ELOCON Cream (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Elocon 0.1% w/w Cream.
Qualitative and quantitative composition
Mometasone furoate 0.1% w/w. For full list of excipients see section 6.1.
Pharmaceutical form
Cream.
Therapeutic indications
Elocon Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
Posology and method of administration
Adults, including elderly patients and Children: A thin film of Elocon Cream should be applied to the affected areas of skin once daily. Use of topical corticosteroids in children or on the face should ...
Contraindications
Elocon is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes ...
Special warnings and precautions for use
If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted. Should an infection develop, use of an appropriate antifungal or antibacterial ...
Interaction with other medicinal products and other forms of interaction
None stated.
Pregnancy and lactation
Pregnancy During pregnancy treatment with Elocon should be performed only on the physicians order. Then however, the application on large body surface areas or over a prolonged period should be avoided. ...
Effects on ability to drive and use machines
None stated.
Undesirable effects
Table 1. Treatment-related adverse reactions reported with Elocon by body system and frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Mometasone ATC code: D07AC13 Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models. In the croton ...
Pharmacokinetic properties
Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of ...
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.
List of excipients
Hexylene glycol Phosphoric acid Hydrogenated soybean lecithin Titanium dioxide Aluminium starch octenylsuccinate White wax White soft paraffin Purified water
Incompatibilities
None known.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
5, 15, 30 and 100 gram size, epoxy lined aluminum tubes having a screw threaded neck finish sealed with an aluminum membrane. Each tube is supplied with a white high density polyethylene (HDPE) screw cap ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Marketing authorization number(s)
PL 00025/0577
Date of first authorization / renewal of the authorization
19 November 1991 / 15 April 2002
Date of revision of the text
19 July 2019
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