Country: Malta
Language: English
Source: Medicines Authority
HYDROCORTISONE BUTYRATE
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
D07AB02
HYDROCORTISONE BUTYRATE
CREAM
HYDROCORTISONE BUTYRATE 1 milligram(s)/gram
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2005-09-23
LOCOID LIPOCREAM ® 0.1% Keep this leaflet, as you may need it again. Consult your doctor or pharmacist if you have any questions. This medicine has been prescribed for you personally so do not give it to anyone else. It could be harmful to them even if their symptoms are similar to yours. CONTENTS OF THIS LEAFLET 1. What Locoid Lipocream is and what it is used for 2. What you should know before using Locoid Lipocream 3. How Locoid Lipocream is used 4. Possible side-effects 5. How to store Locoid Lipocream LOCOID LIPOCREAM ® 0.1%, CREAM Hydrocortisone 17-butyrate. The active substance is 1 mg hydrocortisone 17-butyrate per gram cream. Present as excipients are cetostearyl alcohol, macrogol 25 cetostearyl ether, liquid paraffin, white vaseline, propylparahydroxybenzoate (E216), benzyl alcohol, citric acid (E330), sodium citrate (E331) and purified water. _Marketing Authorization holder:_ LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark_Manufacturer:_ Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands Locoid Lipocream is only available on prescription. 1. WHAT LOCOID LIPOCREAM IS AND WHAT IT IS USED FOR WHAT LOCOID LIPOCREAM LOOKS LIKE AND HOW IS IT PACKED Locoid Lipocream is white and is packed in tubes of 30 grams. The tube is in a yellow/ grey/white pack imprinted with ‘Locoid Lipocream 0.1%’. HOW LOCOID LIPOCREAM WORKS Locoid Lipocream contains a corticosteroid and quickly suppresses symptoms of certain skin conditions such as itching, redness and scaling. Corticosteroids do not generally remove the cause of the symptoms. The Lipocream base ensures that the skin condition becomes less moist. WHAT LOCOID LIPOCREAM CAN BE USED FOR? Locoid Lipocream can be used for the treatment of superficial skin conditions where itching, redness and scaling are often present. It contains more lipid than normal and is therefore suitable for those skin conditions where the skin can be partly dry yet still partly moist. 2. WHAT YOU SHOULD KNOW BEFORE USING LOCOID LIPOCREAM DO NOT USE LOCOID L Read the complete document
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Locoid ® Lipocream, cream 1 mg/g Locoid ® cream, cream 1 mg/g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Locoid Lipocream and Locoid cream contain 1 mg/ml hydrocortisone 17-butyrate. Locoid Lipocream and cream contain buffered oil-in-water emulsions (Locoid Lipocream has a higher lipid content and Locoid cream a higher water content). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Locoid Lipocream and Locoid cream are creams Locoid Lipocream and Locoid cream are white 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Superficial, corticosteroid-responsive dermatoses that are not caused by microorganisms and that are expected to respond inadequately to weak products. Follow-up or maintenance treatment of dermatoses that have been suppressed previously by a stronger corticosteroid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a small amount of Locoid to the skin 1 - 3 times daily. Once the disorder has improved, application once daily or two to three times a week is usually sufficient. Generally, not more than 30-60 g per week should be used. Page 2 of 7 Locoid should be applied evenly in a thin layer onto the affected skin. It may carefully be massaged lightly into the skin to promote penetration. Occlusion may be necessary to obtain a better therapeutic result. 4.3 CONTRAINDICATIONS • Skin lesions caused by: - bacterial infections (e.g. pyodermias, luetic and tuberculous lesions) - viral infections (e.g. varicellae, herpes simplex, herpes zoster, verrucae vulgares, verrucae planae, condylomata, mollusca contagiosa) - fungal and yeast infections - parasitic infections (e.g. scabies) • Ulcerous skin lesions, wounds • Adverse reactions induced by corticosteroids (e.g. dermatitis perioralis, striae atrophicae) • Ichthyosis, juvenile dermatosis plantaris, acne vulgaris, acne rosacea, fragility of the skin vessels, skin atrophy • Allergic hypersensitivity to components of the vehicle or to corticosteroids (the lat Read the complete document