PACKAGE LEAFLET: Information for the patient

INFEUR 3 g granules for oral solution for adults

fosfomycin
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What INFEUR is and what it is used for
What you need to know before taking INFEUR
How to take INFEUR
Possible side effects
How to store INFEUR
Contents of the pack and other information

1. What INFEUR is and what it is used for

INFEUR contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that
works by killing bacteria that can cause infections.
INFEUR is used to treat uncomplicated bladder infections in women and adolescent girls (>12
years of age).
INFEUR is used as antibiotic prophylaxis during transrectal prostate biopsy in adult men.

2. What you need to know before taking INFEUR

Do not take INFEUR
if you are allergic to fosfomycin or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INFEUR if you have any of the following
conditions:

persistent bladder infections
previous episodes of diarrhoea after taking other antibiotics

Conditions you should be aware of
INFEUR may cause serious side effects. These include allergic reactions and inflammation
of the large intestine. You should pay attention to certain symptoms while taking this medicine
in order to reduce the risk of potential problems. See “Serious side effects” in section 4.

Children and adolescents
Do not give this medicine to girls under 12 years of age, as its safety and efficacy have not been evaluated in this age group.

Other medicines and INFEUR
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 particularly important if you are taking:

metoclopramide or other medicines that increase the movement of food through the stomach and intestine, as they may reduce the absorption of fosfomycin by your body;
anticoagulants, since their ability to prevent blood clotting may be altered by fosfomycin and other antibiotics.

INFEUR with food
Food may delay the absorption of trometamol fosfomycin.
Therefore, this medicine should be taken on an empty stomach (2–3 hours before or 2–3 hours after a meal).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will prescribe this medicine only if clearly necessary.
Breastfeeding women may take a single oral dose of this medicine.

Driving and using machines
You may experience side effects such as dizziness, which may affect your
ability to drive or operate machinery.

INFEUR contains saccharose and sunset yellow FCF (E110)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine. Use with caution in patients with diabetes or those on a low-calorie diet.
INFEUR contains the colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

3. How to take INFEUR

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For the treatment of uncomplicated bladder infection in women and adolescents, the
recommended dose is 1 sachet of INFEUR (3 g of fosfomycin).
When used as antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of INFEUR (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of INFEUR (3 g of fosfomycin) 24 hours after the procedure.
Use in patients with renal impairment
This medicine must not be used in patients with severe renal impairment (creatinine clearance < 10 ml/min).
Use in children and adolescents
This medicine must not be used in girls under 12 years of age.
Method of administration
For oral use.
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 and after emptying the bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
If you take more INFEUR than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
If you experience any of the following symptoms while taking INFEUR, you must stop taking the medicine
and contact your doctor immediately:
anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known).
Symptoms include sudden onset of skin rash, itching or hives, and/or shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or throat with breathing difficulties (angioedema) (frequency not known)
moderate to severe diarrhoea, abdominal cramps, blood in the stools and/or fever may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medicines for diarrhoea that inhibit intestinal motility (antiperistaltics)
Other side effects
Common (may affect up to 1 in 10 people):
headache
dizziness
diarrhoea
nausea
dyspepsia
abdominal pain
genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis)
Uncommon (may affect up to 1 in 100 people):
vomiting
rash
urticaria
itching
Rare (may affect up to 1 in 1000 people):
severe bacterial infections (superinfections caused by resistant bacteria);
reduction in the number of red blood cells (aplastic anaemia).
Not known (frequency cannot be estimated from the available data):
allergic reactions
vision disorders
bronchial constriction (bronchospasm)
increase in white blood cells (eosinophils) and platelets
loss of appetite
inflammation of the veins (phlebitis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INFEUR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of that month.
Store the medicine in its original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INFEUR contains
The active substance is fosfomycin trometamol.
Each sachet of INFEUR 3 g granules for oral solution for adults contains 3.0 g of fosfomycin (as
fosfomycin trometamol 5.631 g).
The other components are: Orange flavour (containing: maltodextrin, acacia gum (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA (E320)), sodium saccharin, sucrose, magnesium citrate.

Description of the appearance of INFEUR and contents of the pack
INFEUR is available in sachets containing white or almost white granules to be dissolved in water or another beverage.
The pack contains 1 or 2 sachets of 3 g.

Marketing Authorisation Holder
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense, 87
03013 Ferentino (FR) - Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, n.1, 03012 Anagni (FR)