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, granules for oral solution
Fosfomycin
Monural and Monurol are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. Contents of the packaging 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).
This 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:

• 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 to take Monural, the patient should discuss it with their doctor, pharmacist, or nurse if they have:

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

Matters to be considered
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 specific 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, or have recently taken, and about medicines they 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. This medicine should therefore 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 baby, they should consult their doctor or pharmacist before taking this medicine.
The doctor will only give this medicine to a pregnant woman if it is clearly necessary.
Mothers who are breastfeeding can take a single oral dose of this medicine.

Driving and using machines

It is possible that 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 exactly as advised 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).
When used as part of 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.
This medicine should be taken orally, on an empty stomach (2-3 hours before a meal 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.

Overdose of Monural

If an overdose is taken by mistake, the patient should contact 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 contact 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 may indicate colon infection - antibiotic-associated colitis (frequency not known). The patient should not take anti-diarrheal medicines that reduce intestinal peristalsis (anti-peristaltic medicines).

Other side effects

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

• headache,
• dizziness,
• diarrhea,
• nausea,
• indigestion,
• abdominal pain,
• vaginal infection, inflammation, irritation, 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 any side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Monural

Store 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 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. Contents of the packaging 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 granules, 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 contents of the pack

Monural is a granule for oral solution.
The immediate packaging is a sachet made of paper/PE/Aluminum/PE.
Packaging: 1 sachet of 8 g, in a cardboard box.

Marketing authorization holder in Spain, the 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

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in Spain, the country of export: 694800.2

Parallel import authorization number: 190/24

Date of leaflet approval: 09.05.2024

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