Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Strides Pharma UK Ltd
D07AA02
Hydrocortisone
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5031676000754 8902501008139
PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE CREAM 1% HYDROCORTISONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Hydrocortisone Cream is and what it is used for 2. What you need to know before you use Hydrocortisone Cream 3. How to use Hydrocortisone Cream 4. Possible side effects 5. How to store Hydrocortisone Cream 6. Contents of the pack and other information 1. WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR Hydrocortisone belongs to a group of medicines called topical corticosteroids. These work by calming the inflammation that occurs during certain skin conditions or reactions. Hydrocortisone Cream may be used for treating various skin conditions including: • Eczema • Dermatitis, including intertrigo (irritation between skin folds) • Insect bite reactions • Inflammation of the external ear (otitis externa) • Prurigo nodularis- a long term skin condition where very itchy lumps appear • Neurodermatoses- a long term skin condition where itchy skin becomes thick due to scratching • Nappy rash, if infection exists it is being treated with appropriate antibiotics. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE CREAM DO NOT USE HYDROCORTISONE CREAM IF YOU: • Are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6) • Have any other skin infection such as athlete’s foot (tinea paedis), chickenpox (varicella) or shingles (Herpes zoster), coldsores (Herpes simplex), impetigo, ringworm o Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone Cream 1% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cream containing 1% micronised hydrocortisone Excipient(s) with known effect Chlorocresol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White Cream 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 To be applied evenly and sparingly once or twice daily for a maximum period of one week. Wash hands after application unless these are the intended site of treatment. If the condition is not improved, consult a doctor. _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 _ Long term therapy should be avoided where possible. _Infants _ Therapy should be limited if possible to a maximum of seven days. Do not use for children under 10 years of age without medical advice. Method of administration For topical application. 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 broken or infected skin, including skin lesions caused by infections with viruses (e.g. herpes infections such as cold sores, chicken pox), fungi (e.g. athlete’s foot, ringworm, thrush) or bacteria (e.g. impetigo) • Acne The product is not recommended for use on children under 10 years of age without medical supervision. 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 o Baca dokumen lengkap