Package leaflet: Information for the patient

MONURIL 3 g granules for oral solution

Fosfomycin
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MONURIL is and what it is used for

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

2. What you need to know before taking MONURIL

Do not take MONURIL

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 MONURIL if you suffer from any of the following conditions:

Persistent bladder infections;
Previous episodes of diarrhoea after taking other antibiotics.

Conditions to which you should pay attention
MONURIL may cause serious side effects. These include allergic reactions and inflammation of the large intestine (colitis). You should pay attention to certain symptoms while taking this medicine to reduce the risk of potential problems. See "Serious side effects" in section 4.
Children and adolescents
Do not administer this medicine to girls under 12 years of age, as its safety and efficacy have not been established in this age group.
Other medicines and MONURIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without 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.

MONURIL with 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 might be pregnant, planning to become pregnant, or 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.
MONURIL contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".
MONURIL contains sulfites, including metabisulfites
Sulfites may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take MONURIL

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 MONURIL (3 g of fosfomycin).
When used as antibiotic prophylaxis prior to prostate biopsy, the recommended dose is 1
sachet of MONURIL (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of MONURIL (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 MONURIL 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 experiences them.

Serious side effects

During treatment with MONURIL, 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 breathing difficulties (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 side 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
Rash
Urticaria
Itching

Rare (may affect up to 1 in 1,000 people):

Severe bacterial infections (superinfections caused by resistant bacteria)
Decrease in the number of red blood cells (aplastic anaemia)

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

Allergic reactions
Bronchoconstriction (bronchospasm)
Loss of appetite
Increase in white blood cells (eosinophils) and platelets
Visual disturbances
Inflammation of the veins (phlebitis)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 MONURIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated on the carton.
Store the product in its original packaging. After reconstitution of the solution, the medicine must be taken immediately.
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 MONURIL contains
MONURIL 3 g granules for oral solution

The active substance is fosfomycin trometamol. Each sachet contains 5.631 g of fosfomycin trometamol, equivalent to 3 g of fosfomycin;
The other components are tangerine flavour (containing: saccharose, acacia, sodium, sulphites), orange flavour (containing: maltodextrins, sodium, sulphites), saccharin, saccharose.

Description of the appearance of MONURIL and contents of the package
MONURIL is available in sachets containing white or almost white granules to be dissolved in water or another beverage.
The package contains 1 or 2 sachets of 3 g.
Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)
Manufacturer
ZAMBON S.p.A. - via della Chimica 9 - Vicenza