Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Mometasone furoate
Organon Pharma (Ireland) Limited
D07AC; D07AC13
Mometasone furoate
0.1 percent weight/weight
Ointment
Corticosteroids, potent (group III); mometasone
Marketed
1993-12-20
PACKAGE LEAFLET: INFORMATION FOR THE USER ELOCON® 0.1% W/W OINTMENT mometasone furoate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this lea fl et. 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 Ointment 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 Ointment 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 other similar medicines. on any other skin problems as it could make them worse especially rosacea (a skin condition affecting the face), acne, skin atrophy (thinning of the skin), dermatitis around the mouth, genital itching, nappy rash, cold sores, chickenpox, shingles, ulcerated skin, wounds or other skin infections and widespread plaque psoriasis. Ask your doctor or pharmacist if you are not sure. to treat skin problems in childre Preberite celoten dokument
Health Products Regulatory Authority 01 October 2021 CRN00C80D Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elocon 0.1% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mometasone Furoate 0.1% w/w (equivalent to 1.0mg/g) Propylene glycol stearate 2.0% w/w (equivalent to 20mg/g) Excipients with known effect This medicine contains 20.0 mg propylene glycol stearate (E477) in each gram of the ointment which is equivalent to 600.0 mg propylene glycol stearate per unit (30g tube) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A white to off-white, opaque ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Elocon Ointment is indicated for the topical management of corticosteroid responsive dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults, including elderly patients and Children: _A thin film should be applied to the affected areas of skin once daily. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Safe use in children for more than 6 weeks has not been established. There are limited data in children under 2 years. 4.3 CONTRAINDICATIONS Use in acne vulgaris, rosacea, skin atrophy, perioral dermatosesperianal and genital pruritus, napkin eruptions, varicella, tuberculosis, syphilis or post-vaccine reactions or in widespread plaque psoriasis. Use in the presence of untreated infections of: bacterial (e.g. impetigo, pyodermas); viral (e.g. herpes simplex, herpes zoster, chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum); parasitical and fungal (e.g. candida or dermatophyte) or tuberculousorigin, or post-vaccinal reactions.Elocon should not be used on wounds or on skin which is ulcerated. Dermatoses in children under one year of age, including dermatitis and napkin eruptions. Hypersensitivity to the preparation. Health Products Regulatory Authority 01 October 2021 CRN00C80D Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FO Preberite celoten dokument