देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Kent Pharma (UK) Ltd
D07AA02
Hydrocortisone
5mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
Pharmacode Position * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details HYDROCORTISONE 0.5% & 1% CREAM PIL - UK Black BBBA6623 C Fox 16/10/2019 105 x 171 7pt Teva Jakarta 16/10/2019 1710/2019 1 Version 2 01.11.2017 HYDROCORTISONE 0.5% AND 1.0% CREAM BBBA6623 _Continued over page_ 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 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 e पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone Cream BP 0.5% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 0.50% w/w Hydrocortisone Ph. Eur. Excipients with known effect: cetostearyl alcohol and chlorocresol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hydrocortisone has topical anti-inflammatory activities of value in the treatment of various dermatological conditions including: Eczema- atopic, infantile, discoid or stasis Dermatitis- primary irritant, contact allergic, photo or seborrhoeic Insect bite reactions Prurigo nodularis Neurodermatoses Otitis externa Intertrigo Napkin rash, where concurrent infection is excluded or being addressed Hydrocortisone Cream 0.5% 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 _Posology _ Adults (including elderly) Gently apply a thin layer of cream to the affected area two or three times daily. Children and infants Gently apply a thin layer of cream to the affected area two or three times daily. Avoid prolonged use. In infants, therapy should be limited to five to seven days. Hydrocortisone cream is usually suitable for moist or weeping surfaces, whereas the ointment formulation should be considered for dry, scaly or lichenified conditions. _Method of Administration _ For topical application 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 The use of an occlusive dressing can considerably increase the degree of systemic absorption. If the treatment continues longer than two weeks, the risk of systemic side effec पूरा दस्तावेज़ पढ़ें