BOOTS DERMA CARE ECZEMA & DERMATITIS FLARE-UP 0.05% w/w Cream Ref.[2467] Active ingredients: Alclometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Contraindications

Hypersensitivity to Diprolieve Eczema and Dermatitis Cream or any of the ingredients; rosacea; acne and perioral dermatitis; tuberculous and viral lesions of the skin, particularly Herpes Simplex; vaccinia; varicella.

Diprolieve Eczema and Dermatitis Cream should not be used on broken skin or in fungal (eg candidiasis, tinea) or bacterial skin infections (eg impetigo).

Special warnings and precautions for use

As with all topical corticosteroids absorption can be increased by the use of occlusion, which in infants 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 years and over 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 Diprolieve Eczema and 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 Diprolieve Eczema and Dermatitis Cream on the groin, breast-fold, genitals or between the toes as these are common sites of fungal infections.

Diprolieve Eczema and Dermatitis Cream should not be used on the face as it may cause acneform pustules or perioral dermatitis.

Diprolieve Eczema and Dermatitis Cream is not for ophthalmic use. Care should be taken not to get cream in the eye due to the risk of glaucoma following topical application.

Medical advice should be sought in seborrhoeic dermatitis since this involves areas of skin where Diprolieve Eczema and Dermatitis Cream should not be used.

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 Diprolieve Eczema and Dermatitis Cream as this may increase the risk of unwanted effects.

Consumers should be advised that they should not use topical alclometasone dipropionate for the treatment of psoriasis as rebound exacerbation may be a problem. This condition should be managed under the care of a physician.

Interaction with other medicinal products and other forms of interaction

None Known.

Pregnancy and lactation

There are no adequate data from the use of Diprolieve Eczema and Dermatitis Cream in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3) but the potential risk for humans is unknown.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Women who are pregnant or breast-feeding will be advised not to use Diprolieve Eczema and Dermatitis Cream but to seek the advice of a pharmacist or doctor.

Effects on ability to drive and use machines

There is no evidence that Diprolieve Eczema and Dermatitis Cream can have any effect on the ability to drive or operate machinery.

Undesirable effects

Hypersensitivity and application site reactions, such as burning, stinging and irriation, have occurred rarely in a few patients following short-term (up to 7 days) use. Consumers should be advised to stop treatment if signs of irritation and sensitisation occur.

Exacerbation of symptoms may occur.

Incompatibilities

None Known.

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