Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
MOMETASONE FUROATE
Merck Sharp & Dohme Limited
D07AC13
MOMETASONE FUROATE
CREAM
MOMETASONE FUROATE 0.1 % (W/W)
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2006-09-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ELOCON ® CREAM MOMETASONE FUROATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Elocon is and what it is used for 2. Before you use ELOCON 3. How to use ELOCON 4. Possible side effects 5. How to store ELOCON 6. Further information 1. WHAT ELOCON IS AND WHAT IT IS USED FOR ELOCON Cream is one of a group of medicines called topical corticosteroids. It is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. In adults and children, ELOCON Cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis. Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy. 2. BEFORE YOU USE ELOCON DO NOT USE ELOCON ― if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of ELOCON, or to similar medicines. ― on any other skin problems as it could make them worse especially ― rosacea (a skin condition affecting the face) ― Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS ELOCON CREAM 1. N AME OF THE M EDICINAL P RODUCT Elocon Cream 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Mometasone Furoate 0.1% w/w 3. P HARMACEUTICAL F ORM Cream 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Elocon Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults, including elderly patients and Children :_ A thin film of Elocon Cream should be applied to the affected areas of skin once daily. Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days. 4.3 CONTRAINDICATIONS Elocon is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Elocon should not be used on wounds or on skin which is ulcerated. Elocon should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the ingredients in this medicine. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted. Should an infection develop, use of an appropriate antifungal or Citiți documentul complet