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1 X 3 g
The recommended dose for the treatment of acute uncomplicated lower urinary tract infections is a single 3 g sachet in adults.
The recommended regimen for the prophylaxis of urinary tract infections in surgery and diagnostic procedure involving lower urinary tract in adult males and females is one Monurol 3 g sachet 3 hours before surgery and one 3 g sachet 24 hours after surgery.
Children and young people weighing less than 50 kg and/ or below 12 years old.
Method of administration: Monurol is for oral administration. It should be taken on an empty stomach, about 2-3 hours before or after eating, preferably before bedtime, after emptying the bladder. The dose should be dissolved into a glass of water or any other non-alcoholic beverage and taken immediately after its preparation.
Monurol is indicated as a single dose treatment for acute, uncomplicated urinary tract infection and as prophylaxis in diagnostic and surgical transurethral procedures.
Hypersensitivity, severe renal impairment, hemodialysis.
Antibiotic associated colitis (incl. pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including fosfomycin trometamol; therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of fosfomycin trometamol. In this situation adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.
Food may delay the absorption of the active ingredient of Monurol, with consequent slight decrease in peak plasma levels and urinary concentrations. It is therefore preferable to take the medicine on an empty stomach, about 2-3 hours before or after meals.
Monurol contains sucrose. Patients with rare heredity problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Special warnings for patients with diabetes: during the treatment patients with diabetes should keep in mind that every sachet contains 2.213 g of sucrose equivalent to 37 kJ or 0.22 bread unit.
Children and young people weighing less than 50 kg and/or below 12 years old: At the moment there is not enough experience in children and since the dosage of 3 g is not suitable to people weighing less than 50 kg and/ or below 12 years old, Monurol 3 g should not be used for these patients.
The most common adverse reactions following the single-dose administration of fosfomycin trometamol involve the gastrointestinal tract, mainly diarrhoea. These events are usually selflimited in duration and resolve spontaneously.
See prescribing information for full details.
Fosfomycin/Metoclopramide: when co-administered with fosfomycin, metoclopramide lowers the serum and urine concentrations of fosfomycin.
For this reason a delayed administration (about 2-3 hours) is recommended.
Other drugs that increase gastrointestinal motility may produce similar effects.
Fosfomycin/antacids or calcium salts: Concomitant administration of antacids or calcium salts induces a significant reduction of fosfomycin therapeutically effective plasmatic and urinary concentrations. For this reason a delayed administration (about 2-3 hours) is recommended.
Similar effects can also occur with other medicines which increase gastrointestinal motility.
Fosfomycin/food: Similarly, if fosfomycin trometamol is administered during meals, fosfomycin plasmatic and urinary rates decrease.
Pregnancy and Lactation
Pregnancy: Data concerning a restricted number of pregnant women indicate neither on pregnancy nor on thehealth of the foetus/newborn undesirable effects.
There is no experience resulting from epidemiologic studies.
Studies involving animal experiments indicate neither direct nor indirect toxical effects on pregnancy, embryonic development, development of the foetus and/or postnatal development.
Pregnant women should use extreme caution if administering Monurol.
Lactation: Since Monurol passes into the breast milk, extreme moderation is recommended while breastfeeding.
The following events have been observed in patients who have taken Monurol in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception.
In the event of overdosage, treatment should be symptomatic and supportive. The patient should drink large quantities of water to promote urinary elimination of the drug.