Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
hydrocortisone acetate, Quantity: 10 mg/g
Aspen Pharmacare Australia Pty Ltd
Hydrocortisone acetate
Ointment
Excipient Ingredients: hard paraffin; liquid paraffin; Wool fat; white soft paraffin
Topical
30g, 50g
Medicine Registered
(S3) Pharmacist Only Medicine, (S4) Prescription Only Medicine
Topical corticosteroid therapy for non-infective inflammatory conditions of the skin eg. eczema, dermatitis.
Visual Identification: A soft, yellowish white ointment with an odour faintly of paraffin and lanolin.; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-14
SIGMACORT Cream and Ointment- Consumer Medicine Information Page 1 of 3 SIGMACORT 1% CREAM AND OINTMENT hydrocortisone acetate CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SIGMACORT. It does not contain all the available information. It does not take place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of using SIGMACORT against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS SIGMACORT The name of your medicine is SIGMACORT. It contains the active ingredient called hydrocortisone acetate. It is available as a cream and an ointment. SIGMACORT is a type of cortisone and belongs to the group of medicines called corticosteroids. It is a topical corticosteroid therapy for non-infective inflammatory conditions of the skin e.g. eczema, dermatitis. It is used to relieve the redness, swelling, itching and other discomforts of the skin. Your doctor however, may have prescribed SIGMACORT for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY SIGMACORT HAS BEEN PRESCRIBED FOR YOU. A doctor's prescription is required for the 50 gram tube of SIGMACORT cream or ointment. The 30 gram tube can be purchased without a doctor’s prescription. BEFORE YOU USE IT When you must not use it DO NOT USE SIGMACORT IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • SIGMACORT or hydrocortisone acetate. • Any of the ingredients in SIGMACORT listed at the end of this leaflet. DO NOT USE SIGMACORT IF YOU HAVE: • A viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox) • A fungal skin infection (such as thrush, tinea or ringworm) • Tuberculous condition of the skin • Vaccinia (cowpox: a viral disease passed from cattle) • Varicella (a rare form of chicken pox). SIGMACORT should not be used Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION SIGMACORT 1% (HYDROCORTISONE ACETATE) CREAM & OINTMENT 1 NAME OF THE MEDICINE Hydrocortisone acetate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SIGMACORT 1% CREAM contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base. SIGMACORT 1% OINTMENT contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a paraffin base. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM SIGMACORT 1% CREAM is a soft white cream with an odour faintly of chlorocresol. SIGMACORT 1% OINTMENT is a soft, yellowish white ointment with a faint odour of paraffin and lanolin. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Topical corticosteroid therapy for non-infective inflammatory conditions of the skin e.g. eczema, dermatitis. 4.2 D OSE AND METHOD OF ADMINISTRATION Apply a thin smear to affected areas 2 - 4 times daily. Reduce the number of applications as the disorder subsides. Occlusive dressings are not necessary unless advised by your doctor. 4.3 C ONTRAINDICATIONS • Tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections. • Hypersensitivity to any component of the cream or ointment. • Not to be used in the eye. • Topical steroids should not be used in patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids. • Topical steroid should be used with caution and occlusive dressings should not be used in patients with primary skin infections. 2 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. If irritation develops Sigmacort should be discontinued and alternative therapy instituted. Prolonged and heavy doses of hydrocortisone may have an immunosuppressant effect and thus decrease resistance to infection as well as mask signs of it. If infection of the skin is present suitable antifungal or antibacterial agents should Olvassa el a teljes dokumentumot