Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: ZAMBON S.p.A., Via Lillo Del Duca, 10, 20091 Bresso (Milan) – Italy, Tel: +39 02 665 241, Fax: +39 02 665 01 492
Monuril is indicated in the treatment of acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females.
Monuril is also indicated for prophylaxis in diagnostic and surgical transurethral procedures.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults and adolescent females (>12 years of age): 1 sachet (3 g) once.
Adults: One Monuril 3 g sachet 3 hours before surgery. A second dose of 3 g may be given 24 hours after surgery.
The safety and efficacy of Monuril 3 g in children below 12 years of age have not been established.
Monuril is for oral administration. It should be taken on an empty stomach (about 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after emptying the bladder.
The dose should be dissolved into a glass of water and taken immediately after its preparation.
Experience regarding the overdose of oral fosfomycin is limited. However cases of hypotonia, somnolence, electrolytes disturbances, thrombocytopenia and hypoprothrombinemia have been reported with parenteral use of fosfomycin.
In the event of overdose, treatment should be symptomatic and supportive. Rehydration is recommended to promote urinary elimination of the drug.
Three years.
After reconstitution in water, the solution is stable at room temperature for 24 hours.
Store away from direct sunlight.
Sachets are a four layer laminate: paper, polyethylene, aluminium, polyethylene.
Sachets are supplied in cardboard outer containing 1 sachet, 2 sachets or 5 sachets.
Not all pack sizes may be marketed.
The dose must be dissolved in a glass of water and administered soon after dissolving.
Any unused product or waste material should be disposed in accordance with local requirements.
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