Eumovate Eczema & Dermatitis 0.05% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eumovate Eczema & Dermatitis 0.05% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasone butyrate 0.05% w/w For excipients see 6.1
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Eumovate Eczema & Dermatitis Cream is suitable for the short-term treatment and control of patches of eczema and dermatitis including atopic eczema and primary irritant and allergic dermatitis.
4.2 Posology and method of administration
Eumovate Eczema & Dermatitis Cream is suitable for use in adults and children aged 12 years or older.
Use in children under 12 years only on the advice of a doctor.
Eumovate Eczema & Dermatitis Cream should be applied sparingly (see section 6.6 Instructions for Use/Handling) to the affected area twice a day for up to 7 days. If the condition resolves within 7 days, treatment with Eumovate Eczema & Dermatitis Cream should be stopped. If the condition does not improve in the first 7 days or becomes worse the consumer will be advised to see a doctor. If after 7 days of treatment improvement is seen but further treatment is required, the consumer will be advised to see a doctor.
4.3 Contraindications
Hypersensitivity to Eumovate Eczema & Dermatitis Cream or any of its ingredients.
Broken skin or skin lesions caused by infection with viruses (e.g. herpes simplex, chickenpox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
Acne vulgaris.
4.4 Special warnings and precautions for use
As with all topical corticosteroids absorption can be increased by the use of occlusion, which in infants and children can lead to adrenal suppression. In addition, the management of eczema and dermatitis in infants and young children requires the supervision of a physician. Self-management is therefore limited to adults and children aged 12 and over and for no more than 7 days continuous treatment without occlusion.
Consumers will be advised not to initiate treatment of the same site for a third time without seeking medical advice to confirm the diagnosis.
Consumers should be advised to use Eumovate Eczema & Dermatitis Cream only for the treatment of eczema or dermatitis, as it may mask or exacerbate other conditions. In particular, consumers will be advised not to use Eumovate Eczema & Dermatitis Cream on the groins, genitals or between the toes as these are common sites of fungal infections.
Eumovate Eczema & Dermatitis Cream should not be used on the face as it may cause acneform pustules or perioral dermatitis.
Medical advice should be sought in seborrhoeic dermatitis since this involves areas of skin where Eumovate Eczema & Dermatitis Cream should not be used.
Consumers should be warned against letting the cream get into the eye, as topical steroids can cause glaucoma.
Consumers should be warned not to use other topical corticosteroids, either prescribed or obtained over-the-counter (such as hydrocortisone), at the same time as Eumovate Eczema & Dermatitis Cream as this may increase the risk of unwanted effects.
Consumers should be advised that they should not use topical clobetasone for the treatment of psoriasis as rebound exacerbation may be a problem. This condition should be managed under the care of a physician.
4.5 Interaction with other medicinal products and other forms of interaction
None reported
4.6 Pregnancy and lactation
There are no adequate data from the use of Eumovate Eczema & Dermatitis Cream in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3 Preclinical Safety Data), but the potential risk for humans is unknown.
Women, who are pregnant or breast feeding, will be advised not to use Eumovate Eczema & Dermatitis Cream but to seek the advice of a pharmacist or doctor.
4.7 Effects on ability to drive and use machines
There is no evidence that Eumovate Eczema & Dermatitis Cream can have any effect on the ability to drive or operate machinery.
4.8 Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (>1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally derived from spontaneous data.
Immune System Disorders
Very rare: Hypersensitivity
Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria, local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment.
In the unlikely event of signs of hypersensitivity appearing, application should stop immediately.
Endocrine Disorders
Very rare: Adrenal suppression
When large areas of the body are being treated with clobetasone 17-butyrate, it is possible that some patients will absorb sufficient steroid to cause transient adrenal suppression despite the low degree of systemic activity associated with clobetasone 17- butyrate.
Skin and Subcutaneous Tissue Disorders
Very rare: Skin atrophy, pigmentation changes, hypertrichosis
Local atrophic changes could possibly occur in situations where moisture increases absorption of clobetasone 17-butyrate, but only after prolonged use.
General Disorders and Administration Site Conditions
Very rare: Exacerbation of underlying symptoms.
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
Acute overdose is very unlikely to occur. Chronic overdosage requires continuous use of large quantities for long periods of time. In the case of chronic overdosage or misuse the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression this should be done under medical supervision. There is also a risk of skin atrophy with the chronic use of topical steroids.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacological studies in man and animals have shown that clobetasone butyrate has a relatively high level of topical activity accompanied by a low level of systemic activity.
The anti-inflammatory properties of clobetasone butyrate reduce the erythema and itchiness associated with these conditions. It has been shown that clobetasone butyrate can clear itchiness in as little as 3 days, and can clear erythema and flare-up in as little as 5 days.
When formulated as Eumovate Eczema & Dermatitis Cream, it has little or no effect on hypothalamic-pituitary-adrenal function. This has been so even when Eumovate Eczema & Dermatitis Cream was applied to adults in large amounts under whole-body occlusion.
The cream base in Eumovate Eczema & Dermatitis Cream has long-lasting moisturising properties. Statistically significant 24 hour skin hydration with Eumovate Eczema & Dermatitis Cream has been demonstrated.
5.2 Pharmacokinetic properties
A single application of 30g clobetasone butyrate 0.05% ointment to eight patients (3 with eczema and 5 with psoriasis) resulted in a small rise in plasma clobetasone butyrate levels during the first three hours not exceeding 0.6ng/ml then the levels gradually decreased. The maximum plasma level reached in the first three hours was 0.6ng/ml. This rise in levels was followed by a more gradual decline with plasma levels of clobetasone butyrate falling below 0.1ng/ml (the lower limit of the assay) after 72 hours. The normal diurnal variation in plasma cortisol levels was not affected by the application of clobetasone butyrate ointment.
Although pharmacokinetic studies were not carried out with the cream formulation, plasma clobetasone butyrate levels would be expected to be no greater, or even lower, with the cream formulation, as creams are less occlusive than ointments.
5.3 Preclinical safety data
In studies conducted in rats and dogs, histological changes induced by clobetasone butyrate were typical of corticosteroids (thymic involution, adrenal cortex atrophy, fatty replacement of bone marrow, lympholysis of the spleen and lymph nodes, and a reduction or disappearance of eosinophils from the endometrium). However, these findings were of a lesser severity than those associated with other corticosteroids, illustrating the comparatively low toxicity of clobetasone butyrate.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. Studies in mice, rats and rabbits revealed similar findings following administration of clobetasone butyrate. There is the possibility that such effects could occur in the human foetus, but the potential risk is unknown.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Glycerol monostearate Cetostearyl alcohol Beeswax substitute 6621 Arlacel 165 Dimeticone 20 Chlorocresol Sodium citrate Citric acid monohydrate Purified water
6.2 Incompatibilities
None stated
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25 °C
6.5 Nature and contents of container
Collapsible aluminium tube internally lacquered with an epoxy coat, with a latex band and a wadless polypropylene cap.
15 gm, 5 gm tubes
6.6 Special precautions for disposal
• Wash your hands and dry them
• Squeeze out the correct amount of cream onto your index finger. The picture below gives you an idea of how much to use. Half a fingertip will cover a patch of skin the same size as the palm of your hand
• Gently rub cream into the skin you are treating
• Wash your hands again (unless it is your hands you are treating).
How much to Use
Squeeze out the cream along the top of your index finger: see the picture.
• From the crease in the finger, squeeze the cream halfway to your fingertip. This will cover a patch of skin the same size as the palm of your hand.
• Use the fingertip unit as a guide. For smaller areas, use a smaller amount. This cream isn't meant to treat large areas.
• If you forget or miss a dose, use it when you remember.
• If you use a bit too much of the cream by mistake, don't worry - but try to keep to the fingertip unit.
Half a fingertip will cover a patch of skin the same size as the palm of your hand.
7 MARKETING AUTHORISATION HOLDER
Beecham Group Plc 980 Great West Road Brentford Middlesex TW8 9GS
Trading as
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK
8 MARKETING AUTHORISATION NUMBER
PL 00079/0623
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/08/2007
10 DATE OF REVISION OF THE TEXT
15/03/2016