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FOSFOMYCIN 40 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance(s): FOSFOMYCIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSFOMYCIN 40 mg/ml Powder for solution for infusion
Fosfomycin
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 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, or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What FOSFOMYCIN 40 mg/ml is and what it is used for
What you need to know before you are given FOSFOMYCIN 40 mg/ml
How FOSFOMYCIN 40 mg/ml is given
Possible side effects
How to store FOSFOMYCIN 40 mg/ml
Contents of the pack and other information

1.

What FOSFOMYCIN 40 mg/ml is and what it is used for

FOSFOMYCIN 40 mg/ml (called “FOSFOMYCIN” in this leaflet) belongs to a group of medicines
called antibiotics. It works by killing certain types of germs (bacteria) that cause serious infectious
diseases. Your doctor has decided to treat you with FOSFOMYCIN to help your body fight an
infection. It is important that you receive effective treatment for this condition.
This medicine is given as an infusion into a vein (a drip) by a doctor or a nurse.
FOSFOMYCIN is used in adults and children to treat the following infections caused by bacteria.
• Infections of the lung
• Infections of the bones
• Infections of the kidney and bladder
• Infections of the brain (meningitis)
This medicine is used when other antibiotics cannot be used or have not worked.
This medicine can be given alone or in combination with other antibiotics.

2.

What you need to know before you are given FOSFOMYCIN 40 mg/ml

In certain circumstances your doctor may decide not to give you this medicine.
Do not have FOSFOMYCIN and tell your doctor if:
• You are allergic (hypersensitive) to fosfomycin or any of the other ingredients of this
medicine (listed in section 6).
If you are not sure, talk to your doctor, pharmacist or nurse before having FOSFOMYCIN.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking this medicine if you suffer from one of the
following disorders:

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heart problems (cardiac insufficiency), especially if digitalis medicine is taken (possible
hypokalaemia)
high blood pressure (hypertension)
a certain disorder of the hormone system (hyperaldosteronism)
high levels of blood sodium (hypernatraemia)
fluid accumulation in the lungs (pulmonary oedema)
kidney problems. Your doctor may need to change the dose of your medicine (see section 3 of
this leaflet).

Conditions you need to look out for
FOSFOMYCIN can cause serious side effects. These include allergic reactions and inflammation of
the large intestine. You must look out for certain symptoms while you are taking this medicine, to
reduce the risk of any problems. See “Conditions to look out for” in Section 4.
Other medicines and FOSFOMYCIN
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
So far, no harmful interference has been noted when this medicine is given together with other
medicines.
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 you are given this medicine.
Fosfomycin may pass to the baby in the womb or through breast milk. If you are pregnant or breastfeeding your doctor will only give you this medicine when it is clearly needed.
Driving and using machines
When FOSFOMYCIN is given, there may be side effects such as dizziness, confusion or problems
with the vision (see also section 4 “Possible Side Effects”). If these occur, you should not drive or
operate machinery.
Important information about some of the ingredients of FOSFOMYCIN
This medicine contains sodium (14 mmol (320 mg) sodium per 1 g fosfomycin). One bottle with 2 g
fosfomycin contains 28 mmol (640 mg) sodium, one bottle with 4 g fosfomycin contains 56 mmol (1280
mg) sodium and one botlle with 8 g fosfomycin contains 111 mmol (2560 mg) sodium.
This should be taken in consideration if you are on a controlled sodium diet.
While on treatment with this medicine, you should follow a low-salt diet to reduce your sodium intake.
3.

How FOSFOMYCIN 40 mg/ml is given

Administration
FOSFOMYCIN is given to you into a vein (a drip) by a doctor or a nurse. The infusion will normally
take 15 to 60 minutes, depending on your dose. Usually this medicine is given 2, 3 or 4 times a day.
Dosage
The dose you will be given, and the frequency of the dose will depend on:
• The type and severity of infection you have
• Your kidney function.
In children, it also depends on
• The child’s weight
• The child’s age
The general dosage guidelines for patients with normal kidney function are as follows:

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Age/weight
Premature neonates

Daily dose
100 mg/kg body weight
in 2 divided doses
200 mg/kg body weight
in 3 divided doses
200-300 mg/kg body weight
in 3 divided doses
200-400 mg/kg body weight
in 3-4 divided doses
12-24 g in 2-4 divided doses

Neonates
Infants 1-12 months
(up to 10 kg body weight)
Infants and children aged 1-12 years
(10-40 kg body weight)
Adolescents aged 12-18 years and adults
(> 40 kg body weight)

Individual doses must not exceed 8 g.
If you have problems with your kidneys or require dialysis, your doctor may need to reduce your dose
of this medicine.
Duration of treatment
Your doctor will decide how long your treatment should last depending on how fast your condition will
improve. When treating bacterial infections it is important to complete the full course of treatment. Even
after the fever has passed and the symptoms have abated, treatment should be continued for a few days
more.
Certain infections, such as infections of the bones, may require an even longer treatment period after
the symptoms have subsided.
If you are given more FOSFOMYCIN than you should
It is unlikely that your doctor or nurse will give you too much medicine. Ask them immediately if you
think that you have been given too much of this medicine.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions to look out for
Tell your doctor straight away if you notice any of the following serious side effects – you may need
urgent medical treatment:
• Signs of a serious allergic reaction (very rare, affecting less than 1 person in 10 000). These may
include: breathing or swallowing problems, sudden wheezing, dizziness, swelling of eyelids, face,
lips or tongue, rash or itching.
• Severe and persistent diarrhoea (which may be associated with abdominal pain or fever). This
may be a sign of a serious bowel inflammation. Do not take medicines against diarrhoea that
inhibit the bowel movements (antiperistaltics)!
• Yellowing of the skin or the whites of your eyes (jaundice). This can be an early sign of liver
problems.
• Confusion, muscle twitching or abnormal heart rhythm. This could be caused by high levels of
blood sodium or low levels of blood potassium (uncommon, affecting less than 1 person in 100).
Tell your doctor or nurse as soon as possible if you notice any of the following side effects:
• Pain, burning, redness or swelling along the vein which is used during infusion of this
medicine (common, affecting less than 1 person in 10).

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You bleed or bruise more easily and get more infections as usual. This could be because you
have a low number of white blood cells or blood platelets.

Other side effects can include:
Common side effects (affecting less than 1 person in 10)
• Retching, stomach ache, rash with redness of the skin
• High levels of blood sodium and/or low levels of blood potassium
Uncommon side effects (affecting less than 1 person in 100)
• Feeling sick, vomiting, or mild diarrhoea
• Taste disturbances
• Shortness of breath
• Rash
• Decreased appetite
• Headache
• Feeling of dizziness or “spinning”
• Tiredness
• High levels of blood liver enzymes, possibly associated with liver problems.
• Swelling due to fluid retention (oedema)
Rare side effects (affecting less than 1 person in 1 000)
• Pale skin, weakness or breathlessness (possibly due to a reduction in blood cells)
• High levels of certain white blood cells (eosinophilia), usually associated with allergic
diseases.
Very rare side effects (affecting less than 1 person in 10 000)
• Fatty liver
• Visual impairment
Side effects with unknown frequency
• Liver problems (hepatitis), liver enzymes increased (gamma-glutamyltransferase)
• Shortness of breath, wheezing or a tight feeling in the chest. These may be signs of an asthma
attack.
• Faster heart beat
• Low number of certain white blood cells (neutropenia)
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 or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store FOSFOMYCIN 40 mg/ml





Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and label after
“EXP”. The expiry date refers to the last day of that month.
After being mixed with solvent this medicine should be used immediately or stored in a
refrigerator (at 28°C) protected from light for up to 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

Content of the pack and other information
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What FOSFOMYCIN contains
The active substance is fosfomycin. Each ml of the reconstituted solution contains 40 mg of
fosfomycin.




Each bottle of FOSFOMYCIN 2 g with 2.69 g of powder for reconstitution in 50 ml solvent
contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium.
Each bottle of FOSFOMYCIN 4 g with 5.38 g of powder for reconstitution in 100 ml solvent
contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium.
Each bottle of FOSFOMYCIN 8 g with 10.76 g of powder for reconstitution in 200 ml solvent
contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium.

The other ingredient is succinic acid.
What FOSFOMYCIN looks like and contents of the pack
This medicine is a white to cream-coloured powder for solution for infusion. The reconstituted solution is
clear and colourless to slightly yellowish.
It is packed in clear glass bottles (type II) with a rubber stopper (bromobutyl rubber) and pull-off cap.
Three sizes of vials are available:
• bottles with 2 g fosfomycin
• bottles with 4 g fosfomycin
• bottles with 8 g fosfomycin
Each pack contains 10 bottles.
Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1, 64646 Heppenheim
Germany
Distributor
Nordic Pharma Ltd
Unit 3, Commerce Park
Brunel Road
Theale, Reading
RG7 4AB, UK
This leaflet was last revised in: 10/2017.
__________________________________________________________________________________
The following information is intended for medical or healthcare professionals only:
FOSFOMYCIN 40 mg/ml powder for solution for infusion is for single use only and any unused
solution should be discarded.
The powder must be reconstituted prior to use.
Preparation of the solution for infusion
In order to prepare the solution for infusion:
FOSFOMYCIN 2 g should be dissolved in 50 ml of Water for Injections, Glucose Infusion 50 mg/ml
(5 %) or Glucose Infusion 100 mg/ml (10 %).
FOSFOMYCIN 4 g should be dissolved in 100 ml of Water for Injections, Glucose Infusion 50 mg/ml
(5 %) or Glucose Infusion 100 mg/ml (10 %).
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FOSFOMYCIN 8 g should be dissolved in 200 ml of Water for Injections, Glucose Infusion 50 mg/ml
(5 %) or Glucose Infusion 100 mg/ml (10 %).
A slight degree of warming occurs when the powder is dissolved.
Displacement value
The displacement values for the reconstituted solutions are 1 ml for the 2 g pack size, 2 ml for the 4 g
pack size and 4 ml for the 8 g pack size.
These volumes are equivalent to an increase of volume of 2 %. This has to be considered when
preparing the final solution in case of not using the entire content of the vial.
Method of administration
Disodium fosfomycin is intended for intravenous administration. Each infusion should last at least
15 minutes for the 2 g pack size, at least 30 minutes for the 4 g pack size and at least 60 minutes for
the 8 g pack size.
As damaging effects can result from inadvertent intra-arterial administration of products not
specifically recommended for intra-arterial therapy, it is essential to ensure that fosfomycin is only
administered into veins.
Before administration, the reconstituted solution should be inspected visually. Only clear solutions
should be used.
Shelf life of the reconstituted solution
Chemical and physical in-use stability of the reconstituted solution that has been produced under aseptic
conditions has been demonstrated for 24 hours at 25°C if protected from light.
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.

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