Exelfos Special Precautions

Hypersensitivity reactions: Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during Fosfomycin treatment (see Contraindications and Adverse Reactions). If such reactions occur, treatment with Fosfomycin must be discontinued immediately and adequate emergency measures must be initiated.
Clostridioides difficile-associated diarrhea: Clostridioides difficile-associated colitis and pseudo-membranous colitis have been reported with Fosfomycin and may range in severity from mild to life-threatening (see Adverse Reactions). Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or subsequent to the administration of Fosfomycin. Discontinuation of therapy with Fosfomycin and the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Persistent infections and male patients: 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, see Pharmacology: Pharmacodynamics under Actions). In general, urinary tract infections in male patients have to be considered as complicated UTIs for which this medicinal product is not indicated (see Indications/Uses).
Excipients: Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use this medicine.
Effects on ability to drive and use machines: No specific studies have been performed but patients should be informed that dizziness has been reported. This may influence some patients' ability to drive and use the machines (see Adverse Reactions).
Use in Children: The safety and efficacy of Exelfos in children below 12 years of age have not been established. Therefore, this medicine should not be used in this age group (see Dosage & Administration).