PATIENT INFORMATION LEAFLET

UROFOS adults 3 g granules for oral solution

Fosfomycin trometamol
Generic medicine
Please read this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What UROFOS is and what it is used for

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

2. What you need to know before taking UROFOS

Do not take UROFOS
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 UROFOS if you have any of the following conditions:

Other medicines and UROFOS
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:

UROFOS adults 3 g granules for oral solution (a.s. fosfomycin)

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

UROFOS and food
Food may delay the absorption of 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, your doctor will prescribe this medicine only if clearly necessary.
Women who are breastfeeding may take a single oral dose of this medicine.

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

Important information about certain excipients:
UROFOS
UROFOS
UROFOS

3. How to take UROFOS

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
UROFOS adults 3 g granules for oral solution (p.a. fosfomycin)

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
During treatment with UROFOS, if you develop any of the following symptoms, 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 difficulty breathing (angioedema) (frequency not known)
moderate to severe diarrhoea, abdominal cramps, blood in the stool and/or fever may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics)

Other adverse effects
Common (may affect up to 1 in 10 people):

headache
dizziness
diarrhoea
nausea
indigestion
abdominal pain
genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis)

Uncommon (may affect up to 1 in 100 people):

vomiting
skin rash
earache
itching

Rare:

aplastic anaemia
Superinfections due to resistant bacteria

Not known (frequency cannot be estimated from the available data):

allergic reactions
bronchospasm (severe breathing diﬃculty)
slight increase in white blood cell and platelet count – loss of appetite
visual disturbances
phlebitis

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse effects, you can help provide more information on the safety of this medicine.
UROFOS adults 3 g granules for oral solution (active substance: fosfomycin)

5. How to store UROFOS

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.
Storage conditions:
Expiry: see the expiry date printed on the packaging.
The expiry date applies to the product if unopened and stored correctly.
Warning: do not use the medicine after the expiry date shown on the packaging.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

6. Package contents and other information

What UROFOS contains
The active substance is fosfomycin trometamol.
Each sachet of UROFOS 3 g granules for oral solution contains fosfomycin 3.0 g (as fosfomycin
trometamol 5.631 g).
The excipients are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour (containing:
maltodextrin, dextrose, gum arabic (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA (E320)).

Description of the appearance of UROFOS and the contents of the package
UROFOS is available as sachets containing white or almost white granules to be dissolved in water or another beverage.
The pack contains:
3 g granules for oral solution for adults – 1 sachet of 3 g
3 g granules for oral solution for adults – 2 sachets of 3 g

Marketing Authorization Holder:
Konpharma s.r.l.,
Via Pietro Della Valle 1,
00193 Rome, Italy

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