Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN HYDROCHLORIDE
Helsinn Birex Therapeutics Ltd
250 Milligram
Tablets
2001-12-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Truoxin 250 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ciprofloxacin 250 mg as the hydrochloride. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White or yellowish, scored, 11 mm round, biconvex, film-coated tablets. Scored on both sides and side wall scored, marked C250 on one side. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin is indicated for the treatment of infections caused by sensitive bacteria: _Upper and lower respiratory tract infections: _For example broncho- and lobar-pneumonia, bronchitis (acute and chronic), acute exacerbation of cystic fibrosis, bronchiectasis, empyema, Gram-negative pneumonia (but _not _first-line therapy for pneumococcal pneumonia). _Urinary tract infections: _For example urethritis (complicated and uncomplicated), cystitis, pyelonephritis, prostatitis, epididymitis. _Gastro-intestinal infections: _For example enteric fever, infective diarrhoea. _Gonorrhoea: _For example urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or bacteria moderately sensitive to penicillin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage is determined by the type and severity of infection, sensitivity of the causal organism(s) and the age, weight and renal function status of the patient. Truoxin Tablets should be swallowed whole with an adequate amount of liquid. If Truoxin Tablets are taken on an empty stomach, the active substance is absorbed more rapidly. In this case, the tablets should not be taken concurrently with dairy products or with mineral fortified drinks alone (e.g. milk, yoghurt, calcium and fortified orange juice). Howe Lesen Sie das vollständige Dokument