DIPROSONE Cream (2021)

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Περιεχόμενα

1. Name of the medicinal product

Diprosone 0.05% w/w Cream.

2. Qualitative and quantitative composition

Betamethasone dipropionate 0.064% w/w* (* equivalent to 0.05% betamethasone) <u>Excipients with known effect:</u> Chlorocresol Cetostearyl alcohol For the full list of excipients, see section 6.1

3. Pharmaceutical form

Cream.

4.1. Therapeutic indications

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in eczema and dermatitis of all types, including atopic eczema, ...

4.2. Posology and method of administration

Adults and Children Once to twice daily. In most cases a thin film of Diprosone Cream should be applied to cover the affected area twice daily. For some patients adequate maintenance therapy may be achieved ...

4.3. Contraindications

Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosone presentations contra-indicates their use as does tuberculous and most viral ...

4.4. Special warnings and precautions for use

Local and systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion. If used in children or on the face courses should ...

4.5. Interaction with other medicinal products and other forms of interaction

None stated.

4.6. Fertility, pregnancy and lactation

There are no adequate and well controlled studies of the teratogenic potential of topically applied corticosteroids in pregnant women. Therefore topical steroids should be used during pregnancy only if ...

4.7. Effects on ability to drive and use machines

None stated.

4.8. Undesirable effects

Diprosone skin preparations are generally well tolerated and side-effects are rare. The systemic absorption of betamethasone dipropionate may be increased if extensive body surface areas or skin folds ...

4.9. Overdose

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic ...

5.1. Pharmacodynamic properties

Diprosone preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids. In pharmacological doses, corticosteroids are used ...

5.2. Pharmacokinetic properties

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier and the use of occlusive dressings. Topical corticosteroids ...

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

Chlorocresol Sodium dihydrogen phosphate dihydrate Phosphoric acid White soft paraffin Liquid paraffin Cetomacrogol 1000 Cetostearyl alcohol Sodium hydroxide Purified water

6.2. Incompatibilities

None known.

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

5, 30 or 100 g expoxy-lined aluminium tubes with polypropylene caps. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

8. Marketing authorization number(s)

PL 00025/0571

9. Date of first authorization / renewal of the authorization

10 June 1986 / 20 October 2008

10. Date of revision of the text

03 March 2021

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