Страна: Мальта
Язык: английский
Источник: Medicines Authority
HYDROCORTISONE BUTYRATE
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
D07AB02
HYDROCORTISONE BUTYRATE 1 mg/g
OINTMENT
HYDROCORTISONE BUTYRATE 1 mg/g
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Withdrawn
2005-09-23
LOCOID ® 0.1 % ointment Information for the user We advise you to read this package insert, also if you have used Locoid ointment before. The information may have changed. WHAT IS LOCOID OINTMENT AND HOW DOES IT WORK? _Composition_ Locoid ointment contains as active ingredient 1 mg hydrocortisone 17-butyrate per gram. The other ingredients are: liquid paraffin and polyethylene. _What does Locoid ointment look like and _ _how is it supplied?_ Locoid ointment is white and is packed in tubes of 30 g. The tube is packed in a yellow/grey/white box imprinted Locoid ointment. _How does Locoid ointment work?_ _ _ Locoid ointment contains an adrenal cortex hormone (corticosteroid) and decreases quickly the 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. The ointment base provides for the skin disorder to become less moist. _Authorization holder and manufacturer_ _ _ Locoid ointment 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 ointment is only available on prescription. WHAT CAN LOCOID OINTMENT BE USED FOR? Locoid ointment may be used for the treatment of superficial skin diseases in which itching, redness or scaling are often present. Locoid ointment contains much fat and is therefore suitable for disorders with dry and scaly skin. WHAT YOU SHOULD KNOW BEFORE USING LOCOID OINTMENT _When should you not use Locoid _ _ointment?_ Locoid ointment 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 hyd Прочитать полный документ
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Locoid ® , 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 ointment, Locoid Lipocream and Locoid cream contain 1 mg/g and Locoid scalp lotion 1 mg/ml hydrocortisone 17-butyrate. Locoid ointment 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 ointment 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, moll Прочитать полный документ