Monural

Composition: One 6 g sachet contains: Active ingredient: fosfomycin trometamol 3.754 g (equivalent to fosfomycin 2.0 g). Excipients: mandarin flavouring 0.07 g, orange flavouring 0.06 g, saccharin 0.016 g, sucrose 2.100 g. One 8 g sachet contains: Active ingredient: fosfomycin trometamol 5.631 g (equivalent to fosfomycin 3.0 g). Excipients: mandarin flavouring 0.07 g, orange flavouring 0.07 g, saccharin 0.016 g, sucrose 2.213 g.

Form: Granules for oral solution.

Indications: Infectious and inflammatory diseases caused by microorganisms susceptible to fosfomycin: • Acute bacterial cystitis and acute episodes of recurrent bacterial cystitis. • Nonspecific bacterial urethritis. • Asymptomatic significant bacteriuria in pregnant women. • Postoperative urinary tract infections. Prevention of infections during urinary tract surgery and transurethral diagnostic procedures.

Contraindications: Hypersensitivity to fosfomycin or other components; severe renal impairment (creatinine clearance <10 ml/min); children under 12 years of age for the 3 g strength and under 5 years for the 2 g strength; haemodialysis; sucrase/isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption.

Dosage: Oral administration. Dissolve the granules in 1/2 glass of water (50–75 ml) or another drink, stir until completely dissolved and take immediately. Take Monural® once daily on an empty stomach, 1 hour before or 2–3 hours after food, preferably before bedtime after emptying the bladder. Adults and children aged 12–18: one sachet (3 g) once as a single dose. To prevent infection during urinary tract surgery or transurethral diagnostic procedures: 3 g twice, 3 hours before and 24 hours after the procedure. Children aged 5–12: one sachet (2 g) once as a single dose. For prevention during surgery or transurethral diagnostic procedures: 2 g twice, 3 hours before and 24 hours after the procedure. In more severe cases (elderly patients, recurrent infections), take another sachet after 24 hours. No dose adjustment is required in mild or moderate renal impairment. Contraindicated in severe renal impairment or haemodialysis. No dose adjustment is required in hepatic impairment.

Side effects: Diarrhea, headache, dizziness, skin rash, itching, anaphylactic reactions, dyspepsia, nausea, vomiting, angioedema, hypotension, superinfection, pseudomembranous colitis.

Interactions: Metoclopramide and antacids reduce fosfomycin concentration. May enhance the effect of vitamin K antagonists.

Warnings: Use only as indicated. Risk of anaphylaxis and severe diarrhea. During pregnancy and breastfeeding — only if necessary. Use with caution in patients with taste disorders or diabetes (contains sucrose).

Age restrictions: From 5 years (2g), from 12 years (3g)

Pregnancy: Allowed only if the expected benefit outweighs the potential risk. Breastfeeding should be discontinued if necessary.

Manufacturer: Zambon

Storage conditions: Store at a temperature not exceeding 30°C, out of reach of children.