The SPC has also been revised as follows:
• Dose may be increased to 400 mg twice daily in severe or complicated infections.
• Due to increase in resistance to N. gonorrhoeae, ofloxacin should not be used as empirical treatment option in suspected gonococcal infection (urethral gonococcal infection, pelvic inflammatory disease and epididymo-orchitis), unless the pathogen has been identified and confirmed as susceptible to ofloxacin. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
• For pelvic inflammatory disease, ofloxacin should only be considered in combination with anaerobe coverage.