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Granules for oral solution

Package leaflet: Information for the user
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- 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.
What in this leaflet
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.
1. What Monuril is and what it is used for
Monuril contains the active substance fosfomycin
trometamol. Fosfomycin trometamol is an antibiotic that works by killing bacteria which can cause
Monuril is used to treat or prevent uncomplicated
infections of the bladder.
Monuril is not suitable for the treatment of children
below 12 years of age.
2. What you need to know before you take
Do not take Monuril if you:
-- are allergic to fosfomycin trometamol or any of
the other ingredients of this medicine (listed in
section 6)
-- have severe kidney problems (creatinine clearance below 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 (see
section 4)
-- an intolerance to some sugars (see end of section 2)
-- previously had diarrhoea after taking any other
-- kidney problems, but your creatinine clearance
is above 10 ml/min.
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:
-- 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
-- anticoagulants, as their ability to prevent your
blood from clotting might be altered by fosfomycin trometamol and other antibiotics.
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.
Pregnant women may be able to use fosfomycin
trometamol if it is considered necessary.
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:
• for acute uncomplicated bladder infections, 1 sachet of Monuril 3 g, once
• for prevention of infection in surgery and diagnostic procedures, 1 sachet of Monuril 3 g, 3
hours before surgery. You may be given a further
sachet of 3 g 24 hours after surgery.
Use in children and adolescents
This medicine should not be used in children less
than 12 years of age.
Method of administration
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
Dissolve the content of one sachet in a glass of water and drink immediately.
If you take more Monuril than you should
If you accidentally take more than your prescribed
dose, contact your doctor or pharmacist.

If you forget to take Monuril
If you forget to take a dose, take one as soon as
you remember.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible 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) (the frequency is unknown)
-- 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) (the frequency is unknown).
Other side effects
If any of the following side effects occur, contact
your doctor as soon as possible:
Common (may affect up to 1 in 10 people):
-- headache
-- dizziness
-- diarrhoea - if it becomes severe consult your
doctor immediately
-- nausea
-- infection of the female genital organs with symptoms like inflammation, irritation, itching (vulvovaginitis).
Uncommon (may affect up to 1 in 100 people):
-- vomiting
-- abdominal pain
-- rash
-- urticaria
-- pruritus
Unknown frequency:
-- allergic reactions.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Monuril contains
-- 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).
What Monuril looks like and contents of the
White granules for oral solution in a single dose
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 and Manufacturer
Marketing Authorisation Holder:
Zambon S.p.A.
Via Lillo del Duca, 10
20091 Bresso (Milan) – Italy
Tel: +39 02 665 241
Fax: +39 02 665 01 492
Zambon S.p.A.
Via della Chimica, 9
36100 Vicenza – Italy
Profile Pharma Limited
Bicentennial Building
Southern Gate
West Sussex
PO19 8EZ
Tel: +44 (0) 800 1300 855
This leaflet was last revised in 05/2016.

Reporting of side effects
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
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Monuril
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the carton after . The expiry date refers to the last day of that month.
Store away from direct sunlight.

H02H100 E01.0114 FI506AC (CP 8/9)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.