Ciprofloxan 500 mg film-coated tablets

Ciprofloxacin is indicated for the treatment of the following infections. Before initiating treatment, particular attention should be paid to the available information on resistance to ciprofloxacin and official guidance on the appropriate use of antibacterial agents should be taken into account.

Adults
• Respiratory tract infections with Gram-negative bacteria:
– exacerbation of chronic obstructive pulmonary disease. In exacerbations of chronic obstructive pulmonary disease, Ciprofloxacin should only be used when it is considered inappropriate to use other antibacterial agents that are usually recommended for the treatment of these infections;
– bronchopulmonary infections in cystic fibrosis or bronchiectasis;
– pneumonia.
– Chronic suppurative otitis media.
– Acute exacerbation of chronic sinusitis, especially if caused by Gram-negative bacteria.
– Urinary tract infections:
– uncomplicated acute cystitis. In uncomplicated acute cystitis Ciprofloxacin should only be used when it is considered inappropriate to use other antibacterial agents that are usually recommended for the treatment of these infections;
– acute pyelonephritis;
– complicated urinary tract infections;
– bacterial prostatitis.
• Genital tract infections:
– gonococcal urethritis and cervicitis caused by Neisseria gonorrhoeae susceptible to ciprofloxacin;
– orchiepididymitis, including cases caused by Neisseria gonorrhoeae susceptible to ciprofloxacin;
– pelvic inflammatory disease, including cases caused by Neisseria gonorrhoeae susceptible to ciprofloxacin.
• Gastrointestinal tract infections (so-called travellers’ diarrhoea).
• Intra-abdominal infections.
• Skin and soft tissue infections caused by Gram-negative bacteria.
• ​​Malignant otitis externa.
• Bone and joint infections.
• Prophylaxis of invasive infections caused by Neisseria meningitidis.
• Inhalation anthrax (post-exposure prophylaxis and treatment).

Ciprofloxacin can be used in the treatment of neutropenic patients with fever suspected to be due to a bacterial infection.

Children and adolescents
• Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis;
• Complicated urinary tract infections and acute pyelonephritis;
• Acute exacerbation of chronic obstructive pulmonary disease, including bronchitis;
• Inhalation anthrax (post-exposure prophylaxis and treatment).

Ciprofloxacin can be used to treat severe infections in children and adolescents when considered necessary.

Treatment should only be initiated by physicians experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.