CIPRONAT® is a prescription only medicine, which contains Ciprofloxacin. Ciprofloxacin is a synthetic fluoroquinolone antibiotic with bactericidal action which exhibits antibacterial activity against the majority of gram-positive and gram-negative pathogens. Other pharmaceutical forms CIPRONAT® film coated Tablets 250 mg: blister packs of 14 tablets, each containing ciprofloxacin 250 mg. CIPRONAT® film coated Tablets 500 mg: blister packs of 14 tablets, each containing ciprofloxacin 500 mg. CIPRONAT® is indicated in the treatment of following infections caused by susceptible strains of bacteria: Acute sinusitis: due to Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis. Lower respiratory tract infections: pneumonia, cystic fibrosis and acute exacerbations of chronic bronchitis, due to E.coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae and parainfluenzae, Streptococcus pneumoniae, Moraxella catarrhalis (bronchitis). Note: Although it has been found to be effective in clinical studies ciprofloxacin is not the drug of first choice in the treatment of pneumonia. Urinary tract infections: due to E. Coli, Klebsiella pneumoniae. Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Proteus rettgeri, Morganella morganii, Citrobacter diversus and freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis and saprophyticus, Enterococcus faecalis. Acute uncomplicated cystitis in women, due to Escherichia coli, Staphylococcus saprophyticus. Chronic bacterial prostatitis, due to Escherichia coli, Proteus mirabilis. Uncomplicated intra-abdominal infections (in combination with metronidazole when appropriate): cholecystitis, peritonitis, appendicitis, cholangitis wound, abscess and fistulas, due to Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, Bacteroides fragilis. Skin and Skin-structure infections: pyodermitis, wound infections, abscesses, cellulites, lymphangitis due to E.coli, Proteus mirabilis and vulgaris, Klebsiella pneumoniae, Enterobacter cloacae, Morganella morganii, Providencia stuartii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin susceptible), Staphylococcus epidermidis, Streptococcus pyogenes. Bone and joint infections: osteomyelitis and septic arthritis due to Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa. Infectious diarrhea, due to Escherichia coli (Enterotoxigenic strains), Campylobacter jejuni, Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei. Typhoid fever, due to Salmonella typhi. Note: Eradication of typhoid bacilli in typhoid carriers by ciprofloxacin has not been proven. Uncomplicated cervical and urethral gonorrhoea, due to Neisseria gonorrhoeae. In adults, for the treatment of mild to moderate infections 500 mg every 12 hours, for severe infections 750 mg every 12 hours is recommended. Uncomplicated urinary tract infections can be treated with 250 mg ciprofloxacin administered every 12 hours. CIPRONAT® film coated tablets should be administered orally to adults as described in the Dosage Guidelines table. The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function. The adult oral dose of ciprofloxacin ranges from 250 mg to 750 mg twice daily depending on the severity and nature of the infection. The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminium antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets of pediatric powder for oral solution, or other products containing calcium, iron or zinc. See guidelines for the dosing schedule in the SmpC attached. For children and adolescents (5-17 years) CIPRONAT® is not recommended, but if considered essential, oral dose ranges from 7.5 – 15 mg per kg body weight daily should be used.

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