Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
HYDROCORTISONE
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
D07AA02
HYDROCORTISONE 1 % (W/W)
CREAM
HYDROCORTISONE 1 % (W/W)
OTC
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Withdrawn
2005-11-24
710606 *710606* 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. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. – Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – 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. • It is used to treat conditions such as itching, dermatitis (inflamed skin) and rashes due to allergic reactions to certain things such as plants, jewellery, toiletries and deoderants, soaps and detergents and also insect bites. Hydrocortisyl Skin Cream can be applied to the skin to treat a variety of skin conditions in adults and children. If the child is under 12 years of age your doctor should give you advice on how long and often to use this product. 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 aller Izlasiet visu dokumentu
1. NAME OF THE MEDICINAL PRODUCT Hydrocortisyl Skin Cream 1%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains hydrocortisone 1% w/w. Excipients: Contains Chlorocresol 0.1% w/w and Cetostearyl alcohol For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. 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 & 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. 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 le Izlasiet visu dokumentu