Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
HYDROCORTISONE
Sanofi Malta Limited
D07AA02
HYDROCORTISONE
CREAM
HYDROCORTISONE 1 % (W/W)
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2005-11-24
674273 *674273* PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISYL® SKIN CREAM 1% _Hydrocortisone _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01403 5600 FOR HELP 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 or pharmacist. – This medicine has been prescribed for you. 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 of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. IN THIS LEAFLET: 1. What Hydrocortisyl Skin Cream is and what it is used for 2. What you need to know before you use Hydrocortisyl Skin Cream 3. How to use Hydrocortisyl Skin Cream 4. Possible side effects 5. How to store Hydrocortisyl Skin Cream 6. Contents of the pack and other information 1. WHAT HYDROCRTISYL SKIN CREAM IS AND WHAT IT IS USED FOR The name of your medicine is Hydrocortisyl Skin Cream 1%. Hydrocortisyl Skin Cream contains the active ingredient Hydrocortisone 1% w/w. • Hydrocortisone belongs to a group of medicines called corticosteroids. It works by lowering the production of substances that cause inflammation. This helps lower swelling and itching. Hydrocortisyl Skin Cream can be applied to the skin to treat a variety of skin conditions sensitive to corticosteroid treatment such as itching, eczema, dermatitis (inflamed skin), including the skin of the outer ear (otitis externa) and of your scalp, and rashes due to allergic reactions. 2. BEFORE YOU USE HYDROCORTISYL SKIN CREAM Do not use this medicine and tell your doctor if: • You are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisyl Skin Cream (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You have an Prečítajte si celý dokument
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hydrocortisyl skin cream 1%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone (micronised) 1% w/w. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Cream - water miscible base. A smooth white uniform cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a prescription only medicine: In the management of corticosteroid-sensitive superficial dermatoses. As a pharmacy medicine: External: Use only for contact dermatitis, irritant dermatitis and insect bite reactions. _Route: _ Topical. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS AND CHILDREN: _ Apply one to four times daily, or as directed by a physician. Once improvement is evident frequency of application should be gradually reduced. Do not use on children under 12 years of age without medical supervision. In this group this product should be applied sparingly over a small area once or twice a day for a maximum of one week. Page 2 of 5 4.3 CONTRA-INDICATIONS 1. Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. 2. Use in acne, rosacea or in perioral dermatoses. 3. Use in plaque psoriasis. 4. Not for use on the eye, face, in the anogenital region, on broken or infected skin, including cold sores, acne and athletes foot. 5. Hypersensitivity to active ingredient or to excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation. 2. Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may suppress adrenocortical function. 3. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilatation, particularly on the face. 4. Prolonged use in the management of acne vulgaris should be avoided. 5. Use in psoriasis may lead to generalisati Prečítajte si celý dokument