Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
hydrocortisone butyrate 1 mg/g
Astellas Pharma Europe B.V.
D07AB02
hydrocortisone butyrate
cutaneous solution
Authorised
2005-09-23
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. GENERAL GUIDELINES • This medicine has been prescribed to you by your doctor. You should therefore strictly follow his/her directions. If you have any questions, please consult your doctor or the pharmacist who supplied the medicine. • Never give your medicines to other people, and never use other people’s medicines yourself. • Always make sure that you are using the proper medicine. • Do not keep any medicine you no longer need. Do not throw medicines away but return them to your pharmacist. • In case of complaints always mention the batch number (see package). Council Of Arab Health Ministers Union Of Arab Pharmacists DATE OF LAST REVISION May 2014 LOCOID ® 142652 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_ Marketing authorization holder Astellas Pharma Europe B.V. Leiden, the Netherlands Manufacturer Temmler S.r.L Italia Carugate (MI), Italy 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, red Læs hele dokumentet
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 Læs hele dokumentet