LOCOID CRELO 0.1 %w/w Cutaneous Emulsion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
HYDROCORTISONE BUTYRATE
Available from:
Astellas Pharma Europe BV
INN (International Name):
HYDROCORTISONE BUTYRATE
Dosage:
0.1 %w/w
Pharmaceutical form:
Cutaneous Emulsion
Authorization status:
Withdrawn
Authorization date:
2007-04-03
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid Crelo Topical Emulsion 0.1%w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The emulsion contains Hydrocortisone butyrate 0.1% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Topical emulsion
White to almost white, opaque , viscous, oil-in-water emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids, e.g.
eczema, dermatitis and psoriasis. The product is intended for topical application especially to the scalp or hirsute skin.
Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread
plaque psoriasis provided warnings are given, see section 4.4 Special Warning and special precautions for use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical application.
Dosage: to be applied evenly and sparingly two or three times daily.
Adults and the elderly: the same dose is used for adults and the elderly, as clinical evidence would indicate that no
special dosage regimen is necessary in the elderly.
Children and infants: long term treatment should be avoided. Courses should be limited to seven days where possible.
The formulation of the product makes it suitable for use in both scaly lesions and for moist, weeping lesions.
4.3 CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the ingredients of the lotion.
This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic
lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with
appropriate chemotherapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although
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