Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Sanofi-Aventis Ireland Limited T/A SANOFI
D07AA; D07AA02
Hydrocortisone
1.0 percent weight/weight
Cream
Product not subject to medical prescription
Corticosteroids, weak (group I); hydrocortisone
Marketed
1978-04-01
753892 *753892* 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 any kind of infection, this includes infections caused by viruses, bacteria or fungus or if you are Baca dokumen lengkap
Health Products Regulatory Authority 04 November 2021 CRN00C4MC Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisyl Skin Cream 1% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone (micronized) 1% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream A smooth white uniform cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a prescription only medicine: This medicinal product is indicated in the management of corticosteroid-sensitive superficial dermatoses. As a pharmacy medicine: This medicinal product is indicated for 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 two times daily, or as directed by a physician. Once improvement is evident frequency of application should be gradually reduced. Hydrocortisyl should not be used 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 CONTRAINDICATIONS 1. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 2. In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. 3. In acne rosacea or in perioral dermatoses 4. In plaque psoriasis 5. Not for use on the eye, face, in the anogenital region, on broken or infected skin, including cold sores, acne and athlete's foot. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hydrocortisyl is for external use only. Do not apply to mucosal surfaces. Avoid contact with eyes. 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. Health Products Regulatory Authority 04 November 2021 CRN00C4MC Page 2 of 4 Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may supp Baca dokumen lengkap