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What is MONURAL and what is it used for
MONURAL is an antibiotic containing the active substance phosphomycin.
MONURAL is used to treat acute, uncomplicated lower urinary tract infections (UTIs) caused by phosphomycin-sensitive pathogens in women over 12 years of age.
Prevention of urinary tract infections in diagnostic and surgical procedures involving the lower urinary tract in adult men and women.
2. What you need to know before taking MONURAL
Do not take MONURAL:
if you are allergic (hypersensitive) to fosfomycin or any of the other ingredients of this medicine (listed in section 6).
if you have severe kidney failure (creatinine clearance <10 ml / min).
if you are on hemodialysis.
Take special care with MONURAL
Diarrhea associated with the administered antibiotic has been reported with the use of almost all broad-spectrum antibiotics, including fosfomycin trometamol. This is important to consider in patients who develop severe diarrhea during or after use of fosfomycin trometamol. In this situation, appropriate treatment should be started immediately. In these cases, peristalsis suppressing drugs are contraindicated.
MONURAL with food and drink
Food may delay the absorption of the drug, causing a slight decrease in peak blood and urine levels.
Therefore, MONURAL should be taken on an empty stomach (2-3 hours after a meal), preferably before bedtime, immediately after bladder emptying.
Other medicines and MONURAL
Co-administration with metoclopramide reduces serum and urine phosphomycin concentrations and should be avoided.
Other medicines that increase gastrointestinal peristalsis can cause similar effects.
Pregnancy, breastfeeding and fertility
A small number of data from observations in pregnant women (between 300 and 1000 pregnant women) do not indicate malformations or feto / neonatal toxicity of fosfomycin trometamol. Animal studies do not indicate reproductive toxicity.
The use of MONURAL during pregnancy may be considered if necessary.
It is unknown whether phosphomycin / fosfomycin metabolites are excreted in human milk. Phosphomycin is excreted in human breast milk at a low level after a single injection. Therefore, a single oral dose of fosfomycin may be used during lactation.
Driving and using machines
There is no evidence that MONURAL may affect concentration or reaction time. Patients have reported dizziness. This may affect the ability of some patients to drive and use machines.
Important information about some of the ingredients of MONURAL
MONURAL contains sucrose. If you have been told by your doctor that you have fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency, ask your doctor before taking this product.
3. How to get MONURAL
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Posology and method of administration
The recommended dose for the treatment of uncomplicated infections of the lower urinary tract in women over 12 years is a single dose of MONURAL 3 g of sachet.
The recommended dose for the prevention of urinary tract infections in surgical and diagnostic procedures involving the lower urinary tract in adult men and women is two doses of MONURAL 3 g of sachet, the first dose of MONURAL 3 g to be taken 3 hours before surgery, and one dose of MONURAL 3 g sachet - 24 hours after surgery.
Use in children
The safety and efficacy of Monural 3 g in children below 12 years of age have not been established.
MONURAL is for oral use and should be taken on an empty stomach, preferably at bedtime, immediately after bladder emptying. The contents of the sachet are dissolved in a glass of water and washed immediately.
If you take more MONURAL than you should
When MONURAL is in packs containing only one sachet, there is no risk of overdose.
The following reactions have been observed with MONURAL overdose: vestibular disorders, impaired hearing, metallic taste, and general reduction of taste.
In the case of overdose, it is sufficient to stimulate the elimination of the drug with urine by ingesting sufficient fluid.
POSSIBLE SIDE EFFECTS
Like all medicines, MONURAL can cause side effects, although not everybody gets them.
The most common side effects after single doses of fosfomycin trometamol affect the gastrointestinal tract and are mainly expressed by diarrhea. These reactions are usually short-lived and disappear spontaneously.
The following table shows the side effects reported when using Monural from clinical trials or post-marketing experience. The frequencies shown in the table are classified as follows:
very common (≥1 / 10);
common (≥ 1/100 to <1/10);
wickedness (≥ 1/1,000 to <1/100);
rare (≥ 1/10 000 to <1/1 000);
very rare (<1 / 10,000);
frequency unknown (cannot be estimated from available data).
System organ classes Undesirable effects by frequency
Common (≥ 1/100 to <1/10) Uncommon (≥ 1 / 1,000 to <1/100) Rare (<1/10000 to <1000) Unknown frequency
Vulvovaginitis infections and infestations
Immune system disorders Anaphylactic reactions including anaphylactic shock, hypersensitivity
Nervous system disorders Headache, dizziness Paresthesia (tingling, numbness and other skin sensations)
Cardiac disorders Tachycardia (accelerated heart rate)
Respiratory, thoracic and mediastinal disorders of asthma
Gastrointestinal disorders diarrhea, nausea, dyspepsia (indigestion) vomiting, abdominal pain, colitis related to antibiotic intake
Skin and subcutaneous tissue disorders rash, hives, itching Angioedema (a severe allergic reaction that causes swelling of the face or throat)
Common disorders and effects of application site fatigue
Vascular disorders Hypotension (lowering blood pressure)
5. How to store MONURAL
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date is valid for a properly stored medicinal product in its undamaged packaging.
Keep out of the reach and sight of children.
6. Contents of the pack and other information
Active substance: fosfomycin trometamol (Fosfomycin trometamol) 5.631 g (equivalent to 3 g of fosfomycin).
The other ingredients are mandarin, orange, saccharine, sucrose.
What Monural looks like and contents of the pack
Sachets containing granules for solution for oral administration.
The sachets are delivered in cartons containing 1 or 2 sachets.
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