Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefuroxime axetil
Teva UK Ltd
J01DC02
Cefuroxime axetil
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5020220565023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFUROXIME 125 MG, 250 MG AND 500 MG FILM-COATED TABLETS 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. This includes any possible side effects not listed in this leaflet. See section 4. • . WHAT IS IN THIS LEAFLET 1. WHAT CEFUROXIME IS AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME 3. HOW TO TAKE CEFUROXIME 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CEFUROXIME 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CEFUROXIME IS AND WHAT THEY ARE USED FOR Cefuroxime 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 is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Cefuroxime Film-coated Tablets can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME DON’T NOT TAKE CEFUROXIME: • if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6). • if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). If you think this applies to you, DO NOT TAKE CEFUROXIME until you have checked with your doctor. If you are not sure whether any of the above apply to you speak to your doctor or pharmacist before taking this medicine. WARNINGS AND PRECAUTIONS Talk to y Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 250 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 250 mg film-coated tablet contains 250 mg cefuroxime (as cefuroxime axetil) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Light blue coloured film-coated tablets engraved with “250” on one side and “P125” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime 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) _Paediatric population _ _Table 2. Children (<40 kg)_ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial sinusitis 10 mg/kg twice daily to a maximum of 125 mg twice daily Children aged two years or older with otitis media or, where appropriate, with more severe infections 15 mg/kg twice daily to a maximum of 250 mg twice daily Cystitis 15 mg/kg twice daily to a maximum of 250 mg twice daily Pyelonephritis 15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 Lees het volledige document