Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Sigma Pharmaceuticals Plc
D07AA02
Hydrocortisone
10mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone Ointment 1 % 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ointment containing 1% micronised hydrocortisone Excipient(s) of known effect Wool Fat Liquid For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Smooth off white translucent ointment 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly:_ A small amount to be applied to the affected area evenly and sparingly once or twice a day for a maximum period of one week. 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: _As for adults and the elderly_. _Long term therapy should be avoided and where possible limited to five to seven days. This product is not recommended for use on children under 10 years of age without medical supervision. Method of administration For cutaneous use only. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. • Use on the eyes, face or ano-genital region. • Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy Läs hela dokumentet