


Ask a doctor about a prescription for FOSFOMICINA VIR 3 G ORAL SOLUTION GRANULES EFG
Package Leaflet: Information for the Patient
Fosfomicina Vir 3 g Granules for Oral Solution in Sachets EFG
Fosfomicina (Tromethamine)
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Contents of the Package Leaflet
Fosfomicina Vir contains the active ingredient fosfomicina (as fosfomicina tromethamine). It is an antibiotic that works by eliminating the bacteria that can cause infections.

Fosfomicina Vir is used to treat uncomplicated urinary tract infections in adult and adolescent women.
Fosfomicina Vir is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.
Do not take Fosfomicina Vir
Warnings and Precautions
Consult your doctor, pharmacist, or nurse before starting to use Fosfomicina Vir if you are in any of the following situations:
Symptoms to which you should pay attention
Fosfomicina Vir 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 medication, in order 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 Fosfomicina Vir
Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.
This is especially important if you are taking:
Taking Fosfomicina Vir with Food
Food may delay the absorption of fosfomicina. 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, that could affect your ability to drive or use machines.
Fosfomicina Vir contains Saccharose, Glucose, and Sodium
This medication contains saccharose and glucose. 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 (1mmol) per sachet; it is essentially "sodium-free.
Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.
In the case of treatment for an uncomplicated urinary tract infection in women and adolescent females, the recommended dose is 1 sachet of Fosfomicina Vir (3 g of fosfomicina).
When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Vir (3 g of fosfomicina) 3 hours before the procedure and 1 sachet of Fosfomicina Vir (3 g of fosfomicina) 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 Fosfomicina Vir than you should
If you accidentally take a quantity greater 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 other questions about the use of this medication, ask your doctor or pharmacist.
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Like all medications, this medication can cause side effects, although not everyone will experience them.
Serious Side Effects
If during treatment with Fosfomicina Vir you experience any of the following symptoms, you should stop taking the medication and contact your doctor immediately:
Other Side Effects
Frequent (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Frequency not known (cannot be estimated from available data):
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 package leaflet.
You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.
By reporting side effects, you can help provide more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
This medication does not require special storage conditions. Store in the original packaging.
Do not use this medication after the expiration date shown 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 medications at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.
Composition of Fosfomicina Vir:
The active ingredient is fosfomicina (as fosfomicina tromethamine). Each sachet contains 3 grams of fosfomicina (as fosfomicina tromethamine).
The other components (excipients) are sodium saccharin, saccharose, orange flavor [contains glucose (in maltodextrin from corn) and magnesium citrate.
Appearance of the Product and Package Contents
Granules for oral solution in sachets, white or pinkish-white in color. It is presented in cardboard boxes containing 1 or 2 sachets.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Industria Química y Farmacéutica Vir, S.A.
C/Laguna 66-68-70. Polígono Industrial Urtinsa II. 28923.
Alcorcón. Madrid.
Spain
Manufacturer
La. Fa. Re. S.r.l.
Via Sacerdote Benedetto Cozzolino, 77. 80056 – Ercolano (NA)
Italy
or
Industria Química y Farmacéutica Vir, S.A.
C/Laguna 66-68-70. Polígono Industrial Urtinsa II. 28923.
Alcorcón. Madrid.
Spain
Date of the Last Revision of this Package Leaflet: June 2025
Detailed information about this medication 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 VIR 3 G ORAL SOLUTION GRANULES EFG 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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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FOSFOMICINA VIR 3 G ORAL SOLUTION GRANULES EFG – subject to medical assessment and local rules.