Patient leaflet - MONURIL 3G GRANULES FOR ORAL SOLUTION
1. what monuril is and what it is used for
Monuril contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by killing bacteria which can cause infections.
Monuril is used to treat uncomplicated infection of the bladder in women and female adolescents.
Monuril is used as antibiotic prophylaxis for transrectal prostate biopsy in adult man.
Monuril is not suitable for the treatment of children below 12 years of age.
2. what you need to know before you take monuril
Do not take Monuril if you:
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– are allergic to fosfomycin trometamol or any of the other ingredients of this medicine (listed in section 6)
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– have severe kidney problems (creatinine clearance below 10 ml/min)
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– are undergoing haemodialysis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Monuril if you have:
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– an allergic reaction during treatment (see section 4)
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– an intolerance to some sugars (see end of section 2)
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– previously had diarrhoea after taking any other antibiotics
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– kidney problems, but your creatinine clearance is above 10 ml/min
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– persistent infections of the bladder.
Conditions you need to look out for
Monuril can cause serious side effects. These include allergic reactions and an inflammation of the large intestine. You must look out for certain symptoms while you are taking this medicine, to reduce the risk of any problems. See “Serious side effects” in Section 4.
Children and adolescents
Do not give this medicine to children less than 12 years of age, as its safety and efficacy have not been established in this age group.
Other medicines and Monuril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This is especially important if you are taking:
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- metoclopramide or other drugs that increase the movement of food through the stomach and intestines, because they may reduce the uptake of fosfomycin trometamol by your body
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- anticoagulants, as their ability to prevent your blood from clotting might be altered by fosfomycin trometamol and other antibiotics.
Monuril with food
Food may delay the absorption of fosfomycin. Therefore, this medicinal product should be taken on an empty stomach (2–3 hours before or 2–3 hours after a meal).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant your doctor will only give you this medicine when it is clearly needed.
Breast-feeding mothers can take a single oral dose of this medicine.
There are no known effects of fosfomycin trometamol on fertility.
Driving and using machines
You may experience side effects such as dizziness which may affect your ability to drive or use machines.
Monuril contains 2.213 g of sucrose: if you have been told by your doctor that you have intolerance to some sugars, ask your doctor for advice before taking this product.
3. how to take monuril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended doses are:
- In case of treatment of uncomplicated infection of the bladder in women and female adolescents, the recommended dose is 1 sachet of Monuril (3 g Fosfomycin).
- When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Monuril (3 g fosfomycin) 3 hours prior to the procedure and 1 sachet of Monuril (3 g fosfomycin) 24 hours after the procedure.