Država: Malta
Jezik: angleščina
Source: Medicines Authority
hydrocortisone butyrate 1 mg/g
Astellas Pharma Europe B.V.
D07AB02
hydrocortisone butyrate
ointment
Authorised
2005-09-23
1 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 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 aggr Preberite celoten dokument
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Locoid ® ointment 0.1% Locoid Lipocream ® , cream 0.1% Locoid ® cream 0.1% Locoid Crelo ® , cutaneous emulsion 0.1% Locoid ® scalp lotion 0.1% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Locoid ointment and cream, Locoid Lipocream and Locoid Crelo contain 1 mg/g and Locoid lotion 1mg/ml hydrocortisone 17-butyrate. The ointment base is hydrophobic (fat); Locoid cream, Locoid Lipocream and Locoid Crelo contain buffered oil-in-water emulsions (Locoid Lipocream contains more fat, Locoid cream and Locoid Crelo more water). The lotion is buffered, somewhat viscous and based on isopropanol-water. 3. PHARMACEUTICAL FORM Ointment, cream, cutaneous emulsion and cutaneous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Superficial, corticosteroid responsive dermatoses, which are not caused by micro-organisms. Follow-up or maintenance treatment of dermatoses which have been suppressed previously by a stronger corticosteroid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply 1-3 times daily a small amount of Locoid to the skin. After improvement of the disorder, application once daily or two to three times a week is usually adequate. Do not use more than 30-60 g per week in general. Locoid should be applied evenly in a thin layer onto the diseased skin. To promote penetration it may be lightly massaged into the skin. Occlusion may be necessary to obtain a better therapeutic result. Page 2 of 6 4.3 CONTRAINDICATIONS - Skin lesions caused by: o bacterial infections (e.g. pyodermias, luetic and tuberculous processes) o viral infections (e.g. varicellae, herpes simplex, herpes zoster, verrucae vulgares, verrucae planae, condylomata, mollusca contagiosa) o mycotic and yeast infections o parasitic infections (e.g. scabies) - Ulcerous skin lesions, wounds Preberite celoten dokument