


Ask a doctor about a prescription for FOSFOMICINA QUALIGEN 3 g ORAL SOLUTION GRANULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSFOMICINA QUALIGEN3 ggranulate for oral solution EFG
Fosfomicina trometamol
Read all of this leaflet carefully before you start taking this medicine.
Contents of the package leaflet
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is important that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor. 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. Do not dispose of medicines via wastewater or household waste. |
Fosfomicina Qualigen is used to treat uncomplicated urinary tract infections in adult and adolescent women.
Fosfomicina Qualigen is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Fosfomicina Qualigen if you are in any of the following situations:
Symptoms to which you should pay attention:
Fosfomicina Qualigen may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while being treated with this medicine in order to reduce the risk of problems. See "serious 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.
Other medicines and Fosfomicina Qualigen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
This is especially important if you are taking:
Taking Fosfomicina Qualigen with food:
Food may delay the absorption of fosfomicina. Therefore, this medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will only prescribe this medicine when it is strictly necessary.
Breastfeeding mothers may take a single oral dose of this medicine.
Driving and using machines:
You may experience side effects such as dizziness that could affect your ability to drive or use machines.
Fosfomicina Qualigen contains saccharose, glucose, orange yellow S, and sodium:
This medicine contains saccharose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains glucose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine may cause allergic reactions because it contains "Orange Yellow S (E-110)". It can cause asthma, especially in patients allergic to acetylsalicylic acid.
This medicine contains less than 23 mg of sodium (1mmol) per dose; it is essentially "sodium-free".
Follow exactly the administration instructions indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
In the case of treatment of an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina).
When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina) 3 hours before the procedure and 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina) 24 hours after the procedure.
Use in patients with renal insufficiency
This medicine should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml min).< p>
Use in children and adolescents
This medicine should 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 bedtime and after urinating.
The contents of one sachet should be dissolved in a glass of water and taken immediately.
If you take moreFosfomicina Qualigenthan 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If during treatment with Fosfomicina Qualigen you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:
Other side effects
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Frequency not known (cannot be estimated from the available data):
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.
You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Do not use Fosfomicina Qualigen after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Take the packaging and any unused medicines to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
Composition ofFosfomicina Qualigen
Appearance of the product and package contents
Fosfomicina Qualigen 3 g is presented in the form of sachets containing a granulate to be dissolved in water.
There are packs of 1 and 2 sachets of granulate.
Marketing authorization holder and manufacturer
Marketing authorization holder
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 – Sant Joan Despí
(Barcelona) Spain
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 – Anagni (FR)
Italy
Date of the last revision of this leaflet: May 2021
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
The average price of FOSFOMICINA QUALIGEN 3 g ORAL SOLUTION GRANULES in October, 2025 is around 2.5 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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