Monural

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.
Monural (Monurol), 3 g, granules for oral solution
Fosfomycinum
Monural and Monurol are different trade names of the same medicine.
Please read the leaflet carefully 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, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Monural is and what it is used for
2. Important information before taking Monural
3. How to take Monural
4. Possible side effects
5. How to store Monural
6. 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 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, consult your doctor, pharmacist, or nurse if the patient has:

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

Considerations
Monural may cause serious adverse reactions, including allergic reactions and inflammation of the large intestine. During treatment, be vigilant 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

This is particularly important when taking:

• metoclopramide or other medicinal products that increase gastrointestinal motility, as they may reduce the absorption of fosfomycin,
• anticoagulants, since fosfomycin and other antibiotics may affect their ability to prevent blood clot formation.

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 reactions such as dizziness may occur, which could affect the ability to drive or operate machinery.

Monural contains

Sodium (contained in tangerine flavour and orange flavour)
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. this medicine is considered "sodium-free".

Sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Sulphites (contained in 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 according to the instructions provided by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
For the 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).
When used as prophylactic antibiotic therapy prior to transrectal prostate biopsy, the recommended dose is one sachet of Monural (3 g
of fosfomycin) taken 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 use.
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 urinary bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
Accidental overdose of Monural
If a larger than recommended dose has been taken by accident, contact your doctor
or pharmacist.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Serious side effects

Stop taking Monural immediately and contact your doctor if you experience any of the following symptoms while taking this medicine:

• 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 breathing difficulties;
• Swelling of the face, lips, tongue or throat with breathing difficulties – angioedema (frequency not known);
• Diarrhoea ranging from moderate to severe, abdominal cramps, bloody stools and/or fever, which may indicate an infection of the large intestine – antibiotic-associated colitis (frequency not known). Do not take anti-diarrhoeal medicines that reduce intestinal motility (antiperistaltic agents).

Other side effects

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

• Headache;
• Dizziness;
• Diarrhoea;
• Nausea;
• Indigestion;
• Abdominal pain;
• Infection of female genital organs manifesting as inflammation, irritation, or 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 side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 side effects helps to provide more information on the safety of this medicine.

5. How to store Monural

Keep in the original packaging.
The medicine should be stored out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Monural contains
The active substance 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 ingredients: mandarin flavour (contains sucrose and sulphites (E 220 and E 222)), orange flavour (contains corn starch and sulphites (E 220 and E 222)), saccharin, sucrose.

What Monural looks like and contents of the pack
Monural is a granular powder for oral solution.
The immediate packaging consists of paper/PE/Aluminium/PE laminate sachets.
Pack: 1 sachet of 8 g in a cardboard box.

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

Manufacturer
Zambon S.p.A.
Via della Chimica, 9
36100 Vicenza,
Italy
Zambon S.A.U.
Maresme, 5. Polígono Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda – Barcelona
Spain

Parallel Importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Marketing Authorisation Number in Spain, country of export: 694800.2
Parallel Import Authorisation Number: 190/24