FOSFOMICINA CINFA 3 G ORAL SOLUTION GRANULES EFG

Introduction

Package Leaflet: Information for the Patient

Fosfomycin Cinfa 3 g Granules for Oral Solution in Sachets EFG

Fosfomycin (Trometamol)

Readtheentirepackage leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Fosfomycin Cinfa is and what it is used for.
2. What you need to know before taking Fosfomycin Cinfa.
3. How to take Fosfomycin Cinfa.
4. Possible side effects.
5. Storage of Fosfomycin Cinfa.
6. Package Contents and Additional Information

1. What Fosfomycin Cinfa is and what it is used for

Fosfomycin Cinfa contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by eliminating the bacteria that can cause infections.

Fosfomycin Cinfa is used to treat uncomplicated urinary tract infections in adult and adolescent women.

Fosfomycin Cinfa is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

2. What you need to know before taking Fosfomycin Cinfa

Do not takeFosfomycin Cinfa

• if you are allergic to fosfomycin or 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 Fosfomycin Cinfa 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

Fosfomycin Cinfa can 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 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 Fosfomycin Cinfa

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:

• metoclopramideor 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, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomycin Cinfa with Food

Food can 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 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 can 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.

Fosfomycin Cinfacontains Saccharin and Sodium

This medicine contains saccharin. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to Take Fosfomycin Cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

In the case of treating an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of fosfomycin (3 g of fosfomycin).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomycin Cinfa (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of Fosfomycin Cinfa (3 g of fosfomycin) 24 hours after the procedure.

Use in Patients with Renal Impairment

This medicine should not be used in patients with severe renal impairment (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 More Fosfomycin Cinfa Than You Should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious Side Effects

If during treatment with Fosfomycin Cinfa you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of rash, itching, or hives, and/or shortness of breath, wheezing, 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 medicines that stop intestinal movement (antiperistaltics).

Other Side Effects

Common (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 the available data):

• allergic reactions.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomycin Cinfa

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

No special storage conditions are required.

Before reconstitution: 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.

After reconstitution: Use immediately.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to your usual pharmacy for disposal. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Package Contents and Additional Information

Composition of Fosfomycin Cinfa

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

-The other ingredients (excipients) are: saccharin, sodium saccharin, mandarin flavor, and orange flavor. See section 2. Fosfomycin Cinfa contains saccharin and sodium.

Appearance of the Product and Package Contents

White or almost white granules.

Sachets made of surlyn/aluminum/low-density polyethylene/paper, packaged in cardboard boxes containing 1 or 2 sachets.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain.

Manufacturer

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Package Leaflet:June 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82353/P_82353.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82353/P_82353.html