Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Erythromycin; Zinc Acetate Dihydrate
Leo Laboratories Limited
D10AF; D10AF52
Erythromycin; Zinc Acetate Dihydrate
40 + 12 milligram(s)
Powder and solvent for cutaneous solution
Product subject to prescription which may not be renewed (A)
Antiinfectives for treatment of acne; erythromycin, combinations
Marketed
1992-12-17
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER ZINERYT ® 40 MG + 12 MG 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Zineryt ® is and what is it used for 2. What you need to know before you use Zineryt ® 3. How to use Zineryt ® 4. Possible side effects 5. How to store Zineryt ® 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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 ‘Contents of the pack and other 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. _ _ _ _ WARNINGS AND PRECAUTIONS 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. Contact your doctor for further advice. OTHER MEDICINES AND ZINERYT Please tell your doctor or pharmacist if you are taking or have recently taken, used or migh Read the complete document
Health Products Regulatory Authority 20 December 2018 CRN008K2G Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Erythromycin 40 mg per ml and zinc acetate dihydrate 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 As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. 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 Health Products Regulatory Authority 20 December 2018 CRN008K2G Page 2 of 5 result in superinfection due to micro‑organisms 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 INTERACTIONS Although use with other therapie Read the complete document