Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Teva UK Ltd
D07AA02
Hydrocortisone
5mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5017007597933
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HYDROCORTISONE 0.5% AND 1.0% OINTMENT 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT 3. HOW TO USE HYDROCORTISONE OINTMENT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE HYDROCORTISONE OINTMENT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT HYDROCORTISONE OINTMENT 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 ointment 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 there is no infection present or existing infection is being treated with appropriate antibiotics. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT DO NOT USE Hydrocortisone ointmentif you: are ALLERGIC (hypersensitive) to hydrocortisone or any of the other ingredients of this medicine have any OTHER SKIN INFECTION such as athlete’s foot (tinea pedis), chickenpox (varicella) or shingles (Herpes zoster), coldsore Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efcortelan Ointment 0.5% Hydrocortisone 0.5% Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone BP 0.5% W / W. 3 PHARMACEUTICAL FORM Ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hydrocortisone has topical anti-inflammatory activities of value in the treatment of a wide variety of dermatological conditions, including the following: eczema, including atopic, infantile, discoid and stasis eczemas: prurigo nodularis, neurodermatoses, seborrhoeic dermatitis, intertrigo and contact sensitivity reactions. Hydrocortisone preparations can also be used in the management of insect bites and otitis externa. Hydrocortisone 0.5% preparations can be used as continuation therapy in mild cases of seborrhoeic or atopic eczema once the acute inflammatory phase has passed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, Children and Elderly A small quantity should be applied to the affected area two or three times daily. Hydrocortisone cream is often appropriate for moist or weeping surfaces, and Hydrocortisone ointment for dry-lichenified or scaly lesions, but this is not invariably so. Route of Administration For topical application. 4.3 CONTRAINDICATIONS Skin lesions caused by infection with viruses (e.g. herpes simplex, chicken pox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo). Hypersensitivity to the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption. Treatment should therefore be limited if possible, to a maximum of seven days. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents. As w Read the complete document