Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Cefuroxime
Rowex Ltd
J01DC; J01DC02
Cefuroxime
500 milligram(s)
Coated tablet
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefuroxime
Marketed
2006-10-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFTAL 250 MG COATED TABLETS CEFTAL 500 MG COATED TABLETS CEFUROXIME 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 Ceftal is and what it is used for 2. What you need to know before you take Ceftal 3. How to take Ceftal 4. Possible side effects 5. How to store Ceftal 6. Contents of the pack and other information 1. WHAT CEFTAL IS AND WHAT IT IS USED FOR Ceftal 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_ . Ceftal is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Ceftal can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Ceftal DO NOT TAKE CEFTAL: - IF YOU ARE ALLERGIC to cefuroxime, 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 beta- lactam antibiotic (penicillins, monobactams and carbapenems). If you think this applies to you, DON’T TAKE CEFTAL until you have checked with your doctor. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Ceftal. CEFTAL IS NOT RECOMMENDED FOR CHILDREN AGED UNDER 3 MONTHS , as the safety and effectiveness are not known in this age group. You must look out Belgenin tamamını okuyun
Health Products Regulatory Authority 08 December 2021 CRN00C5X2 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftal 500 mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 500 mg coated tablet contains 601.44 mg cefuroxime (as axetil). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablets White to slightly yellowish, biconvex, oblong tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftal 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) _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 Health Products Regulatory Authority 08 December 2021 CRN00C5X2 Page 2 of 9 Cystitis 15 mg/kg twice daily to a maximum of 250 mg twice daily Pyelonephritis 15 mg/kg twice daily to a Belgenin tamamını okuyun