Package Insert: Information for the Patient

Fosfomicina Vir 3 g Powder for Oral Solution in EFG Blister Packs

Fosfomicina (trometamol)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fosfomicina Vir contains the active ingredient fosfomicina (as fosfomicina trometamol). 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

• 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 watch for

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 you are being treated with this medication, in order to reduce the risk of complications. See “serious side effects” in section 4.

Children and adolescents

This medication should not be administered 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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

• metoclopramidaor 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, or think you may be 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.

Mothers who are breastfeeding may take a single oral dose of this medication.

Driving and operating machinery

You may experience side effects, such as dizziness, that may affect your ability to drive or operate machinery.

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); that is, it is essentially “sodium-free.”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For the treatment of uncomplicated urinary tract infections in women and female adolescents, the recommended dose is 1 packet of Fosfomicina Vir (3 g of fosfomicina).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 packet of Fosfomicina Vir (3 g of fosfomicina) 3 hours before the procedure and 1 packet 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

Use in children and adolescents

This medication should not be used in patients under 12 years of age.

Administration form

For oral use.

This medication should be taken orally, with an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before going to bed and after urinating.

The contents of a packet should be dissolved in a glass of water and consumed immediately.

If you take more Fosfomicina Vir than 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 Toxicological 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 may produce adverse effects, although not all people may experience them.

Severe Adverse Effects

If during treatment with Fosfomicina Vir you experience any of the following symptoms, stop taking the medication and contact your doctor immediately:

− Anaphylactic shock, a potentially fatal allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing, or difficulty breathing,

− Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (unknown frequency),

− Moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other Adverse Effects

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

• Headache
• Dizziness
• Diarrhea
• Nausea
• Indigestion
• Abdominal pain
• Female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

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

• Vomiting
• Hives
• Urticaria
• Itching

Unknown frequency (cannot be estimated from available data):

• Allergic reactions.

Reporting 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 prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fosfomicina Vir:

The active ingredient is fosfomicin (as fosfomicin trometamol). Each sachet contains 3 grams of fosfomicin (as fosfomicin trometamol).

The other components (excipients) are sodium saccharin, sucrose, orange flavor[contains glucose (in maltodextrin from corn)and magnesium citrate.

Appearance of the product and content of the packaging

Oral solution granule in sachet, white or pinkish white in color. It is presented in cardboard boxes containing 1 or 2 sachets.

Holder of the marketing authorization and manufacturer responsible:

Holder of the marketing authorization

Industria Química y Farmacéutica Vir, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II. 28923.

Alcorcón. Madrid.

Spain

Manufacturer responsible

La. Fa. Re. S.r.l.

Via Sacerdote Benedetto Cozzolino, 77. 80056 – Ercolano (NA)

Italy

Last review date of this leaflet: March 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/