Monural

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Monural (Monurol)

3 g, granulate for oral solution preparation
Fosfomycin
Monural and Monurol are different trade names for the same drug.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Monural and what is it used for
• 2. Important information before taking Monural
• 3. How to take Monural
• 4. Possible side effects
• 5. How to store Monural
• 6. Package contents and other information

1. What is Monural and what is it 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 to treat uncomplicated urinary tract infections in women and adolescent girls.
Monural is used as part of prophylactic antibiotic therapy in the case of transrectal prostate biopsy in adult men.

2. Important information before taking Monural

When not to take Monural:

Warnings and precautions

Before taking Monural, the patient should discuss it with their doctor, pharmacist, or nurse if they have:

• chronic urinary tract infections,
• diarrhea that occurred in the past after taking other antibiotics.

Things to consider
Monural may cause severe side effects. These include allergic reactions and inflammation of the colon. While taking the medicine, the patient should be aware of certain symptoms to reduce the risk of problems. See "Severe side effects" in section 4.

Children and adolescents

This medicine should not be given to children under 12 years of age, as the safety and efficacy in this age group have not been established.

Monural and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.
This is especially important when taking:

• metoclopramideor other medicines that increase the passage of food through the stomach and intestines, as they may reduce the absorption of fosfomycin by the body,
• anticoagulant medicines, as fosfomycin and other antibiotics may affect their ability to prevent blood clots.

Taking Monural with food and drink

Food may delay the absorption of fosfomycin. Therefore, the 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will only prescribe this medicine to a pregnant woman if it is clearly necessary. Breastfeeding mothers may take a single oral dose of this medicine.

Driving and using machines

Side effects such as dizziness may occur, which may affect the ability to drive or operate machines.

What Monural contains

Sodium(contained in the tangerine flavor and orange flavor)
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

Sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Sulfites(contained in the tangerine flavor and orange flavor) The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Monural

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
For the treatment of uncomplicated urinary tract 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 the case of transrectal prostate biopsy, the recommended dose is one sachet of Monural (3 g of fosfomycin) 3 hours before the procedure and one sachet of Monural (3 g of fosfomycin) 24 hours after 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.
The medicine should be taken orally, on an empty stomach (2-3 hours before a meal or 2-3 hours after a meal), preferably before bedtime and after emptying the bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.

Overdose of Monural

If an overdose is taken, the patient should consult their doctor or pharmacist.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Monural can cause side effects, although not everybody gets them.

Severe side effects

The patient should stop taking the medicine and consult their doctor immediately if they experience any of the following symptoms while taking Monural:

• anaphylactic shock, a life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching, or hives on the skin, or difficulty breathing, wheezing, or shortness of breath,
• swelling of the face, lips, and tongue, or throat, and difficulty breathing - angioedema (frequency not known),
• diarrhea of moderate to severe intensity, abdominal cramps, bloody stools, and/or fever, which may indicate colon infection - antibiotic-associated colitis (frequency not known). The patient should not take anti-diarrheal medicines that reduce intestinal peristalsis (antiperistaltic medicines).

Other side effects

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

• headache,
• dizziness,
• diarrhea,
• nausea,
• indigestion,
• abdominal pain,
• vaginal infection, inflammation, irritation, or itching (vulvovaginitis).

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

• vomiting,
• rash,
• hives,
• itching.

Unknown (frequency cannot be estimated from the available data):

• allergic reactions.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects helps gather more information on the safety of the medicine.

5. How to store Monural

Store in the original packaging.
The medicine should be kept 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Monural contains

The active substance of Monural is fosfomycin (in the form of fosfomycin trometamol).
1 sachet contains 8 g of granulate, including 3 g of fosfomycin in the form of fosfomycin trometamol (5.631 g).
The other ingredients are: tangerine flavor (contains sucrose and sulfites (E 220 and E 222)), orange flavor (contains corn starch and sulfites (E 220 and E 222)), saccharin, sucrose.

What Monural looks like and what the pack contains

Monural is a granulate for oral solution preparation.
The immediate packaging is a paper/PE/Aluminum/PE sachet.
Packaging: 1 sachet in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the 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

Repackaged by:

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

Marketing authorization number in Spain, the country of export:

• 694800.2
• 694799.9

Parallel import authorization number: 411/24

Date of leaflet approval: 21.11.2024

[Information about the trademark]