Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
A A H Pharmaceuticals Ltd
D07AA02
Hydrocortisone
25mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
Page 1 of 4 90-92/L/m/6a EFCORTELAN CREAM hydrocortisone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT EFCORTELAN CREAM IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE EFCORTELAN CREAM 3. HOW TO USE EFCORTELAN CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE EFCORTELAN CREAM 6. FURTHER INFORMATION 1. WHAT EFCORTELAN CREAM IS AND WHAT IT IS USED FOR Efcortelan Cream contains a medicine called hydrocortisone. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Efcortelan Cream is used to: help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, dermatitis or insect bites help reduce inflammation of the outer ear. 2. BEFORE YOU USE HYDROCORTISONE 2. BEFORE YOU USE EFCORTELAN CREAM DO NOT USE EFCORTELAN CREAM: if you are allergic (hypersensitive) to hydrocortisone, or any of the other ingredients of Efcortelan Cream (listed in Section 6) to treat any of the following skin problems, it could make them worse: - viral infections, such as cold sores, herpes or chicken pox - fungal infections, such as ringworm, athletes foot or thrush - skin blisters or sores that are caused by an infection. Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Efcortelan Cream. TAKE SPECIAL CARE WITH EFCORTELAN CREAM Check with your doctor or pharmacist before using your medicine if: you are applying the cream under an airtight dressing, including a child's nappy. These dressings make it easier for the active ingredient to pass Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efcortelan Cream 2.5% Hydrocortisone 2.5% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone BP 2.5% W / W. 3 PHARMACEUTICAL FORM Aqueous Cream. 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. 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 7 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 with all corticosteroids, pro Read the complete document