid but studies with corticosteroids have shown teratogenic effects. The potential risk for humans is unknown. Fucibet^® Lipid Cream should not be used during pregnancy unless clearly necessary.

Lactation

No effects on the infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid and betamethasone valerate is negligible. Fucibet^® Lipid Cream can be used when breast-feeding but should not be used on the breast.

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

Based on clinical data for Fucibet^® approximately 3% of patients can be expected to experience an undesirable effect.

The most frequently reported undesirable effects are various transient symptoms of application site irritation. Allergic reactions have been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

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

Not known

Allergic reaction

Skin and subcutaneous tissue disorders

Uncommon

Skin irritation

Skin burning sensation

Pruritus

Eczema aggravated

Skin stinging sensation

Erythema

Rare

Urticaria

Dry skin

Not known

Contact dermatitis

Rash

Telangiectasia

Class effect

Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, glaucoma and adrenocortical suppression.

4.9 Overdose

Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

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

Steareth-21

Cetostearyl alcohol

White soft paraffin

Liquid paraffin

Hypromellose

Citric acid monohydrate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Potassium sorbate

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 25ºC. Store in original container.

6.5 Nature And Contents Of Container

Aluminium tubes of 5 gram, 15 gram, 30 gram, and 60 grams.

Not all pack sizes are marketed.

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 00043/0218

9. Date Of First Authorisation/Renewal Of The Authorisation

06/02/2007

10. Date Of Revision Of The Text

4 May 2010