Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Fluticasone propionate is indicated for symptomatic treatment of inflammatory dermatoses not caused by micro-organisms and responsive to corticosteroids such as:
For children aged 1 year and over who are unresponsive to lower potency corticosteroids, this medicine is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis under the supervision of a specialist. Expert opinion should be sought prior to the use of this medicine in other corticosteroid responsive dermatoses in children.
For topical administration.
For adults and children aged 1 year and over, apply a thin film of fluticasone cream to the affected skin areas one to twice daily (see 4.4).
Daily treatment should be continued until adequate control of the condition is achieved.
Frequency of application should thereafter be reduced to the lowest effective dose.
When fluticasone cream is used in the treatment of children, if there is no improvement within 7–14 days, treatment should be withdrawn and the child re-evaluated. Once the condition has been controlled (usually within 7-14 days) frequency of application should be reduced to the lowest effective dose for the shortest possible time. Continuous daily treatment for longer than 4 weeks is not recommended.
An increase in the number of daily applications might aggravate side effects without improving the therapeutic effects.
In adults and children, use the method of finger-tip unit to specify the quantity of cream applied to a given surface. The finger-tip unit corresponds to the amount of cream applied from the distal skin-crease to the tip of the index finger. This quantity permits to treat a skin surface corresponding to 2 hands of an adult (approximately 250 to 300 cm²). A finger-tip unit corresponds to approx. 0.5g of product. A tube of 30 grams contains 60 finger-tip unities.
Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse the features of hypercortisolism may appear.
In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency.
3 years.
Shelf life after first opening: 6 months.
Do not store above 30°C.
30g of cream contained in an aluminium tube with white high-density polypropylene screw cap.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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