Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Teva Pharma B.V.
CEFUROXIME AXETIL
125 Base Milligrams
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME TEVA 125 MG FILM-COATED TABLETS CEFUROXIME TEVA 250 MG FILM-COATED TABLETS CEFUROXIME TEVA 500 MG FILM-COATED TABLETS Cefuroxime (as cefuroxime axetil) 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. WHAT CEFUROXIME TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME TEVA 3. HOW TO TAKE CEFUROXIME TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CEFUROXIME TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CEFUROXIME TEVA IS AND WHAT IT IS USED FOR Cefuroxime Teva 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 Teva is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Cefuroxime Teva can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). 2. WHAT YOU NEED KNOW BEFORE YOU TAKE CEFUROXIME TEVA DON’T TAKE CEFUROXIME TEVA: • if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the ingredients of Cefuroxime Teva. • if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (p Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Teva 125mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 125 mg film-coated tablet contains 125 mg cefuroxime (as cefuroxime axetil) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white coloured film-coated tablets engraved with “125” on one side and “P124” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Teva 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_<. _Table 2. 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) INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial 10 mg/kg twice daily to a maximum of 125 IRISH MEDICINES BOARD ___________________________________________________________________________________________________________ Izlasiet visu dokumentu