Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Hydrocortisone 1%; Natamycin 1%; ; Neomycin sulfate 0.35%
LEO Pharma Limited
Hydrocortisone 1%
Topical ointment
Active: Hydrocortisone 1% Natamycin 1% Neomycin sulfate 0.35% Excipient: Liquid paraffin Polyethylene
Tube, aluminium, 15 g
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Package - Contents - Shelf Life: Tube, aluminium, - 15 g - 60 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 60 months from date of manufacture stored at or below 25°C
1969-12-31
1 CONSUMER MEDICINE INFORMATION PIMAFUCORT ® 1% HYDROCORTISONE, 1% NATAMYCIN AND 0.35% NEOMYCIN CREAM AND OINTMENT WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pimafucort ® Cream and Ointment_. _It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the expected benefits. Use Pimafucort ® as instructed. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PIMAFUCORT ® IS USED FOR Pimafucort ® is used on the skin to relieve the itching and discomfort of many skin problems where these also have an added bacterial and/or candidal (fungal) infection. Pimafucort ® contains the medicines: • hydrocortisone: a corticosteroid which relieves inflammation of the skin • neomycin: an antibiotic which is active against bacterial infections and • natamycin: an antifungal which is active against yeast infections, particularly Candida infections. Your doctor may have prescribed Pimafucort ® for another reason. Ask your doctor why this medicine has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU USE PIMAFUCORT ® _WHEN YOU MUST NOT USE PIMAFUCORT_ _®_ DO NOT USE THIS MEDICINE IF YOU HAVE: 1. AN ALLERGY TO: • ANY MEDICINE CONTAINING HYDROCORTISONE, NATAMYCIN OR NEOMYCIN SULPHATE (or related antibiotics belonging to the aminoglycoside group, such as kanamycin, framycetin, paromomycin and gentamicin). • any of the ingredients listed at the end of this leaflet (see Product Description). Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. 2. A SKIN DISORDER _CAUSED _IN THE FIRST INSTANCE BY A: • BACTERIAL INFECTION • VIRAL INFE Read the complete document
1 NEW ZEALAND DATA SHEET 1. PIMAFUCORT ® Cream Ointment Hydrocortisone, natamycin and neomycin sulphate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CREAM per gram: 10mg hydrocortisone, 10mg natamycin and 3.5mg neomycin (as neomycin sulphate). OINTMENT per gram: 10mg hydrocortisone, 10mg natamycin and to 3.5mg neomycin (as neomycin sulphate). Excipients with known effect: Pimafucort ® cream: methyl hydroxybenzoate, propyl hydroxybenzoate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CREAM Description of the medicinal product: white to lightly yellowish cream OINTMENT Description of the medicinal product: whitish ointment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of superficial dermatoses which are sensitive to corticosteroids, but not primarily caused by micro-organisms, if these are complicated by secondary bacterial and candidal infections sensitive to neomycin or natamycin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pimafucort ® should be applied sparingly to the affected area 2-4 times daily. Treatment should not be continued for longer than 14 days. For treatment of acute and subacute skin disorders and for treatment of disorders of hirsute areas and those in the skin folds, Pimafucort ® cream should preferably be used, whereas in the treatment of chronic disorders of the skin with scaly, dry or fissured skin lesions, and for seborrhoea in particular, Pimafucort ® ointment should be applied. . eDoc-000775370 - Version 1.0 2 4.3 CONTRAINDICATIONS Because Pimafucort ® contains the weak corticosteroid hydrocortisone the following contraindications apply: • Skin disorders caused by: − primary bacterial infections − viral infections − primary fungal and yeast infections − parasitic infections • Ulcerous skin disorders, wounds, ulcera cruris, burn wounds. • Side-effects caused by corticosteroids (dermatitis perioralis, striae atrophicae). • Ichthyosis, juvenile dermatosis plantaris, acne vulgaris, acne rosacea, fragility of skin vessels Read the complete document