Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN, ZINC ACETATE
Astellas Pharma Co. Ltd
D10AF52
ERYTHROMYCIN, ZINC ACETATE
40 mg/ml,1 Micromol
Pdr+Solv for Cut Soln
Product subject to prescription which may not be renewed (A)
Antiinfectives for treatment of acne
Transfer Pending
2005-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER ZINERYT, POWDER AND SOLVENT FOR CUTANEOUS SOLUTION erythromycin and zinc acetate 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 symptoms are the same as yours. - 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 Zineryt is and what is it used for 2. Before you use Zineryt 3. How to use Zineryt 4. Possible side effects 5. How to store Zineryt 6. Further information 7. Information for healthcare professionals 1. WHAT ZINERYT IS AND WHAT IT IS USED FOR The active substance of Zineryt belongs to the group of antibiotics for treatment of acne, often referred to as pimples or spots. These medicines are used to reduce the growth of bacteria which cause acne. 2. BEFORE YOU USE ZINERYT DO NOT USE ZINERYT - if you are allergic (hypersensitive) to erythromycin, or zinc or to any of the other ingredients of Zineryt (see list in section 6 ‘Further information’). Your doctor may decide to give you another medicine instead. - if you are allergic to antibiotics of the macrolide group. Ask your doctor or pharmacist if you are unsure._ _ _ _ TAKE SPECIAL CARE WITH ZINERYT - Avoid contact with the eyes and mucous membranes of the nose and mouth. However, if this occurs, then rinse the affected area immediately with cold or lukewarm water for several minutes Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zineryt, powder and solvent for cutaneous solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Erythromycin 40 mg per ml and zinc acetate 12 mg per ml on constitution. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for cutaneous solution. Powder : White crystalline powder Solvent : Clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adolescents, adults and the elderly. Apply twice daily over the whole of the affected area and immediately surrounding skin. 4.3 CONTRAINDICATIONS Zineryt is contraindicated in patients who are hypersensitive to erythromycin or other macrolide antibiotics, or to zinc, di-isopropyl sebacate or ethanol. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Cross resistance may occur with other antibiotics of the macrolide group and also with lincomycin and clindamycin. Contact with the eyes or the mucous membranes of the nose and mouth should be avoided. Prolonged use of an anti- infective may result in superinfection due to microorganisms resistant to the anti-infective. If there is no response within 10 to 12 weeks alternative measures should be considered. Prolonged use is not recommended. A course should not usually exceed six months. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Although use with other therapies such as benzoyl peroxide has shown an additive effect, the use of Zineryt with other topical treatment should only be carried out with caution in view of possible cumulative local adverse effects. HEALTH PRODUCTS REGULATORY AUTHORITY ______________________________________________________________________________________ Lue koko asiakirja