Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Teva UK Ltd
D07AA02
Hydrocortisone
25mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5017007598114
REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. HOW TO STORE HYDROCORTISONE CREAM KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Hydrocortisone Cream should be stored below 25ºC and not frozen. Do not use Hydrocortisone Cream after the expiry date which is stated on the carton or on the tube after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT HYDROCORTISONE CREAM CONTAINS: • The active substance is hydrocortisone • The other ingredients are white soft paraffin, cetomacrogol emulsifying wax, liquid paraffin, chlorocresol, and purified water. WHAT HYDROCORTISONE CREAM LOOKS LIKE AND CONTENTS OF THE PACK: • Hydrocortisone 0.5 %, 1 %, and 2.5 % Cream is an aqueous cream • Hydrocortisone 0.5 %, 1 %, and 2.5 % Cream is available in 15 g tubes. Hydrocortisone 1 % Cream is also available in 30 g and 50 g tubes. Not all pack sizes may be marketed. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG England and company responsible for manufacture: Teva Pharmaceutical Works Private Limited, Pallagi Street 13, Debrecen, H 4042, Hungary THIS LEAFLET WAS LAST REVISED: JUNE 2019 PL 00289/0753-0755 • are using this cream under occlusive dressing that can considerably increase the absorption of this cream. Caution should be taken to keep away from the eyes. Contact your doctor if you experience blurred vision or other visual dist Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 2.5% m/m Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone 2.5 % m / m For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Aqueous cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eczema and dermatitis of all types including, atopic, infantile, discoid eczema, photodermatitis, otitis extema, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reaction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical application To be applied evenly and sparingly two or three times daily _ADULTS AND 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. 4.3 CONTRAINDICATIONS Hypersensitivity to hydrocortisone or to any of the excipients listed in section 6.1 or 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 (CSCR) which have been reported after use of systemic and topical corticosteroids. Remarks on indications 1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes. 2. Topical corticosteroids ar Прочитајте комплетан документ