MOMETASONE FUROATE Cream Ref.[7528] Active ingredients: Mometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Auden Mckenzie (Pharma Division) Ltd, McKenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

Therapeutic indications

Mometasone Furoate 1mg/g Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

This medicinal product is indicated in adults and children above 6 years of age.

Posology and method of administration

Posology

Adults, including elderly patients, adolescents and children aged 6 years and over

A thin film of Mometasone Furoate 1mg/g Cream should be applied to the affected areas of skin once daily. One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand.

Use of a weaker corticosteroid is often advisable when there is a clinical improvement.

Paediatric population

Mometasone Furoate 1mg/g Cream should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% of body surface area should be treated.

Use of topical corticosteroids in children aged 6 years and over, or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

Children below 6 years

Mometasone Furoate 1mg/g Cream is not recommended for use in children below 6 years of age due to insufficient data on safety (see section 4.8).

Overdose

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

Shelf life

Shelf life: 2 years.

In-use shelf life: 3 months.

Special precautions for storage

Store below 30°C.

Nature and contents of container

Collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a polypropylene cap.

Pack sizes: 30g, 60g or 100g.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

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