Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN HYDROCHLORIDE
Accord Healthcare Limited
J01MA; J01MA02
CIPROFLOXACIN HYDROCHLORIDE
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; ciprofloxacin
Marketed
2004-07-02
Health Products Regulatory Authority 18 December 2018 CRN008RG5 Page 1 of 28 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciplox 500 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg of ciprofloxacin (as hydrochloride). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet White or yellowish, 8.2 x 17 mm oval, biconvex, film-coated tablets. Scored on one side and side-wall scored, marked ‘C500’ on one side. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciplox 500 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 - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia Chronic suppurative otitis media Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria Urinary tract infections Gonococcal uretritis and cervicitis Epididymo-orchitis including cases due to _Neisseria gonorrhoeae_ Health Products Regulatory Authority 18 December 2018 CRN008RG5 Page 2 of 28 Pelvic inflammatory disease including cases due to _Neisseria gonorrhoeae _ _In the above genital tract infections when thought or known to be due to _ _Neisseriagonorrhoeae it is particularly important to obtain local information _ _on the prevalence of resistance to ciprofloxacin and to confirm susceptibility _ _based on laboratory testing._ Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea) Intra-abdominal infections Infections of the skin and soft tissue caused by Gr Read the complete document