Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN, ZINC ACETATE
B & S Healthcare
D10AF52
ERYTHROMYCIN, ZINC ACETATE
40/12 Mg/Ml
Pdr+Solv for Cut Soln
Product subject to prescription which may not be renewed (A)
Antiinfectives for treatment of acne
Authorised
2013-02-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ZINERYT ® 40MG/12MG PER ML POWDER AND SOLVENT FOR CUTANEOUS SOLUTION (erythromycin and zinc acetate dihydrate) 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. The name of your medicine is Zineryt 40mg/12mg per ml Powder and Solvent for Cutaneous Solution but will be referred to as Zineryt throughout this leaflet. IN THIS LEAFLET: 1. What Zineryt is and what it is 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zineryt 40mg/12mg per ml 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. _Product imported from _Bulgaria: Powder: White crystalline powder Solvent: Clear colourless liquid. 4 CLINICAL PARTICULARS As per PA1241/010/001 5 PHARMACOLOGICAL PROPERTIES As per PA1241/010/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Di-isopropyl sebacate Ethanol 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. Upon reconstitution: Use within 5 weeks. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/03/2015_ _CRN 2158714_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER The packaging contains an overlabelled bottle of white crystalline powder, an overlabelled bottle of clear colourless solvent and an applicator in a plastic holder. The contents of the bottles will be mixed together by your pharmacist to form a solution. Your pharmacist will also fit the special applicator top to the bottle containing the mixed solution. The applicator top is protected by a cap. Zineryt is available in packs which, when made up, will contain 30 ml of the solution. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE Read the complete document