Monural

Leaflet attached to the packaging: patient information

MONURAL

3 g, granules for oral solution

Fosfomycin trometamol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack and other information

1. What is Monural and what is it used for

Monural contains the active substance fosfomycin (as 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:

• if you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Monural, discuss it with your doctor, pharmacist, or nurse if you have:

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

Matters to be considered Monural may cause severe side effects, including allergic reactions and inflammation of the colon. While taking the medicine, pay attention to specific symptoms to minimize the risk of problems. See "Severe side effects" in section 4.

Children and adolescents

Do not give this medicine to children under 12 years of age, as the safety and efficacy in this age group have not been established.

Monural and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take, including those obtained 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, take this medicine on an empty stomach (2-3 hours before a meal or 2-3 hours after a meal).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will only give you this medicine during pregnancy if it is clearly necessary. Breastfeeding women may 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 your ability to drive or use machines.

What Monural contains

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

Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sulfites(contained in mandarin flavor and orange flavor) The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Monural

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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 Do not use this medicine in patients with severe renal impairment (creatinine clearance <10 ml min). use in children and adolescents do not this medicine under 12 years of age.< p>

Method of administration

Oral use. Take this medicine by mouth, 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

If you have taken more than the prescribed dose, contact your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Stop taking the medicine and contact your doctor immediately if you 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). Do not take anti-diarrheal medicines that reduce intestinal motility.

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 (vaginitis).

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

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

Not known (frequency cannot be estimated from the available data):

• allergic reactions.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Monural

There are no special precautions for storage. Keep this medicine out of the 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. 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 is fosfomycin (as 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 flavor (flavoring preparations, sucrose, gum arabic (E414), calcium phosphate (E341), butylated hydroxyanisole (E320), sodium, sulfites), orange flavor (flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, sodium octenyl succinate (E1450), sodium, sulfites), 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. The pack contains: 1 sachet in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

ZAMBON S.p.A., Via Lillo del Duca, 10, 20091 Bresso (MI), Italy

Manufacturer

ZAMBON S.p.A., Via della Chimica 9, 36100 Vicenza, Italy For further information on this medicine, please contact the local representative of the marketing authorization holder.

Representative of the marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, [email protected], fax: +48 (22) 755 96 24

Date of last revision of the leaflet: