Package Leaflet: Information for the Patient

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

Fosfomicina (trometamol)

Readallthe package leaflet carefully before you start taking this medicine because it contains important information for you.

• Readthis package leaflet, as you may need to read it again.
• Ask your doctor, pharmacist or nurse if you have any questions.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

1. What isFosfomicina cinfaand what it is used for.

2. What you need to know before takingFosfomicina cinfa.

3. How to takeFosfomicina cinfa.

4. Possible side effects.

5. Storage ofFosfomicina cinfa.

6. Contents of the pack and additional information

Fosfomicina cinfa contains the active ingredient fosfomicina (as fosfomicina trometamol). It is an antibiotic that works by eliminating the bacteria that can cause infections.

Fosfomicina cinfa is used to treat uncomplicated urinary tract infections in adult and adolescent women.

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

Do not takeFosfomicina cinfa

• 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 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 watch for

Fosfomicina cinfa may cause severe 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 “severe 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 cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, even if it is an over-the-counter medication.

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 cinfa 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 if you 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 cinfacontains saccharose and sodium

This medication contains saccharose. 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 1 mmol of sodium (23 mg) per 5 mL; this 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 (3 g of fosfomicina).

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

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service at 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

If you experience any of the following symptoms during treatment with Fosfomicina cinfa, 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

Ifyou experience any type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

No special storage conditions are required.

Before reconstitution: Do not usethis medicationafter the expiration date that appears on the packaging after “CAD.:”. The expiration date is the last day of the month indicated.

After reconstitution: Use immediately.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection pointat your usual pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Content of the container and additional information

Composition of Fosfomicina cinfa

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

- The other components (excipients) are: sacarosa, saccharin sodium, mandarin aroma, and orange aroma. See section 2. Fosfomicina cinfa contains sacarosa and sodium.

Appearance of the product and content of the container

White or almost white granule.

Single-dose surlyn/aluminum/low-density polyethylene/paper sachets 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) – España.

Responsible for manufacturing

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

O

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Last review date of this leaflet: June 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the 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