Uroday Special Precautions

The use of URODAY is not recommended in patients with renal impairment (creatinine clearance <10 ml/min, see Pharmacology: Pharmacokinetics under Actions).
Since there is insufficient data for children under 12 years of age, URODAY should not be given to them. Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during Fosfomycin treatment and may be life-threatening (see Side Effects).
If such reactions occur, fosfomycin should never be re-administered to these patients. An adequate medical treatment is required.
Antibiotic-associated diarrhoea has been reported with the use of nearly all antibacterial agents, including fosfomycin trometamol and may range in severity from mild diarrhoea to fatal colitis. Diarrhoea, particularly if severe and persistent, during or after treatment, may be symptomatic of Clostridium difficile-associated diarrhoea (CDAD). It is therefore important to consider the diagnosis of CDAD in patients who develop serious diarrhoea during or after treatment with URODAY. If CDAD is suspected or confirmed, appropriate treatment should be initiated without delay (see Side Effects). Antiperistaltic medicinal products are contraindicated in this situation.
In case of persistent infections, a thorough examination and a re-evaluation of the diagnosis is recommended as this is often due to complicated urinary tract infections or the prevalence of resistant pathogens (e.g., Staphylococcus saprophyticus). In general, urinary tract infections in male patients have to be considered as complicated urinary tract infections, for which this medicinal product is not indicated (see Indications/Uses).
Uroday contains sugar. Its use is not recommended in patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.
Effects and Ability to Drive and Use Machine: No specific studies have been performed, but patients should be informed that dizziness reports have been received. This may affect the ability of some patients to drive and use the machine.