Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
hydrocortisone butyrate 1 mg/g
Astellas Pharma Europe B.V.
D07AB02
hydrocortisone butyrate
cutaneous emulsion
Authorised
2005-09-23
1 LOCOID CRELO ® 0.1% topical emulsion Information for the user _______________________________________________________________________________________________ We advise you to read this package insert, also if you have used Locoid Crelo before. The information may have changed. WHAT IS LOCOID CRELO AND HOW DOES IT WORK? _Composition _ Locoid Crelo topical emulsion contains as active ingredient 1 mg hydrocortisone 17-butyrate per gram. The other ingredients are: cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, hard paraffin, borage oil, butyl hydroxytoluene, propylene glycol, sodium citrate, citric acid, propyl hydroxybenzoate, butyl hydroxybenzoate and purified water. _ _ _What does Locoid Crelo look like and _ _how is it supplied ? _ Locoid Crelo topical emulsion is white and is packed in bottles of 30 g. The bottle is packed in a yellow/grey/white box imprinted Locoid Crelo 0,1%. _ _ _How does Locoid Crelo topical emulsion _ _work? _ Locoid Crelo 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. _ _ _Authorization holder and manufacturer _ Locoid Crelo has been registered in the name of and is manufactured by Astellas Pharma Europe B.V., Leiden, The Netherlands. Locoid Crelo 0.1% topical emulsion is only available on prescription. WHAT CAN LOCOID CRELO BE USED FOR? Locoid Crelo topical emulsion may be used for the treatment of superficial skin diseases in which itching, redness or scaling are often present. Locoid Crelo is especially suitable for the treatment of hairy skin. WHAT YOU SHOULD KNOW BEFORE USING LOCOID CRELO _ _ _When should you not use Locoid Crelo? _ Loco Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο