The information highlighted (if any) are the most recent updates for this brand.
Each sachet contains 3g of fosfomycin as fosfomycin trometamol.
Excipients/Inactive Ingredients: The other ingredients are: mandarin flavour, orange flavour, saccharin, sucrose (see Precautions for information on sucrose).
Monurol contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by killing bacteria which can cause infections.
Monurol is used to treat uncomplicated infection of the bladder in women and female adolescents.
Monurol is used as antibiotic prophylaxis for transrectal prostate biopsy in adult man.
Always take this medicine exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
In case of treatment of uncomplicated infection of the bladder, in women and female adolescents the recommended dose is 1 sachet of Monurol (3 g Fosfomycin).
When used as antibiotic prophylaxis for transrectal prostate biopsy the recommended dose is 1 sachet of Monurol (3 g fosfomycin) 3 hours prior to the procedure and 1 sachet of Monurol (3 g fosfomycin) 24 hours after the procedure.
Use in patients with renal impairment: This medicine should not be used in patients with severe renal impairment (creatinine clearance < 10 ml/min).
Use in children and adolescents: This medicine should not be used in children less than 12 years of age.
Method of administration: For oral use.
Take this medicine by mouth, on an empty stomach (2-3 hours before or 2-3 hours after a meal), preferably before going to bed after emptying the bladder.
Dissolve the content of one sachet in a glass of water and drink immediately.
If the patient accidentally takes more than the prescribed dose, contact the doctor or pharmacist. If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take Monurol if the patient is allergic to fosfomycin or any of the other ingredients of this medicine (see Description).
Talk to the doctor, pharmacist or nurse before using Monurol if the patient suffers from one of the following disorders: persistent infections of the bladder, previously had diarrhea after taking any other antibiotics.
Conditions that need to look out for: Monurol can cause serious side effects. These include allergic reactions and an inflammation of the large intestine. The patient must look out for certain symptoms while taking this medicine, to reduce the risk of any problems. See Serious side effects under Side Effects.
Monurol contains: Sodium: This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially 'sodium-free'.
Sucrose: If the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Sulphites: May rarely cause severe hypersensitivity reactions and bronchospasm.
Driving and using machines: The patient may experience side effects, such as dizziness, which may affect the ability to drive or use machines.
Use in 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.
Pregnancy, breast-feeding and fertility: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
If the patient is pregnant the doctor will only give this medicine when it is clearly needed.
Breast-feeding mothers can take a single oral dose of this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: While taking Monurol, if the patient develops any of the following symptoms he/she should stop taking the medicine and contact the doctor immediately: Anaphylactic shock, a life-threatening type of allergic reaction (the frequency is unknown). Symptoms include a sudden onset of rash, itching or hives on the skin and/or shortness of breath, wheezing or difficulty in breathing.
Swelling of the face, lips, tongue or throat with breathing difficulties (angioedema) (the frequency is unknown).
Moderate to severe diarrhea, abdominal cramps, bloody stools and/or fever may mean that the patient has an infection of the large intestine (antibiotic-associated colitis) (the frequency is unknown). Do not take medicines against diarrhea that inhibit the bowel movements (antiperistaltics).
Other side effects: Common (may affect up to 1 in 10 people): headache, dizziness, diarrhea, nausea, indigestion, abdominal pain, infection of the female genital organs with symptoms like inflammation, irritation, itching (vulvovaginitis).
Uncommon (may affect up to 1 in 100 people): vomiting, rash, urticaria, itching.
Not known (frequency cannot be estimated from the available data): allergic reactions.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
This is especially important if the patient is taking: metoclopramide or other medicinal products that increase the movement of food through the stomach and intestines, because they may reduce the uptake of fosfomycin by the body; anticoagulants, as their ability to prevent the blood from clotting might be altered by fosfomycin and other antibiotics.
Monurol 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).
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Monurol granules for oral soln 3 g
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