FOSFOMICINA PENSA 3 g ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Fosfomycin Pensa3 gGranules for Oral Solution EFG

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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Fosfomycin Pensa contains the active substance fosfomycin, (as fosfomycin trometamol).

This is an antibiotic that works by eliminating bacteria that can cause infections.

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

2. What you need to know before taking Fosfomycin Pensa

Do not takeFosfomycinPensa

If you are allergic to fosfomycin 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 take Fosfomycin Pensa 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 pay attention to

Fosfomycin Pensa may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking this medication 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 Fosfomycin Pensa

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

This is especially important if you are taking:

• metoclopramide or other medications 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 Pensa with Food

Food may delay the absorption of fosfomycin. 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, which may affect your ability to drive or use machines.

Fosfomycin Pensa contains Saccharose, Glucose, and Yellow Orange S (E-110)

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 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 Yellow Orange S (E-110). This medication may cause allergic reactions because it contains Yellow Orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to Take Fosfomycin Pensa

Follow your doctor's instructions for taking this medication exactly. 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 Pensa (3 g of fosfomycin).

Use in Patients with Renal Impairment

This medication should not be used in patients with severe renal impairment (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 Fosfomycin Pensa than you should

If you accidentally take more 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 further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious Side Effects

If you experience any of the following symptoms while taking Fosfomycin Pensa, 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, 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 a large intestine infection (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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomycin Pensa

No special storage conditions are required.

The medication should be administered immediately after dissolution.

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

Do not use this medication after the expiration date stated on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the packaging is damaged or open.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fosfomycin Pensa

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

The other components are orange flavor [contains glucose (in maltodextrin from corn) and Yellow Orange S, E-110], sodium saccharin, saccharose, and calcium hydroxide.

Appearance of the Product and Package Contents

White or off-white granules. Packaging containing 1 or 2 sachets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Special Product’s Line S.p.A.

Via Fratta Rotonda Vado Largo 1–

03012 Anagni (FR)

Italy

This package leaflet was approved in February 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/