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, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 package 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 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 after taking other antibiotics.

Considerations
Monural may cause serious adverse effects, including allergic reactions and inflammation of the large intestine. While taking this medicine, be aware of certain 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 with other medicines
Tell 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 by the body,
• anticoagulants, 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 a meal 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
This 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 their doctor before taking this medicine.
Sulphites (contained in mandarin 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) 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 must 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, consult your doctor or pharmacist.
If you have any further doubts regarding 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 everyone experiences them.
Serious adverse reactions
Immediately stop taking the medicine 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 rash, itching or hives on the skin, or shortness of breath, wheezing or difficulty breathing;
• swelling of the face, lips, tongue or throat and breathing difficulties – angioedema (frequency unknown);
• diarrhea ranging from moderate to severe, abdominal cramps, bloody stools and/or fever, which may indicate infection of the large intestine – antibiotic-associated colitis (frequency unknown). Medicines for diarrhea that reduce intestinal peristalsis (antiperistaltic drugs) must not be used.

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

• headache,
• dizziness,
• diarrhea,
• 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 reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 in use. This will help protect the environment.

6. Contents of the packaging 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 components: tangerine flavour (containing, among others, sucrose and sulphites (E 220 and E 222)),
orange flavour (containing, among others, 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.
Packs consist of paper/PE/Aluminium/PE sachets in a cardboard box.
Pack size: 1 sachet of 8 g.
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
Zambon S.A.U.
Maresme, 5. Polígono Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda - Barcelona
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation numbers in Spain, the country of export: 694800.2
694799.9
Parallel Import Authorisation number: 97/21