Package leaflet: Information for the patient

Warning! Please 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 brand names of the same medicine.
Please read this 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
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

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 to treat uncomplicated urinary bladder infections in women and adolescent girls.
Monural is also used as prophylactic antibiotic therapy 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 a 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 reactions, including 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 side 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
This is particularly important if the patient is taking:

metoclopramide or other medicinal products that increase gastrointestinal motility, as they may reduce the absorption of fosfomycin into 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 a 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 tangerine flavour and orange flavour)
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. 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 tangerine flavour and orange flavour)
The 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.
In 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).
If 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 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 urinary bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.

Overdose of Monural
If a larger than recommended dose has been taken by accident, contact a 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 unknown). 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 unknown);
Diarrhea ranging from moderate to severe, abdominal cramps, bloody stools and/or fever, which may indicate a bowel infection – antibiotic-associated colitis (frequency unknown). Do not take antidiarrheal medicines that reduce intestinal motility (antiperistaltic agents).

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

Headache;
Dizziness;
Diarrhea;
Nausea;
Indigestion;
Abdominal pain;
Infection of the female genital organs manifested by 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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, Tel: +48 (22) 4921301, Fax: +48 (22) 4921309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Monural

Keep in the original packaging.
This 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. This will help protect the environment.

6. Contents of the pack 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, orange flavour, saccharin, sucrose.

What Monural looks like and contents of the pack
Monural is a granulate for oral solution.
The immediate packaging consists of a paper/PE/Aluminium/PE sachet.
Pack: 1 sachet in a cardboard box.
For further 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Spain, the country of export: 694800.2
Parallel Import Licence Number: 54/20