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FOSFOMYCIN 3 G GRANULES FOR ORAL SOLUTION

Active substance(s): FOSFOMYCIN TROMETAMOL / FOSFOMYCIN TROMETAMOL

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Monuril® 3 g
granules for oral solution

2973
16.12.16[2]

(fosfomycin trometamol)
PATIENT INFORMATION 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.
The name of this medicine is Monuril 3 g granules for oral solution but will
be referred to as Monuril throughout this leaflet.
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.

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

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
- 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.

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.
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 the medicine 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. The expiry date refers to the last day of that month.
- If the granules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- 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 trometamol.
- Each sachet contains fosfomycin trometamol equivalent to 3 g fosfomycin.
- The other ingredients are saccharin, sucrose, orange flavour and
mandarin flavour.
What Monuril looks like and contents of the pack
Monuril is a white granular powder with a characteristic citrus odour.
Monuril is available in packs containing 1 or 2 sachets containing 8g of
granules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Monuril is manufactured by Zambon Switzerland Ltd., Via lndustrie 13,
6814 Cadempino, Switzerland and procured from within the EU by
Product Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2973

Leaflet revision and issue date (Ref). 16.12.16[2]
Monuril is a trademark of Zambon S.p.A.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Fosfomycin 3 g
granules for oral solution

2973
16.12.16[2]

(fosfomycin trometamol)
PATIENT INFORMATION 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.
The name of this medicine is Fosfomycin 3 g granules for oral solution but
will be referred to as Fosfomycin throughout this leaflet.
What is in this leaflet
1. What Fosfomycin is and what it is used for
2. What you need to know before you take Fosfomycin
3. How to take Fosfomycin
4. Possible side effects
5. How to store Fosfomycin
6. Contents of the pack and other information.
1. WHAT FOSFOMYCIN TROMETAMOLIS AND WHAT IT IS USED FOR
The active ingredient, fosfomycin trometamol is an antibiotic that works by
killing bacteria which can cause infections.
Fosfomycin is used to treat or prevent uncomplicated infections of the
bladder.
Fosfomycin is not suitable for the treatment of children below 12 years of
age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOMYCIN
TROMETAMOL
Do not take Fosfomycin 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 Fosfomycin 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 Fosfomycin
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.

Fosfomycin 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 FOSFOMYCIN TROMETAMOL
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 Fosfomycin 3 g,
once
- for prevention of infection in surgery and diagnostic procedures, 1 sachet
of Fosfomycin 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 Fosfomycin than you should
If you accidentally take more than your prescribed dose, contact your doctor
or pharmacist.
If you forget to take Fosfomycin
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 Fosfomycin, 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).

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.

Uncommon (may affect up to 1 in 100 people):
- vomiting
- abdominal pain
- rash
- urticaria
- pruritus

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

Unknown frequency:
- allergic reactions.

Breast-feeding mothers can take a single oral dose of this medicine.

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.

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.

5. HOW TO STORE FOSFOMYCIN TROMETAMOL
- Keep the medicine 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. The expiry date refers to the last day of that month.
- If the granules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- 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 Fosfomycin contains
- The active substance is fosfomycin trometamol.
- Each sachet contains fosfomycin trometamol equivalent to 3 g fosfomycin.
- The other ingredients are saccharin, sucrose, orange flavour and
mandarin flavour.
What Fosfomycin looks like and contents of the pack
Fosfomycin is a white granular powder with a characteristic citrus odour.
Fosfomycin is available in packs containing 1 or 2 sachets containing 8g of
granules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Fosfomycin is manufactured by Zambon Switzerland Ltd., Via lndustrie 13,
6814 cadempino, Switzerland and procured from within the EU by Product
Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2973

Leaflet revision and issue date (Ref). 16.12.16[2]

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Expand Transcript

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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