Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE BUTYRATE
Astellas Pharma Co. Ltd
D07AB02
HYDROCORTISONE BUTYRATE
0.1 %w/w
Cream
Product subject to prescription which may be renewed (B)
Corticosteroids, moderately potent (group II)
Transfer Pending
2005-09-30
PATIENT LEAFLET : INFORMATION FOR THE USER LOCOID® CREAM 0.1% W/W Hydrocortisone butyrate 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Locoid Cream is and what it is used for 2. What you need to know before you use Locoid Cream 3. How to use Locoid Cream 4. Possible side effects 5. How to store Locoid Cream 6. Contents of the pack and other information 1. WHAT LOCOID CREAM IS AND WHAT IT IS USED FOR The active substance in Locoid Cream (hydrocortisone butyrate) is a corticosteroid which when made up as a cream is for use on the skin. This is known as topical application. Topical corticosteroids are ranked as mildly potent, moderately potent, potent and very potent; Locoid Cream is classed as potent. Topical corticosteroids are able to reduce the inflammation caused by a variety of skin conditions, and so allow it to get better. They can also affect the cause of the condition, which can lead to its healing. Locoid Cream is used to treat a variety of skin conditions that respond to topical corticosteroids. Among these are eczema and dermatitis (itching) of all types including atopic (childhood) eczema, photodermatitis (itching caused by exposure to light) and dermatitis caused by skin irritants and allergies. It can also b Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Locoid Cream 0.1 % w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The cream contains Hydrocortisone butyrate 0.1 % w/w. Excipients: also includes cetostearyl alcohol 7.2% w/w; propyl parahydroxybenzoate (E216) 0.1% w/w and butyl parahydroxybenzoate 0.05% w/w. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. A white aqueous-based cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids e.g. eczema, dermatitis and psoriasis not caused by micro-organisms. Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and special precautions for use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical application. Dosage: to be applied evenly and sparingly one to three times daily. Application may be made under occlusion in the more resistant lesions such as thickened psoriatic plaques on elbows and knees. Overnight occlusion is usually sufficient to give a satisfactory response. Adults and older people: the same dose is used for adults and older people , as clinical evidence would indicate that no special dosage regimen is necessary in older people. Children and infants: long term treatment should be avoided and occlusion should not be used. Courses should be limited to seven days where possible. 4.3 CONTRAINDICATIONS Hypersensitivity to hydrocortisone or to any of the excipients listed in section 6.1. This preparation is contraindicated in the presence of untreated viral or fungal infections (mycotic yeast) or parasitic infections, tubercular Διαβάστε το πλήρες έγγραφο