Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
HYDROCORTISONE BUTYRATE
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
D07AB02
HYDROCORTISONE BUTYRATE 1 mg/g
CUTANEOUS SOLUTION
HYDROCORTISONE BUTYRATE 1 mg/g
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Withdrawn
2005-09-23
LOCOID ® scalp lotion 0.1% Information for the user We advise you to read this package insert, also if you have used Locoid lotion before. The information may have changed. WHAT IS LOCOID LOTION AND HOW DOES IT WORK? _Composition_ Locoid lotion contains as active ingredient 1 mg hydrocortisone 17-butyrate per gram. The other ingredients are: isopropanol, glycerol, povidone, citric acid, sodium citrate and purified water. _What does Locoid lotion look like and_ _ _ _how is it supplied ?_ Locoid lotion is a clear colourless liquid which is packed in bottles of 30 ml. The bottle is packed in a yellow/grey/ white box imprinted Locoid lotion 0.1%. _How does Locoid lotion work?_ Locoid lotion contains an adrenal cortex hormone (corticosteroid) and quickly decreases symptoms, such as itching, redness or scaling of the skin, which occur in certain skin disorders. Corticosteroids in general do not cure the underlying disease. _Authorization holder and manufacturer_ _ _ Locoid lotion has been registered in the name of LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark and is manufactured by Astellas Pharma Europe B.V., Leiden, The Netherlands. Locoid lotion is only available on prescription. WHAT CAN LOCOID LOTION BE USED FOR? Locoid lotion may be used for the treatment of superficial skin diseases in which itching, redness or scaling are often pr esent. Locoid lotion is especially suitable for the treatment of the hairy scalp. WHAT YOU SHOULD KNOW BEFORE USING LOCOID LOTION _When should you not use Locoid lotion?_ Locoid lotion should not be used for: - Skin disorders caused by bacterial, viral, fungal, yeast or parasitic infections. These disorders might aggravate or be masked. - Acne, also with redness of the skin. - Wounds, fish skin (ichthyosis). - Skin disorders which might result from previous treatment with corticosteroids, such as inflammation of the skin around the mouth, thin skin, possibly with stripes, fragile blood vessels. If you are hypersensitive to hydrocortisone butyrate or one of the other ingre Διαβάστε το πλήρες έγγραφο
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Locoid ® oleogel, ointment 1 mg/g Locoid ® Lipocream, cream 1 mg/g Locoid ® cream, cream 1 mg/g Locoid ® scalp lotion, lotion 1 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Locoid oleogel, Locoid Lipocream and Locoid cream contain 1 mg/g and Locoid scalp lotion 1 mg/ml hydrocortisone 17-butyrate. Locoid oleogel is hydrophobic (greasy); Locoid Lipocream and cream contain buffered oil-in-water emulsions (Locoid Lipocream has a higher lipid content and Locoid cream a higher water content). The lotion, which is a buffered, slightly viscous solution, is prepared on the basis of an isopropanol/water mixture. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Locoid oleogel is an ointment, Locoid Lipocream and Locoid cream are creams and Locoid scalp lotion is a solution for cutaneous use. Locoid oleogel, Locoid Lipocream and Locoid cream are white. Locoid scalp lotion is clear and colourless. 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, Διαβάστε το πλήρες έγγραφο