EUMOVATE ECZEMA & DERMATITIS 0.05% CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Eumovate Eczema & Dermatitis 0.05% Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Clobetasone butyrate 0.05% w/w

Excipients with known effect:

Cetostearyl alcohol

Chlorocresol

For the full list of excipients, see section 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

This product is suitable for use in adults and children aged 12 years or older.

This product should be applied sparingly (see section 6.6) and gently rub in, using only enough to cover the affected area once or twice a day for up to 7 days. If the condition resolves within 7 days, treatment with this product should be stopped. If the condition does not improve in the first 7 days or becomes worse the consumer should see a doctor. If after 7 days of treatment improvement is seen but further treatment is required, the consumer should see a doctor

Use in children under 12 years only on the advice of a doctor. Children are more likely to develop local and systemic adverse reactions of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.

Care should be taken when using this product to ensure the amount applied is the minimum that provides therapeutic benefit.

Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic adsorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

4.3 Contraindi­cations

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Do not use on broken, inflamed, or infected skin near chronic ulcers or skin lesions caused by infection with viruses (e.g. herpes simplex, chickenpox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).

The following conditions should not be treated with clobetasone butyrate: rosacea, acne vulgaris, pruritus without rash.

4.4Special warnings and precautions for use

Manifestations of hypercortisolism (Cushing’s syn­drome) can occur in some individuals, due to prolonged duration of use, extensive application to the skin, or because of increased systemic absorption due to use of occlusive dressings or application to broken or thin skin.

In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ration compared with adults.

This product should only be used for the treatment of eczema and dermatitis as it may mask or exacerbate other conditions. The management of eczema and dermatitis in adults and children usually requires the supervision of a doctor.

Do not use with occlusive dressings.

This product should not be used on the groins, genitals or between the toes as these are common sites of fungal infections.

This product 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 this product should not be used.

Care should be taken to ensure that the cream does not enter the eye, as cataracts and glaucoma might result from repeated exposure.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

This product should not be used with other corticosteroids (by systemic or topical routes), as this may increase the risk of unwanted effects.

This product should not be used for the treatment of psoriasis as rebound exacerbation may be a problem. This condition should be managed under the care of a doctor.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

For external use only. This and all medication should be kept out of the reach of children. In the case of accidental ingestion, professional assistance should be sought or a national poison control centre contacted immediately (see section 4.9).

The Excipients include cetostearyl alcohol which may cause local skin reactions and chlorocresol which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

4.6 Fertility, pregnancy and lactation

Women, who are pregnant or breast feeding, should consult a doctor before use.

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

There are limited data from the use of clobetasone butyrate in pregnant women.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.

The relevance of this finding to humans has not been established. Administration of clobetasone butyrate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.

The safe use of topical corticosteroids during lactation has not been established

It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.

Administration of clobetasone butyrate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.

If used during lactation, clobetasone butyrate should not be applied to the breasts to avoid accidental ingestion by the infant.

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.

Very rare: Opportunistic infection

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.

Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemi­a/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels.

When large areas of the body are being treated with clobetasone 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 butyrate.

Very rare: Allergic contact dermatitis, urticaria, skin atrophy*, pigmentation changes*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritis, erythema.

Local atrophic changes could possibly occur in situations where moisture increases absorption of clobetasone butyrate, but only after prolonged use.

*Skin features secondary to local and/or systemic effects of hypothalamic- pituitary adrenal (HPA) axis suppression.

General Disorders and Administration Site

Conditions Very rare: Exacerbation of underlying symptoms.

Eye Disorders:

Not Known: Blurred Vision (see section 4.4)

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 under medical supervision because of risk of glucocoticosteroid insufficiency. There is also a risk of skin atrophy with the chronic use of topical steroids.

Further management should be clinically indicated or as recommended by the national poisons centre, where available.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

D07AB01 Corticosteroids, moderately potent (group II)

Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.

Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.

The cream base used in clobetasone cream has long-lasting moisturising properties. Statistically significant 24 hour skin hydration with clobetasone butyrate cream has been demonstrated.

5.2 Pharmacokinetic properties

Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.

Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile

5.3 Preclinical safety data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical clobetasone. However, clobetasone was not mutagenic in vitro or in vivo.

Topical application of clobetasone to rats at doses of 0.5 or 5 mg/kg/day, and subcutaneous administration to mice at doses >3 mg/kg/day or rabbits at doses >30 gg/kg/day during pregnancy resulted in foetal abnormalities including cleft palate, intrauterine growth retardation and foetal loss. The effect on fertility of topical clobetasone has not been evaluated in animals.

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. 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.

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

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0038

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

16/08/2007