FOSFOMYCIN VIR 3 G GRANULES FOR ORAL SOLUTION IN SACHETS EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Fosfomicina Vir 3 g granules for oral solution in sachets EFG

Fosfomycin (trometamol)

Read the entire leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only; do not pass it on 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.

Leaflet contents

1. What Fosfomicina Vir is and what it is used for
2. What you need to know before taking Fosfomicina Vir
3. How to take Fosfomicina Vir
4. Possible side effects
5. How to store Fosfomicina Vir
6. Contents of the pack and other information

1. What Fosfomicina Vir is and what it is used for

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

Fosfomicina Vir is used to treat uncomplicated urinary bladder infections in adult and adolescent women.

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

2. What you need to know before taking Fosfomicina Vir

Do not take Fosfomicina Vir

• if you are allergic to fosfomycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• you suffer from persistent bladder infections,
• you have ever had diarrhea after taking any other antibiotic.

Symptoms to watch for

Fosfomicina Vir 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 Fosfomicina Vir

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even if they are medicines 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 Fosfomicina Vir 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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.

Breastfeeding 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.

Fosfomicina Vir contains sucrose, glucose, and sodium

This medicine contains sucrose and glucose. If your doctor has advised 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.”

3. How to take Fosfomicina Vir

Follow exactly the instructions for use of this medicine as 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 Fosfomicina Vir (3 g of fosfomycin).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Vir (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of Fosfomicina Vir (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 Fosfomicina Vir 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 will experience them.

Serious adverse effects

If during treatment with Fosfomicina Vir you experience any of the following symptoms, 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 through 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 Fosfomycin Vir

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions. 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 point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosfomicina Vir:

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

The other components (excipients) are sodium saccharin, sucrose, orange flavour [contains glucose (in maltodextrin derived from maize)] and magnesium citrate.

Nature of the product and pack contents

Granules for oral solution in sachets, white or pinkish-white in colour. Packaged in cardboard boxes containing 1 or 2 sachets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 most recent revision of this leaflet: June 2025

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/