MONUROL 3 G ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the Patient

Monurol 3 g Granules for Oral Solution in Sachets EFG

Fosfomycin (Trometamol)

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Monurol is and what it is used for
2. What you need to know before taking Monurol
3. How to take Monurol
4. Possible side effects
5. Storage of Monurol
6. Package Contents and Additional Information

1. What Monurol is and what it is used for

Monurol contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Monurol is used to treat uncomplicated urinary tract infections in adult and adolescent women.

Monurol is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

2. What you need to know before taking Monurol

Do not take Monurol

• If you are allergic to fosfomycin or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Monurol if you are in any of the following situations:

• You have persistent urinary tract infections,
• You have ever had diarrhea after taking any other antibiotic.

Symptoms to pay attention to

Monurol may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking this medication to reduce the risk of problems. See "Serious side effects" in section 4.

Children and Adolescents

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

Other Medications and Monurol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

• Metoclopramideor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomycin in your body,
• Anticoagulants, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.

Taking Monurol with Food

Food may delay the absorption of fosfomycin. Therefore, this medication should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, your doctor will only prescribe this medication when it is strictly necessary.

Breastfeeding mothers may take a single oral dose of this medication.

Driving and Using Machines

You may experience side effects such as dizziness, which could affect your ability to drive or use machines.

Monurol contains Saccharose, Sodium, and Sulphites

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially "sodium-free".

Rarely, it may cause severe hypersensitivity reactions and bronchospasm (sudden feeling of suffocation) because it contains sulphites.

3. How to take Monurol

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

In the case of treating an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of Monurol (3 g of fosfomycin).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Monurol (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of Monurol (3 g of fosfomycin) 24 hours after the procedure.

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml min).< p>

Use in children and adolescents

This medication should not be used in children under 12 years of age.

Method of Administration

For oral use.

This medication should be taken orally, on an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after urinating.

The contents of one sachet should be dissolved in a glass of water and taken immediately.

If you take more Monurol than you should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects

If you experience any of the following symptoms during treatment with Monurol, stop taking the medication and contact your doctor immediately:

• Anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a rash, itching, or hives, and/or shortness of breath, wheezing, or difficulty breathing,
• Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• Moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate that you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medications that stop intestinal movement (antiperistaltics).

Other side effects

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

• Headache
• Dizziness
• Diarrhea
• Nausea
• Indigestion
• Abdominal pain
• Infection of the female genital organs with symptoms such as inflammation, irritation, itching (vulvovaginitis).

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

• Vomiting
• Rash
• Hives
• Itching

Frequency not known (cannot be estimated from available data):

• Allergic reactions.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Monurol

Keep this medication out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Monurol

The active substance is fosfomycin (as fosfomycin trometamol). Each sachet contains 3 grams of fosfomycin (as fosfomycin trometamol).

The other components (excipients) are: saccharin, saccharose, orange flavor (contains cornstarch and sulphites (E220 and E222)), and mandarin flavor (contains saccharose and sulphites (E220 and E222)).

Appearance of the Product and Package Contents

Granules for oral solution in sachets, white or almost white in color with a characteristic orange odor

It is presented in cardboard boxes containing 1 or 2 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zambon S.A.U.

Maresme 5, Can Bernades-Subirà Industrial Estate

08130 Sta. Perpètua de Mogoda, Barcelona

Manufacturer

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza, Italy

Zambon S.A.U.

Maresme, 5, Can Bernades-Subirà Industrial Estate

08130 Sta. Perpètua de Mogoda, Barcelona

Date of the last revision of this leaflet: July 2020

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/