Package Insert: Information for the Patient

Monurol 3 g Powder for Oral Solution in EFG Blister Packs

Fosfomycin (trometamol)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

1. What is Monurol and what it is used for

2. What you need to know before starting to take Monurol

3. How to take Monurol

4. Possible side effects

5. Storage of Monurol

6. Contents of the pack and additional information

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

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.

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:

-Have persistent urinary tract infections,

-Have ever had diarrhea after taking any other antibiotic.

Symptoms to pay attention to

Monurol may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while you are being treated with this medication, in order to reduce the risk of complications. See “severe side effects” in section 4.

Children and adolescents

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

Other medications and Monurol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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.

Monurol with food

Foods 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, or think you may be 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.

Mothers who are breastfeeding may take a single oral dose of this medication.

Driving and operating machinery

You may experience side effects, such as dizziness, that may affect your ability to drive or operate machinery.

Monurol contains saccharose, sodium, and sulfites

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); that is, it is essentially “sodium-free”.

Rarely, it may cause severe hypersensitivity reactions and bronchospasm (sudden sensation of choking) due to the presence of sulfites.

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

For the treatment of uncomplicated urinary tract infections in women and female adolescents, the recommended dose is 1 packet of Monurol (3 g of fosfomycin).

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

Use in children and adolescents

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

Administration form

For oral use.

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

The contents of a packet should be dissolved in a glass of water and consumed immediately.

If you take more Monurol than you should

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects

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

• anaphylactic shock, a potentially life-threatening allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing, or difficulty breathing,
• swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (unknown frequency),
• moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other Adverse Effects

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

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

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

• vomiting
• hives
• urticaria
• itching

Unknown frequency (cannot be estimated from available data):

• allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and unused medications.This will help protect the environment.

Composition of Monurol

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

The other components (excipients) are: saccharin, sucrose, orange flavor (contains cornstarch and sulfites (E220 and E 222)) and lemon flavor (contains sucrose and sulfites (E 220 and E 222)).

Appearance of the product and contents of the packaging

Oral solution granules in a sachet, white or almost white in color with a characteristic orange odor.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zambon S.A.U.

Maresme 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Responsible for manufacturing

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

Last review date of this leaflet July 2020

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/