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PRESCRIBING INFORMATION

INDICATIONS AND USAGE Monurol® is an anti-bacterial agent. Monurol® contains fosfomycin trometamol, an orally well absorbed salt of fosfomycin, which is a broad spectrum antibiotic derived from phosphonic acid. It is indicated for the treatment of acute uncomplicated lower urinary tract infections caused by pathogens sensitive to fosfomycin. Monurol® may also be used for prophylaxis in diagnostic and surgical transurethral procedures.

DOSAGE AND ADMINISTRATION Monurol® should be taken on an empty stomach 1 hour before or 2 hours after meals. Ideally Monurol® should be taken before bed-time after emptying the bladder. The contents of the sachet should be dissolved in a glass of water and taken immediately after preparation. For recurrent cystitis: one sachet every 10 days for 3 months.

PREPARATION Monurol® granules should not be taken directly. Pour the entire contents of a single-dose sachet of Monurol® into 3 to 4 ounces of water (1/2 cup) and stir to dissolve. Do not use hot water. Monurol® should be taken immediately after dissolving in water.

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