Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Pinewood Laboratories Ltd
D07AA; D07AA02
Hydrocortisone
1 percent weight/weight
Cream
Product not subject to medical prescription
Corticosteroids, weak (group I); hydrocortisone
Marketed
1989-07-17
PATIENT INFORMATION LEAFLET CORTOPIN 1% W/W CREAM 1% HYDROCORTISONE READ ALL OF THIS LEAFLET BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without a prescription. However, you still need to use this product carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 7 days • 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 Cortopin 1% w/w Cream is and what it is used for 2. Before you use Cortopin 1% w/w Cream 3. How to use Cortopin 1% w/w Cream 4. Possible side effects 5. How to store Cortopin 1% w/w Cream 6. Further information 1. WHAT CORTOPIN 1% W/W CREAM IS AND WHAT IT IS USED FOR Cortopin 1% w/w Cream is a smooth white cream for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Cortopin 1% w/w Cream is used to reduce inflammation in a variety of inflammatory skin conditions, such as: • mild to moderate eczema • dermatitis caused by irritants or allergens • insect bite reactions Hydrocortisone should not be confused with anabolic steroids, used by some body builders and taken as tablets or injections. 2. BEFORE YOU USE CORTOPIN 1% W/W CREAM DO NOT USE CORTOPIN 1% W/W CREAM: • if you are allergic to hydrocortisone or to any of the other ingredients of Cortopin 1% w/w Cream _(see Section 6 and end of Section 2). _ • if you have a bacterial infection (e.g. impetigo), viral infection (e.g. cold sores ‘herpes simplex’, chicken pox) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin. • on your face or near your eyes, on the anal or genital region, or on broken skin. TAKE SPECIAL CARE WITH CORTOPIN 1% W/W CREAM Cortopin 1% w/w Cream is NOT suitable for use i Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cortopin 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The cream contains Hydrocortisone 1% w/w. Also contains 7.2% w/w Cetostearyl alcohol and 0.1% w/w Chlorocresol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A smooth, white, homogenous oil in water cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It can be used to treat contact and allergic dermatitis irritant, insect bite reactions and mild to moderate eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use. Adults and children over 12 years: For use on the skin only. Hands should be washed before and after use. Apply sparingly once or twice a day to the affected area, or as directed by the physician. Do not use for more than 7 days. Children: Do not use on children under 12 years of age unless under medical supervision. If symptoms persist consult your doctor. Do not use on the anal or genital region, or on broken or infected skin. Do not use on the face except if the doctor has advised you. Do not get the cream in your eyes. 4.3 CONTRAINDICATIONS Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Use in acne vulgaris, acne rosacea or in perioral dermatoses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Side effects include local irritation, hypersensitivity and intercurrent infections. 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 or of growth suppression. Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings including napkin may suppress adrenocortical function. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Կարդացեք ամբողջական փաստաթուղթը