Monuril Granules

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.

Garvan

Pharmacist - M.B.A. (Public Health) D.I.C.

Monuril Granules

What is Monuril The active substance contained…

Garvan J. Lynch
MBA (Public Health)

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What is Monuril

  • The active substance contained in Monuril 3g granules for oral solution is fosfomycin trometamol which belongs to a group of antibiotics used to treat infections.
  • Monuril 3g granules for oral solution is used for the treatment of acute uncomplicated urinary tract infections in adults.

Do not use Monuril if you:

  • if you are allergic to fosfomycin trometamol or any of the other ingredients of Monuril 
  • if your kidney function is impaired (creatinine’s clearance is <10 ml/min) are undergoing haemodialysis.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Monuril if you have:

  • an allergic reaction during treatment 
  • an intolerance to some sugars 
  • previously had diarrhoea after taking any other antibiotics
  • kidney problems, but your creatinine clearance is above 10ml/min.

Do not use more than one single dose of Monuril to treat a single episode of acute cystitis. This is because if you use Monuril for a long period of time, it may cause a new infection caused by bacteria that are resistant to this anti-infective. Take special care if you develop diarrhoea whilst taking, or after taking, antibiotics including Monuril. If this becomes severe or persistent or you notice that your stool contains blood or mucous consult your doctor immediately. Do not treat diarrhoea without first checking with your doctor. Diarrhoea has been reported to occur over 2 months after taking antibiotics.

Children and adolescents

  • Do not give this medicine to children less than 18 years of age.

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

  • metoclopramide or other drugs that increase the movement of food through the stomach and intestines, because they may reduce the uptake of Monuril by your body
  • anticoagulants, as their ability to prevent your blood from clotting might be altered by Monuril and other antibiotics.

No information is available on the interaction between fosfomycin and oral contraceptives. If you take any oral contraceptives, you may need to use another method of birth control, if taking Monuril.

Monuril with food and drink

  • Take Monuril on an empty stomach (2-3 hours after the meal), preferably before bedtime, just after emptying the bladder. If you take Monuril during meals, its absorption can be delayed.

Pregnancy, breastfeeding and fertility

Pregnancy

  • At the present time, single-dose antibacterial treatments are not suitable to treat urinary tract infections in pregnant woman.

Breast-feeding

  • When taken by injection, fosfomycin trometamol is present in very low levels in breast-milk and therefore breast-feeding mothers can take a single oral dose of this medicine.

Fertility

  • There are no known effects of Monuril on fertility.

Driving and using machines

  • You may experience side effects such as dizziness which may affect your ability to drive or use machines, if you experience these symptoms do not drive or use machines.

Important information about some of the ingredients of Monuril 3g granules for oral solution Monuril 3g contains 2.213g of sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to use Monuril

  • Always use Monuril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
  • A single dose of 3 g taken on an empty stomach (2-3 hours after the meal), preferably before bedtime, after bladder emptying. The contents of the sachet should be dissolved in water and the solution swallowed immediately. Monuril should be taken on an empty stomach preferably before going to bed, after emptying the bladder.
  • This product is not recommended for use in children and elderly.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects

While taking Monuril, if you develop any of the following symptoms you should contact your 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) 

Rare side effects

  • Faster heart beat (tachycardia)
  • Mild to severe abdominal cramps, bloody stools, diarrhoea and/or fever may mean that you have an infection of the large intestine (antibiotic-associated colitis).

Other side effects

  • Headache
  • Dizziness
  • Diarrhoea - if it becomes severe consult your doctor immediately
  • Nausea
  • Indigestion (dyspepsia)
  • Infection of the female genital organs with symptoms like inflammation, irritation, itching.
  • Vomiting
  • Abdominal pain
  • Rash
  • Nettle like skin rash itching
  • Tiredness
  • Paraesthesia (e.g. tingling)

How to store Monuril

  • Keep out of the sight and reach of children.
  • Do not use Monuril after the expiry date which is stated on the carton or sachet after “do not use after” or “exp”. The expiry date refers to the last day of that month.
  • This medicinal product does not require any special storage conditions.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

References:

https://www.medicines.org.uk/emc/medicine/32238

https://www.hpra.ie/img/uploaded/swedocuments/1f80439c-83a3-49fc-82ca-d29931d087b1.pdf

https://www.fannin.eu/therapeutic-areas-products/monuril

https://www.ncbi.nlm.nih.gov/pubmed/1926651

https://www.drugs.com/uk/monuril-sachets-3g-leaflet.html

https://www.gloshospitals.nhs.uk/media/documents/oral_fosfomycin_3g_sachets.pdf

 

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