Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mometasone furoate
Dowelhurst Ltd
D07AC13
Mometasone furoate
1mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
_S1492 LEAFLET Elocon 20191010 _ PACKAGE LEAFLET: INFORMATION FOR USER ELOCON ® CREAM / MOMETASONE FUROATE 0.1% CREAM (mometasone furoate) Your medicine is known as Elocon ® Cream / Mometasone Furoate 0.1% Cream but will be referred to as Elocon throughout the following leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What Elocon is and what it is used for 2. What you need to know before you use Elocon 3. How to use Elocon 4. Possible side effects 5. How to store Elocon 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE ELOCON Do not use Elocon if you have any of the following: an allergy (hypersensitivity) to mometasone furoate, any of the other ingredients of this medicine (listed in section 6) or to other similar medicines. any other skin prob Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mometasone furoate 0.1% w/w cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone furoate). Excipients: 72.00 mg of cetostearyl alcohol (type A), emulsifying; 10.00 mg of cetyl alcohol and 13 microgram of butylated hydroxytoluene /1 gram cream. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mometasone furoate 0.1% w/w cream is indicated for the symptomatic treatment of inflammatory skin conditions which respond to external treatment with glucocorticoids, such as atopic dermatitis and psoriasis (excluding widespread plaque psoriasis). Mometasone furoate 0.1% w/w cream should be used to treat skin complaints where a topical mometasone preparation is indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults, including elderly patients adolescents and children aged 2 years and _ _older: _ A thin film of Mometasone furoate should be applied to the affected skin area once daily. Strong topical corticosteroids generally should not be applied to the face without close monitoring by the physician. Mometasone furoate should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children aged 2 years and older a maximum of 10% of the body surface area should be treated. It should not be used occlusively or intertriginously. Treatment duration is limited to a maximum of 3 weeks. Use of a weaker corticosteroid is often advisable when there is a clinical improvement. _Children below 2 years: _ Mometasone furoate is a potent group III glucocorticoid. It should not be used in children below 2 years due to insufficient data on safety. For application on the skin (cutaneous use). 4.3 CONTRAINDICATIONS Mometasone furoate 0.1% w/w cream is contraindicated in patients with • hypersensitivity to the active substance or to any of the excipients listed in section Прочитайте повний документ