FOSFOMICINA VIR 3 G ORAL SOLUTION GRANULES EFG

Introduction

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.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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. Storage of Fosfomicina Vir
6. Package Contents and Additional Information

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

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.

2. What you need to know before taking Fosfomicina Vir

Do not take Fosfomicina Vir

• if you are allergic to fosfomicina 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 Fosfomicina Vir if you are in any of the following situations:

• you have persistent urinary tract infections,

• you have ever had diarrhea after taking any other antibiotic.

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:

• metoclopramideor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomicina in your body,
• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

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.

3. How to take Fosfomicina Vir

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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4. Possible Side Effects

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:

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a rash, itching or hives, and/or shortness of breath, wheezing (emission of 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 that you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medications against diarrhea that stop intestinal movement (antiperistaltics).

Other Side Effects

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

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

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

• vomiting
• rash
• hives
• itching

Frequency not known (cannot be estimated from available data):

• allergic reactions.

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.

5. Storage of Fosfomicina Vir

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.

6. Package Contents and Additional Information

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/