Monurol 3 g granules for oral solution EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Monurol 3 g granules for oral solution in sachets EFG
Fosfomycin (trometamol)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Monurol is and what it is used for
- What you need to know before taking Monurol
- How to take Monurol
- Possible side effects
- How to store Monurol
- Contents of the pack and other 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 may cause infections.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or colds.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Monurol is used to treat uncomplicated urinary bladder infections in adult and adolescent females.
Monurol is used as antibiotic prophylaxis for transrectal prostate biopsies in adult males.
2. What you need to know before you start taking Monurol
Do not take Monurol
- If you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Monurol if you are in any of the following situations:
- you suffer from persistent bladder infections,
- you have ever had diarrhoea after taking any other antibiotic.
Symptoms to watch for
Monurol may cause serious adverse effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking this medicine in order to reduce the risk of complications. See “serious adverse effects” in section 4.
Children and adolescents
This medicine should not be given to children under 12 years of age, as safety and efficacy have not been established in this age group.
Other medicines and Monurol
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription.
This is especially important if you are taking:
- metoclopramide or other medicines that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomycin in your body,
- anticoagulants, since fosfomycin and other antibiotics could alter your blood's ability to clot.
Taking Monurol with food
Food may delay the absorption of fosfomycin. Therefore, this medicine should be taken on an empty stomach (2–3 hours before or 2–3 hours after a meal).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will only prescribe this medicine when strictly necessary.
Breast-feeding mothers may take a single oral dose of this medicine.
Driving and using machines
You may experience adverse effects such as dizziness, which could affect your ability to drive or operate machinery.
Monurol contains sucrose, sodium and sulphites
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free”.
Rarely, it may cause severe hypersensitivity reactions and bronchospasm (sudden sensation of suffocation) because it contains sulphites.
3. How to take Monurol
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
For the treatment of uncomplicated bladder infection in women and adolescent females, 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 impairment
This medicine must not be used in patients with severe renal impairment (creatinine clearance <10 ml/min).
Use in children and adolescents
This medicine must not be used in children under 12 years of age.
Method of administration
For oral use.
This medicine should be taken orally on an empty stomach (approximately 2–3 hours before or 2–3 hours after a meal), preferably before going to bed and after having urinated.
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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Serious adverse effects
If you experience any of the following symptoms while being treated with Monurol, you must stop taking the medicine and contact your doctor immediately:
- anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching or hives, and/or shortness of breath, wheezing (whistling sounds when breathing), 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 an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrheal medicines that inhibit intestinal movements (antiperistaltics).
Other adverse effects
Common (may affect up to 1 in 10 people):
- headache
- dizziness
- diarrhea
- nausea
- indigestion
- abdominal pain
- genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis).
Uncommon (may affect up to 1 in 100 people):
- vomiting
- rash
- urticaria
- itching
Frequency not known (cannot be estimated from available data):
- allergic reactions.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Monurol
Keep this medicine out of the sight and reach of children.
No special storage conditions are required. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other 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, sucrose, orange flavour (contains maize starch and sulphites (E220 and E222)), and mandarin flavour (contains sucrose and sulphites (E220 and E222)).
Appearance of the medicinal product and contents of the pack
White or almost white oral granules for solution with a characteristic orange odour.
It is available in cardboard boxes containing 1 or 2 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zambon S.A.U.
Maresme 5. Polígono Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda – Barcelona
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
Date of the most recent review of this leaflet: July 2020
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/