1. Name of the medicinal product Cipro 750 mg film-coated tablets 2. Qualitative and quantitative composition Each film coated tablet contains Ciprofloxacin hydrochloride 873.3mg equivalent to 750 mg ciprofloxacin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet 4. Clinical particulars 4.1 Therapeutic indications Cipro 750 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Adults • Lower Respiratory tract infections due to Gram-negative bacteria - pneumonia - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis • Chronic suppurative otitis media • Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria • Urinary tract infections • Genital tract infections - gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae - epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae - pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae • Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea) • Intra-abdominal infections • Infections of the skin and soft tissue caused by Gram-negative bacteria • Malignant external otitis • Infections of the bones and joints • Prophylaxis of invasive infections due to Neisseria meningitidis • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Fluroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis (ABS),and acute bacterial exacerbation of chronic sinusitis (ABECB). Fluroquinolones should not be used in the following indications: • To treat infections that might get better without treatment or are not severe (such as throat infections); • To treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis; • For preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder); • To treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
