1 NAME OF THE MEDICINAL PRODUCT Levoflox 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains : Levoflox 250 mg Film-coated: 256.21 mg Levofloxacin hemihydrate equivalent to Levofloxacin 250 mg. Levoflox 500 mg film-coated tablet: 512.42 mg Levofloxacin hemihydrate equivalent to Levofloxacin 500mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Physical characters: Levoflox 250 mg Film-coated Tablets: Off white to pale yellow round slightly biconvex film coated tablet.tablet should be taken as a whole without division. Levoflox 500 mg Film-coated Tablets: white to yellowish white oblong biconvex film coated tablet scored from one side and plain from the other side. Tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Because of the risk of prolonged, disabling and potentially irreversible serious adverse drug reactions (see section 4.4 and section 4.8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: • there is resistance to other first-line antibiotics recommended for the infection; • other first-line antibiotics are contraindicated in an individual patient; • other first-line antibiotics have caused side effects requiring treatment to be stopped; • treatment with other first-line antibiotics has failed. Levofloxacin tablets are indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Acute bacterial sinusitis • Acute exacerbation of chronic obstructive pulmonary disease including bronchitis • Community-acquired pneumonia • Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections. • Acute pyelonephritis and complicated urinary tract infections (see section 4.4) • Chronic bacterial prostatitis • Uncomplicated cystitis (see section 4.4) In uncomplicated cystitis Levofloxacin tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. • Inhalation Anthrax: post-exposure prophylaxis and curative treatment (see section 4.4) Levofloxacin tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. Fluoroquinolones 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. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Levofloxacin tablets are administered once or twice daily. The dose depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Levofloxacin tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dose can be used.
