FLUTICASONE PROPIONATE Cream (2019)
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Περιεχόμενα
Name of the medicinal product
Fluticasone Propionate 0.05% cream.
Qualitative and quantitative composition
Each 100g of cream contains: Fluticasone propionate 0.05g. Excipients with known effect: Cetostearyl alcohol 5.25 g Imidurea 0.20 g Propylene glycol 10.00 g For the full list of excipients, see section ...
Pharmaceutical form
Cream. White, viscous and homogeneous cream.
Therapeutic indications
For adults and children aged 1 year and over Fluticasone propionate is indicated for symptomatic treatment of inflammatory dermatoses not caused by micro-organisms and responsive to corticosteroids such ...
Posology and method of administration
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). Duration of use Daily treatment ...
Contraindications
Rosacea. Acne vulgaris. Perioral dermatitis. Primary cutaneous viral infections (e.g.: herpes simplex, chickenpox). Hypersensitivity to the active substance or to any of the excipients listed in section ...
Special warnings and precautions for use
Prolonged application of high doses to large areas of body surface, especially in infants and small children, might lead to adrenal suppression. Children and infants have a greater surface area to body ...
Interaction with other medicinal products and other forms of interaction
None reported.
Pregnancy and lactation
Pregnancy Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, administration ...
Effects on ability to drive and use machines
None reported.
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10.000 and <1/1000) ...
Overdose
Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse the features of hypercortisolism may appear. Treatment In this situation, topical steroids should be discontinued ...
Pharmacodynamic properties
ATC code: D07AC17 Fluticasone propionate as a glucocorticoid has anti-inflammatory and vasoconstrictive features. Applied topically on the skin it suppresses inflammatory reactions and symptoms although ...
Pharmacokinetic properties
Pharmacokinetic data for the rat and the dog indicate rapid elimination and extensive metabolic clearance. Bioavailability is very low after topical or oral administration, due to limited absorption through ...
Preclinical safety data
Non-clinical studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, fertility and general reproductive performance revealed no special hazard for humans, other than ...
List of excipients
Macrogol cetostearyl ether Cetostearyl alcohol Isopropyl myristate Paraffinum liquidum Purified water Propylene glycol Citric acid monohydrate Disodium phosphate anhydrous Imidazolinyl urea
Incompatibilities
None reported.
Shelf life
3 years. Shelf life after first opening: 6 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
30g of cream contained in an aluminium tube with white high-density polypropylene screw cap.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Marketing authorization number(s)
PL35533/0131
Date of first authorization / renewal of the authorization
31/10/2012
Date of revision of the text
11/03/2019
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