BOOTS DERMA CARE ECZEMA & DERMATITIS FLARE-UP 0.05% w/w Cream (2011)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	THE BOOTS COMPANY PLC
Διεύθυνση	1 Thane Road West, Beeston, Nottingham, NG2 3AA

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Name of the medicinal product

Boots Derma Care Eczema & Dermatitis Flare-Up 0.05% w/w Cream.

Qualitative and quantitative composition

Alclometasone Dipropionate 0.05% w/w. For excipients, see 6.1.

Pharmaceutical form

Cream.

Therapeutic indications

Diprolieve Eczema and Dermatitis Cream is indicated for the short-term treatment and control of patches of eczema and dermatitis including atopic eczema and primary irritant and allergic dermatitis.

Posology and method of administration

Diprolieve Eczema and Dermatitis Cream is indicated for use in adults and children 12 years and older. Use in children under 12 years only on advice of a doctor. Diprolieve Eczema and Dermatitis Cream ...

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; ...

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 ...

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 ...

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 ...

Overdose

Acute overdosage is unlikely. Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible. In such ...

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, dermatological preparations – Corticosteroids, moderately potent (group II) ATC code: D07AB10 Alclometasone dipropionate is a non-fluorinated, topically active ...

Pharmacokinetic properties

Not applicable in view of topical action and application.

Preclinical safety data

Alclometasone dipropionate cream appears to be a relatively non-toxic and non-irritating drug product that produces no unusual or unexpected teratologic effects in laboratory animals. A wide margin of ...

List of excipients

Propylene glycol White soft paraffin Cetostearyl alcohol Glyceryl stearate PEG 100 stearate Polyoxyethylene (20) cetyl ether Sodium dihydrogen phosphate dihydrate Chlorocresol Phosphoric acid Purified ...

Incompatibilities

None Known.

Shelf life

60 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Aluminium tubes with white LDPE caps. Pack sizes: 15g.

Special precautions for disposal and other handling

Knowing how much cream to use can be difficult. The fingertip unit method is one easy way. A fingertip unit is the amount of cream you can squeeze on to your fingertip from the tip to the first crease. ...

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization number(s)

PL 00025/0594

Date of first authorization / renewal of the authorization

17/09/2009

Date of revision of the text

30/03/2011