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FOSFOMYCIN 3G GRANULES FOR ORAL SOLUTION

Active substance(s): FOSFOMYCIN TROMETAMOL / FOSFOMYCIN TROMETAMOL / FOSFOMYCIN TROMETAMOL

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Package leaflet: Information for the user
Fosfomycin 3g, granules for oral solution
Fosfomycine Trometamol
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, pharmacist or nurse.
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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
What in in this leaflet:
1. What Fosfomycin is and what it is used for
2. What you need to know before 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 is and what it is used for

Fosfomycin belongs to a group of medicines known as antibiotics. It works by killing
bacteria, which can cause infections.
Fosfomycin is used to treat or prevent infections of the bladder.
Fosfomycin is not suitable for the treatment of children less than 12 years of age.

2.

What you need to know before you take Fosfomycin

Do not use Fosfomycin :
 if you are allergic to fosfomycin or any of the other ingredients of this medicine
(listed in section 6).
 if you suffer from severe kidney problems
 if you are on heamodialysis
 if you are a child
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking < Product Name>:
- if you have an intolerance to some sugars (see below)
- if you have previously experienced diarrhoea upon administration of any other antibiotics.
Children and adolescents
Do not give this medicine to children less than 12 years of age, as its safety has not been
established.
Other medicines and Fosfomycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Especially a medicine called metoclopramide (a medicine to stop you from feeling
sick) as this may have an affect on Fosfomycin.

Fosfomycin with food and drink
Fosfomycin should be taken on an empty stomach preferably before bedtime after emptying
the bladder. The contents of a sachet should be dissolved in a glass of water and taken
immediately.
Pregnancy and breast-feeding
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.
It is preferable to avoid the use of Fosfomycin during pregnancy.
Your doctor will decide whether you should use Fosfomycin.
Small amounts of this medicine may pass into the breast milk and it may affect the baby.
Therefore, your doctor will decide whether you should use Fosfomycin while breast-feeding.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
You may experience side effects such as dizziness or fatigue which may affect your ability to
drive or use machines. Do not drive or use machines if your are affected.
Fosfomycin contains sucrose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Fosfomycin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults including the elderly
The usual dose is one sachet (3 g) of Fosfomycin as a single dose.
Use in Children
Fosfomycin should not be used in children less than 12 years of age.
Methods of administration
Fosfomycin should be taken orally and should be taken on an empty stomach, preferably
before bedtime after emptying the bladder. The contents of the sachet should be dissolved in a
glass of water and taken immediately after its preparation.
If you take more Fosfomycin than you should
If you accidentally use more than your prescribed dose, contact your doctor or nearest
hospital.
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 stop taking Fosfomycin
Do not stop taking Fosfomycin because you feel better. It is important to take this medicine
for as long as the doctor has told you to, otherwise the problem might come back.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Whilst 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 (not known: frequency
cannot be estimated from the available data). The signs may include a sudden onset of
rash, itching or hives on the skin and or shortness of breath, wheezing or trouble
breathing
 Swelling of the face, lips, tongue or throat with breathing difficulties (angiooedema)
 Faster heart beat (tachycardia) (rare, may affect up to 1 in 1,000 people)
 Mild to severe abdominal crumps, bloody stools and /or fever may mean that you
have an infection of the large intestine (pseudomembranous colitis) (not known:
frequency cannot be estimated from the available data)
These are very serious side effects. You may need immediate medical attention.
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
 Indigestion
 Infection of the female genital organs with symptoms like inflamation, irritation,
itching (vulvovaginitis)
Uncommon (may affect up to 1 in 100 people):
 Tingling or numbness
 Diarrhoea
 Nausea
 Vomiting
 Stomachache
 Rash
 Itching
 Tiredness
Rare (may affect up to 1 in 1,000 people):
 Itching
Not known (frequency cannot be estimated from the available data):
 Allergic reactions
 Low blood pressure
 Asthma; with symptoms such as wheezing, shortness of breath, coughing
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

5.

How to store Fosfomycin

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
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

6.

Contents of the pack and other information

What Fosfomycin contains
The active substance is Fosfomycin trometamol. Each sachet contains 5.631 mg Fosfomycin
trometamol, equivalent to 3.000 g fosfomycin.
The other ingredients are:
Orange flavour consisting of maltodextrin, dextrose monohydrate, acacia (E414), anhydrous
citric acid (E330), butylhydroxyanisole (E 320); Saccharin sodium, Sucrose, Calcium
hydroxide.
What Fosfomycin looks like and contents of the pack
White, off-white granules in a single-dose sachet.
Fosfomycin is available in packs of:
Paper/LDPE/Alu/LDPE sachet
1 sachet of 8 g (3g of fosfomycin)
2 sachets of 8 g (3g of fosfomycin)
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Temapharm Sp. z o.o.
ul. Żwirki i Wigury 81
02-091 Warszawa
This medicinal product is authorised in the Member States of the EEA under the
following names:

This leaflet was last approved in 05/2013.

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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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