• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Monuril is and what it is used for
2. What you need to know before you take Monuril
3. How to take Monuril
4. Possible side effects
5. How to store Monuril
6. Contents of the pack and other information.

• are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before using Monuril if you suffer from one of the following disorders:

• persistent infections of the bladder,
• previously had diarrhea after taking any other antibiotics.

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.

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.

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

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).

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.

You may experience side effects, such as dizziness, which may affect your ability to drive or use machines.

Monuril contains

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free’.

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.

Sulphites

May rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine should not be used in patients with severe renal impairment (creatinin clearance < 10 ml/min).

This medicine should not be used in children less than 12 years of age.

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 you accidentally take more than your prescribed dose, contact your doctor or pharmacist.

While taking Monuril, if you develop any of the following symptoms you should stop taking the medicine and 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) (the frequency is unknown),
• moderate to severe diarrhea, abdominal cramps, bloody stools and/or fever may mean that you have 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).

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is fosfomycin. Each sachet contains 5.631 g of fosfomycin trometamol, equivalent to 3 g of fosfomycin
• the other ingredients are mandarin flavour, orange flavour, saccharin, sucrose (see section 2 for information on sucrose).

White granules for oral solution in a single dose sachet.

Sachets are four layers laminate of: paper/polyethylene/aluminium/polyethylene.

Monuril is available in packs containing:

1 sachet of 8 g of granules (3 g fosfomycin)

2 sachets of 8 g of granules (3 g fosfomycin)

5 sachets of 8 g of granules (3 g fosfomycin).

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

Distributor