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MONURIL 3G GRANULES

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Package leaflet: Information for the user
Monuril® 3g Granules for oral solution
(fosfomycin trometamol)
Your medicine is known as the above but will be referred
to as Monuril throughout the remainder of this leaflet.
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 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.

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.

4.

Pregnant women may be able to use fosfomycin trometamol if
it is considered necessary.

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

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.

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
 anticoagulants, as their ability to prevent your blood from
clotting might be altered by fosfomycin trometamol and
other antibiotics.

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.

Possible side effects

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

 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 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.
5.

How to store Monuril

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Keep sachet in the outer carton. Store away from direct
sunlight.
Do not use this medicine after the expiry date which is stated
on the carton and sachet. The expiry date refers to the last day
of that month.
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
3g fosfomycin (as the trometamol salt).
 The other ingredients are mandarin flavour, orange flavour,
saccharin and sucrose.

What Monuril looks like and contents of the pack
Monuril is white granular powder with mandarin scent, in a
single use sachet.
Monuril is available in packs containing 1 sachet.
Manufacturer
Manufactured by Zambon Nederland B.V., Basicweg 14B,
3821 BR Amersfoort, The Netherlands. Procured from within
the EU and repackaged by the Product Licence holder:
G-Pharma Limited, Salford M50 2PU.
POM

PL 16369/1720
Leaflet revision: 27/04/17
Monuril® is a registered trademark of Zambon.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0161 877 8999 to obtain the
leaflet in a format suitable for you.

Package leaflet: Information for the user
Monuril® 3g Granules for oral solution
(fosfomycin trometamol)
Your medicine is known as the above but will be referred
to as Monuril throughout the remainder of this leaflet.
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 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.

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.

4.

Pregnant women may be able to use fosfomycin trometamol if
it is considered necessary.

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

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.

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
 anticoagulants, as their ability to prevent your blood from
clotting might be altered by fosfomycin trometamol and
other antibiotics.

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.

Possible side effects

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

 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 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.
5.

How to store Monuril

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Keep sachet in the outer carton. Store away from direct
sunlight.
Do not use this medicine after the expiry date which is stated
on the carton and sachet. The expiry date refers to the last day
of that month.
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
3g fosfomycin (as the trometamol salt).
 The other ingredients are mandarin flavour, orange flavour,
saccharin and sucrose.

What Monuril looks like and contents of the pack
Monuril is white granular powder with mandarin scent, in a
single use sachet.
Monuril is available in packs containing 1 sachet.
Manufacturer
Manufactured by Zambon Nederland B.V., Basicweg 14B,
3821 BR Amersfoort, The Netherlands. Procured from within
the EU and repackaged by the Product Licence holder:
G-Pharma Limited, Salford M50 2PU.
POM

PL 16369/1720
Leaflet revision: 27/04/17
Monuril® is a registered trademark of Zambon.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0161 877 8999 to obtain the
leaflet in a format suitable for you.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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