Package leaflet: Information for the patient

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

Keep this leaflet to be able to 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 identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 (as trometamol fosfomycin). It is an
antibiotic that works by killing bacteria that can cause infections.
Monural is used for the treatment of uncomplicated urinary bladder infections in women and
adolescent girls.
Monural is also used as antibiotic prophylaxis in adult men undergoing transrectal prostate biopsy.

2. Important 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, discuss with your doctor, pharmacist or
nurse if the patient has:

chronic urinary bladder infections,
a history of diarrhoea after taking other antibiotics.

Considerations
Monural may cause serious adverse effects. These include allergic reactions and inflammation of the large intestine. While taking the medicine, be alert for specific symptoms in order to reduce the risk of complications. See "Serious adverse effects" 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use, 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 by the body,
anticoagulant medicines, because 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 baby, 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 operating machinery
Adverse effects such as dizziness may occur, which could affect the ability to drive or operate machinery.
Monural contains
Sodium (contained in the tangerine flavour and orange flavour)
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "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 (contained in the tangerine flavour and orange flavour) This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Monural

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
For treatment of uncomplicated urinary bladder infections in women and adolescent girls (over 12 years of age),
the recommended dose is one sachet of Monural (3 g of fosfomycin).
For prophylactic antibiotic therapy in connection with 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
the procedure.
Use in patients with renal function disorders
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 an overdose has been taken by accident, contact a doctor or pharmacist.
If there are any further doubts regarding the use of this medicine, consult a
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
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 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),
diarrhoea ranging from moderate to severe, abdominal cramps, bloody stools and/or fever may indicate infection of the large intestine – antibiotic-associated colitis (frequency not known). Medicines for diarrhoea that reduce intestinal motility (antiperistaltic medicines) must not be used.

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

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

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

vomiting,
rash,
urticaria,
itching.

Unknown (frequency cannot be estimated from available data):

allergic reactions.

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

5. How to store Monural

Keep in the original packaging.
The medicine should be stored in a place inaccessible and not visible to children.
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 in use. This will help protect the environment.

6. Package contents and other information

What Monural contains
The active substance in Monural is fosfomycin (in the form of fosfomycin trometamol).
One sachet contains 8 g of granules, including 3 g of fosfomycin as fosfomycin trometamol (5,631 g).
The other ingredients are: mandarin flavour (containing sucrose and sulphites (E 220 and E 222)), orange flavour (containing maize starch and sulphites (E 220 and E 222)), saccharin, sucrose.

What Monural looks like and contents of the pack
Monural is a granular preparation for oral solution.
The immediate packaging is a paper/PE/Aluminium/PE sachet.
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, country of export:
Zambon S.A.U.
Maresme 5. Polígono Can Bernades-Subirá
08130 Sta. Perpètua de Mogoda-Barcelona
Spain

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

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Spanish Marketing Authorisation numbers, country of export: 694800.2
694799.9

Parallel Import Licence number: 411/24