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 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. If you experience frequent flare-ups upon stopping treatment, the consumer should see a doctor.

Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids, especially with potent preparations.

Children

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.

Elderly

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.

Renal/Hepatic Impairment

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.

Method of Administration

• 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.

4.3. Contraindications

Hypersensitivity to the active substance or to 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.

4.4. Special warnings and precautions for use

The label will state moderate steroid.

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.

Topical steroid withdrawal syndrome

Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

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. Pregnancy and lactation

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

Fertility

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

Pregnancy

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.

Lactation

The safe use of topical corticosteroids during lactation has not been establish.

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.

Infections and Infestations

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.

Endocrine Disorders

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.

Skin and Subcutaneous Tissue Disorders

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.

Not known (cannot be estimated from available data): Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see Section 4.4).

General Disorders and Administration Site Conditions

Very rare: Exacerbation of underlying symptoms.

Eye Disorders:

Not known (cannot be estimated from available data):

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.