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MONURIL SACHETS 3G

Active substance(s): FOSFOMYCIN TROMETAMOL

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Granules for oral solution
fosfomycin

Package leaflet: Information for the user



of fosfomycin trometamol by your body
- anticoagulants, as their ability to prevent your
blood from clotting might be altered by fosfomy­
cin trometamol and other antibiotics.



1. What Monuril is and what it is used for

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.
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Monuril contains the active substance fosfomycin
trometamol. Fosfomycin trometamol is an antibiot­
ic that works by killing bacteria which can cause
infections.

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.
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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.

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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.

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

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.

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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 clear­
ance below 10 ml/min)
- are undergoing haemodialysis.

There are no known effects of fosfomycin tromet­
amol on fertility.

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3. How to take Monuril

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Other medicines and Monuril
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medi­
cines, including medicines obtained without a pre­
scription.
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

The recommended doses are:
• for acute uncomplicated bladder infections, 1 sa­
chet of Monuril 3 g, once
• for prevention of infection in surgery and diag­
nostic 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 stom­
ach (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 wa­
ter and drink immediately.
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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.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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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 sec­
tion 2)
- previously had diarrhoea after taking any other
antibiotics
- kidney problems, but your creatinine clearance
is above 10 ml/min.

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

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 sa­
chet contains 5.631 g of fosfomycin trometamol,
equivalent to 3 g of fosfomycin
- the other ingredients are mandarin flavour, or­
ange flavour, saccharin, sucrose (see section 2
for information on sucrose).

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

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Serious side effects
While taking Monuril, if you develop any of the fol­
lowing symptoms you should contact your doc
tor immediately:

What Monuril looks like and contents of the
pack
White granules for oral solution in a single dose
sachet.

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Other side effects
If any of the following side effects occur, contact
your doctor as soon as possible:

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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 Manufac
turer
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
Manufacturer:
Zambon S.p.A.
Via della Chimica, 9
36100 Vicenza – Italy

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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 symp­
toms like inflammation, irritation, itching (vulvo­
vaginitis).

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

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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 frequen­
cy is unknown)
- mild to severe abdominal cramps, bloody
stools, diarrhoea and/or fever may mean that
you have an infection of the large intestine (an­
tibiotic associated colitis) (the frequency is un­
known).

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

Esecuzione impianti: PharmaDesigners s.a.s. - Napoli

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 forgot­
ten dose.

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Uncommon (may affect up to 1 in 100 people):
- vomiting
- abdominal pain
- rash
- urticaria
- pruritus
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This leaflet was last revised in 05/2017.

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Unknown frequency:
- allergic reactions.

Distributor
Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
UK
Tel: +44 (0) 800 0288 942
Email: info.profilepharma@zambongroup.com

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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
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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5. How to store Monuril
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton after . The ex­
piry date refers to the last day of that month.
Store away from direct sunlight.

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H02H100 E02.0417 IS 506 C C (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.

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