Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN
Teva Pharma B.V.
750 Milligram
Film Coated Tablet
2007-04-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Teva 750 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg ciprofloxacin as ciprofloxacin hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule shaped film-coated tablets, debossed “CIP 750” on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Treatment of the following infections in adults when caused by ciprofloxacin-susceptible organisms: Infections of: - The respiratory tract. Ciprofloxacin may be indicated for treating pneumonia due to aerobic Gram-negative pathogens. In pneumococcal pneumonia ciprofloxacin is not the drug of first choice. - The urinary tract: acute uncomplicated cystitis, complicated infections and pyelonephritis. - The genital organs: acute, uncomplicated gonorrhoea, prostatitis. - Severe bacterial enteritis. - Skin and soft tissue infections caused by Gram-negative bacteria. - Osteomyelitis caused by Gram-negative bacteria. - Severe systemic infections caused by Gram-negative bacteria e.g. septicaemia, peritonitis (with addition of an antibacterial agent to cover anaerobes), infections in immunosuppressed patients. _Children and adolescents_ Acute pulmonary exacerbation of cystic fibrosis in children and adolescents (5-17 years) caused by _Pseudomonas_ _aeruginosa_. Ciprofloxacin is not recommended for other indications in this age group. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of ciprofloxacin is determined by the severity and type of infection and the age, weight and renal function of the patient. Treatment may be initiated with t Read the complete document