FOSFOMICINA LABIANA 3 G ORAL SOLUTION GRANULES EFG

Introduction

Leaflet:information for the patient

Fosfomicina Labiana 3 g granulate for oral solution in EFG sachets

fosfomicina

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this 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 leaflet. See section 4.

Contents of the leaflet

1. What is Fosfomicina Labiana and what is it used for
2. What you need to know before taking Fosfomicina Labiana
3. How to take Fosfomicina Labiana
4. Possible side effects
5. Storage of Fosfomicina Labiana
6. Package contents and additional information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

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

2. What you need to know before taking Fosfomicina Labiana

Do not take Fosfomicina Labiana:

• 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 Labiana 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 Labiana 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 to reduce the risk of problems. 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 Labiana

Inform 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 fosfomicina in your body,
• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomicina Labiana 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, which could affect your ability to drive or use machines.

Fosfomicina Labiana contains saccharose, glucose, and sodium

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 sachet; it is essentially "sodium-free".

3. How to take Fosfomicina Labiana

Follow the administration instructions for this medication exactly as indicated 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 Fosfomicina Labiana (3 g of fosfomicina).

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 a sachet should be dissolved in a glass of water and taken immediately.

The reconstituted solution is a nearly white, slightly turbid solution with a fruit flavor (orange-tangerine).

If you take more Fosfomicina Labianathan 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 Toxicology Information Service at 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 during treatment with Fosfomicina Labiana you experience any of the following symptoms, 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 (whistling sound 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 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 possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomicina Labiana

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging after "EXP:". The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and any unused medications at the SIGRE collection point in your usual pharmacy. 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 Labiana

• The active ingredient is fosfomicina (as fosfomicina trometamol). Each sachet contains fosfomicina trometamol equivalent to 3 g of fosfomicina.
• The other ingredients are: saccharose, sodium saccharin (E954), tangerine flavor (contains glucose from corn maltodextrin and sodium), and orange flavor (contains glucose from corn maltodextrin and sodium). See section 2. Fosfomicina Labiana contains saccharose, glucose, and sodium.

Appearance of the product and package contents

Granulate for oral solution in sachets. White or almost white granulate without lumps or particles in single-dose sachets.

Each box contains 1 or 2 sachets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat (Barcelona)

This medication is authorized in the member states of the European Economic Area under the following names:

Germany: Afosfol 3 g Granulat im Beutel zur Herstellung einer Lösung zum Einnehmen

Denmark: Cystifos

France: Fosfomycine Zydus 3 g, granulés pour solution buvable en sachet

Netherlands: Fosfomycine 3 g Focus, granulaat voor drank in sachet

Hungary: Afosfol 3 g granulátum belsoleges oldhatoz

Poland: Uromaste

Portugal: Fosfomicina Pharmakern

Sweden: Cystifos

Spain: Fosfomicina Labiana 3 g granulado para solución oral en sobres EFG

Date of the last revision of this leaflet:December 2020

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