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FOSFOMYCIN 3G GRANULES

Active substance(s): FOSFOMYCIN TROMETAMOL

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Package leaflet: Information for the user

Monuril® 3g Granules /
Fosfomycin 3g Granules
(fosfomycin trometamol)
Your medicine is known by the above names but will be referred to as Monuril throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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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 is 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 infections.
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
Monuril
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 antibiotics
-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

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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 bladder.
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

6. Contents of the pack and other information
What Monuril contains
Each sachet of granules for oral solution contains
3g fosfomycin (as the trometamol salt). Also
includes sucrose, saccharin, mandarin and
orange flavour.
What Monuril looks like and contents of the
pack

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

White granules for oral solution.

Serious side effects
While taking Monuril, if you develop any of the
following symptoms you should contact your
doctor immediately:

Who manufactured your medicine
Manufactured by Zambon S.p.A., Via della
Chimica, 9-Vicenza, Italy. Procured from within
the EU and repackaged by Product Licence
Holder Ennogen Healthcare Ltd, Unit G4
Riverside Industrial Estate, Riverside Way,
Dartford, Kent DA1 5BS.

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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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Monuril
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the carton after Expiry. The
expiry date refers to the last day of that month.
Store away from direct sunlight.
If the granules show signs of deterioration or
discolouration seek the advice of your pharmacist
who will tell you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no
longer use. These measures will help protect the
environment.

Available in packs containing 1 sachet.

PL 40739/0046 POM
Leaflet date: 26 January 2016
Ref: Mon3gG/v1
Monuril is a registered trademark of Zambon
S.p.A.

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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.

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