Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Milpharm Limited
J01DC02
CEFUROXIME AXETIL
125 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins
Authorised
2012-08-03
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME AUROBINDO 125 MG TABLETS CEFUROXIME AUROBINDO 250 MG TABLETS CEFUROXIME AUROBINDO 500 MG TABLETS Cefuroxime CEFUROXIME AUROBINDO P150 CEFUROXIME AUROBINDO P150 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Cefuroxime Aurobindo is and what it is used for 2. What you need to know before you take Cefuroxime Aurobindo 3. How to take Cefuroxime Aurobindo 4. Possible side effects 5. How to store Cefuroxime Aurobindo 6. Contents of the pack and other further information Cefuroxime Aurobindo is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins. Cefuroxime Aurobindo is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Cefuroxime Aurobindo can also be read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Aurobindo 125 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150.36 mg cefuroxime axetil equivalent to 125 mg cefuroxime. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, capsule shaped tablets with ‘A32’ debossed on one side and plain on the other side. The size is 12.5 mm X 5.0 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Aurobindo is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). Acute streptococcal tonsillitis and pharyngitis. Acute bacterial sinusitis. Acute otitis media. Acute exacerbations of chronic bronchitis. Cystitis. Pyelonephritis. Uncomplicated skin and soft tissue infections. Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual course of therapy is seven days (may range from five to ten days). _Table 1. Adults and children ( 40 kg)_ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial sinusitis 250 mg twice daily Acute otitis media 500 mg twice daily Acute exacerbations of chronic bronchitis 500 mg twice daily Cystitis 250 mg twice daily Pyelonephritis 250 mg twice daily Uncomplicated skin and soft tissue infections 250 mg twice daily Lyme disease 500 mg twice daily for 14 days (range of 10 to 21 days) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 25/08/2015_ _CRN 2150659_ _page number: 1_ _Table 2. Children (<40 kg)_ There is no experience of using Cefur read_full_document