Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Monural (Monurol)
3 g, granules for oral solution
Fosfomycinum in the form of Fosfomycinum trometamolum
Monural and Monurol are different trade names of the same medicinal product.
Please read carefully the information contained in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Monural is and what it is used for
Important information before taking Monural
How to take Monural
Possible side effects
How to store Monural
Contents of the pack and other information

1. What Monural is and what it is used for

Monural contains the active substance fosfomycin (in the form of fosfomycin trometamol). It is an
antibiotic that works by killing bacteria that may cause infections.
Monural is used in the treatment of uncomplicated urinary bladder infections in women and
adolescent girls.
Monural is also used for prophylactic antibiotic therapy in adult men undergoing transrectal
prostate biopsy.

2. Information before using Monural

When not to take Monural:

if the patient is allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Monural, consult your doctor, pharmacist, or
nurse if the patient has:

chronic urinary bladder infections,
a history of diarrhoea following the use of other antibiotics.

Points to consider
Monural may cause serious adverse reactions. These include allergic reactions and inflammation of the large intestine. While taking the medicine, be alert for specific symptoms to reduce the risk of complications. See "Serious adverse reactions" in section 4.
Children and adolescents
This medicine should not be given to children under 12 years of age, as safety and efficacy have not been established in this age group.
Monural with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
This is particularly important when taking:

metoclopramide or other medicinal products that increase gastrointestinal motility, as they may reduce the absorption of fosfomycin into the body,
anticoagulant medicines, since fosfomycin and other antibiotics may affect their ability to prevent blood clotting.

Taking Monural with food and drink
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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will prescribe this medicine during pregnancy only if clearly necessary.
Breastfeeding mothers may take a single oral dose of this medicine.
Driving and using machines
Adverse effects such as dizziness may occur, which could affect the ability to drive or operate machinery.
Monural contains
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially "sodium-free".
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sulphites
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Monural

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
For the treatment of uncomplicated bladder infections in women and adolescent girls (over 12 years of age),
the recommended dose is one sachet of Monural (3 g of fosfomycin).
When used as prophylactic antibiotic therapy prior to transrectal prostate biopsy, the recommended dose
is one sachet of Monural (3 g of fosfomycin) three hours before the procedure and one sachet of Monural
(3 g of fosfomycin) 24 hours after completion of the procedure.
Use in patients with renal function impairment
This medicine should not be used in patients with severe renal impairment (creatinine clearance < 10 ml/min).
Use in children and adolescents
This medicine should not be used in children under 12 years of age.
Method of administration
Oral administration.
This medicine should be taken orally 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.
Accidental overdose of Monural
If more than the recommended dose has been taken by mistake, contact your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Serious adverse reactions
Stop taking the medicine immediately and contact your doctor if any of the following symptoms occur during treatment with Monural:

anaphylactic shock, a life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching or hives on the skin, or shortness of breath, wheezing or difficulty breathing,
swelling of the face, lips, tongue or throat and difficulty breathing – angioedema (frequency not known),
moderate to severe diarrhoea, abdominal cramps, bloody stools and/or fever which may indicate infection of the large intestine – antibiotic-associated colitis (frequency not known). Do not take antidiarrhoeal medicines that reduce intestinal motility (antiperistaltic medicines).

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

headache,
dizziness,
diarrhoea,
nausea,
dyspepsia,
abdominal pain,
genital infection causing inflammation, irritation and itching (vulvovaginitis).

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

vomiting,
rash,
urticaria,
itching.

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

allergic reactions.

Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Monural

Keep the medicine out of sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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.

6. Contents of the packaging and other information

What Monural contains
The active substance in Monural is fosfomycin (in the form of fosfomycin trometamol).
Each sachet contains 8 g of granules, including 3 g of fosfomycin as fosfomycin trometamol (5,631 g).
Other components of the medicine are: tangerine flavour, orange flavour, saccharin, sucrose.

What Monural looks like and contents of the pack
Monural is a granular preparation for oral solution.
The immediate packaging consists of a sachet made of paper/PE/Aluminium/PE laminate.
Pack: 1 sachet in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, the country of export:
Zambon S.A.U.
Maresme 5. Polígono Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda – Barcelona
Spain

Manufacturer:
Zambon S.p.A.
Via della Chimica, 9
36100 Vicenza, Italy

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Spanish Marketing Authorisation Numbers (country of export): 694800.2
694799.9

Parallel Import Licence Number: 62/20